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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Class I Food Event

Event ID62374
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Aug-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmCiolino Wholesale Produce, Inc.
CityTemperance
StateMI
CountryUS
Distribution PatternMI and OH distribution only. Retail only.
 

Associated Products

Product DescriptionHighline Mushrooms Sliced, white mushrooms 8 oz.
Code InfoSize: 8 oz. UPC: 7 71163 00005 2 Lot #: L410805 plus 4-digit time code Date Code: Best Before 12AU15
ClassificationClass I
Reason for RecallOn 8/13/12, Highline Mushrooms, of Ontario Canada, voluntarily recalled lots of sliced, white mushrooms that may be contaminated with Listeria monocytogenes. Ciolino Wholesale Produce, Inc. received a shipment of the mushrooms and initiated their own voluntary recall upon receiving notice from Highline Mushrooms.
Product Quantity7cs-84/8 oz. packages, or a total of 588/8 oz
Recall NumberF-2094-2012

Class I Food Event

Event ID62390
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmPure Hothouse Foods Inc.
CityLeamington
State
CountryCA
Distribution PatternMeijer stores in Michigan, Ohio, Indiana, Illinois, and Kentucky
 

Associated Products

Product DescriptionMarkets of Meijer, fresh Grillers, Mushrooms with Rosemary, 10 oz, Ingredients: Mushrooms, Rosemary, Product of Canada, Keep Refrigerated, Pre-heat grill or over to 450 F... Cook 15-20 minutes in oven/BBQ or 4-5 minutes in microwave...
Code InfoBest By Date August 11th August 26th 2012 UPC code 7-08820-85464-2
ClassificationClass I
Reason for RecallAs of the August 16, 2012, Pure Hothouse Foods Inc. is voluntarily recalling fresh cut vegetable grilling trays containing mushrooms with the Sell by dates of August 11th, 2012 through August 26, 2012 because they may be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism that can cause serious or life threatening food borne illness in a person who eats a food item contaminated with it. Symptoms of infection may include fever, muscle aches, gastro intestinal symptoms such as nausea or diarrhea. The illness primarily impacts pregnant women and adults with weakened immune systems. Most healthy adults and children rarely become seriously ill.
Product Quantity8,412 for 3 products under recall
Recall NumberF-2095-2012
Product DescriptionMarkets of Meijer, fresh Grillers Steak Toppers, 10 oz, Ingredients: Red Onions, Mushrooms, Product of Canada, Keep Refrigerated, Pre-heat grill or over to 450 F... Cook 15-20 minutes in oven/BBQ or 4-5 minutes in microwave...
Code InfoBest By Date August 11th August 26th 2012 UPC code 7-08820-85468-0
ClassificationClass I
Reason for RecallAs of the August 16, 2012, Pure Hothouse Foods Inc. is voluntarily recalling fresh cut vegetable grilling trays containing mushrooms with the Sell by dates of August 11th, 2012 through August 26, 2012 because they may be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism that can cause serious or life threatening food borne illness in a person who eats a food item contaminated with it. Symptoms of infection may include fever, muscle aches, gastro intestinal symptoms such as nausea or diarrhea. The illness primarily impacts pregnant women and adults with weakened immune systems. Most healthy adults and children rarely become seriously ill.
Product Quantity8,412 for 3 products under recall
Recall NumberF-2096-2012
Product DescriptionMarkets of Meijer, fresh Grillers Aparagus Blend, 14 oz, Ingredients: Asparagus, Sweet Bell Peppers, Mushrooms,, Sweet White Onions, Product of Canada, Keep Refrigerated, Pre-heat grill or over to 450 F... Cook 15-20 minutes in oven/BBQ or 4-5 minutes in microwave...
Code InfoBest By Date August 11th August 26th 2012 UPC code 7-08820-85353-9
ClassificationClass I
Reason for RecallAs of the August 16, 2012, Pure Hothouse Foods Inc. is voluntarily recalling fresh cut vegetable grilling trays containing mushrooms with the Sell by dates of August 11th, 2012 through August 26, 2012 because they may be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism that can cause serious or life threatening food borne illness in a person who eats a food item contaminated with it. Symptoms of infection may include fever, muscle aches, gastro intestinal symptoms such as nausea or diarrhea. The illness primarily impacts pregnant women and adults with weakened immune systems. Most healthy adults and children rarely become seriously ill.
Product Quantity8,412 units for all products under recall
Recall NumberF-2097-2012

Class I Food Event

Event ID62687
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jul-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmBurch Farms
CityFaison
StateNC
CountryUS
Distribution PatternNY; Expanded on 8/2 to include FL, GA, IL, MD, NC, NJ, PA, SC and VA.
 

Associated Products

Product DescriptionWhole Fresh Cantaloupe, PLU# 4319, Burch Farms, Faison, NC 28341. On 8/2/2012 the recall was expanded to include cantaloupes labeled, Cottle Strawberry, Inc., #4319, Faison, NC. (Cottle Farms is not involved in this recall).
Code InfoPLU 4319
ClassificationClass I
Reason for RecallProduct was found to be contaminated with Listeria monocytogenes.
Product Quantity580 cases (9 whole cantaloupes per case). Additional188,902 cantaloupes.
Recall NumberF-2031-2012
Product DescriptionFresh Whole Honey Dew Melons, packed in paper cartons labeled, Southeastern Growers Association, Fresh Melons. Individual melons were not labeled.
Code InfoNone identified (Product shipped between June 23rd and July 27th).
ClassificationClass I
Reason for RecallProduct was found to be contaminated with Listeria monocytogenes.
Product Quantityunknown
Recall NumberF-2032-2012

Class I Devices Event

Event ID62715
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Jun-09
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE OEC Medical Systems, Inc
CitySalt Lake City
StateUT
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and the countries of India, Japan, Canada, Switzerland, Italy, United Kingdom, Germany, Austria, Hong Kong, France, and Denmark.
 

Associated Products

Product DescriptionOEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems are an aid to locate anatomical structures during open or percutaneous surgical procedures. It is intended 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 CT, MRI, or X-ray.
Code InfoAll serial numbers.
ClassificationClass I
Reason for RecallGE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated configuration with the IT 3000, 2500, 2500 plus, 3500, 3500 plus, ConneCTstat, and ConneCTstat Plus Surgical Navigation equipment.
Product Quantity768 units
Recall NumberZ-2251-2012

Class I Food Event

Event ID62720
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBusch's, Inc. - Central Production Facility
CityClinton
StateMI
CountryUS
Distribution PatternMichigan Distribution only.
 

Associated Products

Product DescriptionGREEN CHILE CHICKEN ENCHILADAS 12 OZ
Code InfoUPC: 20212400000 Distributed: 07/20/2012 through 07/27/2012
ClassificationClass I
Reason for RecallOur product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit.
Product Quantity86 units
Recall NumberF-2081-2012
Product DescriptionPOTATO CKS ORIGINAL BM 1 EA
Code InfoUPC: 20234100000 Distributed: 07/20/2012 through 07/27/2012
ClassificationClass I
Reason for RecallOur product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit.
Product Quantity142
Recall NumberF-2082-2012
Product DescriptionPOTATO CKS SWEET BM 1 EA
Code InfoUPC: 20235100000 Distributed: 07/20/2012 through 07/27/2012
ClassificationClass I
Reason for RecallOur product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit.
Product Quantity166
Recall NumberF-2083-2012
Product DescriptionBUSCHS SHEPHERD'S CHICKEN PIE 14 OZ
Code InfoUPC: 20243200000 Distributed: 07/20/2012 through 07/27/2012
ClassificationClass I
Reason for RecallOur product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit.
Product Quantity88
Recall NumberF-2084-2012
Product Description1/2 PAN BAKED MOSTACCIOLI BM 1 EA
Code InfoUPC: 20308400000 Distributed: 07/20/2012 through 07/27/2012
ClassificationClass I
Reason for RecallOur product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit.
Product Quantity1 unit
Recall NumberF-2085-2012
Product Description1/2 PAN BAKED MEAT LASAGNA BM 1 EA
Code InfoUPC: 20314900000 Distributed: 07/20/2012 through 07/27/2012
ClassificationClass I
Reason for RecallOur product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit.
Product Quantity1
Recall NumberF-2086-2012
Product DescriptionBUSCHS JAMBALAYA WITH SHRIMP B 13 OZ
Code InfoUPC: 20578200000 Distributed: 07/20/2012 through 07/27/2012
ClassificationClass I
Reason for RecallOur product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit.
Product Quantity84
Recall NumberF-2087-2012
Product DescriptionBUSCHS QUESADILLA CHICKEN BM 1 EA
Code InfoUPC: 20769100000 Distributed: 07/20/2012 through 07/27/2012
ClassificationClass I
Reason for RecallOur product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit.
Product Quantity209
Recall NumberF-2088-2012
Product DescriptionBUSCHS BURRITO CHICKEN BM 12 OZ
Code InfoUPC: 20901800000 Distributed: 07/20/2012 through 07/27/2012
ClassificationClass I
Reason for RecallOur product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit.
Product Quantity82
Recall NumberF-2089-2012
Product DescriptionBUSCHS DOWN HOME LASAGNA BM 14 OZ
Code InfoUPC: 20917500000 Distributed: 07/20/2012 through 07/27/2012
ClassificationClass I
Reason for RecallOur product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit.
Product Quantity97
Recall NumberF-2090-2012
Product DescriptionBUSCHS SPAGHETTI & MEATBALLS B 14 OZ
Code InfoUPC: 20919100000 Distributed: 07/20/2012 through 07/27/2012
ClassificationClass I
Reason for RecallOur product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit.
Product Quantity103
Recall NumberF-2091-2012
Product DescriptionBUSCHS SOUP FROM FOOD BAR Random weight/Sold by the pound
Code InfoUPC: 20919100000 Distributed: 07/20/2012 through 07/27/2012
ClassificationClass I
Reason for RecallOur product was recalled because one of the ingredients used was subject to the Gills Onion 07/25/2012 onion recall . That ingredient was sold to us from Sysco Detroit.
Product Quantity1839 LBS
Recall NumberF-2092-2012

Class I Food Event

Event ID62758
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jul-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmFresh Ideas Inc.
CityBoston
StateMA
CountryUS
Distribution PatternMA, ME, RI, NH, CT, VTM, NY AND Nj
 

Associated Products

Product DescriptionUNH Stir Fry: 5 lbs ply bag Broccoli. Bock Choy. Spanish Onions (1" x 1" cut). Celery Packed by: fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Item # 00137
Code InfoProduced on: 7/20/12, 7/24/12, 7/25/12
ClassificationClass I
Reason for RecallProducts contain recalled Gill's Onions due to Listeria monocytogenes
Product Quantity7 cases
Recall NumberF-2064-2012
Product DescriptionCosta 1/16" Sliced Onions, 5 lb poly bag (Item # 00254); Costa 1/4" Sliced Onions, 5 lb poly bag (Item #C50) Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129
Code InfoProduced on: Between 7/18/12, and 7/25/12
ClassificationClass I
Reason for RecallProducts contain recalled Gill's Onions due to Listeria monocytogenes
Product Quantity47 cases
Recall NumberF-2065-2012
Product DescriptionCosta Kabob Cut White Onions 1" x 1", 5 lb poly bag (Item #00275) Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129
Code InfoProduced on: Between 07/18/12 and 7/25/12
ClassificationClass I
Reason for RecallProducts contain recalled Gill's Onions due to Listeria monocytogenes
Product Quantity72 cases
Recall NumberF-2066-2012
Product DescriptionCosta Whole Peeled Onions (Item #00841, #B841) 25 lb poly bag Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Item # 00254
Code InfoProduced On: Between 7/18/12, and 7/25/12
ClassificationClass I
Reason for RecallProducts contain recalled Gill's Onions due to Listeria monocytogenes
Product Quantity262 cases
Recall NumberF-2067-2012
Product DescriptionCosta: 1/2" Diced Onions (Item #C228); 3/4" Diced Onions (Item #C244) 1/4" Diced Onions (Item#C32) 5 lb poly bags Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Legal Seafood Diced Onions 1/16" (Item #L163) 10 lb poly bag OB Double Diced Onions 1/8" (item #OB2), 2 lb poly tub
Code InfoProduced on: Between 7/18/12 and 7/25/12
ClassificationClass I
Reason for RecallProducts contain recalled Gill's Onions due to Listeria monocytogenes
Product Quantity255 cases
Recall NumberF-2068-2012
Product DescriptionSmall Soup Vegetable Mix:-(Item #CC4) Spanish Onions {1/4" dice), Carrots, Celery Medium Soup Mix Vegetables (Item #CC5) Spanish Onions (1/2" dice), Carrots. Celery 5 lb poly bags Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Item # 00254
Code InfoUse By: 7/19/12, 7/20/12, 7/21/12, 7/22/12, 7/24/12, 7/25/12
ClassificationClass I
Reason for RecallProducts contain recalled Gill's Onions due to Listeria monocytogenes
Product Quantity35 cases
Recall NumberF-2069-2012
Product DescriptionJulienne Onions, Item #J705 4.0 lbs poly tub; Legal Onion Strings (Item #L165), 5 lb poly bag Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Item # 00254
Code InfoProduced on: 7/21/12, 7/22/12, 7/24/12, 7/25/12
ClassificationClass I
Reason for RecallProducts contain recalled Gill's Onions due to Listeria monocytogenes
Product Quantity27 cases
Recall NumberF-2070-2012
Product DescriptionCosta Asian Stir- Fry Blend (Item #SAL3) 5 lb poly bag Spanish Onions {1/4" Sliced), Red Onions, Green Peppers. Red Peppers, Zucchini, Carrots, Broccoli, Broccoli Stems, Green Cabbage, Pea Pods, Bok Choy Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129
Code InfoProduced on: 7/18/12, 7/21/12, 7/24/12, 725/12
ClassificationClass I
Reason for RecallProducts contain recalled Gill's Onions due to Listeria monocytogenes
Product Quantity47 cases
Recall NumberF-2071-2012
Product DescriptionCosta Four Bean Salad 4.50 lbs Poly Tub (Item #01385 Green Beans, Kidney Beans (kidney beans, water, salt, CaCI2), Chick Peas (chick peas. water. salt, EDTA to promote color retention), Black Eyed Peas (black eye peas, water, salt, calcium chloride and disodium EDTA to preserve color). White Onions, Red Peppers , Italian Dressing (distilled vinegar. soy bean oil. water, com syrup, salt, onion. red bell pepper. xantham gum, spice and oleo resin paprika, calcium disodium EDTA), Red Peppers (peppers, water, sugar. salt, citric acid, CaCI2). Onion. While Vinegar and Garlic Powder
Code InfoUse By: 7/26/12, 7/27/12, 8/2/12
ClassificationClass I
Reason for RecallProducts contain recalled Gill's Onions due to Listeria monocytogenes
Product Quantity210 cases
Recall NumberF-2072-2012
Product DescriptionCalico bean Salad 5 lbs Poly Tub (Item #01409) packaged under Costa and Stop & Shop brand, Item T1407, C1407, 5 lb Poly Bag Black eye peas , water, salt, calcium chloride and disodium EDTA to preserve color), Chick Peas (cooked dried chick peas, water,salt), Kidney Beans (kidney beans, water. salt, CaCI2), Black Beans (black beans, water. salt, CaCI2, ferrous gluconate), Italian Dressing (distilled vinegar, soy bean oil, water, com syrup,salt. onion, red bell pepper, xantham gum. spice and oleo resin paprika, calcium disodium EDTA). Apple Cider Vinegar, Celery, Green Pepper, Red Pepper, Onion
Code InfoUse By: 7/26/12, 7/27/12, 7/31/12, 8/2/12
ClassificationClass I
Reason for RecallProducts contain recalled Gill's Onions due to Listeria monocytogenes
Product Quantity245 cases
Recall NumberF-2073-2012
Product DescriptionCosta Multiple Bean Salad 4.5 lbs Poly Tub (Item #01407) Black Beans (black beans, water. salt, calcium chloride, ferrous gluconate), Kidney Beans (kidney beans, water. salt, CaCI2), Black Eyed Peas(blackeye peas. water, sail. calcium chloride and disodium EDTA to preserve color). Chick Peas (chick peas, water, salt, EDTA to promote color retention), Italian Dressing (distilled vinegar. soy bean oil, water, com syrup, salt, onion, red bell pepper, xantham gum, spica and oleo resin paprika, calcium disodium EDTA), Red Peppers (peppers, water, sugar, salt, citric acid, CaCI2), Onion, White Vinegar and Garlic Powder
Code InfoUse By: 7/26/12: 7/31/12, 8/2/12
ClassificationClass I
Reason for RecallProducts contain recalled Gill's Onions due to Listeria monocytogenes
Product Quantity95 cases
Recall NumberF-2074-2012
Product DescriptionFajita Mix-Red Pepper, Green Pepper, Spanish Onion {1/4" Sliced) Item #SAL4, 5 lb poly bag
Code InfoProduced on: 7/18/12, 7/21/12, 7/24/12, 7/25/12
ClassificationClass I
Reason for RecallProducts contain recalled Gill's Onions due to Listeria monocytogenes
Product Quantity
Recall NumberF-2075-2012
Product DescriptionTex Mex Sliced Vegetable Blend, Item #TMEX Red Pepper, Green Pepper, Spanish Onion {1/4" Sliced) 5 lb poly bag
Code InfoProduced on: 7/18/12, 7/21/12, 7/24/12, 7/25/12
ClassificationClass I
Reason for RecallProducts contain recalled Gill's Onions due to Listeria monocytogenes
Product Quantity
Recall NumberF-2076-2012

Class I Food Event

Event ID62759
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Jul-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmAmy'S Kitchen
CityPetaluma
StateCA
CountryUS
Distribution PatternProducts were released for distribution in US (PA, TN, IL, CA).
 

Associated Products

Product DescriptionAmy's Brand Pizza Pesto Made with Organic Vegetables & Basil in 7 oz; ; 13.5 oz; Sku# 42272-00104 Product is processed and packaged by Amys Kitchen, White City, Oregon
Code Info7 oz: Best Before July24 2012; Lot Code: 30-G242, sku# 42272-00197; 13.5 oz Best by 7/17/12, Lot No. 30-G172; 383 grams, best by 7/17/12, Lot No. 30-1992AK and best by 7/18/12, Lot No. 30-2002AK (French labeling)
ClassificationClass I
Reason for RecallProduct contains undeclared peanut in the ingredient statement (Peanuts were found in pinenuts).
Product Quantity
Recall NumberF-2079-2012
Product DescriptionTrader Giotto brand Pesto Pizza in 13.5 oz; SKU# 00539937; Product is processed and packaged by Amy's Kitchen, White City, Oregon
Code InfoBest Before July 17, 2012 and July 18, 2012; Lot Code: 30-1992AK and 30-2002AK
ClassificationClass I
Reason for RecallProduct contains undeclared peanut in the ingredient statement (Peanuts were found in pinenuts).
Product Quantity
Recall NumberF-2080-2012

Class I Food Event

Event ID62767
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmReichel Foods, Inc
CityRochester
StateMN
CountryUS
Distribution Patternnationwide
 

Associated Products

Product DescriptionDippin' Stix Sliced Apples & Caramel with Peanuts
Code InfoUSE BY dates 01SEP2012, 02SEP2012, and 03SEP2012
ClassificationClass I
Reason for RecallReichel Foods is recalling these products because the sliced apples have the potential to be contaminated with Listeria monocytogenes.
Product Quantity136,980 trays
Recall NumberF-2077-2012
Product DescriptionApple Slices & Fat Free Caramel Dip contained in the Armour Active Packs Cheese Pizza Lunch Kit
Code InfoPackage code 1026090112
ClassificationClass I
Reason for RecallReichel Foods is recalling these products because the sliced apples have the potential to be contaminated with Listeria monocytogenes.
Product Quantity8096 kits
Recall NumberF-2078-2012

Class I Devices Event

Event ID62769
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmI-Flow Corporation
CityLake Forest
StateCA
CountryUS
Distribution PatternWorldwide Distribution -- USA, Canada, Australia, the EU (Germany), United Arab Emirates, and Cyprus.
 

Associated Products

Product DescriptionON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01. Part Numbers: 101347100, 101347300, 101347400, 101360200, 101368400, 101368600, 101368700, 102987000, 102987200, 102987300, 103161800, 103534300, 5001438, 5001470, 5001651, 5001780, 5001808, 5001809, 5001812, 7000180, 7000181, 7000182, & 7000367. Indicated for continuous and or intermittent delivery of medication to or around surgical wound sites and or close proximity to nerves.
Code InfoProducts having a 10-digit Lot # that is greater than 0200521454 (i.e. 0200521455 and greater) are not impacted by this recall.
ClassificationClass I
Reason for RecallIt was determined that in a small quantity of ON-Q pumps with ONDEMAND, the bolus button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowermost position. As a result, the patient may receive continuous infusion at a rate greater than expected.
Product Quantity80,646 units total (65,926 units in US)
Recall NumberZ-2253-2012

Class I Food Event

Event ID62874
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Aug-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmHoney Heaven Wholesale, Inc.
CityEugene
StateOR
CountryUS
Distribution PatternProduct was distributed to retail stores in California, Oregon and Washington
 

Associated Products

Product DescriptionOrganic Pinenuts. 5lb bag: Organic Pine nuts packed into plastic bag with a twist tie with a White stick on label with hand written product description. 27.5lb bag: Organic Pine nuts inside of a plastic bag with a white stick on label with typed product description.
Code InfoLot 40034 and all organic pinenuts distributed between March 22, 2012 to August 14, 2012
ClassificationClass I
Reason for RecallOrganic Pinenuts are recalled due to potential contamination of peanuts or traces of peanuts.
Product Quantity110 lbs.
Recall NumberF-2098-2012

Class I Food Event

Event ID62883
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Aug-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmReal Mex Foods
CityVernon
StateCA
CountryUS
Distribution PatternDistribution to food service such as restaurants.
 

Associated Products

Product DescriptionPico de Gallo salsa, 2 lbs pouch, packaged in a case of 5/2 lbs. Product labeling reads in part:" REAL MEX FOODS ITEM # 15102 "MILD" PICO DE GALLO*** PACK SIZE: 5/2 LBS. NET WEIGHT: 10 LBS Real Mex Foods 3305 Vernon Ave. Vernon, Ca 90058***".
Code InfoUse by 08/20/12 and 08/21/12. Item number 15102. UPC 7 58897 15102 1.
ClassificationClass I
Reason for RecallThe firm recalled because products manufactured used the cilantro recalled by their supplier has the potential to be contaminated with Salmonella.
Product Quantity37 cases
Recall NumberF-2033-2012
Product DescriptionCheese and red onion enchilada, 2 oz packaged in 240/2oz case, net weight 30 lbs. Product labeling reads in part:" REAL MEX FOODS Item # 14800 CHEESE & RED ONION ENCHILADA***KEEP REFRIGERATED*** PACK SIZE: 240/2 OZ. NET WEIGHT:30.00 LBS Real Mex Foods 3305 E. Vernon Ave. Vernon, Ca 90058.***"
Code InfoUse by date 08/24/12, Item # 14800, UPC 7 58897 14800
ClassificationClass I
Reason for RecallThe firm recalled because products manufactured used the cilantro recalled by their supplier has the potential to be contaminated with Salmonella.
Product Quantity21 cases
Recall NumberF-2034-2012

Class I Food Event

Event ID62910
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTanimura & Antle
CitySalinas
StateCA
CountryUS
Distribution PatternAL, AR, AZ, CA, GA, KS, KY, MD, NC, NM, NV, NJ, PA, SC, TN, TX, VA and WA and Canada.
 

Associated Products

Product DescriptionTanimura & Antle Romaine Lettuce (Laitue Romaine) in plastic bag Wrapped Single Head Romaine marked Field Packed for Freshness.. Distributed by Tanimura & Antle, Salinas, CA.
Code InfoMay have a best buy date of 8/19/12 and available at retail locations from August 2 to 19, 2012.
ClassificationClass I
Reason for RecallFDA was notified by CFIA of a positive result for E-cole O157:H7 in Romaine Lettuce with the brand name of Tanimura & Antle, Salinas, CA.
Product Quantity2095 cases: 1969 cases in US, 126 cases in Canada - 12 to 18 heads per case.
Recall NumberF-2103-2012

Class I Food Event

Event ID62976
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Aug-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmDole Fresh Vegetables Inc
CityMonterey
StateCA
CountryUS
Distribution PatternDistributors in FL, NC, PA, SC, VA, MD and AL
 

Associated Products

Product DescriptionDole Italian Blend; Romaine, Radicchio; 10 oz plastic bag (283g); UPC:7143000819. Dole, Monterey, CA 93942.
Code InfoCode number 0049N2202008. Best by Date of August 20, 2012.
ClassificationClass I
Reason for RecallUSDA MDP program collected samples of finished product Dole Italian Blend and had positive sample results for Listeria Monocytogenes.
Product Quantity1039 cases
Recall NumberF-2099-2012

Class I Food Event

Event ID62992
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNaturally Fresh Inc.
CityAtlanta
StateGA
CountryUS
Distribution PatternAL, FL, GA, LA, MI, SC and TX.
 

Associated Products

Product DescriptionNaturally Fresh Salad Toppings, Roasted & Glazed Pecan Pieces, Net weight 3.5 oz, Distributed by: Naturally Fresh, Atlanta, GA
Code Info07 APR 13 and 08 APR 13 The UPC code is (0)7653905520(0)
ClassificationClass I
Reason for RecallProduct contains undeclared allergen, almonds.
Product Quantity180 cases, 12 pkgs per case
Recall NumberF-2111-2012

Class II Drugs Event

Event ID38329
StatusTerminated
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Jun-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmApotex Corp.
CityWeston
StateFL
CountryUS
Distribution PatternNationwide.
 

Associated Products

Product DescriptionLeflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9
Code InfoLot #: a) GY4197, Exp 11/07; b) GZ1273, Exp 11/07.
ClassificationClass II
Reason for RecallSubpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Product Quantity3063
Recall NumberD-1661-2012
Product DescriptionLeflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9, NDC 60505-2503-3
Code InfoLot #: GZ1274, Exp 11/07.
ClassificationClass II
Reason for RecallSubpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Product Quantity31
Recall NumberD-1662-2012

Class II Biologics Event

Event ID39118
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Apr-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Bank of Lancaster County Medical Society
CityLincoln
StateNE
CountryUS
Distribution PatternNY; Austria
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info6553449
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor with a history of high risk behaviors, were distributed.
Product Quantity1 unit
Recall NumberB-1981-12
Product DescriptionBlood and Blood Products for Reprocessing
Code Info6553449
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor with a history of high risk behaviors, were distributed.
Product Quantity1 unit
Recall NumberB-1982-12

Class II Biologics Event

Event ID39119
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Apr-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Bank of Lancaster County Medical Society
CityLincoln
StateNE
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info3739350 (Part A), 3739350 (Part B)
ClassificationClass II
Reason for RecallBlood products, collected from donors whose suitability to donate was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-1983-12

Class II Biologics Event

Event ID40849
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Aug-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CityWichita
StateKS
CountryUS
Distribution PatternKS, KY
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info02LH70356
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Product Quantity1 unit
Recall NumberB-2105-12

Class II Biologics Event

Event ID40918
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Sep-05
Initial Firm Notification of Consignee or Public FAX
Recalling FirmZLB Bioplasma, Inc.
CityBoca Raton
StateFL
CountryUS
Distribution PatternCA, NC
 

Associated Products

Product DescriptionSource Plasma
Code Info0340752007;0340751638;0340751124;0340750763;0340750089;0340749799;0340749296;0340748991;0340748506;0340748231;0340747468;0340746923;0340746544;0340746190;0340745429;0340745059;0340744705;0340744184;0340743964;0340742694;0340742245;0340741881;0340741554;0340741120;0340740607;0340740379;0340739736;0340739433;0340739020;0340738623;0340737941;0340737774;0340737379;0340737063;0340735931;0340735369;0340735184
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was permanently deferred, were distributed.
Product Quantity37 units
Recall NumberB-2140-12

Class II Biologics Event

Event ID41165
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Oct-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center of Greater Kansas City
CityKansas City
StateMO
CountryUS
Distribution PatternMO
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045005046954
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-2104-12

Class II Biologics Event

Event ID41481
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Dec-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center of Greater Kansas City
CityKansas City
StateMO
CountryUS
Distribution PatternMO, KS
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW045005031764; W045005093155
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity2 units
Recall NumberB-2108-12

Class II Biologics Event

Event ID42885
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Aug-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Bank of Lancaster County Medical Society
CityLincoln
StateNE
CountryUS
Distribution PatternFL, Austria
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info6041690
ClassificationClass II
Reason for RecallBlood products, collected from a donor taking the medication Propecia, were distributed.
Product Quantity1 unit
Recall NumberB-2030-12
Product DescriptionBlood and Blood Products for Reprocessing
Code Info6041690
ClassificationClass II
Reason for RecallBlood products, collected from a donor taking the medication Propecia, were distributed.
Product Quantity1 unit
Recall NumberB-2031-12

Class II Biologics Event

Event ID43895
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Nov-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Bank of Lancaster County Medical Society
CityLincoln
StateNE
CountryUS
Distribution PatternNJ; Austria
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info6066046; 6070284; 6073935; 6075510
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity4 units
Recall NumberB-1979-12
Product DescriptionBlood and Blood Products for Reprocessing
Code Info6067919; 6070284; 6075510
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity3 units
Recall NumberB-1980-12

Class II Biologics Event

Event ID44183
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Feb-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMississippi Valley Regional Blood Center
CityDavenport
StateIA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoKN07114
ClassificationClass II
Reason for RecallBlood product, collected using apheresis kits with small detected leaks, was distributed.
Product Quantity1 Unit
Recall NumberB-2208-12

Class II Biologics Event

Event ID46537
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Nov-07
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCommunity Blood Bank of Lancaster County Medical Society
CityLincoln
StateNE
CountryUS
Distribution PatternNE, Austria
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info6526423
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of Hepatitis A, were distributed
Product Quantity1 unit
Recall NumberB-1976-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info6526423; 6510805
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of Hepatitis A, were distributed
Product Quantity2 units
Recall NumberB-1977-12

Class II Biologics Event

Event ID46540
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Nov-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center of Greater Kansas City
CityKansas City
StateMO
CountryUS
Distribution PatternMO
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045007093412
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-2103-12

Class II Devices Event

Event ID49060
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jul-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSRI Surgical
CityTampa
StateFL
CountryUS
Distribution PatternNationwide Distribution-including the states of CA, FL, GA, KY, MD, MI, NC, NJ, OK, PA, SC, TN, TX, and UT.
 

Associated Products

Product DescriptionVarious SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a sterilization wrap and sterilized. This allows the customer to open one package for a surgical procedure instead of many individual packages.
Code InfoModel Numbers: CY1020 GY1250 GY1274 GY1274A GY1274B GY1274C GS1296 NU1290 OR1288 OR1288A OR1289 GS0880C GS0880D GS0880E GS0880F LD0994D LD1000A GS0983C LD1019A LD1019B LD1029A OR0986B OR0986C OR0986D GS0935B-M GY1223 GY1223A CY1028C CY1028D ET1023A ET1023B ET1023C ET1023D EY1024A EY1024B EY1024C EY1024D EY1024E GS0764D GS0764E GS0780D GS0780E GS1219 LD1022B LD1022C LD1022D LD1132 LD1132A LD1132B OR1025A GS1043 GS1044 GS0937D GS0937E GS0938B GS0938C GS0995 GS0995A GS0995B GS0995C GY0996 HT0980A HT0980B HT0980C HT0987B HT0987C HT1128 NU0939C NU0939D GS1136 GS1136A GS1136B CL1035 CL1035A CL1035B NU0700G ET1243 ET1243A EY1242 GS1200A GS1245 GS1245B GS1248 GS1248A GS1285 GS1285A GS1285B HT1247 HT1247A HT1247B NU1249 NU1249A NU1249B NU1249C OR1196B OR1244 OR1244A OR1244B OR1244C OR1246 OR1246A OR1246B CL0705F CL0705G CL0705H EY0696E HT0482E HT0482F HT0482G HT1228 HT1234A-M HT1234B-M HT1234D-M HT1234E-M HT1234F-M HT1234-M LD0693F LD0693G LD0694C NU0700I NU1157 NU1157A GS1268 GS1268A GS1268C GS1287 GS1287A GS1287B GF1333 GF1333A OR1340 CV0691G CV0691H CY0695G CY0695H CY0695I ED0704K ED0704L ED0704M EY0707F EY0707G GS0689A GS0689C GS0692I GS0692J GS0692K GS0692L GS0697E GS1074 GS1074A GS1074B HT0482I HT0482J HT0482K HT0706B HT0706C NU0690H NU0690I NU0690J NU0690K NU0690L NU0699I NU0699J NU0699K NU0700H OR0698F OR0698G OR0698H OR0925A GS1146 GS1146A GS1147 GY1151 GY1151A OR1148 OR1149 OR1149A OR1150 GS0891C GS0891D CV1186 CV1186A CV1199 ET1197 ET1197A EY1154 EY1183 EY1183A EY1183B EY1183C GS1185 GS1191 GS1193 GS1193A GS1194 GS1194A GS1195 GS1198 GS1200 HT1182 HT1182A HT1182B-M HT1182D LD1301B LD1303 NU1190 NU1190A NU1192 OR1184 OR1184A OR1187 OR1188 OR1188A OR1188B OR1189 OR1196 OR1196A OR1196B OR1263 CL0753C-M CL0753D-M CL0753E CL0753F CL1215 CL1215A CL1215B HT0756H HT0756I HT0756J CL0753G CL0753H CL0753I CL1215A HT0756K BS1209 BS1209A BS1209B CL1253 CL1253A CV1068 CV1069 CY1078 CY1078A CY1078B CY1078C ET1076A ET1076B ET1076C ET1079 ET1079A ET1080A ET1080B EY1077 EY1077A EY1077B GS1061A GS1061B GS1088 HT1252 HT1252A OR1062 OR1062A OR1063A OR1063B OR1065A OR1089A OR1251 OR1257 CV0773F CV0773G GY0957D GY0957E LD0771C LD0772F LD0772G OR0777E OR0777F OR0777G OR0929B OR0929C OR0929D HT0283I ET0222J ET0222K EY0224I EY0224J GS0223I GS0223J GS0506G CV1175 CY1172 ET1109C ET1177 GS1129A GS1169-M GS1170 GS1174 GY0969C GY1164 GY1165 GY1171 GY1176 GY1176A GY1176B GY1218 NU1178 OR1111B OR1112A OR1112B OR1112C OR1114 OR1131 OR1167 OR1168 OR1205 OR1206 OR1216 OR1217 GS1169A GS1170A NU1120E OR1112E OR1167A OR1072A OR1072B OR1072C OR1073A OR1073B OR1073C OR1073D OR1075C OR1075D OR1075E OR1075F OR1075G HT0283J OR1057A OR1138 GS1259-A GS1259-B GS1265-A GS1265A-A HT1313 CL1161 CL1162 CL1163 ET1109 ET1109B ET1109D ET1109E ET1110 ET1110A GS0521E GS1115 GS1115A GS1115B GS1115C GS1124 GS1124C GS1124D GS1124E GS1124F GS1124G GS1125 GS1125A GS1125B GS1125C GS1129 GS1129B GS1139 GS1181 GS1181A GS1181B GY1165A NU1119B NU1120 NU1120A NU1120B NU1120C NU1120D NU1122 NU1122A NU1122B NU1122C OR0432E OR0480E OR0480F OR0480G OR0480H OR0715I OR0715K OR0715L OR1111 OR1111A OR1111C OR1111D OR1112 OR1112D OR1113 OR1114A OR1126 OR1126B OR1126C OR1126D OR1126F OR1202 OR1202A OR1229 PL1123 PL1123A PL1123B PL1123C CL1293 CL1293B CL1293C CL1293D CL1294 CL1294A CL1294B HT1283 HT1283A HT1283B HT1283C GS1030A GS1030B GS1335 GS1335A ET1255 ET1255A ET1256 GS1254 GS1254B GS1261 GS1261A GS1291 GS1291A GS1291B GS1291C GY1308 LD0536G LD0570F LD0916D LD1260 LD1260A LD1260B LD1260C LD1262 LD1262A LD1262B OR1275 OR1275B OR1275C OR1275D OR1275E GS1264 GS1231 GS1231A GS1231B GS1231C GS1232 GS1232A GS1232B GS1232C OR1233 OR1233B PL1230 PL1230A PL1230B PL1230C OR0483E GS1173 GS1173A EY1258 EY1258B EY1258C OR0972D OR0972E OR0973C OR0973D GS1026A GS1026B GS1027A GS1030C GS1031A-M GS1031B CL1018G CL1018H CL1018I CV1011-M CV1070 GS1012-M GS1013-M GS1014-M GS1053 HT1015B-M HT1015C-M HT1016A-M HT1017 ET1212 ET1212A-M ET1212B-M ET1212C-M PL1211 PL1211A-M PL1237 PL1237A GS1153 HT0768D OR0710C GS0788E-M GS0788F-M ET0837F EY0787G GS0959B GS0971B HT0932 HT0932A LD0680C LD0838F NU0685E OR0681D GS1040 GS1040A CV0597H GS0471E HT0456G HT0456H HT0456I HT0456J HT0456K HT0456L-M HT0456M-M HT0456N NU0430J NU0430K NU0430L NU0436K NU0436L NU0436M OR0431H OR0431I OR0431J OR0431K OR0432F OR0432G OR0432H BS0507C BS0679A CL0525H CL0525I CL0525J CL0525K CL0537H CL0537I CL0537J CL0537K CL0537L CL0537N CL0578C CL0578D CL0578E CL0647B CL0647C CL0952C-M CL0952D-M CL0962H CL0962I CL0962J CL0962L CV0527E-M CV0527F-M CV0527G CV0582E CV0582F CV0582G CY0567E CY0567F ET0513J-M ET0513K-M ET0514E-M ET0514F-M ET0577B ET0577C ET1042 EY0511D EY0515F EY0515G GS0517H-M GS0517I GS0519C-M GS0522B GS0522C GS0523I GS0523J-M GS0523K-M GS0528I-M GS0528J-M GS0528K-M GS0528L-M GS0528M-M GS0533B GS0533C GS0533D GS0553E GS0553F GS0553G GS0579F GS0579G GS0579H GS0631E-M GS0631F-M GS0803C GS0804C GS0806F GS0948D GS0948E GS0948F GS1003D GS1003E GS1004A GS1201 GY0534F GY0534G GY0568D GY0568E GY0569D GY0569F HT0540C HT0584M HT0584N HT0584O HT0584P HT0585B LD0536C LD0536D LD0536E LD0536F LD0570E LD0808E NU0512C NU0538C NU0538D NU0539D NU0539E NU0544H NU0544I NU0544J NU0544J-M NU0544K-M NU0544L-M NU0544M-M NU0546H NU0561G NU0561H NU0581D NU0784C-M NU0784D-M NU0807D NU0940C-M OR0510D-M OR0520G OR0524C OR0524D OR0524D-M OR0526E OR0526F-M OR0532E OR0551F OR0558E OR0558F OR0572B OR0574C OR0574D OR0574E OR0574F OR0574G OR0673C OR0673D OR0805D OR0984 OR0991C OR0992B OR0992C OR0993A OR1054 OR1054A OR1135 OR1135A LD0965B LD0965C LD0966B OR0964A OR0967A GS0654D CL0621C CL0926E CL1299 CL1299A CV0605E CV0605F CV0605G CV1006A CV1006B CV1006C CV1006D EY0598F EY0598G GF0670C GF0670D GF0670E GS0600G GS0600H GS0601D GS0601E GS0654C GS1314 HT0611I HT0611J HT0611K HT0611L HT1343A NU0618G NU0618H NU0618I OR0604G OR0604H OR0619E OR0619F OR0619G OR0885G OR0885H OR0885I CL0926B CL0926C CL0926D CL0926G GF1056 GS1071A-M GS1071B-M GS1071C-M GS1071-M OR0883F OR0883G OR0936C GS0844C GS0893C GS0978 GS0978A GY0923C BS0852D BS0852E CL0881E CL0881F CL0881G CL0881H CL0881I CL1286 CV0853D CV0853E CV0853F CV0853G CV0853H CV0854C CV0854D CV0854E CV0855D CV0855E CV0855F CV0855G CV0855H ET0856G ET0856H ET0856I ET0857E ET0857F ET0857G ET0857H ET0857I ET0857J ET0857K ET0857L ET0858G-M ET0858H ET0858I ET0858J ET0858K GF1055B GF1055C GF1055D GF1055E GS0859D GS0859E GS0859F GS0859G GS0859H GS0876B GS0876C GS0876E GS0876F GS1220 GS1300 GY0860E GY0860F HT0861F HT0861H HT0862G HT0862H HT0862I HT0862J HT0863E HT0863F HT0863G HT0863H HT0863I LD0864E LD0864F LD0864G LD0864H LD0864I NU0865E NU0865F NU0865G NU0865H NU0866E NU0866F NU0866G NU0866H NU0867G NU0867H NU0867I NU0867J NU0868E NU0868F NU0869D NU0869E NU0869F OR0870C OR0870D OR0870E OR0871C OR0871D OR0871E OR0871F OR0871G OR0871H OR0871I OR0872A OR0874B OR0874C OR0874D OR0874E PL0875E PL0875F PL0875G PL1306 ET1144 GS1143 GS1143A CL0139M CL0139N GS0056M GY1021 GS1037A LD0832F LD1145A LD1145B LD1145C LD1145D LD1159 LD1159A LD1159B GS0833B CL1033 CL1033A CL1033B CL1034C CL1315 CV0734H CV0734I CV0734J CV0734K CV0734L CY0714B CY0714C CY0714D CY0714E CY0736J CY0736K CY0736L CY0736M CY0736N ET0722K ET0722L ET0722M ET0722N ET0722O ET0722P ET0731L ET0731M ET0731N ET0731O ET0731P ET0731Q ET0731R ET0731S ET0731T ET0733G ET0733H ET0733I ET0733J ET0979B ET0979C ET0979D ET0979E EY0720H EY0720I EY0720J EY0720K EY0724H EY0724I EY0724J GS0712J-M GS0712K GS0712L GS0725H GS0725I GS0725J GS0725K GS0725L GS0725M GS0727J GS0727K GS0727L GS0727M GS0727N GS0727O GS0727P GS0728I GS0728J GS0728K GS0728L GS0728N GS0728O GS0735J GS0735K GS0735L GS0735M GS0735N GS0737I GS0737J GS0960D GS0960E GS0960F GS1334 HT0711L-M HT0711M HT0711N HT0711O HT0711P HT1047 HT1047A HT1047B LD0729M LD0729N LD0729O LD0729P LD0729Q LD1032B LD1032C LD1298 NU0723G NU0723H NU0723I NU0723J OR0715J OR0715M OR0715N OR0715O OR0716H OR0716I OR0716J OR0716K OR0716L OR0716M OR0716N OR0717G OR0717H OR0717I OR0717J OR0718I OR0718J OR0718K OR0718L OR0718M OR0718N OR0718O OR0719J OR0719K OR0719L OR0719M OR0719N OR0719O OR0730K OR0730L OR0730M OR0730N OR0730O OR0730P CL0824F-M CL0824G-M CL0824H CL0824I CL0824J CL1133B-M CL1133C-M CL1133D-M CL1133E-M CL1133F CL1133G CL1133H CL1133I CL1134C-M CL1134D CL1134E CL1134F CL1134G CL1134H ET1048 ET1048B ET1048C ET1049C ET1049D ET1049E ET1051B ET1051C ET1051D GS0816B GS0816C GS0817C GS0817D GS0817E GS0830D GS0830F GS0830G GS0988B GS0988C GS0988D GS0988E GS1081 GS1318 GY0827C GY0827D GY0827F GY0827G GY0827H GY1317 HT0815I HT0815J HT0815L HT0815M HT0815N HT0815O LD0832E LD0832G NU0819E NU0819F NU0819G NU0819H NU0826G NU0826H NU0826I NU0826J OR0818C-M OR0818D OR0818E OR0820C OR0820D OR0820E OR0820F OR0820G OR0820I OR0821E OR0822E OR0822F OR0822G OR0822H OR0823E OR0828E OR0828F OR0829B OR0829C OR0968A OR0968B OR1104A OR1104B OR1104C OR1105A OR1105B OR1106 OR1106A OR1106B OR1106C OR1107 OR1107A OR1107B OR1166 CL0927A-M CL0927B CL0927C BS0781A CL0684F GS1323 GS1338 EY0376E CL1158B CV1140 GS1141 OR1271 OR1271A OR1271B OR1271D OR1272 GS1339 GS0997 OR0998 OR0999 CL0280F CL0280G HT1052 HT1052A LD1009B GS1179 GS1179A GS1179B GS1210 GS1210A GS1210B GS1224-TPA GS1270 GS1270A GS1273 OR1226 OR1226A OR1226B OR1235 OR1235A OR1236 OR1236A OR0048L OR0048M OR0048N OR1235A GS1137 GS1001C OR1002B CL1158 CL1158A CL1158C CL1158D CL1158E CL1158F EY0034I EY0034J EY0034L EY0034M EY0034N EY0035I EY0035J EY0035K EY0035L EY0035M EY0035N EY0035O EY0036F EY0036G EY0036H EY0036I EY0036J EY0036K EY0036L EY1221 EY1222 CY1332 ET1110B ET1110C ET1320 ET1320A ET1321 GS1324 GS1325 GS1346 GY1165B GY1326 GY1344 NU1329 OR1319 OR1322 OR1322A OR1327 OR1328 CL1133E-M CV1006D ET1043 OR0431I OR1188B
ClassificationClass II
Reason for RecallDistribution of a product that did not meet specifications. (labeling error)
Product Quantity802,135
Recall NumberZ-2300-2012

Class II Biologics Event

Event ID49145
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Oct-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Bank of Lancaster County Medical Society
CityLincoln
StateNE
CountryUS
Distribution PatternFL, NJ, NY
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info6073807; 6070221; 6067675
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who had lived in a malarial endemic area, were distributed.
Product Quantity3 units
Recall NumberB-2059-12

Class II Biologics Event

Event ID49940
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Aug-08
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCsl Plasma Inc
CityBoca Raton
StateFL
CountryUS
Distribution PatternIllinois, California, Switzerland, Germany
 

Associated Products

Product DescriptionSource Plasma/Liquid Plasma
Code Info4240228453;4240222051;4240221194;4240220429 4240217429;4240217015;4240215818;4240215153 4240214180;4240213527;4240212618;4240211936; 4240211053;4240210380;4240204976;4240203217; 4240202258;4240201459;4240200737;4240199762 4240198982;4240198238;4240197408;4240196568; 4240195885 4240194962;4240194221;4240193356; 4240192718;4240191996;4240191136;4240190596; 4240189368;4240189069;4240188121;4240187675; 4240186875;4240186466;4240185529;4240185085 4240184047;4240183522;4240182433;4240181871; 4240180806;4240180300;4240166955;4240166504; 4240165368;4240164901;4240163784;4240162932; 4240162091;4240161313;4240160497;4240158208; 4240157190;4240155530;4240155054;4240152977 4240152542;4240151504;4240150999;4240150060; 4240149516;4240148483
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose physical was rescheduled as a sample only, were distributed.
Product Quantity66 units
Recall NumberB-1984-12

Class II Biologics Event

Event ID49993
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Aug-08
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCsl Plasma Inc
CityBoca Raton
StateFL
CountryUS
Distribution PatternIllinois, Switzerland, Germany
 

Associated Products

Product DescriptionSource Plasma
Code Info4150162098;4150159365;4150158968;4150157895 4150157508;4150154891;4150153300;4150150738 4150149785;4150149203;4150147948;4150147223; 4150146605;4150145206;4150142055;4150141380 4150139234;4150138581;4150135674;4150135265 4150131794;4150131382;4150126722;4150126413 4150124573;4150124379;4150122978;4150122592; 4150120868;4150120657;4150119094;4150118448 4150117306;4150117012;4150112756;4150112283 4150109774
ClassificationClass II
Reason for RecallBlood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity37 units
Recall NumberB-2021-12

Class II Biologics Event

Event ID50293
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Oct-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Bank of Lancaster County Medical Society
CityLincoln
StateNE
CountryUS
Distribution PatternNY
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW087908303776(Part A); W087908303776(Part B)
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications for release, were distributed.
Product Quantity2 units
Recall NumberB-2066-12

Class II Devices Event

Event ID51437
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAlphatec Spine, Inc.
CityCarlsbad
StateCA
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionTRESTLE LUXE® Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion.
Code InfoProduct code KWQ. 510(k) K102820 Part Number 71721. Lot numbers: 6629701, 6594701, 6434301, 6434302, 6434302R1.
ClassificationClass II
Reason for RecallOn May 9th 2012 Alphatec Spine received a complaint which reported that the distal tip of the Trestle Luxe Slide Alignment Tool (Part Number 71721), does not properly fit into the hexalobe screw on the Trestle Luxe Plate.
Product Quantity38
Recall NumberZ-2273-2012

Class II Devices Event

Event ID53055
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jul-09
Initial Firm Notification of Consignee or Public Letter
Recalling FirmToshiba American Medical Systems Inc
CityTustin
StateCA
CountryUS
Distribution PatternNationwide distribution: USA including states of: AL, AR, CA, CO, FL, GA, KY, MA, MD, MT, ND, NJ, NV, NY, OH, PA and Puerto Rico.
 

Associated Products

Product DescriptionWhole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.
Code InfoSerial Number: 2DA0882051
ClassificationClass II
Reason for Recall1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time, incorrect couch positions and scan times are displayed on the reconstructed images for the data acquired by Return scanning, while all related information is displayed on the reconstructed images for the data acquired by Go scanning. This phenomenon is due to a problem in the image reconstruction software. It should be noted that this error occurs, the error does not occur for in-scan reconstructed images or images obtained by selecting and reconstructing the acquired raw data for each scan individually after scanning is completed. 2. It has been found that when scanning is performed while the tube current is modulated (Sure Exposure 3D), a transmission of the modulation data to X-ray control section may fail due to a hardware problem, and an error occurs at the time of scan setup as a result. If this error occurs at the time of scan setup as a result. If this error occurs, the error message shown in the figure on the right is displayed on the monitor and the eXam Plan is interrupted. In addition, if this error occurs in an eXam Plan in which Sure Exposure 3D is selected as the actual scan for SureStart, the right error message is displayed after monitoring scan. Monitoring scan therefore cannot be switched to the actual scan and the eXam Plan is interrupted as a result. It should be noted that this error does not occur when the tube current is modulated in ECG synchronization.
Product Quantity24 Systems
Recall NumberZ-2282-2012

Class II Biologics Event

Event ID54945
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Dec-09
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma Inc
CityBoca Raton
StateFL
CountryUS
Distribution PatternIllinois; Switzerland; Germany
 

Associated Products

Product DescriptionSource Plasma
Code Info0120597139;0120590536;0120590190;0120589168 0120586695;0120584937;0120584539;0120582630 0120581765;0120580126;0120579149;0120578781 0120577239;0120576214;0120575394;0120575116 0120574297;0120574054;0120573289;0120573072 0120572321;0120572153;0120571209;0120570976 0120569673;0120569301;0120564594;0120546159 0120545371;0120543100;0120540957;0120536887 0120535196;0120533314;0120532463;0120530002 0120528419;0120527706;0120523135;0120523057 0120521616;0120521341;0120519981;0120517362 0120516945;0120515595;0120514242;0120513990 0120509144;0120508031;0120505944;0120505217 0120504120;0120504008;0120503244;0120503144 0120498668;0120498477;0120497398;0120496813 0120496307;0120495869;0120495250;0120494977 0120494217;0120492124;0120491476;0120490909 0120489065;0120487331;0120486061;0120485518 0120484778;0120484519;0120483374;0120482775 0120482626;0120482065;0120481950;0120481397 0120480831;0120479700;0120478351;0120478107 0120475884;0120475585;0120475081;0120474780 0120472786;0120472470;0120471658
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred, were distributed.
Product Quantity91
Recall NumberB-2102-12

Class II Biologics Event

Event ID54966
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Dec-09
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCsl Plasma Inc
CityBoca Raton
StateFL
CountryUS
Distribution PatternIL, California
 

Associated Products

Product DescriptionSource Plasma
Code Info6200120127;6200116213;6200100423;6200099327 6200098074;6200097081;6200096853;95525747 80133612;80131519;80125075;80122722;80114949 80100430;80097570;80092315;80089339;80084402 80082637;80075318;80070610;80069959;80066224 80064152;80060734;80056935;80053286;80043027 80039044;80036777;80030058;80024750;80021964 80017141;79968669;79891554;79881302;79847148 79834650;79821872;79802048;53006622;53003010 52994845;52990441;52979408;52975417;52971778 52967474;52959592;52953552;52946189;52910685 52906268;52895241;95537597;95534459;95529684 95527246;95519203
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred, were distributed
Product Quantity60 units
Recall NumberB-2101-12

Class II Devices Event

Event ID60514
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Jun-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmSendx Medical Inc
CityCarlsbad
StateCA
CountryUS
Distribution PatternWorldwide Distribution - US Nationwide including the state of OH.
 

Associated Products

Product DescriptionABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gases, electrolytes, glucose and oximetry (ABL80 FLEX CO-OX only) in whole blood. The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) analyzer systems are intended for use by trained technologists, nurses, physicians and therapists. They are intended for use in a laboratory environment, near patient or point-of-care setting.
Code InfoModel Numbers: 393-839 (with 933-082 software) and 393-841 (with 933-132 software) All Serial Numbers
ClassificationClass II
Reason for RecallThe firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient's clinical condition.
Product QuantityABL80 FLEX is 1680, ABL80 CO-OX is 1759
Recall NumberZ-2304-2012

Class II Devices Event

Event ID61171
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Dec-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAdvanced Neuromodulation Systems Inc.
CityPlano
StateTX
CountryUS
Distribution PatternNationwide within the US, and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Isreal, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
 

Associated Products

Product DescriptionEon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connected to 4, 8, or 16 electrode leads or a lead extension. Product Usage: The Eon and Eon Mini Neurostimulation Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Code InfoAll lots of the Eon (Product Code 65-3716)
ClassificationClass II
Reason for RecallAs of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at the implantable pulse generators (IPGs) implant site during charging for the Eon IPG and 116 reports of similar symptoms for the Eon Mini IPG, respectively.
Product Quantity26,388 units
Recall NumberZ-2280-2012
Product DescriptionThe Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with 4, 8, and 16 electrode leads. Product Usage: The Eon and Eon Mini Neurostimulation Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Code InfoAll lots of Eon Mini (Product Code 65-3788)
ClassificationClass II
Reason for RecallAs of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at the implantable pulse generators (IPGs) implant site during charging for the Eon IPG and 116 reports of similar symptoms for the Eon Mini IPG, respectively.
Product Quantity30,560 units
Recall NumberZ-2281-2012

Class II Devices Event

Event ID61982
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jun-10
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmUnimed Surgical Products, Inc.
CityLargo
StateFL
CountryUS
Distribution PatternUS Nationwide Distribution - including the state of IL.
 

Associated Products

Product DescriptionProduct is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0016 -- Lot #: 030608-01 and 121808-19. Product Usage: Intended for cutting and coagulation of soft tissue.
Code InfoLot #s: 030608-01, 121808-19.
ClassificationClass II
Reason for RecallOn 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Product Quantity1440 ea
Recall NumberZ-2286-2012
Product DescriptionProduct is labeled in part: "***MEDLINE***Extended PTFE Coated Needle 4.0" (10.16cm) Length***Reorder: ES0016A***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0016A -- Lot #: 121808-20. Product Usage: Intended for cutting and coagulation of soft tissue.
Code InfoLot #: 121808-20.
ClassificationClass II
Reason for RecallOn 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Product Quantity240 each
Recall NumberZ-2287-2012
Product DescriptionProduct is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) Length***Reorder: ES0016AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0016AM -- Lot #: 062408-08, 062509-01. Product Usage: Intended for cutting and coagulation of soft tissue.
Code InfoLot #: 062408-08, 062509-01.
ClassificationClass II
Reason for RecallOn 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Product Quantity1440 each
Recall NumberZ-2288-2012
Product DescriptionProduct is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75" (6.99cm) Length***Reorder: ES0013***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0013 -- Lot # 030309-02 and 030509-05 Product Usage: Intended for cutting and coagulation of soft tissue.
Code InfoLot # 030309-02 and 030509-05
ClassificationClass II
Reason for RecallOn 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Product Quantity3600 each
Recall NumberZ-2289-2012
Product DescriptionProduct is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm (1.81) Length***Reorder: ESE1651***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ESE1651 -- Lot # 03059-03 Product Usage: Intended for cutting and coagulation of soft tissue.
Code InfoLot # 03059-03
ClassificationClass II
Reason for RecallOn 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Product Quantity1200 each
Recall NumberZ-2290-2012
Product DescriptionProduct is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm) Length***Reorder: ES0013M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0013M -- Lot # 042209-02 Product Usage: Intended for cutting and coagulation of soft tissue.
Code InfoLot # 030509-07, 062309-02.
ClassificationClass II
Reason for RecallOn 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Product Quantity1800 each
Recall NumberZ-2291-2012
Product DescriptionProduct is labeled in part: "***MEDLINE***Extended PTFE Coated Blade 6.5 (16.51cm) Length***Reorder: ES0014***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0014 -- Lot # 042209-03. Product Usage: Intended for cutting and coagulation of soft tissue.
Code Info Lot # 042209-03.
ClassificationClass II
Reason for RecallOn 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Product Quantity1920 each
Recall NumberZ-2292-2012
Product DescriptionProduct is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 4.0 (10.16cm) Length***Reorder: ES0014AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0014AM -- Lot # 050409-05, 050609-05. Product Usage: Intended for cutting and coagulation of soft tissue.
Code InfoLot # 050409-05, 050609-05.
ClassificationClass II
Reason for RecallOn 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Product Quantity2400 each
Recall NumberZ-2293-2012
Product DescriptionProduct is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 (12.70cm) Length***Reorder: ES0009***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0009 -- Lot # 052709-01 Product Usage: Intended for cutting and coagulation of soft tissue.
Code InfoLot # 052709-01
ClassificationClass II
Reason for RecallOn 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Product Quantity1200 each
Recall NumberZ-2294-2012
Product DescriptionProduct is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with Extended Insulation 2.50 (6.40cm) Length***Reorder: ES0012M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0012M -- Lot # 030509-07, 052909-02, 062309-02. Product Usage: Intended for cutting and coagulation of soft tissue.
Code InfoLot # 052909-05, 062309-02.
ClassificationClass II
Reason for RecallOn 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Product Quantity6600 each
Recall NumberZ-2295-2012
Product DescriptionProduct is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 6.5 (16.51cm) Length***Reorder: ES0014M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0014M-- Lot # 050609-05, 052909-05, 062309-04. Product Usage: Intended for cutting and coagulation of soft tissue.
Code InfoLot # 050609-05, 052909-05, 062309-04.
ClassificationClass II
Reason for RecallOn 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Product Quantity3600 each
Recall NumberZ-2296-2012

Class II Devices Event

Event ID62564
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jun-09
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAtlas Spine, Inc.
CityJupiter
StateFL
CountryUS
Distribution PatternUSA Distribution to the state of Florida only.
 

Associated Products

Product DescriptionApelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter Park Drive #4***Jupiter, Florida 33458***561-741-1108***Tissue Sleeve***MFG Date: XX/XX/XXXX***Lot #: XXXX***Weldment***MFG Date: 03/23/2009***Sleeve Assembly***MFG Date: XX/XX/XXXX***Lot #: XXXX***Qty: 1 Rx Only***Non-Sterile. Sterilize Prior to Use*** Rev. A***. The Modular Screwdriver is used to insert modular pedicle screw implants which are part of the Apelo System.
Code InfoPN# 70175-001 CAT#2006-41-0000 Lot # 00686
ClassificationClass II
Reason for RecallAtlas Spine, Inc. recalled their Apelo Modular Screwdriver, a component of the Apelo Pedicle Screw System Instrumentation, because of complaints received about the tip breaking. If the tip is fractured inside of the modular screw, the tip could become implanted in the body or if the entire screw is removed, it could cause a delay in the surgery.
Product Quantity4 pieces
Recall NumberZ-2274-2012

Class II Devices Event

Event ID62578
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomet 3i, LLC
CityPalm Beach Gardens
StateFL
CountryUS
Distribution PatternWorldwide Distribution-Distributed in the USA and the countries to Spain, France, Germany, Switzerland, and Australia.
 

Associated Products

Product DescriptionLow Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cylinder***Cylinder; Cylindre; Zylinder; Cilindro; Cilindro; Cilindro***RX only***NON STERILE***Caution: Law prohibits dispensing without prescription***Consult instructions for use*** Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast.
Code InfoLots: 2010100001, 2010080684, and 2010090191
ClassificationClass II
Reason for RecallBiomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due to some packages labeled LPCCC1, Hexed Castable Cylinder possibly containing LPCCC2, Non-Hexed Castable Cylinders.
Product Quantity611 units
Recall NumberZ-2271-2012

Class II Devices Event

Event ID62678
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc
CityMalvern
StatePA
CountryUS
Distribution PatternNationwide Distribution-CA, CO, CT, FL, GA, IL, IN, IA, KS, MD, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.
 

Associated Products

Product Descriptionsyngo Imaging XS. Radiological image processing system.
Code InfoModel number 10496279
ClassificationClass II
Reason for RecallThere is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions "Regions of Interest", "Pixel Lens", "Edge Enhancement" and "Histograms".
Product Quantity52
Recall NumberZ-2264-2012

Class II Devices Event

Event ID62679
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc
CityMalvern
StatePA
CountryUS
Distribution PatternNationwide Distribution -- CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.
 

Associated Products

Product Descriptionsyngo.plaza, Model number 10592457. Intended use: radiological image processing system.
Code InfoSerial Numbers: 100263, 100401, 100177, 100138, 100174, 100219, 100406, 100249, 200040, 100201, 100198, 100181, 100301, & 100146.
ClassificationClass II
Reason for RecallThere is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions.
Product Quantity14
Recall NumberZ-2275-2012

Class II Food Event

Event ID62692
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRita's Fine Food, Inc. Dba Da Vinci's
CityLa Mesa
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product Description6" Club Sandwich, 8" Club Sandwich, Club Sandwich Triangle, and Wide Wedge Club Sandwich
Code InfoUPC 697436000058 (6" size); UPC 697436000355 (8" size); UPC 697436000928 (triangle); UPC 697436001437 (wide wedge).
ClassificationClass II
Reason for RecallThe recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese.
Product Quantity430 units total
Recall NumberF-2018-2012
Product Description6" Ham & Cheese Sandwich, 8" Ham & Cheese Sandwich, and Ham & Cheese Triangle Sandwich
Code InfoUPC 697436000065 (6" size); UPC 697436000409 (8" size); UPC 697436000966 (triangle).
ClassificationClass II
Reason for RecallThe recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese.
Product Quantity430 units total
Recall NumberF-2019-2012
Product Description6" Turkey & Cheese Sandwich, Turkey & Cheese Triangle Sandwich, and Wide Wedge Turkey & Cheese
Code InfoUPC 697436000102 (6" size); UPC 697436001000 (triangle); UPC 697436001406 (wide wedge).
ClassificationClass II
Reason for RecallThe recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese.
Product Quantity430 units total
Recall NumberF-2020-2012
Product Description8" Roast Beef Sandwich, 6" Roast Beef Sandwich, Roast Beef Triangle Sandwich, and Wide Wedge Roast Beef Sandwich
Code InfoUPC 697436000454 (8" size); UPC 697436000089 (6" size); UPC 697436000980 (triangle); UPC 697436001420 (wide wedge).
ClassificationClass II
Reason for RecallThe recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese.
Product Quantity430 units total
Recall NumberF-2021-2012
Product Description8" Turkey Sandwich
Code InfoUPC 697436000485 (8" size)
ClassificationClass II
Reason for RecallThe recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese.
Product Quantity430 units total
Recall NumberF-2022-2012
Product DescriptionWide Wedge Ham Sandwich
Code InfoUPC 697436001413 (wide wedge).
ClassificationClass II
Reason for RecallThe recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese.
Product Quantity430 units total
Recall NumberF-2023-2012
Product Description8" Meatball Sandwich
Code InfoUPC 697436000416.
ClassificationClass II
Reason for RecallThe recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese.
Product Quantity430 units total
Recall NumberF-2024-2012
Product DescriptionMedium Chef Salad
Code InfoUPC 697436001833.
ClassificationClass II
Reason for RecallThe recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese.
Product Quantity430 units total
Recall NumberF-2025-2012
Product DescriptionPita Pocket Club Sandwich
Code InfoUPC 697436000645
ClassificationClass II
Reason for RecallThe recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese.
Product Quantity430 units total
Recall NumberF-2026-2012
Product DescriptionPita Pocket Turkey & Cheese
Code InfoUPC 697436000706
ClassificationClass II
Reason for RecallThe recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese.
Product Quantity
Recall NumberF-2027-2012
Product DescriptionPita Pocket Ham & Cheese
Code InfoUPC 697436000676
ClassificationClass II
Reason for RecallThe recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese.
Product Quantity
Recall NumberF-2028-2012
Product DescriptionPita Pocket Roast Beef
Code InfoPita Pocket Roast Beef UPC 697436000683
ClassificationClass II
Reason for RecallThe recall was initiated because Rita's Fine Food sandwiches have undeclared milk as a sub-ingredient in cheese.
Product Quantity
Recall NumberF-2029-2012

Class II Devices Event

Event ID62705
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNellcor Puritan Bennett Inc. (dba Covidien LP)
CityBoulder
StateCO
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and countries including: Australia, Brazil, Canada, Columbia, Deutchland, France, Japan, Mexico, Panama, Puerto Rico, Singapore, and Uruguay.
 

Associated Products

Product DescriptionDGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures.
Code InfoACT1020, 168583 through , 210055X; ACTC1525, 168575 through, 208115X; ACT1030, 171291 through , 209598X; ACTC2025, 168853 through, 209457X; ACT1507, 168576 through, 209455X; SWCT1530, 170383 through, 210057X; ACT1510, 170882 through , 207901X; SWCT15303, 169683 through, 207900X; ACT1520, 168571 through, 210054X; SWCT1540, 170384 through, 197330; ACT1530, 169419 through, 209547X; SWCT20303, 191407 through, 191407; ACT2020, 168854 through, 210720X; SWCT2303, 195745 through, 195745; ACT2030, 168574 through, 209453X; SWCT2530, 205456 through, 205456; ACT2530, 169684 through, 209599X; SWCT25303, 177906 through, 213729X; ACTC1025, 171300 through, 208194X; SWCT2540, 191404 through, 205455, , , , DGPHP, 162732 through, 214867X,
ClassificationClass II
Reason for RecallCovidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP single use grounding pad which may result in an electrical burn to the patient at the application site.
Product Quantity184,934 units
Recall NumberZ-2301-2012

Class II Devices Event

Event ID62708
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Dec-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSunquest Information Systems, Inc.
CityTucson
StateAZ
CountryUS
Distribution PatternWorldwide Distribution -- USA (nationwide) and the country of Canada.
 

Associated Products

Product DescriptionSunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
Code InfoVersions 6.4 and later
ClassificationClass II
Reason for RecallThe recall was initiated because Sunquest has confirmed that the Sunquest Laboratory versions 6.4 and later while using Microbiology Result Entry (MRE), the specimen ribbon containing the Accession Number (AN) and the Battery Name may be missing or contain the wrong information.
Product Quantity127 sites
Recall NumberZ-2270-2012

Class II Devices Event

Event ID62714
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Oct-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSunquest Information Systems, Inc.
CityTucson
StateAZ
CountryUS
Distribution PatternWorldwide Distribution, including Nationwide (USA) and the countries of Canada, Denmark, Ireland, the United Arab Emirates and the United Kingdom.
 

Associated Products

Product DescriptionSunquest Laboratory LabAccess Results Workstation (LARS)
Code InfoSunquest Laboratory versions 5.3.3 and 6.3.0 SP3
ClassificationClass II
Reason for RecallThe recall was initiated because Sunquest has confirmed that the Sunquest Laboratory LabAccess Results Workstation (LARS) may file results to the wrong patient by incorrectly combining results.
Product Quantity151 sites
Recall NumberZ-2272-2012

Class II Food Event

Event ID62730
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFour Brothers Packaging Corporation
CityOak Park
StateMI
CountryUS
Distribution PatternMI distribution only...others unknown
 

Associated Products

Product DescriptionJakes Spice Drop, Jake's Jelly Spice Drops 3oz, 4.5oz, 5oz, 6oz and 7oz packages Distributed by Jake's Liberty Packaging Oak Park, MI 48237 248-747-2223
Code InfoPackaging is labeled with a best buy date of 1 year from repackaging date.
ClassificationClass II
Reason for RecallNew York State Department of Agriculture sampled the product and found undeclared colors in Jakes Candy Spice Drops. The firm was notified on 4/19/2012 via letter from New York. FDA conducted follow up and associated inspections on 6/29/12, 7/26/12 and 7/27/12 and determined the labels continued to have the undeclared colors, including FD & C Red 40, Yellow 6, Blue1 and Red 3.
Product QuantityUNKNOWN
Recall NumberF-2104-2012

Class II Drugs Event

Event ID62735
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Apr-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBracco Diagnostic Inc
CityPrinceton
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionMultihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, Rx only, a) 50 mL Single Dose Vial, b) 100 mL Single Dose Vial, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Nycomed GmbH, 78224 Singen (Germany), NDC a) 0270-5264-16, b) 0270-5264-17.
Code InfoLot #: a) 9J37457, 9J44058, Exp 10/12; b) 9I28973, Exp 09/12
ClassificationClass II
Reason for RecallLack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
Product Quantity4,870 Vials
Recall NumberD-1665-2012

Class II Drugs Event

Event ID62756
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCapco Custom Packaging Inc
CitySanta Fe Springs
StateCA
CountryUS
Distribution PatternNationwide and Canada
 

Associated Products

Product DescriptionEco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral Wound Cleanser/Oral Debriding Agent, 8 fl oz (237 mL) bottle, Alcohol Free, Dist By: Eco Dent, 1100 Lakes Dr., Silver Lake, WI 53170 USA, UPC Code: 00037541
Code InfoLot #: 4052, Exp 01/15; 4063, Exp 02/15; 4150, Exp 03/15.
ClassificationClass II
Reason for RecallMicrobial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis bacteria.
Product Quantity14380 Bottles
Recall NumberD-1664-2012

Class II Devices Event

Event ID62770
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCisco Systems Inc
CitySan Jose
StateCA
CountryUS
Distribution PatternNationwide Distribution including the state of TN.
 

Associated Products

Product DescriptionCisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San Jose, CA Cisco HealthPresence, version 2 is intended for remote consultation of patients with a healthcare provider. Cisco HealthPresence enables remote collaboration between a physician and a patient by providing: high-definition video and advanced audio; transmission and display of third-party medical device data; integration with third party EMR: scheduling: and other software applications for remote consultations and exams. Cisco Health Presence is not intended for use in emergency situations. Cisco HealthPresence is not intended for use in active patient monitoring or alarming.
Code InfoSerial/Code Number: 2.1.0.87
ClassificationClass II
Reason for RecallSoftware anomaly may result in incorrect values and interpretations. The initial vital signs reading will display accurately on the Cisco Health Presence Vitals tab and the OnePlace tab. However, subsequent vital signs readings will only update on the Cisco HealthPresence Vitals tab and within the OnePlace database, but will not update under the OnePlace tab, and thus, will not provide current vital signs on the OnePlace display, unless the OnePlace tab is manually refreshed by the user.
Product Quantity1 unit
Recall NumberZ-2263-2012

Class II Devices Event

Event ID62776
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Aug-12
Initial Firm Notification of Consignee or Public Visit
Recalling FirmSteris Corporation
CityMentor
StateOH
CountryUS
Distribution PatternNationwide distribution: USA including states of: AR, AK, CA, CO, DE, FL, IL, MA, MD, NC, NE, NH, NY, OH, PA, SD, TN, TX, WI, and WV.
 

Associated Products

Product DescriptionQKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
Code InfoLot numbers: 1879717, 1943786, 2054914, 2143717, 2177723, 2342319, 2730752, 2922565, 3094190
ClassificationClass II
Reason for RecallSTERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the design of seven (7) models in one quick connect. Due to the unavailability of these two validation devices, STERIS will remove 7 models from the labeling of QKC1692E and will re-label all QKC1692Es in the field..
Product Quantity64 units
Recall NumberZ-2284-2012

Class II Drugs Event

Event ID62779
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jul-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmIsland Kinetics dba Covalence
CityChandler
StateAZ
CountryUS
Distribution PatternAtlanta, Georgia
 

Associated Products

Product DescriptionCosMedix Serious Protection, Natural SPF 28 Sunscreen, 3.3 fl.oz/100mL (100 g), Distributed by CosMedix, LLC, Atlanta, GA --- Also labeled as RESULTS RX, Serious Protection Rx, SPF 28 Sunscreen, Net Wt. 4oz/120g.
Code InfoBatch # P030911C, Exp 03/13; Batch # P022811A, Exp 02/13.
ClassificationClass II
Reason for RecallMicrobial Contamination of Non Sterile Product; mold
Product Quantity5311 bottles
Recall NumberD-1670-2012

Class II Food Event

Event ID62788
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Aug-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmShin Shin Foods, Inc.
CityPortland
StateOR
CountryUS
Distribution PatternProduct was distributed in Oregon.
 

Associated Products

Product DescriptionYogurt Parfait Strawberry, Net weight 9 oz. (225 g), UPC 0 20728 70004 4. Product contains yogurt and strawberry filling and one cup of granola, packaged in a clear container, and granola is in the inner container. The product is labeled in part: '***YOGURT PARFAIT STRAWBERRY***9oz (225g)***Distributed by PACIFIC COAST FRUIT CO***Portland, OR 97267***
Code InfoExpiration dates: 8/10 and 8/12
ClassificationClass II
Reason for RecallThe Yogurt Parfait Strawberry contains coconut, but the label does not declare coconut.
Product Quantity300 cups (9 oz per cup)
Recall NumberF-2093-2012

Class II Food Event

Event ID62795
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmLucky Country, Inc.
CityLincolnton
StateNC
CountryUS
Distribution PatternAZ, CA, UT
 

Associated Products

Product DescriptionAussie-Style Lucky Country Soft Licorice in 1.5 lb. bags. The product is packaged 1.5lb x 18 bags per tray.
Code InfoLot A3057, UPC Code 817795000944
ClassificationClass II
Reason for RecallLead contamination
Product Quantity1577 trays
Recall NumberF-2110-2012

Class II Drugs Event

Event ID62799
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGlaxoSmithKline Inc
CityZebulon
StateNC
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionVentolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSmithKline, Reasearch Triangle Park, NC 27709 NDC 0173-0682-20
Code InfoLot 1ZP7355 Exp. 01/13, 1ZP7749 Exp. 01/13, 1ZP8141 Exp. 01/13, 1ZP8147 Exp. 01/13, 1ZP7729 Exp. 01/13, 1ZP0414 Exp. 03/13, 1ZP0464 Exp. 03/13, 1ZP0570 Exp. 03/13, 1ZP0576 Exp. 03/13, 1ZP0919 Exp. 03/13, 2ZP4959 Exp. 04/13, 2ZP4966 Exp. 04/13
ClassificationClass II
Reason for RecallDoes Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
Product Quantity1,412,566 inhalers
Recall NumberD-1666-2012

Class II Devices Event

Event ID62801
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmEncore Medical, Lp
CityAustin
StateTX
CountryUS
Distribution PatternWorldwide Distribution including Venezuela.
 

Associated Products

Product Description3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along with the other components that comprise the 3DKnee System.
Code InfoModel Number 392-09-706, Lot Number 59602519
ClassificationClass II
Reason for RecallThe firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired.
Product Quantity7 units
Recall NumberZ-2302-2012

Class II Devices Event

Event ID62828
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Nov-10
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCanon Inc.
CityTokyo
State
CountryJP
Distribution PatternNationwide Distribution (USA)
 

Associated Products

Product DescriptionCanon Solid Stale X-ray Imaqer (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
Code InfoCatalog numbers 3930B002AA, 3928B002AA, and 4066B002AA.
ClassificationClass II
Reason for RecallScrews holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.
Product Quantity468 units
Recall NumberZ-2265-2012

Class II Devices Event

Event ID62851
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Feb-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmToshiba American Medical Systems Inc
CityTustin
StateCA
CountryUS
Distribution PatternUSA ( Nationwide Distribution )
 

Associated Products

Product DescriptionToshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received an improved table by an upgrade purchase. This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstruction!;, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the marketplace.
Code InfoSerial Number Range (last 4): (2665-3149), (2211-2237), (2057-2067), A3622041, A4582122 + (2690-3131), (2001-2171), (2001-2124), (2001-2255), (2001-3007), (2015-2061), (2001-2008). The following Device Name/Model Number: Asteion Super 4 / TSX-021B Aquilion Super 4 / TSX-101A/7 Aquilion 8 / TSX-101A/F Aqui1ion 16/ TSX-101A/6 Aqui1ion 16/ TSX-101A/G Aquilion 32 / TSX-101A/D Aquilion 32 / TSX-101A/I Aquilion 64/TSX-101A/E Aquilion 64 / TSX-101AIH Aquilion 16 LB / TSX-201A AquilionONE / TSX-301A
ClassificationClass II
Reason for RecallThe systems all have a similar table control board. It has been found that this board may cause the table position to be incorrect if the table cradle is moved manually. This is referred to as "Free" mode in the operation manuals. If this error does occur it is possible that the patient could be scanned at an incorrect position.
Product Quantity757
Recall NumberZ-2266-2012

Class II Devices Event

Event ID62853
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-May-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmToshiba American Medical Systems Inc
CityTustin
StateCA
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionEXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy.
Code InfoModels MRT-1503 and MRT-1504 " MRT-1503 systems with software V9.01 *R240 through V9.20*R242 " MRT-1504 systems with software V9.21 *R24
ClassificationClass II
Reason for RecallThe status display in the sequence queue window may not change from "Current" to "Done".
Product Quantity54
Recall NumberZ-2278-2012

Class II Devices Event

Event ID62864
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Feb-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMetrex Research, LLC.
CityRomulus
StateMI
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of Canada, AE, and YE.
 

Associated Products

Product DescriptionCaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate brands: EnviroCide, part number: 13-3325. Private labeled products of Cavicide: Backscratchers Cavicide, part number: 13-4800. MaxiSpray Plus, part numbers: 13-7400 and 13-7405. pdCARE Surface Disinfectant, part numbers: 13-7525 and 13-7500. Z3 Surface Disinfectant, part number: 13-7900. CaviCide is a multi-purpose disinfectant/decontaminant cleaner for use on hard, non-porous inanimate surfaces. CaviCide is a bactericidal, virucidal, fungicidal, and tuberulocidal which is available in a ready-to-use, liquid form typically contained in 1 gallon bottles, 2.5 gallon bottles, 25 oz. spray bottles, or 55 gallon drums (depending on the item number). CaviCide may also be branded as a private label (see (1)(vi) below for names and Table 1 above for additional details). The product may be used (1) for precleaning non-instrument surfaces prior to disinfection; (2) for precleaning instruments prior to disinfection; (3) as a virucide on non-instrument surfaces; (4) as a disinfectant on non-instrument surfaces; (5) as a virucide on precleaned non-critical medical devices, instruments and implements; and (6) as a disinfectant on precleaned non-critical medical devices, instruments, and instruments. It is useful in health care settings such as hospitals, emergency medical settings, surgical centers, isolation areas, neonatal units, patient care areas, ophthalmic and optometric facilities, dental offices, dental operatories, animal care facilities, salon settings, emergency vehicles, schools, health club facilities, kitchens, bathrooms, prisons, morgues, and other critical care areas.
Code InfoCaviCide Lot # 10-1301, 10-2301, 10-2302, 10-2328, 10-2328A, 10-2328B, 10-2331, 10-2333, 10-1334, 10-2334, 10-1335, 10-2335, 10-1342A, 10-1343, 10-2345. EnviroCide Lot # 10-2331. Backscratchers Cavicide lot # 10-1342. MaxiSpray Plus lot # 10-2328A and 10-1343. pdCARE Surface Disinfectant lot # 10-2331 and 10-2345. Z3 Surface Disinfectant lot # 10-2328.
ClassificationClass II
Reason for RecallMetrex Research is recalling Cavicide containing the Spring Fresh Fragrance because the affected lot of product containing this fragance has caused an increase in reported health reactions in some individuals such as headache, nausea, and respiratory discomfort.
Product Quantity17,690 units
Recall NumberZ-2267-2012

Class II Devices Event

Event ID62865
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Healthcare Inc.
CityAndover
StateMA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, DENMARK, EL SALVADOR, FRANCE, GERMANY, ICELAND, INDIA, IRELAND ISRAEL, ITALY, JORDAN, KENYA, LEBANON, MALAYSIA,NAMIBIA NETHERLANDS, NORWAY, POLAND, PORTUGAL, RWANDA SAUDI ARABIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.
 

Associated Products

Product DescriptionPhilips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279. The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility. The SureSigns VSi vital signs monitor is for measurement of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility
Code InfoSerial Number Range CN14800101-CN14801360 CN21201362-CN21202440, CN21202525, SP13701043, USPP101007
ClassificationClass II
Reason for RecallPhilips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wall mount
Product Quantity2314 units
Recall NumberZ-2303-2012

Class II Devices Event

Event ID62880
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMindray DS USA, Inc. d.b.a. Mindray North America
CityMahwah
StateNJ
CountryUS
Distribution PatternWorldwide Distribution - US Nationwide including the states of: NY, SD, NE, IL, MO, CA, OH, OK, WA, IN, WY, CO, TX, FL, NC, AL and Puerto Rico. and the countries of: Australia, Canada, Columbia, New Zealand, Pakistan, Russia, Saudi Arabia, United Kingdom and Venezuela.
 

Associated Products

Product DescriptionV Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5, 6 and 12 lead measurements; Heart Rate; Pulse Oximetry (SpO2); ST Segment Analysis; Arrhythmia Detection; Non Invasive Blood Pressure (NIBP); Invasive Blood Pressure (IBP); Cardiac Output (CO); Respiratory Gasses; Respiration Rate; and Temperature. The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. The target populations are adult, pediatric and neonate with the exception of: Arrhythmia detection and ST Segment Analysis, for which the target populations are adult and pediatric only; IV Drug Calculations for which the target population is adult only; and Cardiac Output for which the target population is adult and pediatric only.
Code InfoV Series Monitor Part Numbers 0998-00-1800-101 and 0998-00-1800-201.
ClassificationClass II
Reason for RecallMindray has identified two software anomalies contained in the V Series Monitoring System. There have been no reports of injuries associated with these anomalies. These anomalies affect V Series Systems distributed between September 31, 2010 and January 9, 2012.
Product Quantity979 units
Recall NumberZ-2279-2012

Class II Food Event

Event ID62913
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Apr-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSUNFRESH NATURAL LLC.
CityPassaic
StateNJ
CountryUS
Distribution PatternNew Jersey and New York
 

Associated Products

Product DescriptionSunFresh Natural Fruit & Nut, Distributed by: Sunfresh Natural, LLC. Passaic, NJ 07055. Please visit us at: www.sunfreshnatural.com. 6 ounce and 10 ounce packages (Net wt.).
Code InfoNet wt. 6 ounce (plastic bag) and 10 ounce (rigid plastic container).
ClassificationClass II
Reason for RecallSunFresh Natural 6 ounce Fruit & Nut product label does not list sulfites and FD&C Yellow #6 ingredients.
Product Quantity264 units
Recall NumberF-2017-2012

Class II Devices Event

Event ID62919
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAdvanced Sterilization Products
CityIrvine
StateCA
CountryUS
Distribution PatternWorldwide Distribution, including Nationwide (USA).
 

Associated Products

Product DescriptionCIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection.
Code InfoProduct codes: 20390 (US), 20391 (EMEA and WW), 20394 (Canada), and 20690 (Korea).
ClassificationClass II
Reason for RecallThe recall was initiated because Advanced Sterilization Products has discovered instances of missing labels on bottles of CIDEX OPA Solution, Part # 20390 manufactured between May 2011 and April 2012.
Product Quantity
Recall NumberZ-2276-2012

Class II Drugs Event

Event ID62999
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionPropofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24
Code Info07-893-DJ, exp. 7/2013, 10-123-DJ, 10-125-DJ, exp. 10/2013
ClassificationClass II
Reason for RecallPresence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.
Product Quantity56,420 vials
Recall NumberD-1672-2012

Class II Food Event

Event ID63005
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmInterstate Seafood Inc
CityLos Angeles
StateCA
CountryUS
Distribution PatternNationwide in the US: CA, CO, IL, TX, UT
 

Associated Products

Product DescriptionFrozen tiny oyster meat I.Q.F. , 40x8oz (20lbs/case);
Code InfoLot Number: Oyster Tiny: GL07240
ClassificationClass II
Reason for RecallInterstate Seafood is recalling Korean Frozen Oysters because they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
Product Quantity5,512 cases total
Recall NumberF-2100-2012
Product DescriptionFrozen Large Oyster meat I.Q.F, 6x5lbs.(20lbs)
Code InfoLot Number:Oyster Large: GL07141;
ClassificationClass II
Reason for RecallInterstate Seafood is recalling Korean Frozen Oysters because they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
Product Quantity5,512 cases total
Recall NumberF-2101-2012
Product DescriptionFrozen Half Shell Oyster meat I.Q.F, 5x4lbs (144pieces/case).
Code InfoLot Number: Oyster Half Shell: GL06256.
ClassificationClass II
Reason for RecallInterstate Seafood is recalling Korean Frozen Oysters because they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
Product Quantity5,512 cases total
Recall NumberF-2102-2012

Class III Biologics Event

Event ID39126
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jul-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternMissouri.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045007065480
ClassificationClass III
Reason for RecallBlood product, collected from a donor for whom the arm appearance was not acceptable was distributed.
Product Quantity1 Unit
Recall NumberB-2109-12

Class III Biologics Event

Event ID49636
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jul-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternMissouri, California
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW038308081577;W038308071828;W038308052365
ClassificationClass III
Reason for RecallBlood products, which were labeled with an incorrect volume, were distributed.
Product Quantity3 Units
Recall NumberB-2065-12

Class III Biologics Event

Event ID59515
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Jul-11
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmOctapharma Plasma, Inc.
CityCharlotte
StateNC
CountryUS
Distribution PatternCA, Austria
 

Associated Products

Product DescriptionSource Plasma
Code Info4270048655, 4270047980, 4270047086, 4270046540, 4270045902, 4270044950, 4270044614, 4270044149, 4270043875, 4270042392, 4270042054, 4270041511, 4270040729, 4270040476, 4270039910, 4270039604, 4270038051, 4270037444, 4270034510, 4270034756, 4270035549, 4270036211, 4270036424, 4270033296, 4270033874, 4270037101, 4270032362, 4270025109, 4270031713, 4270032690, 4270029598, 4270029850, 4270030688, 4270030976, 4270027551, 4270029059
ClassificationClass III
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity36 units
Recall NumberB-2195-12

Class III Devices Event

Event ID62572
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhadia US Inc
CityPortage
StateMI
CountryUS
Distribution PatternUSA Nationwide.
 

Associated Products

Product DescriptionPHADIA VarelisA Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Code InfoArticle Number 15696 Lot number #0067
ClassificationClass III
Reason for RecallCustomers were not following the labeled assay procedure. This was due to a letter issued to them in 2004 from Phadia GmbH, which indicated that customers could omit the pre-wash step. The omission of the pre-wash step, when combined with a change in material source in kit lot #0067, caused elevated results.
Product Quantity837 kits (96 assays per kit), total of 80,352 individual assays
Recall NumberZ-2285-2012

Class III Drugs Event

Event ID62636
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Apr-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBracco Diagnostic Inc
CityPrinceton
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionBracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufactured for: Bracco Diagnostics Inc., Princeton, NJ 08543 USA, NDC 0270-5164-15
Code InfoLot S1P272A Expiry Date: December 2014
ClassificationClass III
Reason for RecallShort Fill: The product is being recalled due to a potential underfill of the affected vials.
Product Quantity47,750 vials
Recall NumberD-1663-2012

Class III Devices Event

Event ID62712
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics, Inc.
CityNewark
StateDE
CountryUS
Distribution PatternNationwide Distribution - USA including AK, AL, AR, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, WA, WI, WV, and WY.
 

Associated Products

Product DescriptionSiemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDMR CalPak), Catalog No. CDDMR-C is an in-vitro diagnostic product intended to be used for the calibration of the Stratus(R) CS Acute Care(TM) D-dimer )DDMR) method
Code InfoDDMR CalPak lots 502058002, exp 2012/11/23 and 501318002, exp 2012/08/10
ClassificationClass III
Reason for RecallSiemens has confirmed that the Stratus(R) CS Acute Care(TM) D-Dimer CalPak calibrator lots 502058002 and 501318002 may exhibit SLOPE or CALCV error messages (instrument errors), which indicate calibration failures.
Product Quantity786 cartons
Recall NumberZ-2283-2012

Class III Drugs Event

Event ID62761
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jul-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNatural Essentials Inc
CityStreetsboro
StateOH
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionOasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 fl oz) bottle, Oasis Consumer Healthcare LLC, 812 Huron Road, Cleveland, Ohio 44115, UPC 8 51076 00300 2.
Code InfoLot #: 11741, 11842, 11851, Exp 05/14
ClassificationClass III
Reason for RecallMicrobial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.
Product Quantity11,058 bottles
Recall NumberD-1671-2012

Class III Food Event

Event ID62762
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmNha Trang Seafoods, Inc
CityRosemead
StateCA
CountryUS
Distribution PatternOne consignee (distributor) in CA.
 

Associated Products

Product DescriptionFrozen Pangasius Fish, brand name T&T, in the following sizes: a. IQF 15 lbs bulk carton: 3/5 oz, 5/7 oz, 7/9 oz, 9/11 oz b. 11lbs x 2 per carton: 8/10 oz and 10 oz/up c. 2lbs x 5 per carton: 2/3 oz d. 15lbs carton: 2/3 oz Product labeling reads in part:" T&T SWAI ROSE ROLL(Pangasius hypophtalmus)***FARM-RAISED PRODUCT OF VIETNAM***". Packaged in paper box carton.
Code InfoFor IQF 15 lbs bulk, lot numbers: 070S8 070C9 071C6 071C7 071C5 071S5 071C8 072S7 072S9 072S8 072S4 072S5; For 11lbsx2 cartons: 054S; For 2lbsx 5 cartons: 070C3 and 070C4; For 15 lbs cartons: 070S7
ClassificationClass III
Reason for RecallThe product was recalled because nitrofuran residue was detected.
Product Quantity2529 cartons
Recall NumberF-2109-2012

Class III Devices Event

Event ID62780
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBard Access Systems
CitySalt Lake City
StateUT
CountryUS
Distribution PatternNational US distribution only: MO, KS, AZ, OK, OR, AL, MA, TX, FL, MI, OH, LA, NJ, NC, WA, AR.
 

Associated Products

Product Description16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device is used for patients requiring hemodialysis. The HemoStar XK catheter is made of radio-opaque polyurethane and allows for flow rates as high as 500 ml/min during hemodialysis treatment.
Code InfoProduct Code 5883730 lot number REVK0125.
ClassificationClass III
Reason for RecallBard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters because they were identified with an incorrect expiration date, 03/2015 rather than 10/2013.
Product Quantity120 units
Recall NumberZ-2277-2012

Class III Drugs Event

Event ID62803
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGalderma Laboratories, L.P.
CityFort Worth
StateTX
CountryUS
Distribution PatternNationwide and Puerto Rico.
 

Associated Products

Product DescriptionCapex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz bottle, Marketed by: Galderma Laboratories, LP, Fort Worth, TX, Mfd. by: Hill Dermaceuticals, Inc., Sanford, FL --- NDC 0299-5500-04,
Code InfoLots J090181-H100089, J090181-J100096, and J090181-K100102.
ClassificationClass III
Reason for RecallSubpotent; fluocinolone acetonide.
Product Quantity17,160 bottles
Recall NumberD-1660-2012

Class III Devices Event

Event ID62881
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Mar-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBaxter Healthcare Corp.
CityRound Lake
StateIL
CountryUS
Distribution Pattern45,865 units
 

Associated Products

Product DescriptionMini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump; Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage: The Mini-Infuser System is designed for controlled intermittent administration of intravenous medication.
Code Infoproduct codes 2M8170 and 2M8170R, all serial numbers
ClassificationClass III
Reason for RecallShould a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the Mini-Infuser will not operate. The reason being that the Mini-Infuser Battery Spring has a flat contact that measures .53 inches ±.01 inches on the inner diameter of the spring coil. The IEC 60086-2 and ANSI 08 standards specify a minimum of .51 inches for the negative terminal diameter.
Product Quantity26,485 units
Recall NumberZ-2268-2012
Product DescriptionMini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syringe infusion pump with an active time scale and rate selector switch; product codes 2M8171 and 2M8171R. Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage: The Mini-Infuser System is designed for controlled intermittent administration of intravenous medication.
Code Infoproduct codes 2M8171 and 2M8171R, all serial numbers
ClassificationClass III
Reason for RecallShould a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the Mini-Infuser will not operate. The reason being that the Mini-Infuser Battery Spring has a flat contact that measures .53 inches ±.01 inches on the inner diameter of the spring coil. The IEC 60086-2 and ANSI 08 standards specify a minimum of .51 inches for the negative terminal diameter.
Product Quantity19,380 units
Recall NumberZ-2269-2012

Class III Drugs Event

Event ID62887
StatusTerminated
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jan-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmVistaPharm, Inc.
CityLargo
StateFL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionMETOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only, Manufactured by VistaPharm, Inc., Largo FL33771
Code Info195900 exp. 01/12.
ClassificationClass III
Reason for RecallLabeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50,"
Product Quantity73,800 cups
Recall NumberD-1669-2012

Class III Drugs Event

Event ID62930
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Jun-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmApotex Corp.
CityWeston
StateFL
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionAzelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5.
Code InfoLot #: JK9130, JM0925, Exp 05/12; JN6514, Exp 07/12; JN1125, JN1127, Exp 08/12; JR5780, JR5782, Exp 12/12.
ClassificationClass III
Reason for RecallCGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Product Quantity963,407 bottles
Recall NumberD-1667-2012

Mixed Classification Biologics Event

Event ID42120
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-May-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternKS, Switzerland.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045006012221
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2106-12
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW045006012221
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2107-12

Mixed Classification Food Event

Event ID62644
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jul-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmCass Clay Creamery AMPI Fargo Division
CityFargo
StateND
CountryUS
Distribution PatternND, AZ, MN, SD, KS
 

Associated Products

Product DescriptionCASS-CLAY, Ice Cream, Artificially Flavored MAPLE NUT, One Gallon (3.78 L), 0 70422 03404 4 HORNBACHERS, MAPLE NUT, Ice Cream, HALF GALLON(1.89 L), 0 41130 21666 4 COLUMBIA VALLEY FARMS, MAPLE NUT, 62438, 3 GALLON(11.34L), 0 41493 62438 0
Code InfoAll products that has a plant code of "38-25".
ClassificationClass I
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared Brazil nuts.
Product Quantity22757
Recall NumberF-2035-2012
Product DescriptionCASS-CLAY, DOUBLE CHOCOLATE FUDGE, Premium Light Ice Cream, HALF GALLON (1.89L), 0 70422 24061 2
Code Infoall products that has a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy lecithin and peanut oil.
Product Quantity1,064
Recall NumberF-2036-2012
Product DescriptionCass Clay, COOKIES 'N CREAM, 1 gallon ( 3.78 L), 0 70422 45034 9 Cass Clay, COOKIES 'N CREAM, half gallon (1.89 L), 0 70422 04010 6
Code Infoall products that has a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy lecithin.
Product Quantity43,089 containers
Recall NumberF-2037-2012
Product DescriptionCASS-CLAY: LIGHT DUSTY ROAD, ONE GALLON (3.78 L), 0 70422 23480 2. LIGHT ICE CREAM, DUSTY ROAD, HALF GALLON (1.89L), 0 70422 24080 3
Code Infoall products that has a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy lecithin and wheat.
Product Quantity6,192 containers
Recall NumberF-2038-2012
Product DescriptionHORNBACHERS, LIGHT FRENCH VANILLA, HALF GALLON (1.89L), 0 41130 21662 6 (Missing Egg from Contains statement) SUNNYBROOK, LIGHT FRENCH VANILLA, HALF GALLON (1.89 L), 0 70422 24917 2 . (MISSING YELLOW 5 FROM LABEL) DAN'S, LIGHT FRENCH VANILLA, HALF GALLON(1.89 L), 0 70422 24317 0 (MISSING YELLOW 5 FROM LABEL )
Code Infoall products that has a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because labelling of egg ingredient is not FALCPA compliant and for undeclared color Yellow 5.
Product Quantity23,852 containers
Recall NumberF-2039-2012
Product DescriptionCASS-CLAY, PRALINE PECAN, 3 GALLON (11.34 L).
Code Infoall products that has a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared yellow #6, and soy (lecithin).
Product Quantity512 containers
Recall NumberF-2040-2012
Product DescriptionCASS-CLAY, BUBBLE GUM, 3 GALLON (11.34 L).
Code Infoall products that has a plant code of "38-25".
ClassificationClass III
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared red 40, Blue 1, and Blue 2.
Product Quantity335 containers
Recall NumberF-2041-2012
Product DescriptionCASS CLAY, DULUTH DARK CHOCOLATE, 3 GALLON (11.34 L).
Code Infoall products that has a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared yellow #5.
Product Quantity36 containers
Recall NumberF-2042-2012
Product DescriptionCASS CLAY, NEW YORK CHERRY ICE CREAM, 3 GALLON (11.34 L).
Code Infoall products that has a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared yellow #5.
Product Quantity119 containers
Recall NumberF-2043-2012
Product DescriptionDan's, LIGHT BUTTER PECAN, half gallon *(1.89 L), 0 70422 24210 4 Hornbachers, LIGHT BUTTER PECAN, half gallon (1.89 L), 0 41130 21661 9 Sunnybrook, LIGHT BUTTER PECAN, half gallon (1.89 L), 0 70422 24908 0
Code Infoall products that has a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin).
Product Quantity8,141 containers
Recall NumberF-2044-2012
Product DescriptionSunnyBrook, Chocolate Chip one gallon and one quart ( (4.73 L), 0 70422 02905 7 SunnyBrook, CHOCOLATE CHIP half gallon ( (1.89 L), 0 70422 04905 5 Cass Clay, CHOCOLATE CHIP 3 Gallon (11.34 L)
Code Infoall products that has a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin).
Product Quantity11,461 containers
Recall NumberF-2045-2012
Product DescriptionCass-Clay, UND CHAMPION CHIP, half gallon (1.89 L) 0 70422 04062 5 Cass-Clay, UND CHAMPION CHIP 3 Gallon (11.34 L)
Code Infoall products that has a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin).
Product Quantity46 containers
Recall NumberF-2046-2012
Product DescriptionCass Clay, LIGHT BROWNIE FDG, one gallon ( 3.78 L) 0 70422 23485 7 Cass Clay, LIGHT BROWNIE FUDGE, half gallon (1.89 L) 0 70422 24085 8
Code Infoall products that has a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin).
Product Quantity6390 containers
Recall NumberF-2047-2012
Product DescriptionCass Clay CHOCOLATE MONSTER, half gallon (1.89 L) 0 70422 00032 2 Cass Clay CHOCOLATE MONSTER, 3 Gallon (11.34 L) Soy (Lecithin) N/A
Code Infoall products that has a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin).
Product Quantity23,870
Recall NumberF-2048-2012
Product DescriptionCass Clay, TIN ROOF SUNDAE 3 Gallon (11.34 L) Cass Clay, TIN ROOF SUNDAE, one gallon (3.78 L), 0 70422 03474 7
Code Infoall products that has a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin).
Product Quantity9,094 containers
Recall NumberF-2049-2012
Product DescriptionCass Clay, BISON CRUNCH, half gallon (1.89 L) 0 70422 04033 5 Cass Clay, BISON CRUNCH, 3 Gallon (11.34 L)
Code Infoall products that has a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin).
Product Quantity35,996 containers
Recall NumberF-2050-2012
Product Description Cass Clay, LIGHT CANDY BAR, half gallon (1.89 L ) 0 70422 24032 2
Code Infoall products that has a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin).
Product Quantity4,357 containers
Recall NumberF-2051-2012
Product Description Cass Clay, LIGHT MUDDY SNEAKERS, half gallon (1.89 L) 0 70422 24072 8
Code Infoall products that has a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin).
Product Quantity5,347 containers
Recall NumberF-2052-2012
Product Description Cass Clay, PEPPERMINT CANDY, half gallon (1.89 L), 0 70422 00100 8 Cass Clay, Peppermint Stic, 3 Gallon (11.34 L).
Code Infoall products that has a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin).
Product Quantity11,288 containers
Recall NumberF-2053-2012
Product Description Cass Clay, WINTER WONDER, half gallon (1.89 L) , 0 70422 00100 8 Cass Clay, Winter Wonder, 3 Gallon (11.334 L)
Code Infoall products that has a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin).
Product Quantity4321 containers
Recall NumberF-2054-2012
Product Description Schroeder, Ice Cream, Chocolate Chip Cookie Dough, half gallon (1.89 L), 0 72340 00183 2
Code Infoall products that has a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared wheat.
Product Quantity2,100 containers
Recall NumberF-2055-2012
Product DescriptionHornbachers, Peanut Butter Fudge, Half Gallon, (1.89L), 0 41130-21659 6.
Code Infoall products that has a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because it may contain undeclared peanuts in contains statement. Milk and peanuts listed in ingredient deck, however, only milk listed in contains statement.
Product Quantity4221 containers
Recall NumberF-2056-2012
Product Description Cass-Clay , Swiss Chip, 3 Gallon(11.34 L).
Code Infoall products that has a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin).
Product Quantity81 containers
Recall NumberF-2057-2012
Product DescriptionCass-Clay, Strawberry Cheesecake, 3 Gallon (11.34 L).
Code Infoall products that has a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared yellow 5, Yellow 6, Blue 1, Blue 2 and or soy (lecithin).
Product Quantity443 containers
Recall NumberF-2058-2012
Product DescriptionCASS-CLAY, Ice cream, LIGHT MAPLE NUT, One Gallon (3.78L), 0 70422 23404 8
Code Infoall products with a plant code of "38-25".
ClassificationClass I
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared Brazil nuts.
Product Quantity
Recall NumberF-2059-2012
Product DescriptionSUNNYBROOK, LIGHT COOKIES 'N CREAM, half gallon (1.89 L), 0 70422 24943 1
Code Infoall products with a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy lecithin.
Product Quantity
Recall NumberF-2060-2012
Product DescriptionCass-Clay, COOKIES 'N VANILLA 3 Gallon (11.34 L)
Code Infoall products with a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy lecithin.
Product Quantity
Recall NumberF-2061-2012
Product DescriptionHORNBACHERS, FRENCH VANILLA ICE CREAM, Half-gallon (1.89 L), 0 41130 21658 9 (Missing Egg in the Contains statement)
Code Infoall products with a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because labelling of egg ingredient is not FALCPA compliant.
Product Quantity
Recall NumberF-2062-2012
Product DescriptionCass-Clay, BUTTER PECAN, 3 Gallon (11.34 L)
Code Infoall products with a plant code of "38-25".
ClassificationClass II
Reason for RecallCass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy lecithin.
Product Quantity
Recall NumberF-2063-2012
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