Enforcement Report - Week of August 15, 2012
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Class I Food/Cosmetics Event
| Event ID | 55924 |
|---|---|
| Status | Ongoing |
| Product Type | Food/Cosmetics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 17-Jul-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Gills Onions, LLC |
|---|---|
| City | Oxnard |
| State | CA |
| Country | US |
| Distribution Pattern | Nationwide in the US and to Canada |
Associated Products
| Product Description | Diced Yellow Onions, 7oz, UPC 643550000405, Gills Onions Label; Diced Yellow onions, 5lb bag, UPC 898634001018, True Leaf label; Diced Yellow onions, 8oz, UPC 643550000498, clear plastic containers sold in Wegmans stores; Diced Yellow Onions, Oignons jaunes frais, en des, 198 grams, UPC 643550000443, Gills Onions Label. Diced Yellow Onions, 5lbs, "Gills Onions" label, no UPC. |
|---|---|
| Code Info | USA Lot code: 22YAA1A2184 for 7oz, and Canada Lot code: 22YAA1A2184 for 198g. Recall expanded on July 25, 2012 with the following codes: USA Lot code: all for 7oz, 8oz, and 5lbs on or before August 3, 2012. Canada Lot code: all for 198 g on or before August 3, 2012. |
| Classification | Class I |
| Reason for Recall | Gills Onions is recalling diced and slivered red and yellow onions and diced celery and onion mix because they may be contaminated by Listeria monocytogenes. |
| Product Quantity | 787,457 lbs total |
| Recall Number | F-1847-2012 |
| Product Description | Diced Red Onions, 7oz, UPC 643550000412; Diced Red Onions, Oignons rouge frais, en des, 198 grams, UPC 643550000450. Diced Red Onions, 5lbs., "Gills Onions" Label, no UPC; Diced Red Onions, 5lbs, "Crossvalley" label, no UPC. Diced Red Onions, 5lbs, "Markon" label, no UPC. Diced Red Oninos, 5lbs, "Cisco" label, no UPC. |
|---|---|
| Code Info | USA Lot code: 22RAA1A2184 for 7oz., and Canada Lot code: 22RAA1A2184 for 198g. Recall expanded to include following lots: USA lot code: All lots on or before August 3, 2012. Canada Lot code: all lot codes on or before August 3, 2012. |
| Classification | Class I |
| Reason for Recall | Gills Onions is recalling diced and slivered red and yellow onions and diced celery and onion mix because they may be contaminated by Listeria monocytogenes. |
| Product Quantity | 787,457 lbs total |
| Recall Number | F-1848-2012 |
| Product Description | Slivered Yellow Sweet Onions, 5 oz, UPC 643550000092. Slivered Yellow Onions, 5lbs, "Gills Onions" label, no UPC. Slivered Yellow Onions, 5lbs, "Crossvalley" label, no UPC; Slivered Yellow Onions, 5lbs, "Sysco" label, no UPC. Slivered Yellow Onions, 5lbs, "Markon" label, no UPC. Slivered Yellow Onions, 5lbs, "Nourish & Delight" label, no UPC. |
|---|---|
| Code Info | USA Lot code: 22YAA1A2184, Recall expanded to include following lots: USA lot code: All lots on or before August 3, 2012. |
| Classification | Class I |
| Reason for Recall | Gills Onions is recalling diced and slivered red and yellow onions and diced celery and onion mix because they may be contaminated by Listeria monocytogenes. |
| Product Quantity | 787,457 lbs total |
| Recall Number | F-1849-2012 |
| Product Description | Slivered Red Onions, 5 oz, UPC 643550000009. Slivered Red Onions, 5lbs, "Gills Onions" label, no UPC; Slivered Red Onions, 5lbs, "Markon" label, no UPC. Slivered Red Onions, 5lbs, "Sysco" label, no UPC; Slivered Red Onions, 5lbs, "Crossvalley", no UPC. |
|---|---|
| Code Info | USA Lot code: 22RAA1A2184, |
| Classification | Class I |
| Reason for Recall | Gills Onions is recalling diced and slivered red and yellow onions and diced celery and onion mix because they may be contaminated by Listeria monocytogenes. |
| Product Quantity | 787,457 lbs total |
| Recall Number | F-1850-2012 |
| Product Description | Diced Celery and Onion, 7 oz, UPC 643550000429; Diced Celery and Onion, 19 oz, UPC 643550000351; Diced Celery and Onions, 8oz, UPC 643550000504, clear plastic containers sold in Wegmans; Diced Celery & Onions, Celeri et oignons frais, en des, 198g, UPC 643550000467. Diced Celery and Onions, 5lbs, "Crossvalley" label, no UPC. |
|---|---|
| Code Info | USA Lot code: 22YAA1A2184 for 7oz and 19oz., Canada Lot code: 22YAA1A2184 for 198 g. Expanded on July 25, 2012 to include: USA Lot code: All lots for 7oz, 8oz, and 19 oz on or before August 3, 2012. Canada Lot Code: All lots for 198 g on or before August 3, 2012. |
| Classification | Class I |
| Reason for Recall | Gills Onions is recalling diced and slivered red and yellow onions and diced celery and onion mix because they may be contaminated by Listeria monocytogenes. |
| Product Quantity | 787,457 lbs total |
| Recall Number | F-1851-2012 |
| Product Description | Whole peeled Yellow onions, 30 lbs, UPC 02060042553, "Western Onion" label; Whole peeled yellow onions, 1400lbs and 1200 bins, "Gills Onions" label, no UPC Whole peeled Yellow onions, 20lbs, "Gills Onions" label; 25lbs, "Crossvalley" label; 30lbs, "Sysco" label; 30lbs, "Crossvalley" label; 30lbs, "Markon" label. |
|---|---|
| Code Info | USA Lot code: all lots on or before August 3, 2012. |
| Classification | Class I |
| Reason for Recall | Gills Onions is recalling diced and slivered red and yellow onions and diced celery and onion mix because they may be contaminated by Listeria monocytogenes. |
| Product Quantity | 787,457 lbs total |
| Recall Number | F-1852-2012 |
| Product Description | Diced Organic Yellow Onions, 5lbs, "Gills Onions" label, no UPC. |
|---|---|
| Code Info | USA Lot code: all lots on or before August 3, 2012. |
| Classification | Class I |
| Reason for Recall | Gills Onions is recalling diced and slivered red and yellow onions and diced celery and onion mix because they may be contaminated by Listeria monocytogenes. |
| Product Quantity | 787,457 lbs total |
| Recall Number | F-1853-2012 |
| Product Description | 4 Piece Wedge Cutted Onions, 28lbs, "Gills Onions" label, no UPC. |
|---|---|
| Code Info | USA Lot code: all lots on or before August 3, 2012. |
| Classification | Class I |
| Reason for Recall | Gills Onions is recalling diced and slivered red and yellow onions and diced celery and onion mix because they may be contaminated by Listeria monocytogenes. |
| Product Quantity | 787,457 lbs total |
| Recall Number | F-1854-2012 |
| Product Description | Diced Red Tomatoes, 5lbs tray, "Nourish & Delight", no UPC. |
|---|---|
| Code Info | USA Lot code: all lots on or before August 3, 2012. |
| Classification | Class I |
| Reason for Recall | Gills Onions is recalling diced and slivered red and yellow onions and diced celery and onion mix because they may be contaminated by Listeria monocytogenes. |
| Product Quantity | 787,457 lbs total |
| Recall Number | F-1855-2012 |
| Product Description | Yellow Onion Puree, 38lbs, "Gills Onions" label, no UPC. |
|---|---|
| Code Info | USA Lot code: all lots on or before August 3, 2012. |
| Classification | Class I |
| Reason for Recall | Gills Onions is recalling diced and slivered red and yellow onions and diced celery and onion mix because they may be contaminated by Listeria monocytogenes. |
| Product Quantity | 787,457 lbs total |
| Recall Number | F-1856-2012 |
| Product Description | Red Onion Puree, 38lbs, "Gills Onions" label, no UPC. |
|---|---|
| Code Info | USA Lot code: all lots on or before August 3, 2012. |
| Classification | Class I |
| Reason for Recall | Gills Onions is recalling diced and slivered red and yellow onions and diced celery and onion mix because they may be contaminated by Listeria monocytogenes. |
| Product Quantity | 787,457 lbs total |
| Recall Number | F-1857-2012 |
Class I Veterinary Event
| Event ID | 61634 |
|---|---|
| Status | Ongoing |
| Product Type | Veterinary |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 06-Apr-12 |
| Initial Firm Notification of Consignee or Public |
| Recalling Firm | Central Garden & Pet Company |
|---|---|
| City | Phoenix |
| State | AZ |
| Country | US |
| Distribution Pattern | Nationwide including Puerto Rico. OUS to include: Australia, Canada, China, Dominican Republic, Guam, Hong Kong, Japan, Korea, Mexico, New Zealand, South Africa, and Thailand. |
Associated Products
| Product Description | Kaytee exact Hand Feeding Formula, formulated for All Baby Birds. with DHA Omega-3 For Growth and Development. Packaged into the following sizes with Product Code/SKU/Material # and UPC codes: 1. Net Wt. 7.5 oz (213g) 100032326, UPC 71859-47510; 2. Net Wt. 18 oz (510g), 100032328, UPC 71859-47511; 3. Net Wt 5 lb (2.27kg) 100032330 and 100034332, UPC 71859-47512; 4. Net Wt 22 lb (9.98kg) 100032336, UPC 71859-47518. Manufactured by Kaytee Products, Inc., Chilton, WI 53014 USA. |
|---|---|
| Code Info | Best Before 9 Mar 2013, 14 Mar 2013, 21 Mar 2013, 30 Mar 2013, 30 March 2013, 13 Apr 2012, 19 Apr 2013, 20 Apr 2013, and 16 May 2013. |
| Classification | Class I |
| Reason for Recall | Kaytee exact Hand Feeding Formula Baby Bird and Kaytee exact hand Feeding Formula Baby Macaw food may contain an elevated amount of Vitamin D. |
| Product Quantity | 25,164 containers (total for both products) |
| Recall Number | V-195-2012 |
| Product Description | Kaytee exact Hand Feeding Formula, Specifically Formulated for Baby Macaws. with DHA Omega-3 For Growth and Development. Net Wt 5 lb (2.27kg), Product Code/SKU/Material # 100032337, UPC 71859-47515. Manufactured by Kaytee Products, Inc., Chilton, WI 53014 USA. |
|---|---|
| Code Info | Best Before 1 Mar 2013, 14 Mar 2013, and 19 Apr 2013. |
| Classification | Class I |
| Reason for Recall | Kaytee exact Hand Feeding Formula Baby Bird and Kaytee exact hand Feeding Formula Baby Macaw food may contain an elevated amount of Vitamin D. |
| Product Quantity | 25,164 containers (total for both products) |
| Recall Number | V-196-2012 |
Class I Veterinary Event
| Event ID | 61833 |
|---|---|
| Status | Terminated |
| Product Type | Veterinary |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 10-May-12 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Recalling Firm | Land O Lakes Purina LLC |
|---|---|
| City | Shoreview |
| State | MN |
| Country | US |
| Distribution Pattern | The feed was distributed in IA. |
Associated Products
| Product Description | Bulk Honor Show Chow Showlamb Creep Pellet, DX Medicated, containing 0.0029% (13.6 MG/LB) Decoquinate. The firm name on the label is Purina Mills, LLC, St. Louis, MO. |
|---|---|
| Code Info | date of manufacture: 4/19/2012 |
| Classification | Class I |
| Reason for Recall | Lamb feed was contaminated with cattle feed containing monensin sodium. |
| Product Quantity | 2 tons |
| Recall Number | V-194-2012 |
Class I Drugs Event
| Event ID | 61847 |
|---|---|
| Status | Ongoing |
| Product Type | Drugs |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 12-May-12 |
| Initial Firm Notification of Consignee or Public | Press Release |
| Recalling Firm | Hospira Inc. |
|---|---|
| City | Lake Forest |
| State | IL |
| Country | US |
| Distribution Pattern | Nationwide. |
Associated Products
| Product Description | HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1283-31, Barcode (01) 1 030409 128331 9 (carton), (01) 0 030409 128331 2 (cartridge unit). |
|---|---|
| Code Info | Lot #07547LL, Exp 07/01/13 |
| Classification | Class I |
| Reason for Recall | Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume. |
| Product Quantity | 223,750 prefilled cartridge units |
| Recall Number | D-1444-2012 |
Class I Food/Cosmetics Event
| Event ID | 62124 |
|---|---|
| Status | Ongoing |
| Product Type | Food/Cosmetics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 06-Jun-12 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Recalling Firm | Altura Food, Inc. |
|---|---|
| City | Ciales |
| State | PR |
| Country | US |
| Distribution Pattern | Puerto Rico- Only one consignee |
Associated Products
| Product Description | "***Tres Monjitas***Tropical Splash***Guanabana***15 oz***" |
|---|---|
| Code Info | Lot # 0464 |
| Classification | Class I |
| Reason for Recall | Undeclared sub-ingredients considered allergens: hydrogenated coconut oil, sodium caseinate and soy lecithin. |
| Product Quantity | 9528 bottles |
| Recall Number | F-1859-2012 |
| Product Description | "***Tres Monjitas***Tropical Splash***Acerola***15 oz***" |
|---|---|
| Code Info | Lot 0465 |
| Classification | Class I |
| Reason for Recall | Undeclared sub-ingredients considered allergens: hydrogenated coconut oil, sodium caseinate and soy lecithin. |
| Product Quantity | 81, 2 bottles |
| Recall Number | F-1860-2012 |
Class I Devices Event
| Event ID | 62414 |
|---|---|
| Status | Completed |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 02-Apr-07 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | GE OEC Medical Systems, Inc |
|---|---|
| City | Salt Lake City |
| State | UT |
| Country | US |
| Distribution Pattern | Worldwide Distribution - USA including MO, IL, LA, FL, NH, TX, IN, PA, NJ and the countries of France and China |
Associated Products
| Product Description | Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CS, MR, or X-ray. |
|---|---|
| Code Info | E9-0002-G, ES-0013-G, E9-0036-G, E9-0040-G, E9-0041-G, ES-0014-G, ES-0016-G, ES-0033-G, ES-0043-G, ES-0041-G, ES-0042-G, ES-OO84-G, ES-0086-G, ES-0163-G, E9-0089-G, ES-0026-G, ES-0044-G |
| Classification | Class I |
| Reason for Recall | The FluoroTrak Spinal Navigation Application on the OEC 9900 EliteNAV could result in an incorrect position of the navigated instrument(s) versus the displayed reference image. |
| Product Quantity | 17 |
| Recall Number | Z-2136-2012 |
Class I Devices Event
| Event ID | 62558 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 13-Jul-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Baxter Healthcare Corp. |
|---|---|
| City | Round Lake |
| State | IL |
| Country | US |
| Distribution Pattern | Worldwide Distribution - USA - Nationwide including Puerto Rico, and internationally to Brazil, Canada, Colombia, Costa Rica, Czech Republic, El Salvador, Egypt, Germany, Guatemala, Honduras, Luxembourg, Mexico, Panama, Saudi Arabia, Singapore, Switzerland, Taiwan, Trinidad, Turkey, United Arab Emirates and United Kingdom. |
Associated Products
| Product Description | AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing. |
|---|---|
| Code Info | Product code 2M8077, all serial numbers |
| Classification | Class I |
| Reason for Recall | After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the AUTOMIX system may experience an intermittent electrical failure, in which unexpected pump motor operations will occur. Also, the AUTOMIX system may intermittently experience an electrical failure where the compounder may stop compounding without an alarm and not be detected by the user. |
| Product Quantity | 270 units |
| Recall Number | Z-2139-2012 |
| Product Description | AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing. |
|---|---|
| Code Info | Product code 2M8075, all serial numbers |
| Classification | Class I |
| Reason for Recall | After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the AUTOMIX system may experience an intermittent electrical failure, in which unexpected pump motor operations will occur. Also, the AUTOMIX system may intermittently experience an electrical failure where the compounder may stop compounding without an alarm and not be detected by the user. |
| Product Quantity | 840 units |
| Recall Number | Z-2140-2012 |
| Product Description | AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing. |
|---|---|
| Code Info | Product codes 2M8286 and 2M8286K, all serial numbers |
| Classification | Class I |
| Reason for Recall | After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the AUTOMIX system may experience an intermittent electrical failure, in which unexpected pump motor operations will occur. Also, the AUTOMIX system may intermittently experience an electrical failure where the compounder may stop compounding without an alarm and not be detected by the user. |
| Product Quantity | 3106 units |
| Recall Number | Z-2141-2012 |
| Product Description | AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing. |
|---|---|
| Code Info | Product code 2M8287, all serial numbers |
| Classification | Class I |
| Reason for Recall | After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the AUTOMIX system may experience an intermittent electrical failure, in which unexpected pump motor operations will occur. Also, the AUTOMIX system may intermittently experience an electrical failure where the compounder may stop compounding without an alarm and not be detected by the user. |
| Product Quantity | 950 units |
| Recall Number | Z-2142-2012 |
Class I Food/Cosmetics Event
| Event ID | 62672 |
|---|---|
| Status | Ongoing |
| Product Type | Food/Cosmetics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 24-Jul-12 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Recalling Firm | Shah Distributors |
|---|---|
| City | Tracy |
| State | CA |
| Country | US |
| Distribution Pattern | Northern CA only. |
Associated Products
| Product Description | CRISPY Just Baked Punjabi Cookies 800 g/1.76 lb (28.2 oz): Product of Canada Manufactured by: TWIK Foods Inc. Mississauga, ON, Canada. |
|---|---|
| Code Info | UPC 6 27265 00152 0 |
| Classification | Class I |
| Reason for Recall | FDA was notified of a recall by CFIA for Punjabi Cookies manufactured by TWI Food, Canada, that may not declare milk as an ingredient. |
| Product Quantity | Unknown |
| Recall Number | F-1842-2012 |
Class I Food/Cosmetics Event
| Event ID | 62673 |
|---|---|
| Status | Ongoing |
| Product Type | Food/Cosmetics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 23-Jul-12 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Recalling Firm | Mount Franklin Foods LLC |
|---|---|
| City | El Paso |
| State | TX |
| Country | US |
| Distribution Pattern | AZ, CA, KY, OK, and VA. |
Associated Products
| Product Description | Sunrise Indian Corn Candy which is packaged in 16 oz clear plastic tubs/12 tubs per case |
|---|---|
| Code Info | Best By date of MAR 26 2013 and with Lot # 2321811. This lot had UPC number 0-76500-16651-5. |
| Classification | Class I |
| Reason for Recall | Mount Franklin Foods, LLC. is voluntarily recalling Safeway Autumn Mix, Sunrise Autumn Mix, and Sunrise Indian Corn because the candy contains undeclared milk and sulfites. People with an allergy or severe sensitivity to milk can run the risk of serious or life-threatening allergic reactions if they consume this product. |
| Product Quantity | 123 cases |
| Recall Number | F-1843-2012 |
| Product Description | Autumn Mix sold under the following name brands: 1) Sunrise Autumn Mix which is packaged in 8 oz bags/36 bags per case; 2) Safeway Autum Mix which is packages in 10 oz bags/24 bags per case |
|---|---|
| Code Info | 1) Lot Number 0921722, Best By Date March 17, 2013; 2) Lot # 1221802, Best By Date March 25, 2013; Lot # 1221811, Best By Date March 25, 2013; Lot # 0821812, Best By Date March 26, 2013; Lot # 0821822, Best By Date March 27, 2013; Lot # 0821831, Best By Date March 28, 2013; Lot # 0821832, Best By Date March 28, 2013; and Lot # 0821852, Best By Date March 30, 2013 |
| Classification | Class I |
| Reason for Recall | Mount Franklin Foods, LLC. is voluntarily recalling Safeway Autumn Mix, Sunrise Autumn Mix, and Sunrise Indian Corn because the candy contains undeclared milk and sulfites. People with an allergy or severe sensitivity to milk can run the risk of serious or life-threatening allergic reactions if they consume this product. |
| Product Quantity | 1) 728 cases; 2) 4,227 cases |
| Recall Number | F-1844-2012 |
Class I Food/Cosmetics Event
| Event ID | 62680 |
|---|---|
| Status | Ongoing |
| Product Type | Food/Cosmetics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 26-Jul-12 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Recalling Firm | Ken's Foods, Inc. |
|---|---|
| City | Marlborough |
| State | MA |
| Country | US |
| Distribution Pattern | AL,FL,GA,IL,KY,MS,NC,NE,NM,NV,OH,OK,SC,TN,TX,WI |
Associated Products
| Product Description | Tartar Sauce sold under the following brand names: 1) Golden Corral Tartar Sauce, 1 gallon,refrigerated Product Code: GD2517; 2) Fatz Tartar Sauce, 1 gallon cases, refrigerated, Product Code FD0666; 3) Ken's Tartar Sauce, 1 gallon cases refrigerated, Product Code: KE0666, 1.5 oz. cups, Product Code: KE066A5 |
|---|---|
| Code Info | 1) Date Code:MFG: 17/JUL/12; 2) Date Code: MFG:23J/UL/12; 3) 1 gallon Date Code: MFG:009/JUL/12, 1.5 oz. cups: Date Code: EXP:011313 |
| Classification | Class I |
| Reason for Recall | Products manufactured with Gills Onions recalled due to potential for Listeria monocytogenes |
| Product Quantity | 1) 489 cases; 2) 20 cases; 3) 1 gal, 514 cases, 1.5 oz, 519 cases |
| Recall Number | F-1864-2012 |
| Product Description | Dickey's BBQ Bean Sauce, 48oz pouches, refrigerated Product Code: DI2063 |
|---|---|
| Code Info | Date Code: USE BY: 11MAR13 |
| Classification | Class I |
| Reason for Recall | Products manufactured with Gills Onions recalled due to potential for Listeria monocytogenes |
| Product Quantity | 215 cases |
| Recall Number | F-1865-2012 |
| Product Description | Lee's Cole Slaw Dressing 40oz pouches Product Code: FQ2103 |
|---|---|
| Code Info | Date Code: MFG: 23/JUL/12 |
| Classification | Class I |
| Reason for Recall | Products manufactured with Gills Onions recalled due to potential for Listeria monocytogenes |
| Product Quantity | 220 cases |
| Recall Number | F-1866-2012 |
Class I Food/Cosmetics Event
| Event ID | 62693 |
|---|---|
| Status | Ongoing |
| Product Type | Food/Cosmetics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 26-Jul-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Fahman Enterprises, Inc |
|---|---|
| City | Dallas |
| State | TX |
| Country | US |
| Distribution Pattern | Products were distributed to the states of Texas, Kansas, and Arkansas |
Associated Products
| Product Description | Crispy By TWI Foods Punjabi Cookies Just Baked Product of Canada 2600 Drew Road, Mississauga, ON Canada L4T 3M5 Net Wt. 800g/1.76 lb Ingredients: Wheat Flour, soybean oil, margarine, sugar, semolina, baking powder, ammonium carbonate. |
|---|---|
| Code Info | UPC 6 27265 00152 0. The recall is for all codes that do not declare milk on the ingredient statement. |
| Classification | Class I |
| Reason for Recall | Undeclared milk. |
| Product Quantity | 32 cases (14 packages/case) |
| Recall Number | F-1863-2012 |
Class I Food/Cosmetics Event
| Event ID | 62704 |
|---|---|
| Status | Ongoing |
| Product Type | Food/Cosmetics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 25-Jul-12 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Recalling Firm | FreshPoint Central Florida |
|---|---|
| City | Orlando |
| State | FL |
| Country | US |
| Distribution Pattern | Onion products were distributed to restaurant/food service in FL only. |
Associated Products
| Product Description | Onions Diced. Products are labeled in part: "***Onions Yellow Diced***Ready To Eat Product***4/5 LB***Slot Location***". "***FP CENTRAL FL. FRESHCUTS ONIONS, FC YELLOW DICED***4/5#***RT # FC***" Item # 599104 ONIONS, FC YEL DICED 1/4" CORONADO 4/5# bags; Item # 599645 ONIONS, FC YELLOW DICED 1/2" 4/5# bags; Item # 514524 ONIONS, FC YELLOW DICED 1/4" FC 4/5# bags; Item # 481258 ONIONS, FC YELLOW DICED 1/4" FL HO 4/5# bags; Item # 481271 ONIONS, FC YELLOW DICED 1/4" FW 4/5# bags; Item # 599997 ONIONS, FC YELLOW DICED 3/4" 4/5# bags; Item # 514007 ONIONS, FC YELLOW DICED 3/8" 4/5# bags; Item # 514012 ONIONS, FC YELLOW DICED 1/4" 1# BA 10/1#. |
|---|---|
| Code Info | Item #: 599104; 599645; 514524; 481258; 481271; 514012; 599997; 514007. |
| Classification | Class I |
| Reason for Recall | FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. |
| Product Quantity | 484 bags |
| Recall Number | F-1867-2012 |
| Product Description | Onions Julienne Sliced. Products are labeled in part: "***Onions Yellow Julienne Sliced***Ready To Eat Product***4/5 LB***" "***FP CENTRAL FL. FRESHCUTS ONIONS, FC YELLOW JUL SLICED 1/4"***4/5 #***RT # FC***" Item # 514098 ONIONS, FC YELLOW JUL SLICED 1/4" 4/5 #. |
|---|---|
| Code Info | Item #: 514098. |
| Classification | Class I |
| Reason for Recall | FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. |
| Product Quantity | 43 bags |
| Recall Number | F-1868-2012 |
| Product Description | Onions Peeled. Products are labeled in part: "***Onions ***Yellow Whole Peeled***Read To Eat Product***4/5 LB***". "***FP CENTRAL FL. FRESHCUTS ONIONS, FC YELLOW COLOSSAL PEELED***4/5#***RT # FC***" Item # 515670 ONIONS, FC YELLOW COLOSSAL PEELED 4/5#; Item # 514003 ONIONS, FC YELLOW WHOLE PEELED FC 4/5#; Item # 480142 ONIONS, FC YELLOW WHOLE PLD UNIVER 1 1/5# Item # 514035 ONIONS, FC YELLOW WHOLE PEELED 2/10#. |
|---|---|
| Code Info | Item #: 515670; 514003; 514035 ; 480142. |
| Classification | Class I |
| Reason for Recall | FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. |
| Product Quantity | 699 BAGS |
| Recall Number | F-1869-2012 |
| Product Description | Onions Cubed. Products are labeled in part: "***Onions Yellow Cubed 1"***Ready To Eat Product***LB***". FP CENTRAL FL. FRESHCUTS ONIONS, FC YELLOW CUBED 1"***2/5#***RT # FC***" Item # 514061 ONIONS, FC YELLOW CUBED 1" 2/5# . |
|---|---|
| Code Info | Item #: 514061. |
| Classification | Class I |
| Reason for Recall | FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. |
| Product Quantity | 3 BAGS |
| Recall Number | F-1870-2012 |
| Product Description | Onion Rings. Products are labeled in part: "***FP CENTRAL FL. FRESHCUTS***ONIONS FC YELLOW COLOSSAL RINGS 1/2 IN***LB***". Item # 481253 ONIONS, FC YELLOW COLOSSAL RIN 4/5#. |
|---|---|
| Code Info | Item #: 481253. |
| Classification | Class I |
| Reason for Recall | FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. |
| Product Quantity | 18 BAGS |
| Recall Number | F-1871-2012 |
| Product Description | Onion Slab Cut. Products are labeled in part: "***Onions Yellow Slab***Ready To Eat Product***LB***" "***FP CENTRAL FL. FRESHCUTS ONIONS, FC YELLOW SLAB***RT # FC***" Item # 514064 ONIONS, FC YELLOW SLAB 1/16" 2/5# Item # 514058 ONIONS, FC YELLOW SLAB 1/4" 4/5#; Item # 514034 ONIONS, FC YELLOW SLAB 3/8" NO 4/5#; Item # 481155 ONIONS, FC YELLOW SLAB CUT 1/8 2/5#. |
|---|---|
| Code Info | Item #: 514064; 514058; 514034; 481155. |
| Classification | Class I |
| Reason for Recall | FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. |
| Product Quantity | 58 bags |
| Recall Number | F-1872-2012 |
| Product Description | Onions Yellow Fajita. Products are labeled in part: "***Onions Yellow Slab*** "***FP CENTRAL FL. FRESHCUTS ONIONS, FC YELLOW FAJITA***LB***" Item # 513996 ONIONS, FC YELLOW FAJITA |
|---|---|
| Code Info | Item #: 513996. |
| Classification | Class I |
| Reason for Recall | FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. |
| Product Quantity | 3 bags |
| Recall Number | F-1873-2012 |
| Product Description | MIX w/yellow onions used as an ingredient. Product may be labeled in part: "***FP CENTRAL FL. FRESHCUTS MIXES, FC BLACK BEAN/CORN SALSA***2/5#***RT # FC***". Item # 511536 MIXES, FC BLACK BEAN/CORN SALS |
|---|---|
| Code Info | Item # 511536 |
| Classification | Class I |
| Reason for Recall | FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. |
| Product Quantity | 6 BOXES |
| Recall Number | F-1874-2012 |
| Product Description | MIX w/yellow onions used as an ingredient. Product may be labeled in part: "***LSG Pico De Gallo***Ready To Eat Product***2/5LB***" Item # 481744 MIXES, FC LSG PICO. |
|---|---|
| Code Info | Item # 481744 |
| Classification | Class I |
| Reason for Recall | FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. |
| Product Quantity | 42 boxes |
| Recall Number | F-1875-2012 |
| Product Description | MIX w/yellow onions used as an ingredient. Product may be labeled in part: "***Pico De Gallo***Ready To Eat Product***2/5 LB***" Item # 512514 MIXES, FC PICO DE GALLO |
|---|---|
| Code Info | Item # 512514 |
| Classification | Class I |
| Reason for Recall | FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. |
| Product Quantity | 168 boxes |
| Recall Number | F-1876-2012 |
| Product Description | MIX w/yellow onions used as an ingredient. Product may be labeled in part: 1) "***Pico De Gallo 3/8" Cut***Ready To Eat Product***2/5 LB***", "***FP CENTRAL FL. FRESHCUTS MIXES, FC PICO DE GALLO 3/8#***2/5#***RT # FC***", Item # 511511 MIXES, FC PICO DE GALLO 3/8" 2) "***FP CENTRAL FL. FRESHCUTS MIXES, FC T.G.I. PICO 3/8" SMALL PACK***4/2.5LB***RT # FC***", Item # 481603 MIXES, FC T.G.I. PICO 3/8" SMA |
|---|---|
| Code Info | 1) Item # 511511; 2) Item #481603 |
| Classification | Class I |
| Reason for Recall | FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. |
| Product Quantity | 1) 13 cases; 2) 6 boxes |
| Recall Number | F-1877-2012 |
| Product Description | MIX w/yellow onions used as an ingredient. Product may be labeled in part: "***Mixes***RP, Cel, YO Diced 1/4:***Ready To Eat Product***2/5 LB***" "***FP CENTRAL FL. FRESHCUTS MIXES, FC RP, CEL, YO DICED 1/4"***2/5 LB***RT # FC***" Item # 481240 MIXES, FC RP,CEL,YO DICED 1/4" |
|---|---|
| Code Info | Item # 481240 |
| Classification | Class I |
| Reason for Recall | FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. |
| Product Quantity | 46 cases |
| Recall Number | F-1878-2012 |
| Product Description | MIX w/yellow onions used as an ingredient. Product may be labeled in part: "***FP CENTRAL FL. FRESHCUTS***MIXES, FC SHEPPARD PIE MIX RR***2/5#***RT # FC***" Item # 481273 MIXES, FC SHEPPARD PIE MIX RR |
|---|---|
| Code Info | Item # 481273 |
| Classification | Class I |
| Reason for Recall | FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. |
| Product Quantity | 14 boxes |
| Recall Number | F-1879-2012 |
| Product Description | MIX w/yellow onions used as an ingredient. Product may be labeled in part: "***Stir Fry Mix D***Ready To Eat Product***4/5 LB***" Item # 513450 MIXES, FC STIR FRY"D" |
|---|---|
| Code Info | Item # 513450 |
| Classification | Class I |
| Reason for Recall | FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. |
| Product Quantity | 175 boxes |
| Recall Number | F-1880-2012 |
| Product Description | MIX w/yellow onions used as an ingredient. Product may be labeled in part: "***Mixes Tropical Salsa***Ready To Eat Product 2/5 LB***" "***FP CENTRAL FL. FRESHCUTS MIXES, FC TROPICAL SALSA***2/5#***RT # FC***" Item # 597778 MIXES, FC TROPICAL SALSA |
|---|---|
| Code Info | Item # 597778 |
| Classification | Class I |
| Reason for Recall | FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. |
| Product Quantity | 4 BOXES |
| Recall Number | F-1881-2012 |
Class I Food/Cosmetics Event
| Event ID | 62718 |
|---|---|
| Status | Ongoing |
| Product Type | Food/Cosmetics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 26-Jul-12 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Recalling Firm | San Miguel Produce, Inc. |
|---|---|
| City | Oxnard |
| State | CA |
| Country | US |
| Distribution Pattern | Distributed to AZ, CA, IA, and NV. |
Associated Products
| Product Description | Cut N Clean Greens Comfort Greens Kit, Ready-to-Cook Kit, 24 oz. Packaged in 24 oz plastic clamshell at 6 per case. This product is sold as a 24oz clamshell (plastic container with lid) cooking greens kit. Product is identifiable by the UPC Number 028764000616 this is located on the back label of the product. Product labeling reads in part:" Cut N Clean Greens COMFORT GREENS KIT Complete with collard, mustard and turnip greens, bacon, red cabbage, sweet onion and seasoning Ready-to-Cook Kit NET WT 680g 24 oz***Produce of U.S.A.***SAN MIGUEL PRODUCE, INC. Grown in Ventura County, California U.S.A.***". |
|---|---|
| Code Info | UPC Number 028764000616. The run numbers with its best used by dates are below: 20260-07/25/12 20651-08/03/12 20260-07/26/12 20756-08/06/12 20340-07/27/12 20756-08/07/12 20437-07/30/12 20546-08/02/12 |
| Classification | Class I |
| Reason for Recall | The firm initiated the recall because the product contain onions from Gills Onions, which has the potential to be contaminated with Listeria monocytogenes. |
| Product Quantity | 47 cases |
| Recall Number | F-1862-2012 |
Class I Food/Cosmetics Event
| Event ID | 62727 |
|---|---|
| Status | Ongoing |
| Product Type | Food/Cosmetics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 26-Jul-12 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Recalling Firm | Nuts and Spice Co., Inc. |
|---|---|
| City | Union City |
| State | CA |
| Country | US |
| Distribution Pattern | Northern CA, and one customer in WA, NV, UT. |
Associated Products
| Product Description | CRISPY Just Baked Punjabi Cookies by TWI Foods, Net Wt 800 gr, (1.76 lbs, 28.2 oz). Product of Canada Manufactured by TWI Foods, Mississauga, Ontario, Canada. |
|---|---|
| Code Info | UPC 6 27265 00152 0 |
| Classification | Class I |
| Reason for Recall | FDA was notified by CFIA of a recall of Punjabi cookies manufactured by TWI Foods, Mississauga, Ontario, Canada due to the potential for undeclared milk. |
| Product Quantity | not provided. |
| Recall Number | F-1845-2012 |
Class I Food/Cosmetics Event
| Event ID | 62750 |
|---|---|
| Status | Ongoing |
| Product Type | Food/Cosmetics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 27-Jul-12 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Recalling Firm | FreshPoint South Florida |
|---|---|
| City | Pompano Beach |
| State | FL |
| Country | US |
| Distribution Pattern | Products were distributed in South Florida. |
Associated Products
| Product Description | Diced Yellow Onion. 1) Product is labeled in part: "***Onion Yellow Diced***ORB***Orthodox Rabbinical Board of Broward and Palm Beach Counties***Refrigerate at 34 F***" "***FC Onion Yellow Diced***ORB***Orthodox Rabbinical Board of Broward and Palm Beach Counties***Refrigerate at 34 F***" Item # 159280 Onion Yellow Diced 1/4" 4/5#. Item # 301540 FC ONION YELLOW DICED 1/2" 4/5#. Item # 301560 FC ONION YELLOW DICED 1/4" 2/7#. Item # 301580 FC ONION YELLOW DICED 3/4" #. 2) Yellow Onion. Product is labeled in part: "***FC Onion Diced 1/4" EVB***ORB***Orthodox Rabbinical Board of Broward and Palm Beach Counties***Refrigerate at 34 F***" Item # 301565 FC ONION DICED 1/4" EVB. |
|---|---|
| Code Info | 1) Item # 159280, 301540, 301560, 301580. 2) 301565 |
| Classification | Class I |
| Reason for Recall | FreshPoint South Florida is recalling sliced fresh yellow onions and salsa products processed using yellow onions sourced from Gills Onions, LLC which were recalled for Listeria monocytogenes. |
| Product Quantity | 1) 746 cases; 2) 6 cases |
| Recall Number | F-1915-2012 |
| Product Description | Yellow Onion. Product is labeled in part: "***Onion Yellow Julienne***ORB***Orthodox Rabbinical Board of Broward and Palm Beach Counties***Refrigerate at 34 F***" "***FC Onion Yellow Julienne***ORB***Orthodox Rabbinical Board of Broward and Palm Beach Counties***Refrigerate at 34 F***" Item # 301570 FC ONION YELLOW JULIENNE 3/8" 2/5#. Item # 301590 FC ONION YELLOW JULIENNE 1/4" 4/5#. |
|---|---|
| Code Info | Item # 301570, 301590. |
| Classification | Class I |
| Reason for Recall | FreshPoint South Florida is recalling sliced fresh yellow onions and salsa products processed using yellow onions sourced from Gills Onions, LLC which were recalled for Listeria monocytogenes. |
| Product Quantity | 21 cases |
| Recall Number | F-1916-2012 |
| Product Description | Yellow Onion. Product is labeled in part: "***Onion Yellow Ring***ORB***Orthodox Rabbinical Board of Broward and Palm Beach Counties***Refrigerate at 34 F***" "***FC Onion Yellow Ring***ORB***Orthodox Rabbinical Board of Broward and Palm Beach Counties***Refrigerate at 34 F***" Item # 301586 FC ONION YELLOW RING 1/4" TRAY. Item # 301587 FC ONION YELLOW RING 3/16" . |
|---|---|
| Code Info | Item # 301586, 301587. |
| Classification | Class I |
| Reason for Recall | FreshPoint South Florida is recalling sliced fresh yellow onions and salsa products processed using yellow onions sourced from Gills Onions, LLC which were recalled for Listeria monocytogenes. |
| Product Quantity | 15 cases |
| Recall Number | F-1917-2012 |
| Product Description | Yellow Onion. Product is labeled in part: "***Onion Yellow Whole***ORB***Orthodox Rabbinical Board of Broward and Palm Beach Counties***Refrigerate at 34 F***" Item # 159760 ONION YELLOW WHOLE PEELED 4/5#. |
|---|---|
| Code Info | Item # 159760. |
| Classification | Class I |
| Reason for Recall | FreshPoint South Florida is recalling sliced fresh yellow onions and salsa products processed using yellow onions sourced from Gills Onions, LLC which were recalled for Listeria monocytogenes. |
| Product Quantity | 134 cases |
| Recall Number | F-1918-2012 |
| Product Description | Yellow Onion. Product is labeled in part: "***FC Mix Fajita (Jul Mix Pep/Yo)***ORB***Orthodox Rabbinical Board of Broward and Palm Beach Counties***Refrigerate at 34 F***" Item # 301255 FC MIX FAJITA (JUL MIX PEP/YO) 4/5#. Product is rinsed to reduce microbial load, dried and vacuum sealed. |
|---|---|
| Code Info | Item # 301255. |
| Classification | Class I |
| Reason for Recall | FreshPoint South Florida is recalling sliced fresh yellow onions and salsa products processed using yellow onions sourced from Gills Onions, LLC which were recalled for Listeria monocytogenes. |
| Product Quantity | 1 case |
| Recall Number | F-1919-2012 |
| Product Description | Yellow Onion. Product is labeled in part: "***FC Mix Stir Fry "D"***Refrigerate at 34 F***" Item # 301280 FC MIX STIR FRY "D" 4/5#. Fresh Made - Ready To Eat. |
|---|---|
| Code Info | Item # 301280. |
| Classification | Class I |
| Reason for Recall | FreshPoint South Florida is recalling sliced fresh yellow onions and salsa products processed using yellow onions sourced from Gills Onions, LLC which were recalled for Listeria monocytogenes. |
| Product Quantity | 7 cases |
| Recall Number | F-1920-2012 |
| Product Description | Yellow Onion. Product is labeled in part: "***FC Salsa Chunky Tomato"***Refrigerate at 34 F***" Item # 302920 FC SALSA CHUNKY TOMATO 2/5#. Fresh made - Ready to Eat.. |
|---|---|
| Code Info | Item # 302920. |
| Classification | Class I |
| Reason for Recall | FreshPoint South Florida is recalling sliced fresh yellow onions and salsa products processed using yellow onions sourced from Gills Onions, LLC which were recalled for Listeria monocytogenes. |
| Product Quantity | 2 cases |
| Recall Number | F-1921-2012 |
| Product Description | Yellow Onion. Product is labeled in part: "***FC Salsa Mango"***Refrigerate at 34 F***" Item # 302940 FC SALSA MANGO 2/5#. Product is fresh made - Ready To Eat. |
|---|---|
| Code Info | Item # 302940. |
| Classification | Class I |
| Reason for Recall | FreshPoint South Florida is recalling sliced fresh yellow onions and salsa products processed using yellow onions sourced from Gills Onions, LLC which were recalled for Listeria monocytogenes. |
| Product Quantity | 7 cases |
| Recall Number | F-1922-2012 |
| Product Description | Yellow Onion. Product is labeled in part: "***FC Salsa Pico de Gallo"***Refrigerate at 34 F***" Item # 302945 FC SALSA PICO DE GALLO 2/5#. Product is fresh made - Ready To Eat. |
|---|---|
| Code Info | Item # 302945 |
| Classification | Class I |
| Reason for Recall | FreshPoint South Florida is recalling sliced fresh yellow onions and salsa products processed using yellow onions sourced from Gills Onions, LLC which were recalled for Listeria monocytogenes. |
| Product Quantity | 9 cases |
| Recall Number | F-1923-2012 |
| Product Description | Yellow Onion. Product is labeled in part: "***FC Salsa Pineapple & Papaya"***Refrigerate at 34 F***" Item # 302950 FC SALSA PINEAPPLE 2/5#. Product is fresh made - Ready To Eat. |
|---|---|
| Code Info | Item # 302950 |
| Classification | Class I |
| Reason for Recall | FreshPoint South Florida is recalling sliced fresh yellow onions and salsa products processed using yellow onions sourced from Gills Onions, LLC which were recalled for Listeria monocytogenes. |
| Product Quantity | 1 case |
| Recall Number | F-1924-2012 |
Class I Food/Cosmetics Event
| Event ID | 62753 |
|---|---|
| Status | Ongoing |
| Product Type | Food/Cosmetics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 27-Jul-12 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Recalling Firm | Keys Fisheries, Inc. |
|---|---|
| City | Marathon |
| State | FL |
| Country | US |
| Distribution Pattern | Product was distributed to Whole Food Stores in Florida. |
Associated Products
| Product Description | Conch Salad w/onions. Product is labeled in part: "***KEYS FISHERIES CONCH SALAD***Ingredients Ground Conch, Fresh tomatoes, Fresh Cucmber, Mojo (grapefruit juice, lime juice, orange juice, extra virgin olive oil, garlic, onion, sugar, spices, cumin) Tomatoe juice, Line juice, Parsley, Black pepper, Salt, Spices, Paprika.***FRESH PRODUCT KEEP REFRIGERATED***" CODE: 07294144950 Product was packaged in 5 lb plastic containers with 4 per case. Onions used in the manufacture of the above item is subject to recall for Listeria monocytogenes. |
|---|---|
| Code Info | CODE: 07294144950 |
| Classification | Class I |
| Reason for Recall | Keys Fisheries, Inc. is recalling Keys Fisheries Conch Salad. The Conch Salad was prepared with onions sourced from Gills Onions, LLC being recalled for possible Listeria monocytogenes. |
| Product Quantity | 5 cases |
| Recall Number | F-1930-2012 |
Class II Biologics Event
| Event ID | 40154 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 02-May-05 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Community Blood Center of Greater Kansas City |
|---|---|
| City | Kansas City |
| State | MO |
| Country | US |
| Distribution Pattern | MO |
Associated Products
| Product Description | Red Blood Cells |
|---|---|
| Code Info | W045004052739;W045004113287 |
| Classification | Class II |
| Reason for Recall | Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. |
| Product Quantity | 2 units |
| Recall Number | B-2051-12 |
Class II Biologics Event
| Event ID | 40771 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 13-Sep-05 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Recalling Firm | Community Blood Center of Greater Kansas City |
|---|---|
| City | Kansas City |
| State | MO |
| Country | US |
| Distribution Pattern | MO |
Associated Products
| Product Description | Platelets Pheresis Leukocytes Reduced |
|---|---|
| Code Info | W045005910246 |
| Classification | Class II |
| Reason for Recall | Blood product, which did not meet acceptable product specifications, was distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2047-12 |
Class II Biologics Event
| Event ID | 40997 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 12-Oct-05 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Community Blood Center of Greater Kansas City |
|---|---|
| City | Kansas City |
| State | MO |
| Country | US |
| Distribution Pattern | , MO |
Associated Products
| Product Description | Red Blood Cells Leukocytes Reduced |
|---|---|
| Code Info | W045005055407; W045005074435 |
| Classification | Class II |
| Reason for Recall | Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed |
| Product Quantity | 2 units |
| Recall Number | B-2045-12 |
Class II Biologics Event
| Event ID | 41400 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 09-Dec-05 |
| Initial Firm Notification of Consignee or Public | Other |
| Recalling Firm | CSL Plasma Inc |
|---|---|
| City | Boca Raton |
| State | FL |
| Country | US |
| Distribution Pattern | IL, NC |
Associated Products
| Product Description | Source Plasma |
|---|---|
| Code Info | 4210035209;4210034732;4210033969;4210033556; 4210032838;4210032339;4210031541;4210031077; 4210030338;4210029885;4210029191;4210028901; 4210051188;4210050153;4210049932;4210048992; 4210044186;4210043671;4210042848;4210042402; 4210041503;4210041005;4210040192;4210039709; 4210039056;4210038579;4210037747;4210037271 4210036475;4210035991 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. |
| Product Quantity | 30 units |
| Recall Number | B-1286-12 |
Class II Biologics Event
| Event ID | 41786 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 13-Feb-06 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | American National Red Cross (The) |
|---|---|
| City | Toledo |
| State | OH |
| Country | US |
| Distribution Pattern | OH |
Associated Products
| Product Description | Red Blood Cells Leukocytes Reduced |
|---|---|
| Code Info | 50E41930; 50LJ90522; 50LW38383; 50LH71894; 50LC19120; 50LC19119; 50LC18780; 50LC18883; 50LC18941; 50LW38261; 50LW38273; 50LH71767; 50LH71774; 50LC19079; 50LC19100; 50LC19118; 50LW38267 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from donors whose arm scrubs may have been incorrectly performed, were distributed. |
| Product Quantity | 17 units |
| Recall Number | B-1785-12 |
Class II Biologics Event
| Event ID | 42196 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 21-Apr-06 |
| Initial Firm Notification of Consignee or Public |
| Recalling Firm | ZLB Bioplasma, Inc. |
|---|---|
| City | Boca Raton |
| State | FL |
| Country | US |
| Distribution Pattern | IL |
Associated Products
| Product Description | Source Plasma |
|---|---|
| Code Info | 4030064251; 4030063654; 4030063261; 4030062710; 4030062320; 4030061734; 4030061410; 4030060712; 4030060289; 4030059562; 4030059145; 4030058428; 4030057176; 4030056764; 4030056135; 4030055633; 4030054832; 4030054000; 4030053605 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who had been incarcerated, were distributed. |
| Product Quantity | 19 units |
| Recall Number | B-1792-12 |
Class II Biologics Event
| Event ID | 42331 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 11-May-06 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Recalling Firm | American National Red Cross (The) |
|---|---|
| City | Louisville |
| State | KY |
| Country | US |
| Distribution Pattern | KY, OH, IN |
Associated Products
| Product Description | Platelets Pheresis Leukocytes Reduced Irradiated |
|---|---|
| Code Info | 24FY08611; 24FY08614; 24FY08615 |
| Classification | Class II |
| Reason for Recall | Blood products, collected using equipment that had not been validated, were distributed. |
| Product Quantity | 3 units |
| Recall Number | B-1752-12 |
| Product Description | Platelets Pheresis Leukocytes Reduced |
|---|---|
| Code Info | 24FY08618; 24FY08617; 24FY08608; 24FY08609; 24FY08611; 24FY08612; 24FY08612; 24FY08613; 24FY08613; 24FY08614; 24FY08615; 24FY08616; 24FY08616 |
| Classification | Class II |
| Reason for Recall | Blood products, collected using equipment that had not been validated, were distributed. |
| Product Quantity | 13 units |
| Recall Number | B-1753-12 |
Class II Biologics Event
| Event ID | 42933 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 18-Aug-06 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | American National Red Cross (The) |
|---|---|
| City | Louisville |
| State | KY |
| Country | US |
| Distribution Pattern | KY |
Associated Products
| Product Description | Platelets Pheresis Leukocytes Reduced |
|---|---|
| Code Info | 24FH48890 |
| Classification | Class II |
| Reason for Recall | Blood product, collected in a manner that may have compromised the sterility of the collection system, was distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-1791-12 |
Class II Biologics Event
| Event ID | 42943 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 10-Aug-06 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Community Blood Center |
|---|---|
| City | Dayton |
| State | OH |
| Country | US |
| Distribution Pattern | OH |
Associated Products
| Product Description | Red Blood Cells |
|---|---|
| Code Info | 1279445 |
| Classification | Class II |
| Reason for Recall | Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-1751-12 |
Class II Biologics Event
| Event ID | 44338 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 03-Jan-07 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Hoxworth Blood Center University of Cincinnati Medical Center |
|---|---|
| City | Cincinnati |
| State | OH |
| Country | US |
| Distribution Pattern | OH and KY |
Associated Products
| Product Description | Red Blood Cells Leukocytes Reduced |
|---|---|
| Code Info | 2816618 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who lived in a country at risk for HIV Group O, were distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-1493-12 |
| Product Description | Fresh Frozen Plasma |
|---|---|
| Code Info | 2816618 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who lived in a country at risk for HIV Group O, were distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-1494-12 |
Class II Biologics Event
| Event ID | 49766 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 14-Apr-08 |
| Initial Firm Notification of Consignee or Public | FAX |
| Recalling Firm | Talecris Plasma Resources, Inc. |
|---|---|
| City | Research Triangle Park |
| State | NC |
| Country | US |
| Distribution Pattern | NC |
Associated Products
| Product Description | Source Plasma |
|---|---|
| Code Info | 383019214;383018948;383036249;383036056; 383035479;383035354;383034064;383033640; 383033452;383033117;383032912;383030664; 383029720;383029305;383029137;383026151; 383019723;383019597;383024769;383024567; 383024292;383023250;383023217 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who was previously deferred, were distributed. |
| Product Quantity | 23 |
| Recall Number | B-2042-12 |
Class II Food/Cosmetics Event
| Event ID | 51820 |
|---|---|
| Status | Ongoing |
| Product Type | Food/Cosmetics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 29-Jun-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Designer Protein LLC |
|---|---|
| City | Carlsbad |
| State | CA |
| Country | US |
| Distribution Pattern | nationwide in the US and worldwide to Philippines and Brazil. |
Associated Products
| Product Description | Designer Whey Chocolate, 2lbs, item#10200131, 4 units/case. UPC 8-44334-00131-5. |
|---|---|
| Code Info | Lot code: 201306 |
| Classification | Class II |
| Reason for Recall | The recall was initiated because Designer Protein has confirmed that Designer Whey 2lb Protein Powder products claim gluten free, and lab results from the Canadian Food Inspection Agency (CFIA) found the products to contain gluten. |
| Product Quantity | 6366 units total |
| Recall Number | F-1926-2012 |
| Product Description | Designer Whey French Vanilla, 2lbs, item # 10200133, 4 units/case. UPC 8-44334-00133-9. Designer Whey French Vanilla, 3lbs, Item#10200134, 5 units/case. UPC 8-4434-00133-10. |
|---|---|
| Code Info | Lot code: 201306, 201305. |
| Classification | Class II |
| Reason for Recall | The recall was initiated because Designer Protein has confirmed that Designer Whey 2lb Protein Powder products claim gluten free, and lab results from the Canadian Food Inspection Agency (CFIA) found the products to contain gluten. |
| Product Quantity | 6366 units total |
| Recall Number | F-1927-2012 |
| Product Description | Designer Whey Strawberry, 2lbs, Item#10200137, 4 units/case. UPC 8-44334-00137-7. |
|---|---|
| Code Info | Lot code: 201305 |
| Classification | Class II |
| Reason for Recall | The recall was initiated because Designer Protein has confirmed that Designer Whey 2lb Protein Powder products claim gluten free, and lab results from the Canadian Food Inspection Agency (CFIA) found the products to contain gluten. |
| Product Quantity | 6366 units total |
| Recall Number | F-1928-2012 |
Class II Food/Cosmetics Event
| Event ID | 51823 |
|---|---|
| Status | Ongoing |
| Product Type | Food/Cosmetics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 05-Jul-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Southwind Foods LLC dba Great American Seafood Imports Co. |
|---|---|
| City | Vernon |
| State | CA |
| Country | US |
| Distribution Pattern | Nationwide |
Associated Products
| Product Description | Great American Seafood Imports Co. Cooked Shrimp Meat. Size: 300/500 count per pound in 2-lb (item #06834) and 5-lb (Item #07756) packages. |
|---|---|
| Code Info | 2-lb package: Lots #93059, #93124, #93584, #93150, #93023 and #93048. 5-lb package: Lot #93061 |
| Classification | Class II |
| Reason for Recall | Southwind is recalling cooked shrimp meat because it contains undeclared red #40 and yellow #6 colors. |
| Product Quantity | 150 units (2,160 lbs) |
| Recall Number | F-1929-2012 |
Class II Biologics Event
| Event ID | 53642 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 11-Sep-09 |
| Initial Firm Notification of Consignee or Public | FAX |
| Recalling Firm | Interstate Blood Bank Inc |
|---|---|
| City | Memphis |
| State | TN |
| Country | US |
| Distribution Pattern | CA |
Associated Products
| Product Description | Source Plasma |
|---|---|
| Code Info | 09KWIB8731;09KWIB8443;09KWIB8100;09KWIB7843;09KWIB7470; 09KWIB7195;09KWIB6849;09KWIB6580;09KWIB6077;09KWIB5968; 09KWIB5382;09KWIB5036;09KWIB4770;09KWIB4406;09KWIB4112; 09KWIB3709;09KWIB3470;09KWIB2886 09KWIB2560, 09KWIB2195, 09KWIB1875, 09KWIA9619, 09KWIA9398, 09KWIA8733, 09KWIA8432, 09KWIA8104, 09KWIA7796, 09KWIA7464, 09KWIA7064, 09KWIA6883, 09KWIA6200, 09KWIA6025, 09KWIA5673, 09KWIA5460, 09KWIA5113, 09KWIA4568, 09KWIA4076, 09KWIA3992, 09KWIA3528, 09KWIA3471, 09KWIA3011, 09KWIA2921, 09KWIA2498, 09KWIA1879, 09KWIA1814, 09KWIA1330, 09KWIA0918, 09KWIA0677, 09KWIA0395, 09KWIA0135, 08KWIC0511, 08KWIC0219, 08KWIC0086, 08KWIB9715, 08KWIB9465, 08KWIB9234, 08KWIB8883, 08KWIB8716, 08KWIB8327, 08KWIB8255, 08KWIB7830, 08KWIB7450, 08KWIB7308, 08KWIB6949, 08KWIB6785, 08KWIB6469, 08KWIB6340, 08KWIB5993, 08KWIB5812, 08KWIB5546, 08KWIB4949, 08KWIB4676, 08KWIB4559, 08KWIB4295, 08KWIB4083, 08KWIB3904, 08KWIB3666, 08KWIB3520, 08KWIB3327, 08KWIB3134, 08KWIB2802, 08KWIB2677, 08KWIB2474 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who was previously deferred, were distributed. |
| Product Quantity | 83 units |
| Recall Number | B-2044-12 |
Class II Biologics Event
| Event ID | 54948 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 02-Feb-10 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Recalling Firm | CSL Plasma, Inc. |
|---|---|
| City | Duluth |
| State | MN |
| Country | US |
| Distribution Pattern | IL, Switzerland, Germany, North Carolina |
Associated Products
| Product Description | Source Plasma |
|---|---|
| Code Info | 6130388170,6130386936,6130386073,6130385314, 6130381439,6130378266,6130376520,6130375438, 6130374544,6130373548,6130373236,6130372194, 6130371735,6130370734,6130370156,6130369427, 6130368822,6130366953,6130362858,6130361897, 6130357900,6130356107,6130355771,6130354109 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a previously deferred donor, were distributed. |
| Product Quantity | 24 units |
| Recall Number | B-2043-12 |
Class II Biologics Event
| Event ID | 61992 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 01-May-12 |
| Initial Firm Notification of Consignee or Public | FAX |
| Recalling Firm | Blood Assurance Inc |
|---|---|
| City | Chattanooga |
| State | TN |
| Country | US |
| Distribution Pattern | TN, GA, NY |
Associated Products
| Product Description | Plasma Cryoprecipitated Reduced |
|---|---|
| Code Info | W043210088572 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2009-12 |
| Product Description | Red Blood Cells (Apheresis) Leukocytes Reduced |
|---|---|
| Code Info | W043211094961-A; W043211094961-B; W043211044082-A; W043211025338-A; W043211044082-B; W043211025338-B |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. |
| Product Quantity | 6 units |
| Recall Number | B-2010-12 |
| Product Description | Cryoprecipitated AHF, Pooled |
|---|---|
| Code Info | W043210088572 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2011-12 |
| Product Description | Red Blood Cells Leukocytes Reduced |
|---|---|
| Code Info | V89413; V26698; W043210088572; W043210075817 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. |
| Product Quantity | 4 units |
| Recall Number | B-2012-12 |
| Product Description | Plasma Frozen within 24 hours (FP24) |
|---|---|
| Code Info | W043210075817 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2013-12 |
| Product Description | Blood and Blood Products for Reprocessing |
|---|---|
| Code Info | V89413 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2014-12 |
| Product Description | Fresh Frozen Plasma |
|---|---|
| Code Info | V26698 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2015-12 |
Class II Biologics Event
| Event ID | 61997 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 02-May-12 |
| Initial Firm Notification of Consignee or Public | FAX |
| Recalling Firm | Central California Blood Center |
|---|---|
| City | Fresno |
| State | CA |
| Country | US |
| Distribution Pattern | CA |
Associated Products
| Product Description | Platelets Leukocytes Reduced |
|---|---|
| Code Info | W115911013637 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2036-12 |
| Product Description | Red Blood Cells Leukocytes Reduced |
|---|---|
| Code Info | W115911274353; W115911045584 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. |
| Product Quantity | 2 units |
| Recall Number | B-2037-12 |
Class II Biologics Event
| Event ID | 62011 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 07-May-12 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Recalling Firm | LifeServe Blood Center |
|---|---|
| City | Des Moines |
| State | IA |
| Country | US |
| Distribution Pattern | IA and FL |
Associated Products
| Product Description | Plasma Frozen within 24 hours (FP24) |
|---|---|
| Code Info | W037911146400 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2033-12 |
| Product Description | Blood and Blood Products for Reprocessing |
|---|---|
| Code Info | W037911171995 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2034-12 |
Class II Biologics Event
| Event ID | 62012 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 18-Apr-12 |
| Initial Firm Notification of Consignee or Public | FAX |
| Recalling Firm | American National Red Cross (The) - North Central Region |
|---|---|
| City | Saint Paul |
| State | MN |
| Country | US |
| Distribution Pattern | MN |
Associated Products
| Product Description | Red Blood Cells Leukocytes Reduced |
|---|---|
| Code Info | 017FR95345 |
| Classification | Class II |
| Reason for Recall | Blood product, incorrectly labeled for Jk(a) red cell antigen, was distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2035-12 |
Class II Devices Event
| Event ID | 62023 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 17-Oct-11 |
| Initial Firm Notification of Consignee or Public | Other |
| Recalling Firm | SCC Soft Computer |
|---|---|
| City | Clearwater |
| State | FL |
| Country | US |
| Distribution Pattern | US Nationwide Distribution |
Associated Products
| Product Description | SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data. |
|---|---|
| Code Info | SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. |
| Classification | Class II |
| Reason for Recall | On 10/17/2011 SCC Soft Computer, Clearwater, FL initiated a correction on SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. A client reported an issue which caused two different sets of results from the Sysmex series of Hematology instruments to display under the same order on the instrument menu. |
| Product Quantity | 88 |
| Recall Number | Z-2143-2012 |
Class II Biologics Event
| Event ID | 62027 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 01-May-12 |
| Initial Firm Notification of Consignee or Public | FAX |
| Recalling Firm | So Ca Permamente Med Group Blood Donor Cntr |
|---|---|
| City | Los Angeles |
| State | CA |
| Country | US |
| Distribution Pattern | CA |
Associated Products
| Product Description | Red Blood Cells |
|---|---|
| Code Info | W071911006426; W071912000837 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. |
| Product Quantity | 2 units |
| Recall Number | B-2273-12 |
Class II Biologics Event
| Event ID | 62029 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 19-Apr-12 |
| Initial Firm Notification of Consignee or Public | FAX |
| Recalling Firm | Florida's Blood Centers, Inc. |
|---|---|
| City | Orlando |
| State | FL |
| Country | US |
| Distribution Pattern | FL |
Associated Products
| Product Description | Blood and Blood Products for Reprocessing |
|---|---|
| Code Info | W038111302401 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-1409-12 |
Class II Drugs Event
| Event ID | 62241 |
|---|---|
| Status | Ongoing |
| Product Type | Drugs |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 18-May-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Teva Pharmaceuticals USA, Inc. |
|---|---|
| City | Sellersville |
| State | PA |
| Country | US |
| Distribution Pattern | Nationwide |
Associated Products
| Product Description | Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30 |
|---|---|
| Code Info | Lot number X05011, Exp 08/13 |
| Classification | Class II |
| Reason for Recall | Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint. |
| Product Quantity | 6,647 cartons |
| Recall Number | D-1442-2012 |
Class II Biologics Event
| Event ID | 62267 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 19-Apr-12 |
| Initial Firm Notification of Consignee or Public | FAX |
| Recalling Firm | Plasma Biological Services, Inc |
|---|---|
| City | Nashville |
| State | TN |
| Country | US |
| Distribution Pattern | NC |
Associated Products
| Product Description | Source Plasma |
|---|---|
| Code Info | NQ078882 |
| Classification | Class II |
| Reason for Recall | Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2278-12 |
Class II Biologics Event
| Event ID | 62296 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 24-May-12 |
| Initial Firm Notification of Consignee or Public |
| Recalling Firm | Blood Center of Northcentral Wisconsin, Inc. |
|---|---|
| City | Wausau |
| State | WI |
| Country | US |
| Distribution Pattern | WI |
Associated Products
| Product Description | Red Blood Cells Leukocytes Reduced |
|---|---|
| Code Info | W229812501160 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2281-12 |
| Product Description | Fresh Frozen Plasma |
|---|---|
| Code Info | W229812501160 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2282-12 |
Class II Biologics Event
| Event ID | 62298 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 24-May-12 |
| Initial Firm Notification of Consignee or Public | FAX |
| Recalling Firm | Walter L. Shepeard Community Blood Center, Inc. |
|---|---|
| City | Augusta |
| State | GA |
| Country | US |
| Distribution Pattern | GA |
Associated Products
| Product Description | Red Blood Cells |
|---|---|
| Code Info | W038512380006 |
| Classification | Class II |
| Reason for Recall | Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2285-12 |
Class II Devices Event
| Event ID | 62341 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 15-Jun-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Angiodynamics Worldwide Headquarters |
|---|---|
| City | Latham |
| State | NY |
| Country | US |
| Distribution Pattern | Worldwide distribution: USA (nationwide) including states of: CA, KS, MO, and NC and countries of: Czech Republic and Switzerland. |
Associated Products
| Product Description | AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA. Intended use: angiographic diagnosis. |
|---|---|
| Code Info | Lot: 564325 |
| Classification | Class II |
| Reason for Recall | AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter pouches within the outer box may be mislabeled. |
| Product Quantity | 7 boxes/35 units |
| Recall Number | Z-2180-2012 |
Class II Biologics Event
| Event ID | 62352 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 08-Jun-11 |
| Initial Firm Notification of Consignee or Public | FAX |
| Recalling Firm | New York Blood Center, Inc. |
|---|---|
| City | Westbury |
| State | NY |
| Country | US |
| Distribution Pattern | New York |
Associated Products
| Product Description | Plasma Frozen within 24 hours (FP24) |
|---|---|
| Code Info | W047011067810 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who was previously deferred for a history of intravenous drug use, were distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2138-12 |
| Product Description | Red Blood Cells (Apheresis) Leukocytes Reduced |
|---|---|
| Code Info | W047011067810 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who was previously deferred for a history of intravenous drug use, were distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2139-12 |
Class II Biologics Event
| Event ID | 62359 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 18-May-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Memorial Blood Centers |
|---|---|
| City | Saint Paul |
| State | MN |
| Country | US |
| Distribution Pattern | Minnesota |
Associated Products
| Product Description | Red Blood Cells Leukocytes Reduced Irradiated |
|---|---|
| Code Info | W051512006389 |
| Classification | Class II |
| Reason for Recall | Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2130-12 |
Class II Devices Event
| Event ID | 62375 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 23-Mar-12 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Recalling Firm | Biomet 3i, LLC |
|---|---|
| City | Palm Beach Gardens |
| State | FL |
| Country | US |
| Distribution Pattern | Worldwide Distribution -- United States, UK, France, Canada, Mexico, Poland, Lebanon and Hong Kong. |
Associated Products
| Product Description | ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798. Intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully endentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridge work and to retain over dentures. |
|---|---|
| Code Info | Lot Number 2011110798 |
| Classification | Class II |
| Reason for Recall | Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth of the implant's internal hex is too shallow. The condition, if present, may prevent the driver; cover screw or abutment from fully engaging the implant. |
| Product Quantity | 240 |
| Recall Number | Z-2158-2012 |
Class II Devices Event
| Event ID | 62395 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 12-Aug-11 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Recalling Firm | Linvatec Corp. dba ConMed Linvatec |
|---|---|
| City | Largo |
| State | FL |
| Country | US |
| Distribution Pattern | Nationwide Distribution, including the states of Colorado and Pennsylvania. |
Associated Products
| Product Description | CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone. |
|---|---|
| Code Info | Lot #156920 |
| Classification | Class II |
| Reason for Recall | ConMed Linvatec recalled lot number #156920, PFT-45M, CrossFT Punch because there is a possibility that the device was etched incorrectly listing the item number as PFT-00M and includes incorrect depth lines for insertion. |
| Product Quantity | 2 |
| Recall Number | Z-2147-2012 |
Class II Devices Event
| Event ID | 62403 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 07-Jun-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
|---|---|
| City | Newark |
| State | DE |
| Country | US |
| Distribution Pattern | USA (nationwide) including the states of AZ, CA, MS, MO, NJ, NC, OH, OR, PA, and TX. |
Associated Products
| Product Description | Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments |
|---|---|
| Code Info | Version VA11B and all previously released versions. |
| Classification | Class II |
| Reason for Recall | The recalling firm has discovered that when using a Sysmex(R) CA-7000 or CA-1500 coagulation analyzer with the syngo Lab Data Manager (LDM), there is a potential for the syngo LDM system, to display and transmit to the LIS an incorrect result following the syngo LDM's application of the configured result number format. The problem is encountered when the result number format configured on the Sysmex(R) CA-7000 or CA-1500 coagulation analyzer does not match the syngo LDM settings. |
| Product Quantity | 15 |
| Recall Number | Z-2173-2012 |
Class II Biologics Event
| Event ID | 62411 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 03-May-12 |
| Initial Firm Notification of Consignee or Public | FAX |
| Recalling Firm | South Texas Blood & Tissue Center |
|---|---|
| City | San Antonio |
| State | TX |
| Country | US |
| Distribution Pattern | Austria, Florida, Texas |
Associated Products
| Product Description | Plasma Frozen Cryoprecipitated Reduced |
|---|---|
| Code Info | 2487825 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2114-12 |
| Product Description | Cryoprecipitated AHF, Pooled |
|---|---|
| Code Info | 2424507, 2487825 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. |
| Product Quantity | 2 units |
| Recall Number | B-2115-12 |
| Product Description | Fresh Frozen Plasma |
|---|---|
| Code Info | 2590622, 2699615, 2522388 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. |
| Product Quantity | 3 units |
| Recall Number | B-2116-12 |
| Product Description | Recovered Plasma |
|---|---|
| Code Info | 2386094, 2424507, 2459485, 2613407, 2555602 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. |
| Product Quantity | 5 units |
| Recall Number | B-2117-12 |
| Product Description | Red Blood Cells Leukocytes Reduced |
|---|---|
| Code Info | 2386094, 2424507, 2459485, 2487825, 2522388, 2555602, 2590622, 2699615 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. |
| Product Quantity | 8 units |
| Recall Number | B-2118-12 |
| Product Description | Red Blood Cells (Apheresis) Leukocytes Reduced |
|---|---|
| Code Info | 6325565 (2 units) |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. |
| Product Quantity | 2 units |
| Recall Number | B-2119-12 |
Class II Devices Event
| Event ID | 62415 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 21-Mar-11 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Stryker Spine |
|---|---|
| City | Allendale |
| State | NJ |
| Country | US |
| Distribution Pattern | Nationwide Distribution including NC, AR, TN, MA, IL, GA, NY, LA, MN, MO, OH, KS, NM, TX, KS,and IN. |
Associated Products
| Product Description | Stryker Reliance AL Implant Blocker (Various sizes) Manufactured by: Stryker Spine SAS Z1 Marticot-33610-Cestas-France +33 ()) 5.57.97.08.30 http://www.stryker.com Distributed in the USA by: STryker Spine 2 Pearl Court Allendale NJ 07401-1677 USA +1-201-760-8000 The SLIDE Implant Blocker is a reusable instrument, sterilized prior to use. It allows the surgeon to distract the disc space in the lumbar region of the spine using an anterior or anterolateral approach while also allowing them to insert the implant into final position. |
|---|---|
| Code Info | Catalog Number: 48361223, 48361224, 48361225, 48361226, 48361227, 48361228 Lot Code: 084505, 084506, 084507, 084508, 084509, 084510 |
| Classification | Class II |
| Reason for Recall | Stryker Spine has received six reports regarding the breakage of one or more prongs at the extremity of the instrument. |
| Product Quantity | 109 Lots |
| Recall Number | Z-2176-2012 |
Class II Drugs Event
| Event ID | 62436 |
|---|---|
| Status | Ongoing |
| Product Type | Drugs |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 05-Apr-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Apotex Corp. |
|---|---|
| City | Weston |
| State | FL |
| Country | US |
| Distribution Pattern | Nationwide |
Associated Products
| Product Description | Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Strides Acrolab Ltd., Bangalore-560 076, India, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-3579-1. |
|---|---|
| Code Info | Lot: 7212558, Exp 12/12. |
| Classification | Class II |
| Reason for Recall | Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot. |
| Product Quantity | 1,749 Bottles |
| Recall Number | D-1443-2012 |
Class II Devices Event
| Event ID | 62444 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 26-Jul-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Terumo Cardiovascular Systems Corporation |
|---|---|
| City | Ann Arbor |
| State | MI |
| Country | US |
| Distribution Pattern | Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Japan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam. |
Associated Products
| Product Description | System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. |
|---|---|
| Code Info | catalog number: 801763 and serial numbers: 0011-0335, 0337-0610,1001-1034, 1037-1049,1100,1103-1106,1109-1450, and 1452. |
| Classification | Class II |
| Reason for Recall | Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined number of Terumo Advanced Perfusion System 1 users. The investigation of the malfunction found a faulty component on the modules' application board caused the failures. Terumo CVS replaced all modules in the affected population. Terumo CVS has subsequently received two additional reports of similar malfunctions. The ensuing investigation concluded that, though highly unlikely, it is possible for the same component to fail in any module. Therefore, Terumo CVS is sending a Safety Advisory (with the same instruction as was provided in AA-2010-007-C) to all Terumo System 1 users and is updating the Operator's Manual with instructions on how to respond to a failure. |
| Product Quantity | 992 units |
| Recall Number | Z-2177-2012 |
| Product Description | System 1 base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. |
|---|---|
| Code Info | catalog number: 801764 and serial numbers: 0006-0066, 0100-0311, 0313-0322, 1001-1027, 1100-1434, 1436, 1440, and 1441. |
| Classification | Class II |
| Reason for Recall | Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined number of Terumo Advanced Perfusion System 1 users. The investigation of the malfunction found a faulty component on the modules' application board caused the failures. Terumo CVS replaced all modules in the affected population. Terumo CVS has subsequently received two additional reports of similar malfunctions. The ensuing investigation concluded that, though highly unlikely, it is possible for the same component to fail in any module. Therefore, Terumo CVS is sending a Safety Advisory (with the same instruction as was provided in AA-2010-007-C) to all Terumo System 1 users and is updating the Operator's Manual with instructions on how to respond to a failure. |
| Product Quantity | 649 units |
| Recall Number | Z-2178-2012 |
Class II Devices Event
| Event ID | 62448 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 07-Jun-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
|---|---|
| City | Newark |
| State | DE |
| Country | US |
| Distribution Pattern | Worldwide distribution, including the countries of Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Italy, Netherlands, New Zealand, Slovakia, Spain, Switzerland and the United States, with nationwide distribution. Center Recall Depth is Retail. |
Associated Products
| Product Description | EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices. |
|---|---|
| Code Info | Version 5.0 and Version 5.0 Service Pack 1 through 4 |
| Classification | Class II |
| Reason for Recall | There is a potential for the EasyLink system to display and transmit to the Laboratory Information System networks an incorrect result following the EasyLink systems application of the configured result number format. The problem is encountered when the result number format configured on the Sysmex CA-7000 or CA-1500 coagulation analyzer does not match the EasyLink system settings on the following page. |
| Product Quantity | 237 |
| Recall Number | Z-2172-2012 |
Class II Devices Event
| Event ID | 62514 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 26-Mar-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Tango3 LLC |
|---|---|
| City | Simpsonville |
| State | KY |
| Country | US |
| Distribution Pattern | Product was shipped to the following states: CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, NH, NJ, NM, OH, PA, RI, TX and VA. |
Associated Products
| Product Description | TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY 40067. Models are WOZ-250-PE, WOZ-240-SS, WOZ-180-SS. The TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disinfection of the water distribution system of a dialysis facility. |
|---|---|
| Code Info | Model WOZ -250-PE, Serial #s: 1031, 1032, 1033, 1035, 1036, 1038, 1039, 1042, 1043, 1044, 1045, 1046, 1047, 1048, 1049, 1050, 1051, 1053, 1054, 1055, 1056, 1057, 1058, 1059, 1060, 1061, 1062, 1063, 1065, 1066, 1067, 1068, 1069, 1070, 1071, 1072, 1073, 1074, 1075, 1076 & 1077. Model WOZ-180-SS, Serial #s: 1034, 1037, 1040 & 1064. Model WOZ-240-SS, Serial #s: 1041 & 1052. |
| Classification | Class II |
| Reason for Recall | During an FDA inspection, the firm was notified of Quality System deficiencies, which included lack of procedures for design control and customized modifications that were either not reviewed or received proper clearance from FDA. There was no assurance that all systems in the field were working properly and operating at a minimum of 0.2ppm of ozone. |
| Product Quantity | 44 units |
| Recall Number | Z-2138-2012 |
Class II Devices Event
| Event ID | 62525 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 03-Jul-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Smith & Nephew, Inc. Endoscopy Division |
|---|---|
| City | Andover |
| State | MA |
| Country | US |
| Distribution Pattern | Worldwide Distribution - US Nationwide and the countries of: Argentina, AUSTRALIA, AUSTRIA, Belgium, CANADA,CHILE COLOMBIA, Denmark, DUBAI, FINLAND, FRANCE GDC BAAR Distribution,GERMANY, GREECE, INDIA ITALY, KOREA, MALAYSIA, MEXICO, NETHERLAND, NORWAY PORTUGAL, PUERTO RICO, SHANGHAI, SOUTH AFRICA SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM. |
Associated Products
| Product Description | Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles Product Usage: intended for use for the reattachment of soft tissue to bone Part Number: 72202618 |
|---|---|
| Code Info | Lot Numbers: 50396501, 50396505, 50396506, 50397570, 50408062, 50412964, 50416842: |
| Classification | Class II |
| Reason for Recall | Distal part of the anchor may break on insertion into bone during surgery |
| Product Quantity | 913 units |
| Recall Number | Z-2165-2012 |
| Product Description | Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile Part Number: 72202895 Product Usage: intended for use for the reattachment of soft tissue to bone |
|---|---|
| Code Info | Lot Numbers: 50388181, 50389102, 50392406, 50394176, 50395679, 50395801, 50399411, 50400927, 50402475, 50403491, 50407007, 50410403, 50412883, 50414234, 50415663, 50416800, 50418329, 50419173, 50421006, 50422555 |
| Classification | Class II |
| Reason for Recall | Distal part of the anchor may break on insertion into bone during surgery |
| Product Quantity | 4,661 units |
| Recall Number | Z-2166-2012 |
| Product Description | Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Part Number: 72202896 Product Usage: intended for use for the reattachment of soft tissue to bone |
|---|---|
| Code Info | Lot Numbers: 50388182, 50389253, 50391626, 50392272, 50392407, 50395081, 50395680, 50396197, 50400556, 50401558, 50402228, 50403940, 50406036, 50407582, 50409406, 50413407, 50414970, 50412647, 50415864, 50416801, 50418088, 50420654, 50421030, 50421495 |
| Classification | Class II |
| Reason for Recall | Distal part of the anchor may break on insertion into bone during surgery |
| Product Quantity | 2,204 units |
| Recall Number | Z-2167-2012 |
| Product Description | Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile Part Number: 72202897 Product Usage: intended for use for the reattachment of soft tissue to bone |
|---|---|
| Code Info | Lot Numbers: 50388188, 50389268, 50392431, 50393764, 50394899, 50395675, 50396849, 50397464, 50398727, 50399817, 50400184, 50402082, 50403278, 50405085, 50406197, 50406805, 50408994, 50410001, 50412043, 50412967, 50414260, 50415224, 50416542, 50415681, 50417216, 50418491, 50420660, 50421624 |
| Classification | Class II |
| Reason for Recall | Distal part of the anchor may break on insertion into bone during surgery |
| Product Quantity | 4,411 units |
| Recall Number | Z-2168-2012 |
Class II Devices Event
| Event ID | 62533 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 01-Feb-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Abbott Point Of Care Inc. |
|---|---|
| City | Princeton |
| State | NJ |
| Country | US |
| Distribution Pattern | Worldwide Distribution - USA including AZ and CO and internationally to Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Chile, China, Columbia, Costa Rica, Dominican Republic, El Salvador, Finland, France, Georgia, Germany, Greece, Honduras, Hong Kong, India, Ireland, Italy, Korea, Kuwait, Mauritius, Mexico, Netherland (Antilles), Nigeria, Norway, Oman, Paraquay, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, R.O.C., Thailand, UAE, United Kingdom, and Yemen. |
Associated Products
| Product Description | i-Stat cTnl cartridges Abbott Point of Care Inc. Abbott Park, IL 60064 USA The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. The cartridge is to be used with the i-Stat Analyzer, but not with the i-Stat Portable Clinical Analyzer or the Philips Medical System (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-Stat System, the cTnl test is to be used by trained health care professionals in accordance with a facility's policies and procedures. |
|---|---|
| Code Info | List number 06F15-03, 06F15-04, 03P90-23, 600-9009-25 All lots |
| Classification | Class II |
| Reason for Recall | Abbott Point of Care has determined that the frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure. |
| Product Quantity | 7,057,675 cartridges US ; 772,400 OUS |
| Recall Number | Z-2169-2012 |
| Product Description | i-Stat BNP cartridges Abbott Point of Care Inc. Abbott Park, IL 60064 USA The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuertic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure. |
|---|---|
| Code Info | List number 06F30-01, 06F30-02, 03P93-25, 600-9010-25 All lots |
| Classification | Class II |
| Reason for Recall | Abbott Point of Care has determined that the frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure. |
| Product Quantity | 1,004,200 cartridges US; 54,200 cartridges OUS |
| Recall Number | Z-2170-2012 |
| Product Description | i-Stat CK-MP cartridges Abbott Point of Care Inc. Abbott Park, IL 60064 USA The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (MI). |
|---|---|
| Code Info | List number 06F25-01, 06F25-02, 03P92-25, All lots |
| Classification | Class II |
| Reason for Recall | Abbott Point of Care has determined that the frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure. |
| Product Quantity | 368,149 cartridges US; 32,725 OUS |
| Recall Number | Z-2171-2012 |
Class II Devices Event
| Event ID | 62536 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 01-Mar-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Abbott Point Of Care Inc. |
|---|---|
| City | Princeton |
| State | NJ |
| Country | US |
| Distribution Pattern | Worldwide Distribution -- (USA) nationwide |
Associated Products
| Product Description | I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin. |
|---|---|
| Code Info | List number 04J50-01 04J5O-02 03P89-24 Lots begininng with R11 or R12 |
| Classification | Class II |
| Reason for Recall | The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results. |
| Product Quantity | 2,950,296 cartridges US; 156,408 cartridges OUS |
| Recall Number | Z-2157-2012 |
Class II Food/Cosmetics Event
| Event ID | 62542 |
|---|---|
| Status | Ongoing |
| Product Type | Food/Cosmetics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 26-Jun-12 |
| Initial Firm Notification of Consignee or Public |
| Recalling Firm | Two Chefs On A Roll, Inc |
|---|---|
| City | Carson |
| State | CA |
| Country | US |
| Distribution Pattern | Product is manufactured for and distributed to Maya Kaimal Fine Indian Foods, 4755 27th Street, Long Island City, NY (PO Box 700, Rhinebeck, NY 12572). Secondary distribution to accounts in CT, MA, ME, NH, NJ, NY, RI and VT. |
Associated Products
| Product Description | Maya Kaimal All Natural Coconut Curry Indian Simmer Sauce, Net Wt 15 oz, Medium, Coconut Milk & Ginger (refrigerated product in flexible plastic tub) |
|---|---|
| Code Info | Use by code 08/16/12, UPC 89175600037 |
| Classification | Class II |
| Reason for Recall | Product is being recalled due to bloated containers. |
| Product Quantity | 888 cups |
| Recall Number | F-1925-2012 |
Class II Devices Event
| Event ID | 62551 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 11-Jul-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Philips Healthcare Inc. |
|---|---|
| City | Andover |
| State | MA |
| Country | US |
| Distribution Pattern | Worldwide Distribution - US (nationwide) including the states of CA, CT, MI, MN, MN, NC, NY, NY, VA and the countries of Belgium, Columbia, Czech Republic and Denmark. France Germany Italy Latvia Luxembourg Netherlands Russian Fed. Spain Sweden Switzerland Thailand United Kingdom |
Associated Products
| Product Description | Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System |
|---|---|
| Code Info | US Serial Numbers: 96 104 111 120 170 222 223 272 278 WW: 41 70 83 96 104 111 120 132 154 155 156 157 167 170 171 176 179 190 194 195 200 208 216 222 223 224 237 244 245 247 248 249 251 253 259 261 262 264 265 272 278 |
| Classification | Class II |
| Reason for Recall | When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired. |
| Product Quantity | 41 units |
| Recall Number | Z-2156-2012 |
Class II Devices Event
| Event ID | 62556 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 06-Jul-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | FMS, Finapres Medical Systems BV |
|---|---|
| City | Amsterdam |
| State | |
| Country | NL |
| Distribution Pattern | US Nationwide Distribution - including the states of: OH and NY |
Associated Products
| Product Description | Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used. |
|---|---|
| Code Info | Serial Numbers: 12 02 006, 12 02 008, 12 02 013 |
| Classification | Class II |
| Reason for Recall | Battery may become hot and leak |
| Product Quantity | 3 units US |
| Recall Number | Z-2150-2012 |
Class II Devices Event
| Event ID | 62561 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 16-Jul-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Encore Medical, Lp |
|---|---|
| City | Austin |
| State | TX |
| Country | US |
| Distribution Pattern | Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT. |
Associated Products
| Product Description | djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair |
|---|---|
| Code Info | Lot 007A1037, Ref 010-55-25. |
| Classification | Class II |
| Reason for Recall | One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually 25mm. |
| Product Quantity | 18 devices |
| Recall Number | Z-2146-2012 |
Class II Devices Event
| Event ID | 62562 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 02-Jul-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Varian Medical Systems, Inc. Oncology Systems |
|---|---|
| City | Palo Alto |
| State | CA |
| Country | US |
| Distribution Pattern | Nationwide Distribution including the states of New York and Ohio. |
Associated Products
| Product Description | Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information. |
|---|---|
| Code Info | Serial Numbers/CODES: HIT0535, HIT2953 |
| Classification | Class II |
| Reason for Recall | A software anomaly has been identified with the Import Export Application version 11.0 where MLC leaf positions for plans using BrainLab m3 and mMLC are incorrectly imported. |
| Product Quantity | 2 Units. |
| Recall Number | Z-2153-2012 |
Class II Devices Event
| Event ID | 62575 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 11-Jul-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Straumann USA, LLC |
|---|---|
| City | Andover |
| State | MA |
| Country | US |
| Distribution Pattern | US Nationwide Distribution including the countries of FL, IN, LA, NY and TX. |
Associated Products
| Product Description | Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations using a Straumann Narrow CrossFit CARES ZrO2 Abutment in edentulous or partially edentulous patients. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function a Straumann Narrow CrossFit CARES ZrO2 abutment is attached by screw to the dental implant. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used. |
|---|---|
| Code Info | 26217US_10008_00_b00; 25262US_10115_00_b05; 25262US_10115_00_b06; 21408US_10073_00_b01; 26199US _10021_00_b00; 25143US_ 10215_00_ b01; 25267US_10278- 00_ b01; 25267US _10280_ 00_b01; 25267US_ 1280_ 00_b03; 25310US_10342_03_b01; 25310US_10342_03_b03; 25310US_10342_03_b05; 25310US_10345_00_b01; 26249US_10019_00_b01; |
| Classification | Class II |
| Reason for Recall | Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC Abutment ZrO2 |
| Product Quantity | 14 Distributed in US |
| Recall Number | Z-2161-2012 |
Class II Devices Event
| Event ID | 62583 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 02-Jul-12 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Recalling Firm | Transenterix, Inc |
|---|---|
| City | Morrisville |
| State | NC |
| Country | US |
| Distribution Pattern | Worldwide Distribution - USA (nationwide) and the countries of Austria, Germany, Italy, Qatar and Switzerland |
Associated Products
| Product Description | SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER® Surgical Instruments are intended for use in minimally invasive surgical procedures for grasping, mobilizing, dissecting, retracting, cutting, cauterizing, ligating, suction/irrigation and other manipulation of tissues and vessels during a laparoscopic procedure under direct and/or endoscopic visualization. |
|---|---|
| Code Info | Model Number: 9000029, Lot #DC301112, Exp. Date: Oct 2013; Lot #DC313111, Exp. Date: Nov 2013; Lot #DC061121, Exp. Date: Mar 2013; Lot #DC082122, Exp. Date: Feb 2014; Lot #DC168112, Exp. Date: Jun 2013; Lot #DC265111 Exp. Date: Sept 2013; Lot #DC341111, Exp. Date: Dec 2013; Lot #DC019125, Exp. Date: Jan 2014; Lot #DC061122, Exp. Date: Mar 2014; Lot #DC082121, Exp. Date: Feb 2014; Lot #DC102122, Exp. Date: Apr 2014; Lot #DC102123, Exp. Date: Apr 2014 and Lot #DC144121, Exp. Date: May 2014. |
| Classification | Class II |
| Reason for Recall | Some clip applier units may be inadequate to achieve clip closure. |
| Product Quantity | 89 boxes(6 units per box) |
| Recall Number | Z-2137-2012 |
Class II Devices Event
| Event ID | 62595 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 02-Jul-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Greiner Bio-One North America, Inc. |
|---|---|
| City | Monroe |
| State | NC |
| Country | US |
| Distribution Pattern | Nationwide Distribution |
Associated Products
| Product Description | 3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes. |
|---|---|
| Code Info | Lot #B041206 |
| Classification | Class II |
| Reason for Recall | Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests. |
| Product Quantity | 838.9 cases (1,006,700 pieces) |
| Recall Number | Z-2154-2012 |
Class II Devices Event
| Event ID | 62596 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 27-Apr-12 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Recalling Firm | Kimberly-Clark Corporation |
|---|---|
| City | Roswell |
| State | GA |
| Country | US |
| Distribution Pattern | Nationwide Distribution-including the states of AZ, CA, CO, DE, FL, GA, IA, ID, IN, IL, KS, KY, LA, MA, MD, ME, MO, MS, NE, NM, OH, OR, PA, RI, SC, TN, TX, VA, WI and WV. |
Associated Products
| Product Description | Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient Warming System - Model 1000 Control Unit and Energy Transfer Pads is a thermal regulating system, indicated for monitoring and controlling patient temperature. |
|---|---|
| Code Info | Catalogue #01000-01 and 01000-01R, Units with 4-Digit Serial Numbers: Lot #4297, 4324, 4332, 4519, 4559, 4572; Units with 10 Character Serial Numbers: SA08017027, SA08017028, SA08017029, SA08017030, SA08017031, SA08017032, SA08017033, SA08017034, SA08017035, SA08017036, SA08017037, SA08017038, SA08017039, SA08017040, SA08017041, SA08017042, SA08017043, SA08017044, SA08017045, SA08017046, SA08017047, SA08017048, SA08017049, SA08343100, SA11137004, SA11137005, SA11137006, SA11137007, SA11137008, SA08094124, SA08094125, SA08094126, SA08094127, SA08094128, SA08094129, SA08094130, SA08094131, SA08094132, SA08094133, SA08094134, SA08094135, SA08094136, SA08094137, SA08094138, SA08094139, SA08094140, SA08094141, SA08094142, SA08094143, SA08094144, SA08094145, SA08094146, SA08094147, SA08094148, SA08094149, SA08094150, SA08094151, SA08094152, SA08094153, SA09020004, SA09020005, SA09020007, SA09020008, SA09020010, SA09020013, SA11298011, SA11298012, SA11298013, SA11298014, SA11298015, SA11298016, SA11298017, SA11298018, SA11298019, SA08136001, SA08136002, SA08136003, SA08136004, SA08136005, SA08136006, SA08136007, SA08136008, SA08136009, SA08136010, SA09043001, SA09043002, SA09043003, SA09043004, SA09043007, SA09043008, SA09043009, SA09043010, SA09043010, SA09043011, SA09043012, SA09043013, SA09043014, SA09043015, SA09043016, SA09043017, SA09043018, SA09043019, SA09043020, SA08343061, SA08343082, SA08343083, SA08343084, SA08343085, SA08343086, SA08343087, SA08343088, SA08343089, SA08343090, SA08343091, SA08343092, SA08343093, SA08343094, SA08343095, SA08343096, SA10337006, SA10337007, SA10337008, SA10337009 and SA10337010. |
| Classification | Class II |
| Reason for Recall | A defect of the "fuse holder" can lead to a Control Unit failure that may cause the device to lose its ability to warm and maintain set temperature and may also result in excessive heat with the fuse assembly that could lead to the generation of smoke. |
| Product Quantity | 129 units |
| Recall Number | Z-2181-2012 |
Class II Drugs Event
| Event ID | 62604 |
|---|---|
| Status | Ongoing |
| Product Type | Drugs |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 22-Jun-11 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Recalling Firm | Nephron Pharmaceuticals Corp. |
|---|---|
| City | Orlando |
| State | FL |
| Country | US |
| Distribution Pattern | Nationwide and Puerto Rico |
Associated Products
| Product Description | Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 32811, NDC 0487-9501-60. |
|---|---|
| Code Info | Lot #: A0654A, Exp 07/12; A0A62A, Exp 10/12 |
| Classification | Class II |
| Reason for Recall | Lack of Assurance of Sterility |
| Product Quantity | 56,028 cartons |
| Recall Number | D-1446-2012 |
Class II Devices Event
| Event ID | 62611 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 17-Jul-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
|---|---|
| City | Newark |
| State | DE |
| Country | US |
| Distribution Pattern | Distributed in the US including Washington, DC, Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WI, WV, and WY and the Virgin and Pacific Islands. |
Associated Products
| Product Description | Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare Diagnostics Dimension(R) clinical chemistry analyzers are floor model, fully automated, microprocessor-controlled, integrated instrument systems that use prepackaged Flex(R) reagent test cartridges to measure a variety of analytes in human body fluids. |
|---|---|
| Code Info | Serial numbers 99060001 - 99062554 |
| Classification | Class II |
| Reason for Recall | Siemens Healthcare Diagnostics has confirmed that partial insertion of the power cord on the Dimension Reagent Management System (RMS) power input module can cause the plug to overheat and potentially create a fire hazard. RMS without a power cord retention clip may be affected. |
| Product Quantity | 2,554 |
| Recall Number | Z-2182-2012 |
Class II Food/Cosmetics Event
| Event ID | 62616 |
|---|---|
| Status | Ongoing |
| Product Type | Food/Cosmetics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 07-Aug-12 |
| Initial Firm Notification of Consignee or Public | Visit |
| Recalling Firm | Pal-Do Company, Inc d.b.a. Pal-Do World |
|---|---|
| City | Lakewood |
| State | WA |
| Country | US |
| Distribution Pattern | Product was distributed to one consignee in Lakewood, WA. |
Associated Products
| Product Description | Frozen fermented seasoned oysters, bulk packaged 22 lbs per case. |
|---|---|
| Code Info | no codes |
| Classification | Class II |
| Reason for Recall | Korean frozen fermented seasoned oysters being recalled because the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. |
| Product Quantity | 440 lbs. |
| Recall Number | F-1861-2012 |
Class II Devices Event
| Event ID | 62617 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 14-Jul-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Smith & Nephew, Inc. Endoscopy Division |
|---|---|
| City | Andover |
| State | MA |
| Country | US |
| Distribution Pattern | Worldwide Distribution - US Nationwide and the countries of : Australia, Canada, Korea, Turkey, UAE, and Japan. |
Associated Products
| Product Description | Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade Resector is effective in soft and osseous tissue resection and in hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringers lactate or other conductive solutions as an irrigant under direct or video assisted fiberoptic visualization. |
|---|---|
| Code Info | Lot Numbers: 950135R, 950136R, 950137R, 950138R |
| Classification | Class II |
| Reason for Recall | Devices labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated. |
| Product Quantity | 340 units |
| Recall Number | Z-2144-2012 |
| Product Description | Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade Resector is effective in soft and osseous tissue resection and in hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringers lactate or other conductive solutions as an irrigant under direct or video assisted fiberoptic visualization. |
|---|---|
| Code Info | Lot Numbers: 655844R, 950143R, 950144R, 950145R, 950146R |
| Classification | Class II |
| Reason for Recall | Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated. |
| Product Quantity | 108 units |
| Recall Number | Z-2145-2012 |
Class II Devices Event
| Event ID | 62648 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 23-Apr-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Stryker Spine |
|---|---|
| City | Allendale |
| State | NJ |
| Country | US |
| Distribution Pattern | Worldwide Distribution -- US, Switzerland, Netherlands, Brazil, Hong Kong, Germany, and Taiwan. |
Associated Products
| Product Description | LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I MARTICOT-33610-CESTAS-FRANCE; Distributed in the USA by: Stryker Spine. 2 Pearl Ct. Allendale, NJ 07401. Provides access to the thoracic and lumbar spine from a posterior approach via a small incision. |
|---|---|
| Code Info | Lot Code: 093309 |
| Classification | Class II |
| Reason for Recall | Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from the base causing the retractor to collapse insitu. |
| Product Quantity | 30 devices |
| Recall Number | Z-2155-2012 |
Class II Devices Event
| Event ID | 62665 |
|---|---|
| Status | Completed |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 06-Jul-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Linvatec Corp. dba ConMed Linvatec |
|---|---|
| City | Largo |
| State | FL |
| Country | US |
| Distribution Pattern | Worldwide Distribution -- US and Korea. |
Associated Products
| Product Description | PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch. |
|---|---|
| Code Info | Lot 318455 |
| Classification | Class II |
| Reason for Recall | ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm when it should have been 3.5mm. |
| Product Quantity | 2 |
| Recall Number | Z-2151-2012 |
Class II Drugs Event
| Event ID | 62698 |
|---|---|
| Status | Completed |
| Product Type | Drugs |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 21-Jun-12 |
| Initial Firm Notification of Consignee or Public | Visit |
| Recalling Firm | Oklahoma Respiratory Care Inc |
|---|---|
| City | Norman |
| State | OK |
| Country | US |
| Distribution Pattern | OK |
Associated Products
| Product Description | OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L, Rx only, Oklahoma Respiratory Care, Norman, OK |
|---|---|
| Code Info | All lots distributed January 1, 2011 - October 18, 2011. |
| Classification | Class II |
| Reason for Recall | CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation |
| Product Quantity | 861 cylinders |
| Recall Number | D-1445-2012 |
Class II Food/Cosmetics Event
| Event ID | 62717 |
|---|---|
| Status | Terminated |
| Product Type | Food/Cosmetics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 18-May-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | High Liner Foods Inc. |
|---|---|
| City | Portsmouth |
| State | NH |
| Country | US |
| Distribution Pattern | Nationwide |
Associated Products
| Product Description | Fishery Products International (FPI) Brand : Frozen Breaded Raw Oysters, Net Wt. 10 lbs (4.54 kg) Manufactured by: High Liner Foods, Portsmouth, NH 03801 SKU#: 89695 |
|---|---|
| Code Info | All lot codes from May 2010 |
| Classification | Class II |
| Reason for Recall | The product was manufactured with Korean Molluscan Shellfish which are considered adulterated as they may have been harvested from polluted waters. FDA revoked approval status for all Molluscan shellfish shippers from South Korea as of May 1, 2012. |
| Product Quantity | 2,048 cases |
| Recall Number | F-1846-2012 |
Class II Devices Event
| Event ID | 62747 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 03-Aug-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Medical Specialties Distributors, Inc. |
|---|---|
| City | Stoughton |
| State | MA |
| Country | US |
| Distribution Pattern | Nationwide Distribution |
Associated Products
| Product Description | Medstream 81" (206cm) 20 Universal Administration Set with Y-Site, Sterile Manufactured for MSD (Medical Specialties Distributors LLC, Stoughton, MA. Product of China Product Number: MS721 Disposable Infusion set |
|---|---|
| Code Info | LOT NUMBER: 20111115 |
| Classification | Class II |
| Reason for Recall | Devices leaking at the Y-site |
| Product Quantity | 472 cases (50/case) |
| Recall Number | Z-2179-2012 |
Class II Food/Cosmetics Event
| Event ID | 62784 |
|---|---|
| Status | Terminated |
| Product Type | Food/Cosmetics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 28-Jun-12 |
| Initial Firm Notification of Consignee or Public | FAX |
| Recalling Firm | SJBW Corp |
|---|---|
| City | Los Angeles |
| State | CA |
| Country | US |
| Distribution Pattern | CA, NV, GA, WA |
Associated Products
| Product Description | Frozen Fermented Salted and Seasoned Oyster, 39.7 lbs, 2 packs/container. |
|---|---|
| Code Info | not available. |
| Classification | Class II |
| Reason for Recall | Charm Han Enterprise Inc. is recalling seasoned oyster because it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. |
| Product Quantity | 40 units |
| Recall Number | F-1931-2012 |
Class III Biologics Event
| Event ID | 40477 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 28-Jul-05 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Recalling Firm | Community Blood Center of Greater Kansas City |
|---|---|
| City | Kansas City |
| State | MO |
| Country | US |
| Distribution Pattern | MO |
Associated Products
| Product Description | Red Blood Cells Leukocytes Reduced |
|---|---|
| Code Info | W045005058349; W045005058368 |
| Classification | Class III |
| Reason for Recall | Blood products, which may have been exposed to unacceptable storage temperatures, were distributed. |
| Product Quantity | 2 units |
| Recall Number | B-2048-12 |
Class III Biologics Event
| Event ID | 40560 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 02-Aug-05 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Recalling Firm | Community Blood Center of Greater Kansas City |
|---|---|
| City | Kansas City |
| State | MO |
| Country | US |
| Distribution Pattern | MO |
Associated Products
| Product Description | Red Blood Cells Leukocytes Reduced |
|---|---|
| Code Info | W045005053221 |
| Classification | Class III |
| Reason for Recall | Blood product, which did not have the preservative solution added but labeled with a 42 day expiration date, was distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2049-12 |
Class III Biologics Event
| Event ID | 40721 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 02-Sep-05 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Recalling Firm | Community Blood Center of Greater Kansas City |
|---|---|
| City | Kansas City |
| State | MO |
| Country | US |
| Distribution Pattern | MO |
Associated Products
| Product Description | Red Blood Cells Leukocytes Reduced |
|---|---|
| Code Info | W045005075084 |
| Classification | Class III |
| Reason for Recall | Blood product, which did not have the preservative solution added but labeled with a 42 day expiration date, was distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2050-12 |
Class III Biologics Event
| Event ID | 62010 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 09-May-12 |
| Initial Firm Notification of Consignee or Public |
| Recalling Firm | Plasmacare Inc |
|---|---|
| City | Cleveland |
| State | OH |
| Country | US |
| Distribution Pattern | CA |
Associated Products
| Product Description | Source Plasma |
|---|---|
| Code Info | 2160057721; 2160058109; 2160060202; 2160073434; 2160078442; |
| Classification | Class III |
| Reason for Recall | Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. |
| Product Quantity | 5 units |
| Recall Number | B-2032-12 |
Class III Biologics Event
| Event ID | 62258 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 09-May-12 |
| Initial Firm Notification of Consignee or Public |
| Recalling Firm | Plasmacare Inc |
|---|---|
| City | Cleveland |
| State | OH |
| Country | US |
| Distribution Pattern | CA |
Associated Products
| Product Description | Source Plasma |
|---|---|
| Code Info | 2160080280; 2160063587; 2160083178 |
| Classification | Class III |
| Reason for Recall | Blood products, collected from a donor, whose suitability to donate was not adequately determined, was distributed. |
| Product Quantity | 3 units |
| Recall Number | B-2274-12 |
Class III Biologics Event
| Event ID | 62259 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 09-May-12 |
| Initial Firm Notification of Consignee or Public |
| Recalling Firm | Plasmacare Inc |
|---|---|
| City | Cleveland |
| State | OH |
| Country | US |
| Distribution Pattern | CA |
Associated Products
| Product Description | Source Plasma |
|---|---|
| Code Info | 2160077796 |
| Classification | Class III |
| Reason for Recall | Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2276-12 |
Class III Biologics Event
| Event ID | 62260 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 09-May-12 |
| Initial Firm Notification of Consignee or Public |
| Recalling Firm | Plasmacare Inc |
|---|---|
| City | Cleveland |
| State | OH |
| Country | US |
| Distribution Pattern | CA |
Associated Products
| Product Description | Source Plasma |
|---|---|
| Code Info | 2160080329; 2160082127 |
| Classification | Class III |
| Reason for Recall | Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. |
| Product Quantity | 2 units |
| Recall Number | B-2277-12 |
Class III Biologics Event
| Event ID | 62261 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 09-May-12 |
| Initial Firm Notification of Consignee or Public |
| Recalling Firm | Plasmacare Inc |
|---|---|
| City | Cleveland |
| State | OH |
| Country | US |
| Distribution Pattern | CA |
Associated Products
| Product Description | Source Plasma |
|---|---|
| Code Info | 2160076394 |
| Classification | Class III |
| Reason for Recall | Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2275-12 |
Class III Biologics Event
| Event ID | 62266 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 19-Apr-12 |
| Initial Firm Notification of Consignee or Public | FAX |
| Recalling Firm | Interstate Blood Bank, Inc. WI |
|---|---|
| City | Kenosha |
| State | WI |
| Country | US |
| Distribution Pattern | CA |
Associated Products
| Product Description | Source Plasma |
|---|---|
| Code Info | 12KWIA3540; 12KWIA3311; 12KWIA2924 |
| Classification | Class III |
| Reason for Recall | Blood products, collected from a donor who was previously deferred, were distributed. |
| Product Quantity | 3 units |
| Recall Number | B-2279-12 |
Class III Biologics Event
| Event ID | 62355 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 10-May-12 |
| Initial Firm Notification of Consignee or Public | FAX |
| Recalling Firm | Florida's Blood Centers, Inc. |
|---|---|
| City | Orlando |
| State | FL |
| Country | US |
| Distribution Pattern | Florida |
Associated Products
| Product Description | Red Blood Cells Leukocytes Reduced |
|---|---|
| Code Info | W038111305828 |
| Classification | Class III |
| Reason for Recall | Blood product, collected from a therapeutic donor with a history of polycythemia vera, was distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2134-12 |
Class III Biologics Event
| Event ID | 62356 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 26-May-12 |
| Initial Firm Notification of Consignee or Public | FAX |
| Recalling Firm | Talecris Plasma Resources, Inc. |
|---|---|
| City | Indianapolis |
| State | IN |
| Country | US |
| Distribution Pattern | North Carolina |
Associated Products
| Product Description | Source Plasma |
|---|---|
| Code Info | 3270188347, 3270187833, 3270186174, 3270185904, 3270184947, 3270209668, 3270209101, 3270208775, 3270208200, 3270207880, 3270207303, 3270206968, 3270206410, 3270206106, 3270205543, 3270205233, 3270204604, 3270204322, 3270203751, 3270203417, 3270202882, 3270202560, 3270202006, 3270201709, 3270201150, 3270200829, 3270200273, 3270199969, 3270199389, 3270199089, 3270198499, 3270198181, 3270197543, 3270197188, 3270196532, 3270196114, 3270195019, 3270194450, 3270193990, 3270193500, 3270191564, 3270190082, 3270188723, 3270187148, 3270185258, 3270192964, 3270192093, 3270191039, 3270190592, 3270189609, 3270189148 |
| Classification | Class III |
| Reason for Recall | Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. |
| Product Quantity | 51 units |
| Recall Number | B-2133-12 |
Class III Biologics Event
| Event ID | 62357 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 22-Apr-12 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Recalling Firm | Memorial Blood Centers |
|---|---|
| City | Saint Paul |
| State | MN |
| Country | US |
| Distribution Pattern | Minnesota |
Associated Products
| Product Description | Red Blood Cells, Irradiated, Leukocytes Reduced, Plasma Reduced |
|---|---|
| Code Info | W051512035031 |
| Classification | Class III |
| Reason for Recall | Blood product, labeled with an extended expiration date, was distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2132-12 |
Class III Devices Event
| Event ID | 62500 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 24-Feb-12 |
| Initial Firm Notification of Consignee or Public |
| Recalling Firm | Roche Molecular Systems, Inc. |
|---|---|
| City | Branchburg |
| State | NJ |
| Country | US |
| Distribution Pattern | Worldwide Distribution - including the countries of Austria, Belgium, Czech Republic, Denmark, Germany, Italy, Luxemburg, Netherlands, Poland, Slovakia, Slovenia, Spain, United Kingdom, Canada, Chile, Greenland, Hong Kong, Israel, Malaysia, New Zealand, Philippines, S. Africa, Switzerland, Taiwan and Turkey. |
Associated Products
| Product Description | cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The cobas KRAS Mutation Test, for use with the cobas 4800 System, is a real-time PCR test intended for the identification of mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer (CRC). |
|---|---|
| Code Info | 05852170190; Lot P06778 |
| Classification | Class III |
| Reason for Recall | During the real-time stability testing for the cobas KRAS Mutation Test on the commercial lot PO6778, it was identified that the kit was just within specifications for the codon 61 peak height ratio, and that the kit has trended towards the upper specification limit at the 6 month time point but did passed the 6 month stability testing. The kit is labeled for 9 months shelf life stability. The data shows that the commercial kits are degrading at an accelerated rate when compared to pilot lots. The degradation will lead to an increased rate of invalid results but will not cause incorrect calls. |
| Product Quantity | 264 kits to 13 EU countries; 2 kits to Canada and 33 kits to 11 countries in the Rest of the World |
| Recall Number | Z-2159-2012 |
Class III Devices Event
| Event ID | 62535 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 19-Mar-12 |
| Initial Firm Notification of Consignee or Public |
| Recalling Firm | Impact Instrumentation, Inc. |
|---|---|
| City | West Caldwell |
| State | NJ |
| Country | US |
| Distribution Pattern | US Distribution to the state of Illinois. |
Associated Products
| Product Description | Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation. |
|---|---|
| Code Info | Serial numbers: VCDB120315, VCDB120316, VCDB120299, VCDB120300, VCDB120313, VCDB120307, VCDB120312, VCDB120303, VCDB120310, VCDB120297. |
| Classification | Class III |
| Reason for Recall | Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was completed for a new integrated circuit (IC) on the CPU PCB. |
| Product Quantity | Ten Units |
| Recall Number | Z-2152-2012 |
Class III Devices Event
| Event ID | 62609 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 17-Jul-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
|---|---|
| City | Newark |
| State | DE |
| Country | US |
| Distribution Pattern | Worldwide Distribution -- US, including Washington, DC and the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WV, and the countries of Canada, New Zealand, Germany, and Puerto Rico. |
Associated Products
| Product Description | Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system. |
|---|---|
| Code Info | lot 12095AD, exp 2013-04-04 |
| Classification | Class III |
| Reason for Recall | Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) reagent cartridge lot 12095AD. This results in a slope failure and prevents the VANC assay from being run on the Dimension Vista(R) System. |
| Product Quantity | 1,894 cartons |
| Recall Number | Z-2175-2012 |
Class III Food/Cosmetics Event
| Event ID | 62653 |
|---|---|
| Status | Ongoing |
| Product Type | Food/Cosmetics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 18-Apr-12 |
| Initial Firm Notification of Consignee or Public |
| Recalling Firm | Naturex Inc. |
|---|---|
| City | S Hackensack |
| State | NJ |
| Country | US |
| Distribution Pattern | 1 firm in New Jersey and 1 firm in South Carolina |
Associated Products
| Product Description | Dried Brewers Yeast TG_YFS004 Naturex 375 Huyler Street, South Hackensack, NJ 07606 USA Phone: 1 201 440 5000 Net Wt 25 kg |
|---|---|
| Code Info | Lot #0215/007/A11 Lot #C308/029/A11 |
| Classification | Class III |
| Reason for Recall | The affected lots were tested and found to contain an unusual high level of selenium. |
| Product Quantity | 4500 kg |
| Recall Number | F-1858-2012 |
Class III Devices Event
| Event ID | 62683 |
|---|---|
| Status | Ongoing |
| Product Type | Devices |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 10-Jul-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Recalling Firm | Berchtold Corp. |
|---|---|
| City | N Charleston |
| State | SC |
| Country | US |
| Distribution Pattern | Nationwide Distribution including FL, MI, MS, and NH. |
Associated Products
| Product Description | Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures. |
|---|---|
| Code Info | Serial numbers: 350111-S10017, 350111-S10018, 350111-S10019, 350111-S10020, 350111-S10021, 350111-S10022, 350111-S10023, 350111-S10024, 350111-S10025, 350111-S10026, 350111-S10027, 350111-S10028, 350111-S10030, 350111-S10031, 350111-S10032, 350111-S10033, 350111-S10034, 350111-S10035, 350111-S10036, 350111-S10037, 350111-S10038, 350111-S10039, 350111-S10040, 350111-S10041, 350111-S10043, 350111-S10044, 350111-S10045, 350111-S10046, 350111-S10047, 350111-S10048, 350111-S10049, 350111-S10050, 350111-S10051, 350111-S10052, 350111-S10053, 350111-S10054, 350111-S10055, 350111-S10056, 350111-S10060, 350111-S10061, 350111-S10062, 350111-S10063, 350111-S10064, 350111-S10065, 350111-S10066, 350111-S10067, 350111-S10068, 350111-S10069, 350111-S10070, 350111-S10071, 350111-S10072, 350111-S10073, 350111-S10074, 350111-S10075, 350111-S10076, 350111-S10077, 350111-S10078, 350111-S10079, 350111-S10080, 350111-S10081, 350111-S10082, 350111-S10083, 350111-S10084, 350111-S10085, 350111-S10086, 350111-S10087, 350111-S10088, 350111-S10089, 350111-S10090, 350111-S10091, 350111-S10092, 350111-S10093, 350111-S10094, 350111-S10095, 350111-S10096, 350111-S10097, 350111-S10098, 350111-S10099, 350111-S10100, 350111-S10101, 350111-S10102, 350111-S10103, 350111-S10104, 350111-S10105, 350111-S10106, 350111-S10107, 350111-S10108, 350111-S10109, 350111-S10110, 350111-S10111, 350111-S10112, 350111-S10113, 350111-S10114, 350111-S10115, 350111-S10116, 350111-S10117, 350111-S10118, 350111-S10119, 350111-S10120, 350111-S10121, 350111-S10122, 350111-S10123, 350111-S10124, 350111-S10125, 350111-S10126, 350111-S10127, 350111-S10128, 350111-S10129, 350111-S10130, 350111-S10131, 350111-S10132, 350111-S10133, 350111-S10134, 350111-S10135, 350111-S10136, 350111-S10137, 350111-S10138, 350111-S10139, 350111-S10140, 350111-S10141, 350111-S10142, 350111-S10143, 350111-S10144, 350111-S10145, 350111-S10146, 350111-S10147, 350111-S10148, 350111-S10149, 350111-S10150, 350111-S10151, 350111-S10152, 350111-S10153, 350111-S10154, 350111-S10155, 350111-S10156, 350111-S10157, 350111-S10158, 350111-S10159, 350111-S10160, 350111-S10161, 350111-S10162, 350111-S10164, 350111-S10165, 350111-S10166, 350111-S10167, 350111-S10168, 350111-S10169, 350111-S10170, 350111-S10171, 350111-S10172, 350111-S10173, 350111-S10176, 350111-S10177, 350111-S10178, 350111-S10179, 350111-S10180, 350111-S10181, 350111-S10192, 350111-S10193, 350111-S10194, 350111-S10195, 350111-S10196, 350111-S10197, 350111-S10198, 350111-S10199, 350111-S10200, 350111-S10201, 350111-S10202, 350111-S10203, 350111-S10204, 350111-S10205, 350111-S10206, 350111-S10207, 350111-S10208, 350111-S10209, 350111-S10210, 350111-S10211, 350111-S10212, 350111-S10213, 350111-S10215, 350111-S10216, 350111-S10218, 350111-S10219, 350111-S10220, 350111-S10221, 350111-S10222, 350111-S10223, 350111-S10224, 350111-S10225, 350111-S10226, 350111-S10227, 350111-S10228, 350111-S10229, 350111-S10230, 350111-S10231, 350111-S10232, 350111-S10233, 350111-S10234, 350111-S10235, 350111-S10236, 350111-S10237, 350111-S10238, 350111-S10239, 350111-S10248, 350111-S10249, 350111-S10250, 350111-S10251, 350111-S10252, 350111-S10253, 350111-S10254, 350111-S10255, 350111-S10256, 350111-S10257, 350111-S10258, 350111-S10259, 350111-S10260, 350111-S10261, 350111-S10262, 350111-S10263, 350111-S10265, 350111-S10266, 350111-S10267, 350111-S10268, 350111-S10269, 350111-S10270, 350111-S10273, 350111-S10274, 350111-S10276, 350111-S10277, 350111-S10278, 350111-S10279, 350111-S10280, 350111-S10281, 350111-S10282, 350111-S10283, 350111-S10284, 350111-S10285, 350111-S10286, 350111-S10287, 350111-S10288, 350111-S10289, 350111-S10290, 350111-S10291, 350111-S10292, 350111-S10293, 350111-S10295, 350111-S10296, 350111-S10297, 350111-S10298, 350111-S10300, 350111-S10301, 350111-S10302, 350111-S10303, 350111-S10305, 350111-S10306, 350111-S10307, 350111-S10309 and 350111-S10310. |
| Classification | Class III |
| Reason for Recall | Defective camera: There is a possibility that the connection of the wires to the connector may become loose, causing image distortion or loss. |
| Product Quantity | 17 cameras |
| Recall Number | Z-2148-2012 |
Mixed Classification Food/Cosmetics Event
| Event ID | 61901 |
|---|---|
| Status | Ongoing |
| Product Type | Food/Cosmetics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 18-May-12 |
| Initial Firm Notification of Consignee or Public | Press Release |
| Recalling Firm | River Ranch Fresh Foods LLC |
|---|---|
| City | Salinas |
| State | CA |
| Country | US |
| Distribution Pattern | Products were released for distribution in US and Canada. |
Associated Products
| Product Description | River Ranch brand Three-Color Cole Slaw Mix, 16 oz bag, UPC: 45388-10046; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1544-2012 |
| Product Description | River Ranch brand Angel Hair, 10 oz bag, UPC: 45388-10031;Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1545-2012 |
| Product Description | River Ranch brand Creamy Homestyle Cole Slaw Kit, 11.5oz bag, UPC: 45388-10037;Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1546-2012 |
| Product Description | River Ranch brand Iceberg & Romaine European, 12 oz bag, UPC: 45388-60019;Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1547-2012 |
| Product Description | River Ranch brand Iceberg & Romaine American, 12 oz bag, UPC: 45388-60042;Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1548-2012 |
| Product Description | River Ranch brand Greener Garden, 12 oz bag, UPC: 45388-60040;Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1549-2012 |
| Product Description | River Ranch brand Classic Garden, 6 oz, 16 oz bags, UPCs: 45388-60001, 45388-60002; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1550-2012 |
| Product Description | River Ranch brand Chopped Romaine, 10 oz bag, UPC: 45388-88030;Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1551-2012 |
| Product Description | River Ranch brand Complete Caesar Salad Kit, 10 oz bag, UPC: 45388-60043;Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1552-2012 |
| Product Description | River Ranch brand Italian Salad, 10 oz bag, UPC: 45388-60020;Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1553-2012 |
| Product Description | River Ranch brand Romaine Garden, 10 oz bag, UPC: 45388-60044;Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1554-2012 |
| Product Description | River Ranch brand Iceberg Shreds, 8 oz bag, UPC: 45388-60045; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1555-2012 |
| Product Description | River Ranch brand Restaurant-Style Cole Slaw, 16 oz bag, UPC: 45388-10024; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1556-2012 |
| Product Description | River Ranch brand Spring Mix, 24 oz bag, 48 oz bag, UPCs: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1557-2012 |
| Product Description | River Ranch brand Heritage Blend, 16 oz bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1558-2012 |
| Product Description | Farm Stand brand Iceberg Garden Salad, 16 oz bag, 24 oz bag, UPCs: 41163-45452, 41163-45453; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1559-2012 |
| Product Description | Hy Vee brand Cole Slaw, 16 oz bag, UPC: 75450-12051; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1560-2012 |
| Product Description | Hy Vee brand European Blend, 12 oz bag, UPC: 75450-12049; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1561-2012 |
| Product Description | Hy Vee brand American Blend, 12 oz bag, UPC: 75450-12047; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1562-2012 |
| Product Description | Hy Vee brand Garden Supreme ,12 oz bag, UPC: 75450-12046; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1563-2012 |
| Product Description | Hy Vee brand Garden Salad, 16 oz, 48 oz bag, UPC: 75450-12052, 75450-12065;Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1564-2012 |
| Product Description | Hy Vee brand Italian Blend, 10 oz bag, UPC: 75450-12048; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1565-2012 |
| Product Description | Hy Vee brand Shredded Lettuce, 8 oz bag, UPC: 75450-12053; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1566-2012 |
| Product Description | Hy Vee brand Caesar Salad Kit, 10 oz bag, UPC: 75450-12050; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1567-2012 |
| Product Description | Hy Vee brand Chopped Romaine, 10 oz bag, UPC: 75450-12055; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1568-2012 |
| Product Description | Hy Vee brand Romaine Garden Blend, 12 oz bag, UPC: 75450-12058; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1569-2012 |
| Product Description | Shurfresh brand Greener Garden Salad, 12 oz bag, UPC: 11161-40133; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1570-2012 |
| Product Description | Shurfresh brand Romaine Garden Salad, 10 oz bag, UPC: 11161-40134; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1571-2012 |
| Product Description | Shurfresh brand Iceberg Garden Salad, 16 oz bag, UPC: 11161-49092; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1572-2012 |
| Product Description | Shurfresh brand Cole Slaw, 16 oz bag, UPC: 11161-49088; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1573-2012 |
| Product Description | Sysco brand Spring Mix, 48 oz bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1574-2012 |
| Product Description | The Farmers Market brand Cole Slaw, 16 oz bag, UPC: 30034-30013; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1575-2012 |
| Product Description | The Farmers Market brand American Salad Blend, 12 oz bag, UPC: 30034-30105; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1576-2012 |
| Product Description | The Farmers Market brand Italian Salad Blend, 10 oz bag, UPC: 30034-30115; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1577-2012 |
| Product Description | The Farmers Market brand Romaine Garden Salad Blend, 12 oz bag, UPC: 30034-30220; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1578-2012 |
| Product Description | The Farmers Market brand Romaine Chopped, 10 oz bag, UPC: 30034-30141; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1579-2012 |
| Product Description | The Farmers Market brand Garden Supreme, 12 oz bag, UPC: 30034-30146; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1580-2012 |
| Product Description | The Farmers Market brand Parisian Salad Blend, 7 oz bag, UPC: 30034-30259; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1581-2012 |
| Product Description | The Farmers Market brand Angel Hair Cole Slaw, 10 oz bag, UPC: 30034-30266; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1582-2012 |
| Product Description | The Farmers Market brand European Salad Blend, 12 oz bag, UPC: 30034-30125; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1583-2012 |
| Product Description | The Farmers Market brand Leafy Romaine Blend, 9 oz bag, UPC: 30034-30364; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1584-2012 |
| Product Description | The Farmers Market brand Garden Salad, 6 oz, 12 oz, 24 oz bags, UPCs: 30034-30012, 30034-30400, 30034-30363; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1585-2012 |
| Product Description | The Farmers Market brand ColeSlaw Kit, 11 oz bag, UPC: 30034-99829; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1586-2012 |
| Product Description | The Farmers Market brand Iceberg Shredded, 8 oz, 16 oz bags, UPCs: 30034-30195, 30034-99888; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1587-2012 |
| Product Description | River Ranch brand Classic Garden, 32 oz bag, UPC: 45388-60011; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1588-2012 |
| Product Description | Marketside brand Classic Iceberg Salad, 6 oz, 12 oz, 24 oz bags, UPCs: 81131-32893, 81131-32894, 81131-32895; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1589-2012 |
| Product Description | Marketside brand Shredded Iceberg Lettuce, 8 oz bag, 16 oz bag, UPC: 81131-32896, 81131-53209; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1590-2012 |
| Product Description | River Ranch brand Diced Grn Cabbage w/Color, 4 x 5lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Salinas, CA |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1591-2012 |
| Product Description | River Ranch brand Shred Grn Cabbage w/Color, 4 x 5lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1592-2012 |
| Product Description | River Ranch brand Shred Grn Cabb w/Carr, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1593-2012 |
| Product Description | River Ranch brand Diced Green Cabb w/Carrot, 4 x 5lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1594-2012 |
| Product Description | River Ranch brand Shredded Red Cabbage, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1595-2012 |
| Product Description | River Ranch brand Carrot Shreds, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1596-2012 |
| Product Description | River Ranch brand Valley Blend, 6 x 2 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1597-2012 |
| Product Description | River Ranch brand California Blend, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1598-2012 |
| Product Description | River Ranch brand Chopped Iceberg, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1599-2012 |
| Product Description | River Ranch brand Iceberg Salad Mix, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1600-2012 |
| Product Description | River Ranch brand Garden with Romaine, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1601-2012 |
| Product Description | River Ranch brand Iceberg/Romaine w/Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1602-2012 |
| Product Description | River Ranch brand Shredded Icebreg (1/4"), (1/8"), 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1603-2012 |
| Product Description | River Ranch brand Iceberg & Romaine 50/50, 4 x 5lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1604-2012 |
| Product Description | River Ranch brand Iceberg & Romaine, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1605-2012 |
| Product Description | River Ranch brand Shredded Romaine, 6 x 2 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1606-2012 |
| Product Description | River Ranch brand Spring Mix, 3 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1607-2012 |
| Product Description | River Ranch brand Chopped Romaine w/ Liner, 6 x 2 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1608-2012 |
| Product Description | Cross Valley brand Shred Grn Cabbage w/Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1609-2012 |
| Product Description | Cross Valley brand Chopped Iceberg, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1610-2012 |
| Product Description | Cross Valley brand Iceberg Salad Mix, 4 x 5lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1611-2012 |
| Product Description | Cross Valley brand Garden with Romaine, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1612-2012 |
| Product Description | Cross Valley brand Chopped Iceberg w/Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1613-2012 |
| Product Description | Cross Valley brand Iceberg / Romaine w/Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1614-2012 |
| Product Description | Cross Valley brand Shredded Icebreg (1/4"), (1/8") 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1615-2012 |
| Product Description | Fresh n Easy brand Shred Grn Cabbage w/Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1616-2012 |
| Product Description | Fresh n Easy brand Chopped Iceberg, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1617-2012 |
| Product Description | Fresh n Easy brand Garden with Romaine, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1618-2012 |
| Product Description | Fresh n Easy brand Chopped Iceberg w/ Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1619-2012 |
| Product Description | Fresh n Easy brand Shredded Icebreg (1/4"), (1/8"), 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1620-2012 |
| Product Description | Promark brand Chopped Iceberg w/ Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1621-2012 |
| Product Description | Promark brand Shredded Icebreg (1/8"), 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1622-2012 |
| Product Description | Sysco brand Shred Grn Cabbage w/ Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1623-2012 |
| Product Description | Sysco brand Chopped Iceberg, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1624-2012 |
| Product Description | Sysco brand Iceberg Salad Mix, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1625-2012 |
| Product Description | Sysco brand Garden with Romaine, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1626-2012 |
| Product Description | Sysco brand Chopped Iceberg w/ Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1627-2012 |
| Product Description | Sysco brand Shredded Iceberg (1/4"), (1/8") 4 x 5 lb bag, UPCs: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1628-2012 |
| Product Description | Sysco brand Chopped Romaine, 6 x 2 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class I |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1629-2012 |
| Product Description | Sysco brand Spring Mix, 3 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC |
|---|---|
| Code Info | Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. |
| Classification | Class II |
| Reason for Recall | River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. |
| Product Quantity | |
| Recall Number | F-1630-2012 |
Mixed Classification Food/Cosmetics Event
| Event ID | 62676 |
|---|---|
| Status | Ongoing |
| Product Type | Food/Cosmetics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 26-Jul-12 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Recalling Firm | GH Foods CA LLC |
|---|---|
| City | Sacramento |
| State | CA |
| Country | US |
| Distribution Pattern | CA, NV, AZ, UT, AZ, CO, NM, SD, WY, NE. |
Associated Products
| Product Description | Asian Stir Fry, packaged under the following labels and sizes: Delish, 8.5 oz. Albertson's Generic Label, 10 oz, Chef Essentials - 10 oz. Raley's, 10 oz. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Delish UPC 0 4902255868 7; Albertsons UPC 8 26766 79000 5; Chef Essentials UPC: 8 26766 71600 5; Raley;s UPC 0 46567 71759 3. All with best if Sold by dates of 7/19/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xx |
| Recall Number | F-1882-2012 |
| Product Description | Egg Salad Sandwich , 8.5 oz, packaged under Delish brand name: Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Delish UPC 0 49022 51925 1 All with best if Sold by dates of 7/15/12 to 7/27/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xx |
| Recall Number | F-1883-2012 |
| Product Description | Southwest Crimini Mushrooms, 8.0 oz, packaged under Delish brand name: and 7 oz package under Chef Essentials Brand name. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Delish UPC 0 49022 59602.3; Chef Essentials UPC: 8 26766 71632 6. All with best if Sold by dates of 7/19/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xx |
| Recall Number | F-1884-2012 |
| Product Description | Southwestern Snack Bites 5.0 oz, packaged under Delish brand name: Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Delish UPC 0 49022 60220 5 All with best if Sold by dates of 7/19/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xx |
| Recall Number | F-1885-2012 |
| Product Description | Stuffed mushrooms, packaged under the following brand names: Delish - 7 oz package; Garden Highway Chef Essentials - 7 oz package; Pacific Coast Directions; 7 oz and 8 oz package Raleys - 7 oz package; Safeway - 7 oz package; Sprouts - 7 oz package. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Delish UPC 0 49022 55872 4; Garden Highway Chef Essentials UPC 8 26766 71121 5; Pacific Coast: 7 oz UPC: 0 98447 10131 0 8 oz UPC: 0 98487 20361 8; Raley's UPC: 0 46567 71753 1; Safeway Farms UPC: 0 21130 28410 8 Sprouts UPC: 8 26766 89325 6. All with best if Sold by dates of 7/19/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xx |
| Recall Number | F-1886-2012 |
| Product Description | Fajita Mix, 9.5 oz package; packaged under the following brand names: Albertsons, Garden Highway Chef Essentials, Raley's, Safeway , Marketside and Sprouts Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Albertson's UPC: 9 26766 79002 9; Chef Essentials UPC: 8 26766 71604 3 Raley's UPC: 0 46567 02011 2; Safeway Farms UPC: 0 21130 28404 7 Sprouts UPC: 8 26766 89372 0; Marketside UPC: 6 81131 03747 1. All with best if Sold by dates of 7/19/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xxx |
| Recall Number | F-1887-2012 |
| Product Description | Fresh Pico de Gallo packaged under the following brand names and sizes: Albertson's - 12 oz container; Garden Highway - 7 oz; 1 lb containers and Fresh Party Favorites 1 lb and 7 oz; Natural Directions - 1 lb; Pacific Coast Directions - 7 oz and 1 lb; Raley's 7 oz and 1 lb Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Albertson's UPC: 8 26766 41725 4; Garden Highway UPC's; 7 oz. 8 26766 41700 1 and 8 26766 77088 5; 1 lb 8 26766 41710 0 and 8 26766 77089 2; Garden Highway Frash Party Favorites UPC: 7 oz. 8 26766 41710 1 1 lb: 8 26766 77089.2. Natural Directions UPC: 1 lb - 0 15400 19446 4; Pacific Coast Directions UPC: 7 oz 0 98487 20449 3 1 lb 0 98487 20448 6 Raley's UPC: 7 oz: 0 46567 71724 1; 1 lb 0 46567 71725 8. All with best if Sold by dates of 7/19/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xx |
| Recall Number | F-1888-2012 |
| Product Description | Seasoned Squash, Onion & Dill sold under the following brand names and package sizes: Albertson's - 10.5 oz Chefs Essentials - 10.5 oz; Raley's - 10.5 oz. Safeway Farms - 10. 5 oz and Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Albertson's UPC: 8 26766 7900607; Garden Highway UPC's; 7 oz. 8 26766 71120 8; Raley's UPC: 7 oz: 0 46567 71752.4 All with best if Sold by dates of 7/19/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | |
| Recall Number | F-1889-2012 |
| Product Description | Tuna Sandwich under Delish brand name; 8.5 oz. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | UPC: 0 49022 51928 2. All with best if Sold by dates of 7/17/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xx |
| Recall Number | F-1890-2012 |
| Product Description | Stir Fry Vegetables, 10 oz package. Packaged under the brand names of Albertson's;s Garden Highway Chef Essentials, and Sprouts. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Albertson's UPC: 8 26766 79007 4 Garden Highway Chef Essentials UPC: 8 26766 71155 0. All with best if Sold by dates of 7/19/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xx |
| Recall Number | F-1891-2012 |
| Product Description | Bean Dip Bowl, 20 oz, packaged under Garden Highway label. Bean Dip snack tray, packaged under the brand names of Garden Highway (24 oz) and Garden Highway Fresh Party Favorites 20 oz); Bean Dip Tray under brand name of Pacific Coast Directions, 52 oz. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Garden Highway UPC Bean Dip bowl: 8 26766 41775 9; Garden Highway UPC Bean Dip Snack Tray; 8 26766 41780 3; Fresh Party Favorites Bean Dip snack Tray UPC: 8 26766 41775 9; Garden Highway Bean Dip Tray UPC 8 26766 41758 2 Pacific Coast Bean Dip Tray UPC: 0 98487 20341 0 All with best if Sold by dates of 7/17/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | |
| Recall Number | F-1892-2012 |
| Product Description | Bean Dip Tray NO Salsa, 52 oz. packaged under Garden Highway label. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | UPC: 8 26766 41785 8; All with best if Sold by dates of 7/17/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xx |
| Recall Number | F-1893-2012 |
| Product Description | Bean Dip Tray w/Salsa, 52 oz. packaged under Garden Highway label; Fresh Bean Dip with Salsa, 40 oz under Garden Highway Label and Pacific Coast Directions Label Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | 52 oz UPC: 8 26766 41750 6; 40 oz. Garden Highway UPC 8 26766 41752 0; Pacific Coast Highway UPC: 0 98487 20450 9 All with best if Sold by dates of 7/17/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | |
| Recall Number | F-1894-2012 |
| Product Description | Fiesta Bean Dip Tray 20 oz. packaged under Garden Highway and Pacific Coast Highway labels. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Garden Highway UPC: 8 26766 41793 3; Pacific Coast Highway UPC: 0 98477 20358 8 All with best if Sold by dates of 7/17/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | |
| Recall Number | F-1895-2012 |
| Product Description | Garden Highway brand Caldo mix, 48 oz.; Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Garden Highway UPC: 8 26766 30710 4; All with best if Sold by dates of 7/19/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xx |
| Recall Number | F-1896-2012 |
| Product Description | Cacciatore Mix under the brand name of Garden Highway Chef Essentials, Safeway Farms, 11 oz packages. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Garden Highway UPC: 8 26766 71603 6; Safeway Farms UPC 0 21130 09336 6. All with best if Sold by dates of 7/17/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xx |
| Recall Number | F-1897-2012 |
| Product Description | Garden Highway Chef Essentials Carrots, Celery, Onions, diced: 5 oz Natural Directions Carrots, Celery, onions deli cup , 5 oz; Safeway Farms Carrots, Celery, onions. , 5 oz. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Garden Highway UPC: 8 26766 77050 2; Natural Coast Directions UPC: 0 15400 19454 9; Safeway Farms UPC 0 21130 28421 4. All with best if Sold by dates of 7/17/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xx |
| Recall Number | F-1898-2012 |
| Product Description | Garden Highway Chef Essentials Celery, Onions, diced: 5 oz Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Garden Highway UPC: 8 26766 77000 7; All with best if Sold by dates of 7/19/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | |
| Recall Number | F-1899-2012 |
| Product Description | Mushroom & Bleu Cheese Steak Topper: 7.5 oz packaged under the following brand names: Garden Highway Chef Essentials , Raley's, Sprouts Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Garden Highway UPC: 8 26766 71024 9; Raley's UPC: 0 46567 02008 2; Sprouts UPC: 8 26766 89379 9. All with best if Sold by dates of 7/19/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xx |
| Recall Number | F-1900-2012 |
| Product Description | Mushroom Garlic Herb Steak Topper: 7.5 oz packaged under the following brand names: Garden Highway Chef Essentials, Safeway Farms. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Garden Highway UPC: 8 26766 71623 4; Safeway Farms UPC: 0 21130 09352 6 All with best if Sold by dates of 7/17/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xx |
| Recall Number | F-1901-2012 |
| Product Description | Garden Highway Chef Essentials Pizza Crimini Mushrooms: 7.0 oz . Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Garden Highway UPC: 8 26766 71630 2; All with best if Sold by dates of 7/19/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xx |
| Recall Number | F-1902-2012 |
| Product Description | Garden Highway Chef Essentials Pizza Style Portabella Mushrooms: 8.0 oz . Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Garden Highway UPC: 8 26766 71619 7; All with best if Sold by dates of 7/19/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xx |
| Recall Number | F-1903-2012 |
| Product Description | Southwest Style Portabella Mushrooms: 8.0 oz . Packaged under the brand names of Garden Highway Chef Essentials, Raley's and Sprouts. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Garden Highway UPC: 8 26766 71620 3; Raley's UPC: 0 46567 02006 8; Sprouts UPC: 8 26766 89368 3. All with best if Sold by dates of 7/19/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | |
| Recall Number | F-1904-2012 |
| Product Description | Sweet and Sour Stir Fry packaged under the following brand names and sizes: Garden Highway Chef Essentials 10.5 oz; Raley's 10.5 oz Safeway Farms 10.5 oz . Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Garden Highway UPC: 8 26766 71155 0; Raley's UPC: 0 46567 02002 0; Safeway Farms UPC 0 21130 09335 9. All with best if Sold by dates of 7/17/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | |
| Recall Number | F-1905-2012 |
| Product Description | Traditional Gourmet Portabella Mushrooms Garden Highway Chef Essentials brand, 8 oz package . Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Garden Highway UPC: 8 26766 71621 0; All with best if Sold by dates of 7/17/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | |
| Recall Number | F-1906-2012 |
| Product Description | Diced yellow onions, 5 oz cup packaged under the brand names of Garden Highway Chef Essentials, Natural Directions, Raley's. 5 lb under Garden highway label. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Garden Highway UPC: 5 oz. 8 26766 77015 1; 5 lb. 10 826766 85045 4 Natural Direction UPC: 0 15400 19451 8; Raley's UPC: 0 46567 71730 2. All with best if Sold by dates of 7/17/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xx |
| Recall Number | F-1907-2012 |
| Product Description | Garden Highway Green Peppers & Yellow Onion sliced 3/8" 2 lb package. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Garden Highway UPC: 2 lb. 20 826766 85344 5 All with best if Sold by dates of 7/17/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xx |
| Recall Number | F-1908-2012 |
| Product Description | Trader Joe's Diced Onions, Garlic & Shallots; 2 lb package. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | UPC: 0093 0277. All with best if Sold by dates of 7/19/12 to 7/31/12. |
| Classification | Class II |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xx |
| Recall Number | F-1909-2012 |
| Product Description | Garden Highway brand Spicy Corn Salsa, 7 oz package. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | UPC: 8 26766 42283 8. All with best if Sold by dates of 7/19/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xx |
| Recall Number | F-1910-2012 |
| Product Description | Garden Highway brand Traditional Guacamole Kit, 3 lb package. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | UPC: 10 826766 00491 8. All with best if Sold by dates of 7/19/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | |
| Recall Number | F-1911-2012 |
| Product Description | Pacific Coast brand Pizza Stuffed Mushrooms, 8 oz package. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | UPC: 0 98487 20359 5. All with best if Sold by dates of 7/19/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xx |
| Recall Number | F-1912-2012 |
| Product Description | Raley's Mirepoix, 5 oz package.. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | UPC: 0 46567 71749 4. All with best if Sold by dates of 7/19/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xx |
| Recall Number | F-1913-2012 |
| Product Description | Signature Cafe Sandwich Philly Cheesesteak hot and cold;regular and large sizes. All Signature Cafe Made to order sandwiches for which customers asked for optional green Pepper and yellow onion mix. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. |
|---|---|
| Code Info | Reg hot UPC: 21012800000; Reg cold UPC: 21009100000; Large hot UPC: 21012700000; Large cold UPC: 2109900000 All with best if Sold by dates of 7/19/12 to 7/31/12. |
| Classification | Class I |
| Reason for Recall | GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. |
| Product Quantity | xx |
| Recall Number | F-1914-2012 |
Mixed Classification Biologics Event
| Event ID | 61994 |
|---|---|
| Status | Terminated |
| Product Type | Biologics |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 08-May-12 |
| Initial Firm Notification of Consignee or Public | FAX |
| Recalling Firm | Blood Assurance Inc |
|---|---|
| City | Chattanooga |
| State | TN |
| Country | US |
| Distribution Pattern | GA, IN |
Associated Products
| Product Description | Red Blood Cells Leukocytes Reduced |
|---|---|
| Code Info | W043211081138 |
| Classification | Class II |
| Reason for Recall | Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2038-12 |
| Product Description | Blood and Blood Products for Reprocessing |
|---|---|
| Code Info | W043211081138 |
| Classification | Class III |
| Reason for Recall | Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. |
| Product Quantity | 1 unit |
| Recall Number | B-2039-12 |
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