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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Class I Food Event

Event ID61944
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-May-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmHocean Inc
CityCity Of Commerce
StateCA
CountryUS
Distribution PatternDistributed to wholesale distributors and Asian grocery stores nationwide to US states: California, Texas, Oregon, Nebraska, Georgia, Florida, Colorado, Oklahoma, Washington, New Mexico, Ohio, Arizona, Tennessee, North Carolina, and Virginia.
 

Associated Products

Product DescriptionNitre powder. Brand "Selected Product", 4oz plastic bags, UPC 0 45027 97918 2.
Code InfoThe product does not bear any manufacturing codes. All product on the market at the time the recall was initiated on 5/25/2012 is subject to recall.
ClassificationClass I
Reason for RecallFDA analysis of the product found that the product consisted of mainly sodium nitrite. The product's label failed to bear adequate directions for use as required in 21 CFR 172.175. Failure to provide these directions for use may result in overuse that can pose an life-threatening hazard to health.
Product Quantity50 cases with 100, 4-oz packages per case
Recall NumberF-2356-2012

Class I Devices Event

Event ID62132
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Sep-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCustom Medical Specialties, Inc.
CityPine Level
StateNC
CountryUS
Distribution PatternUS Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.
 

Associated Products

Product DescriptionCMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info20182-1006
ClassificationClass I
Reason for RecallThe firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
Product Quantity5 cases
Recall NumberZ-2349-2012
Product DescriptionCMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info15011-0904 and 16363-0908
ClassificationClass I
Reason for RecallThe firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Product Quantity3 cases
Recall NumberZ-2350-2012
Product DescriptionCMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info15287-0905, 15974-0906, 17052-0910
ClassificationClass I
Reason for RecallThe firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Product Quantity6 cases
Recall NumberZ-2351-2012
Product DescriptionCMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info14161-0901
ClassificationClass I
Reason for RecallThe firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Product Quantity3 cases
Recall NumberZ-2352-2012
Product DescriptionCMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info20144-1006, 19702-1005
ClassificationClass I
Reason for RecallThe firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Product Quantity7 cases
Recall NumberZ-2353-2012
Product DescriptionCMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info14163-0901
ClassificationClass I
Reason for RecallThe firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Product Quantity75 cases
Recall NumberZ-2354-2012
Product DescriptionCMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology Drainage Pack containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info14267-0901, 14452-0902, 15205-0904, 16147-0907, 16690-0909, 17431-0911, 17708-0912, 17913-1001, 18240-1002, 18308-1002, 18345-1002, 18511-1002, 18739-1003, 18829-1003
ClassificationClass I
Reason for RecallThe firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Product Quantity195 cases
Recall NumberZ-2355-2012
Product DescriptionCMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info15924-0906, 16975-0910, 17709-0912
ClassificationClass I
Reason for RecallThe firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Product Quantity15 cases
Recall NumberZ-2356-2012
Product DescriptionCMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info16661-0909, 16662-0909, 17272-0910, 17566-0911, 17566-0911, 17923-1001, 18188-1001, 18195-1001, 18793-1003, 19158-1004
ClassificationClass I
Reason for RecallThe firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Product Quantity538 cases
Recall NumberZ-2357-2012
Product DescriptionCMS-4975 HSG Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info19134-1004
ClassificationClass I
Reason for RecallThe firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Product Quantity4 cases
Recall NumberZ-2358-2012
Product DescriptionCMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info19850-1006
ClassificationClass I
Reason for RecallThe firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Product Quantity8 cases
Recall NumberZ-2359-2012
Product DescriptionBR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info14255-0901
ClassificationClass I
Reason for RecallThe firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Product Quantity75 cases & 60 Bottles for reps
Recall NumberZ-2360-2012

Class I Food Event

Event ID62789
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmVaqueria Tres Monjitas, Inc.
CitySan Juan
StatePR
CountryUS
Distribution PatternPR only
 

Associated Products

Product Description"Tres Monjitas***Pineapple and guava beverage***Distribuido por Vaquería Tres Monjitas Inc***" Package sizes: gallons, 1/2 gallons, quarts, 14 oz and 8 oz.
Code InfoNo codes
ClassificationClass I
Reason for RecallJuice beverage contains undeclared allergenic sub-ingredient (sodium caseinate).
Product Quantity44,764 units
Recall NumberF-2360-2012

Class I Food Event

Event ID62846
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Aug-12
Initial Firm Notification of Consignee or Public Visit
Recalling FirmSingh And Singh Distributors Inc.
CityCarteret
StateNJ
CountryUS
Distribution PatternNew Jersey and New York
 

Associated Products

Product DescriptionCrispy Punjabi Cookies, By TWI Foods, Net Wt. 800g/1.76 lb, Manufactured by TWI Foods, Inc. 1-866-9-CRISPY, www.crispyjustbaked.com, UPC 627265001520, Product of Canada.
Code InfoManufacturing Date 01/SEP/11; Use Before 31/AUG/12
ClassificationClass I
Reason for RecallProduct contains milk products and labeling does not declare milk as an ingredient. Milk is an allergen.
Product Quantity48 cases (14 clamshells/case)
Recall NumberF-2328-2012

Class I Food Event

Event ID62849
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmIndian Foods & Spices, LLC
CityRahway
StateNJ
CountryUS
Distribution PatternNew Jersey, New York and Pennsylvania.
 

Associated Products

Product DescriptionCrispy Punjabi Cookies, By TWI Foods, Net Wt. 800g/1.76 lb, Manufactured by TWI Foods, Inc. 1-866-9-CRISPY, www.crispyjustbaked.com, UPC 627265001520, Product of Canada.
Code InfoManufacturing Date 20/JUL/12; Use Before 19/JUL/13.
ClassificationClass I
Reason for RecallThis recall has been initiated as a precaution due to Non-Declared Milk. Certain packages may be packaged with ingredient statements not labeled to include the milk ingredient.
Product Quantity96 Cases (14 packages/case)
Recall NumberF-2327-2012

Class I Food Event

Event ID62963
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 FirmChamberlain Farms Inc.
CityOwensville
StateIN
CountryUS
Distribution PatternIndiana, Kentucky, Missouri, Illinois, and Iowa with further shipment including Tennessee, Ohio, and Wisconsin. Counties involved include Vanderburgh, Warrick, Gibson, and Dubois County, Indiana, and Wabash County,Illinois.
 

Associated Products

Product DescriptionWhole Cantaloupe. Both unlabeled and labeled "MIDWEST BEST" PRODUCE INC. HOMEGROWN CANTALOUPE #4319 PRODUCT OF THE USA
Code Infonone or #4319
ClassificationClass I
Reason for RecallChamberlain Farm Produce, Inc., of Owensville, Indiana, is voluntarily recalling all of its cantaloupes from the 2012 growing season that may remain in the marketplace. This recall is occurring because of concern some that cantaloupes may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
Product Quantity222,172
Recall NumberF-2357-2012

Class I Food Event

Event ID62972
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSpence & Co., Ltd.
CityBrockton
StateMA
CountryUS
Distribution PatternCO, FL, NC, GA, DE, PA, MD, NJ,NY, VA, OH, NV, OK, WY, KY, TN, CO.
 

Associated Products

Product DescriptionSpence & Co Ltd brand 8oz Smoked Salmon Trim
Code InfoLot Number: 6704701
ClassificationClass I
Reason for RecallProduct tested positive for Listeria monocytogenes
Product Quantity119 units
Recall NumberF-2329-2012
Product DescriptionWellsley Farms 1 LB Nova Salmon
Code InfoLot Number: 6704701
ClassificationClass I
Reason for RecallProduct tested positive for Listeria monocytogenes
Product Quantity596 units
Recall NumberF-2330-2012

Class I Food Event

Event ID63049
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTriple B Corporation - Charlie's Produce
CitySeattle
StateWA
CountryUS
Distribution PatternDistributed in Alaska and Washington.
 

Associated Products

Product DescriptionFresh Tropical Fruit Mix has the Item # 027-01480, and the UPC is 0 45009 01480 1. Haggen Label reads in part "HAGGAEN'S ORIGINAL *** Tropical Mixed Fruit *** Ingredients: Fresh Pineapple, Papaya, Mango & Kiwi ***Distributed with Pride by: Haggen, Inc., Bellingham, WA *** Net Weight 8 oz. ( 227 g.)***".
Code InfoUse-By date range 7/21/12-8/29/12
ClassificationClass I
Reason for RecallDaniella brand mangos are recalled because they may be contaminated with Salmonella.
Product Quantity29 cases (1-8 oz pkg per case)
Recall NumberF-2361-2012
Product DescriptionCut Tropical Mixed Fruit has the item #028-00165 and the UPC is 0 45009 00165 8. Metropolitan Market Label is read in part " Cut Mango / Papaya w/ Lime Net Weight 10 oz (284 g.) Distributed By metropolitan market *** Seattle, WA***".
Code InfoUse By 7/21/12 through 8/29/12
ClassificationClass I
Reason for RecallDaniella brand mangos are recalled because they may be contaminated with Salmonella.
Product Quantity6 cases ( 6-10 oz per case)
Recall NumberF-2362-2012
Product DescriptionCut Seasonal Fruit -Item # 028-00172 - Net Weight 20 oz UPC 045009 00172 6; Cut Seasonal Fruit - Item # 028-00173 - Net Weight 10 oz UPC 0 45009 00173 3; Label reads in part "CUT SEASONAL FRUIT Ingredients: Pineapple, Mango, Papaya, Strawberries, Grapes & Kiwi*** Distributed By metropolitan market *** Seattle, WA***"; Seasonal Fruit - Item # 028-06037 - Net Weight 10 oz UPC 0 45009 06037 2; Seasonal Fruit - Item # 028-06454 - Net Weight 20 oz UPC 0 45009 06454 7. Label reads in part "SEASONAL FRUIT Ingredients: Pineapple, Mango, Papaya, Strawberries, Grapes & Kiwi*** Produced by: Real Foods *** Kent, WA***" Use By 7/21/12 through 8/29/12
Code InfoUse By 7/21/12 through 8/29/12
ClassificationClass I
Reason for RecallDaniella brand mangos are recalled because they have the potential to be contaminated with Salmonella.
Product Quantity100 cs [Metro Market (MM) 20 oz - 12 cs (4 pk/cs); MM 10 oz - 24 cs (6 pk/cs);Real Foods 10 oz - 57 cs (4 pk/cs); Real Foods 20 oz - 7 cs (4 pk/cs)]
Recall NumberF-2363-2012
Product DescriptionSeasonal Berries with the Item # 028-02071 and the UPC for case 0 45009 02063 5, UPC for package 0 45009 02017 8; Case label reads in part "***ALASKA CARROT Seasonal Berries 6/8 oz *** Packed By: Charlie's Produce, Anchorage, AK***"; Package label reads in part "***Seasonal Berries Blueberry: USA Strawberry, Mango: Mexico Kiwi: New Zealand***" . Seasonal Berries with the item # 028-02063, and the UPC for case 0 45009 02063 5, UPC for package 0 45009 0206305; Case label reads in part "***ALASKA CARROT Seasonal Berries 6/16oz *** Packed By: Charlie's Produce, Anchorage, AK***"; Package label reads in part "*** 16 oz Seasonal Berries Blueberry: USA Pineapple: Costa Rica Mango: Mexico Kiwi: New Zealand***" .
Code InfoUse By 7/21/12 through 8/31/12
ClassificationClass I
Reason for RecallDaniella brand mangos are recalled because they have the potential to be contaminated with Salmonella.
Product Quantity203 cs total - 8 oz - 133 cs (6 pk/cs); 16 oz - 70 (6 pk/cs)
Recall NumberF-2364-2012
Product DescriptionFruit Bowls: 1) Seasonal Fruit Bowl (Walmart) Item # 028-06480***" and the UPC of the package is 0 45009 06480 6 and Case UPC is 0 45009 06480 6. Case label reads in part "***ALASKA CARROT Seasonal Fruit Bowl 6/40 oz *** Packed By: Charlie's Produce, Anchorage, AK***" Use By 7/21/12 through 8/31/12; Package label reads in part "*** Fruit Bowl Gold Pineapple, Cantaloupe, Red Grapes, Strawberry Mango and Kiwi *** PRODUCT OF: Blueberry: USA Strawberry: Mexico Mango: Mexico Kiwi: New Zealand 2) Gourmet Fruit Bowl has the Item # 028-006693, and UPC 6 97327 06693 4. Label reads in part "*** ALASKA CARROT *** FRESH Sliced FRUIT *** ANCHORAGE, AK***" "*** 64oz Gourmet Fruit Bowl Gold Pineapple, Cantaloupe, Red Grapes, Strawberry Mango and Kiwi***" "PRODUCT OF: Pineapple - COSTA RICA Cantaloupe - USA Red Grapes - USA Mangoes - Mexico Kiwi - NEW ZELAND Strawberry - USA ***" "*** Packed By: Charlie's Produce, Anchorage, AK***".
Code Info1) Use By 7/21/12 through 8/31/12; 2) Use By 7/21/12 through 9/05/12
ClassificationClass I
Reason for RecallDaniella brand mangos are recalled because they have the potential to be contaminated with Salmonella.
Product Quantity1) 193 cs; 2) 361 cs (6 pk/cs)
Recall NumberF-2365-2012
Product DescriptionFruit Cup has Item # 028-07140, and the UPC 0 45009 07140 8. Label reads in part "*** ALASKA CARROT Fruit Cup Mango / Red Grape 42/4 oz *** Packed By: Charlie's Produce, Anchorage, AL***". Use By 8/22/12 through 9/01/12.
Code InfoUse By 8/22/12 through 9/01/12
ClassificationClass I
Reason for RecallDaniella brand mangos are recalled because they have the potential to be contaminated with Salmonella.
Product Quantity323 cs
Recall NumberF-2366-2012

Class I Food Event

Event ID63054
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmWorld Food LLC.
CityOrlando
StateFL
CountryUS
Distribution PatternProducts were distributed in FL only.
 

Associated Products

Product DescriptionTropical Salsa Product is labeled in part: "***FRESH***Garden Highway***Fresh Party Favorites!***PERISHABLE***KEEP REFRIGERATED***Tropical Salsa***Net Wt. 11 oz (312 g)***Best if Sold By***Renaissance Food Group LLC***Rancho Cordova, CA 95670***1-888-4 -HWYFUN***www.gardenhighway.com***"
Code Info8/31/12 and 9/1/12
ClassificationClass I
Reason for RecallWorld Foods, LLC, Florida is recalling multiple cut fruit and salsa products that contain Daniella Mangoes distributed by Splendid Products that have the potential to be contaminated with Salmonella. The products were distributed in Florida only.
Product Quantity83 lbs
Recall NumberF-2332-2012
Product DescriptionFresh Fruit Product is labeled in part: "***Fresh Island Medley***1 LB (454g)***Best If Sold By***Ingredients: Pineapple, Mango, Papaya.***Packed in its own juice***Distributed by: Winn-Dixie Stores Inc. Jacksonville, FL 32254***For Nutrition Information Call 1-888-449-9386***P-009***0 21140 01696 6***PERISHABLE KEEP REFRIGERATED***"
Code Info8/30/12 and 8/31/12
ClassificationClass I
Reason for RecallWorld Foods, LLC, Florida is recalling multiple cut fruit and salsa products that contain Daniella Mangoes distributed by Splendid Products that have the potential to be contaminated with Salmonella. The products were distributed in Florida only.
Product Quantity60 lbs
Recall NumberF-2333-2012
Product DescriptionFresh Fruit Product is labeled in part: "***Fruit Burst Bowl***1 LB (454g)***Best If Sold By***Ingredients: Watermelon, Cantaloupe, Pineapple, Honeydew, Grapes, Mango, Blueberries.***Packed in its own juice***Distributed by: Winn-Dixie Stores Inc. Jacksonville, FL 32254***For Nutrition Information Call 1-888-449-9386***P-009***0 21140 01701 7***PERISHABLE KEEP REFRIGERATED***" Recalled Products: UPC 0 21140 01701 7 1 LB and UPC 0 21149 01707 9 1.5 LB
Code Info1 lb: 8/30/12 and 8/31/12 1.5 lb: 8/30/12 and 8/31/12
ClassificationClass I
Reason for RecallWorld Foods, LLC, Florida is recalling multiple cut fruit and salsa products that contain Daniella Mangoes distributed by Splendid Products that have the potential to be contaminated with Salmonella. The products were distributed in Florida only.
Product Quantity4,310 lbs
Recall NumberF-2334-2012

Class I Food Event

Event ID63068
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmF & S Produce Co., Inc. (Site II)
CityDeerfield
StateNJ
CountryUS
Distribution PatternCT, DE, MA, MD, ME, NH, NJ, NY, PA, RI, VA, FL and Washington D.C.
 

Associated Products

Product DescriptionMango Spears: 1) Delish Mango Spears Net Wt. 5 oz. (142 g) Enjoy by: 8/28/2012 and before Prepared for Walgreens Inc. Deerfield, Illinois 60015 Distributed by Walgreens UPC 0 49022 53700 2; Delish Mango Spears 1 lb .(454 g) UPC 0 49022 58823 3 2) Mango Spears Best if Sold By: 08/28/12 and before 16 oz (1 lb) Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716
Code InfoEnjoy by: 8/28/2012 and before
ClassificationClass I
Reason for RecallF&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity1) 2,370 units; 750 units
Recall NumberF-2335-2012
Product DescriptionDelish Pineapple, Mango and cantaloupe Spears Net Wt. 5 oz. Enjoy by: 8/28/2012 and before Prepared for: Walgreens Inc. Deerfield, Illinois, 60015 Distributed by Walgreens UPC 0 49022 537019
Code InfoEnjoy by: 8/28/2012 and before UPC 0-49022-53701-9
ClassificationClass I
Reason for RecallF&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity1,640 units
Recall NumberF-2336-2012
Product DescriptionDelish Fruit Burst 10 oz.(283 g) Enjoy by: 8/28/12 Distributed by: Walgreen Co. 200 Wilmot Road, Deerfield, IL 60015 Distributed by Walgreens UPC 049022 55862 5
Code InfoEnjoy by: 8/28/2012 UPC 0 49022 55862 5
ClassificationClass I
Reason for RecallF&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity4,658 units
Recall NumberF-2337-2012
Product DescriptionDelish Tropical Medley 10 oz.(283 g) Enjoy by: 8/28/12 and before Distributed by: Walgreen Co. 200 Wilmot Road, Deerfield, IL 60015 Distributed by Walgreens UPC 04 902253699 9
Code InfoEnjoy by: 8/28/2012 and before UPC 0 4902253699 9
ClassificationClass I
Reason for RecallF&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity285 units
Recall NumberF-2338-2012
Product DescriptionDelish Mango & Berry Mix 10 oz.(283 g) Enjoy by: 8/28/12 Distributed by: Walgreen Co. 200 Wilmot Road, Deerfield, IL 60015 Distributed by Walgreens UPC 0 49022 63779 5
Code InfoEnjoy by: 8/28/2012 UPC 0 49022 63779 5
ClassificationClass I
Reason for RecallF&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity180 units
Recall NumberF-2339-2012
Product DescriptionGarden Highway Fresh Fruit Mango Medley 1 lb .(454 g) Best if sold by: 8/28/12 and before Renaissance Food Group LLC Rancho Cordova, CA 95670 UPC 8 26766 21437 2
Code InfoBest if sold by: 8/28/12 and before UPC 8 26766 21437 2
ClassificationClass I
Reason for RecallF&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity78 units
Recall NumberF-2340-2012
Product DescriptionGarden Highway Tropical Mango Spinach Salad with Zesty Orange Vinaigrette 7 oz .(198 g) Best if sold by: 8/28/12 and before Distributed by: Renaissance Food Group LLC Rancho Cordova, CA 95670 UPC 8 26766 801850 5
Code InfoBest if sold by:8/28/12 and before UPC 8 26766 801850 5
ClassificationClass I
Reason for RecallF&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity60 units
Recall NumberF-2341-2012
Product DescriptionGarden Pure Fresh Cut Mango 9 oz .(255 g) Best By: 08/28/12 and before Packed by F& S Produce Co. Inc. Headquarters, Rosehayn, NJ 06532 UPC 8 01172 20149 5
Code InfoBest By: 08/28/12 and before UPC 8 01172 20149 5
ClassificationClass I
Reason for RecallF&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity2,148 units
Recall NumberF-2342-2012
Product DescriptionFresh Cut Fruit Mango Chunks 1/5 lbs Best Use By: 08/28/12 and before F& S Produce Co. Inc. Headquarters, Rosenhayn, NJ 08532 No UPC
Code InfoBest if sold by: 8/28/12 and before No UPC
ClassificationClass I
Reason for RecallF&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity142 units
Recall NumberF-2343-2012
Product DescriptionGarden Pure Mixed Fruit Net Wt. 48 oz (1.36 kg) Best By: 8/28/12 and before F& S Produce Co. Inc. Headquarters, Rosenhayn, NJ 08532 6 001172 00264 1
Code InfoBest By: 8/28/12 and before 6 001172 00264 1
ClassificationClass I
Reason for RecallF&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity652 units
Recall NumberF-2344-2012
Product DescriptionGarden Pure Holiday Fruit Bowl 4 lbs (1.81kg) Best By: 8/28/12 and before F& S Produce Co. Inc. Headquarters, Rosenhayn, NJ 08532 UPC 6 01172 00264 1
Code InfoBest By: 8/28/12 and before UPC 6 01172 00264 1
ClassificationClass I
Reason for RecallF&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity330 units
Recall NumberF-2345-2012
Product DescriptionSIgnature Cafe Fruit Basket Medley, 30 oz, Use By: AUG 28 12 and before Distributed by Lucerne Foods, Inc., PO Box 99, Pleasonton, CA 94566-0009 1-877-232-4271 UPC 0 2113006918 7
Code InfoUse By: AUG 28 12 and before UPC 0 2113006918 7
ClassificationClass I
Reason for RecallF&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity5,556 units
Recall NumberF-2346-2012
Product DescriptionTrader Joe's Tropical Fruit Medley, 16 oz, Best By: 08/28/12 and before Dist. & Sold exclusively by: Trader Joe's, Monorovia, CA 91016 UPC 00949361
Code InfoBest By: 08/28/12 and before UPC 00949361
ClassificationClass I
Reason for RecallF&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity4,836 units
Recall NumberF-2347-2012

Class I Food Event

Event ID63076
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSomersault Snack Co., LLC
CitySausalito
StateCA
CountryUS
Distribution PatternCA, NH, NV, RI, MD, PA, TN, FL, CT. WA, TX, NJ, MN, IN, GA.
 

Associated Products

Product DescriptionSomersaults Crunchy Nuggets baked with sunflower seed and toasted grains. Pacific Sea Salt Flavor, Net Wt. 6 oz. UPC 8-98403 00201-7;
Code InfoSell By Date MAR1113 G6.
ClassificationClass I
Reason for RecallConsumer complaints and subsequent investigation found that packages of Pacific Sea Salt snack crackers had some Santa Fe Salsa snack crackers mixed in. Santa Fe Salsa crackers contain milk protein which is not declared on the ingredient labeling.
Product Quantity418 cases of 12.6oz packages
Recall NumberF-2331-2012

Class II Biologics Event

Event ID35009
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Feb-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSCC Soft Computer
CityPalm Harbor
StateFL
CountryUS
Distribution PatternProduct was distributed to 85 consignees within the United States and 2 Canadian consignees.
 

Associated Products

Product DescriptionProduct is SoftBank software (versions 21.4.2 to 23.0.0).
Code InfoSoftBank Version 21.4.2 with 3.1.2 ASCII base; SoftBank Version 21.4.3 with 3.1.3 ASCII base; SoftBank Version 21.4.3 with 3.1.4 ASCII base; SoftBank Version 21.4.4 with 3.1.4 ASCII base; SoftBank Version 22.4.0 with 3.1.3 ASCII base; SoftBank Version 22.4.1 with 3.1.4 ASCII base; SoftBank Version 23.0.0 with 3.1.4 ASCII base; SoftBank Version 23.0.0 with 3.2.0 ASCII base; SoftBank Version 23.0.0 with 3.2.3 ASCII base; SoftBank Version 23.0.0 with 3.2.4 ASCII base
ClassificationClass II
Reason for RecallSoftware, with a glitch or defect, was distributed.
Product Quantity10 Units
Recall NumberB-2337-12

Class II Biologics Event

Event ID38787
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Feb-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center
CityDayton
StateOH
CountryUS
Distribution PatternIN, OH
 

Associated Products

Product DescriptionRed Blood Cells
Code Info1280475
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-2267-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info1295730
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-2268-12

Class II Biologics Event

Event ID38788
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Mar-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center
CityDayton
StateOH
CountryUS
Distribution PatternOhio
 

Associated Products

Product DescriptionRed Blood Cells
Code Info4198405, 4200938
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Product Quantity2 units
Recall NumberB-2213-12

Class II Biologics Event

Event ID38789
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Apr-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Center
CityDayton
StateOH
CountryUS
Distribution PatternOhio, Switzerland
 

Associated Products

Product DescriptionRed Blood Cells
Code Info3549179, 3547437
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed.
Product Quantity2 units
Recall NumberB-2122-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info9038318
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed.
Product Quantity1 unit
Recall NumberB-2123-12
Product DescriptionRecovered Plasma
Code Info9038318, 3547437
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed.
Product Quantity2 units
Recall NumberB-2124-12

Class II Biologics Event

Event ID38790
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-May-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center
CityDayton
StateOH
CountryUS
Distribution PatternOhio
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info6054316
ClassificationClass II
Reason for RecallBlood product, with a low platelet count, was distributed.
Product Quantity1 unit
Recall NumberB-2126-12

Class II Biologics Event

Event ID38791
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Jun-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center
CityDayton
StateOH
CountryUS
Distribution PatternOhio
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info6054666
ClassificationClass II
Reason for RecallBlood product, with a low platelet count, was distributed.
Product Quantity1 unit
Recall NumberB-2344-12

Class II Biologics Event

Event ID40459
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jun-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CityWichita
StateKS
CountryUS
Distribution PatternKS
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info02LC59689
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Product Quantity1 unit
Recall NumberB-2266-12

Class II Biologics Event

Event ID41043
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Aug-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomat USA, Inc.
CitySeattle
StateWA
CountryUS
Distribution PatternSpain
 

Associated Products

Product DescriptionSource Plasma
Code Info330060575, 330060732, 330061380, 330061712
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within one year of donation, were distributed.
Product Quantity4 units
Recall NumberB-2217-12

Class II Biologics Event

Event ID41780
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Feb-06
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmAmerican Red Cross Blood Services
CityWichita
StateKS
CountryUS
Distribution PatternTX, CA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info02LJ48701
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-2451-12
Product DescriptionRecovered Plasma
Code Info02LJ48701
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-2452-12

Class II Biologics Event

Event ID42835
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jul-06
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma Inc
CityOmaha
StateNE
CountryUS
Distribution PatternGermany, Switzerland, IL, NC
 

Associated Products

Product DescriptionSource Plasma
Code Info4210087445, 4210086539, 4210085985, 4210084967, 4210084427, 4210083400, 4210082857, 4210081860, 4210081310, 4210080472, 4210080007, 4210078342, 4210077910, 4210076935, 4210076450, 4210075537, 4210075213, 4210074270, 4210073891, 4210073088, 4210072653, 4210071612, 4210071224, 4210070322, 4210069960, 4210069078, 4210068483, 4210067206, 4210066479, 4210065781, 4210064777, 4210063218, 4210062738, 4210061939, 4210061350, 4210060514, 4210060086, 4210059008, 4210058606, 4210057603, 4210057170, 4210055403, 4210054727, 4210053865, 04210053444
ClassificationClass II
Reason for RecallBlood products, collected from a donor who did not have a physical examination, were distributed.
Product Quantity45 units
Recall NumberB-2125-12

Class II Biologics Event

Event ID50573
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Jul-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info370055602
ClassificationClass II
Reason for RecallBlood product, collected from a donor who did not have a complete physical examination, was distributed.
Product Quantity1 unit
Recall NumberB-2495-12

Class II Biologics Event

Event ID54066
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Oct-09
Initial Firm Notification of Consignee or Public Other
Recalling FirmCsl Plasma Inc
CityBoca Raton
StateFL
CountryUS
Distribution PatternIL
 

Associated Products

Product DescriptionSource Plasma
Code Info4100385656, 4100384401, 4100382991, 4100378926, 4100377543, 4100376601, 4100372446, 4100367994, 4100366798, 4100365448, 4100362864, 4100360304, 4100357558, 4100356358, 4100341534, 4100337267, 4100328589, 4100323411, 4100315386, 4100299217, 4100288682, 4100283746, 4100280969
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a piercing within one year of donation, were distributed.
Product Quantity23 units
Recall NumberB-2215-12

Class II Biologics Event

Event ID54208
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Nov-09
Initial Firm Notification of Consignee or Public Other
Recalling FirmCsl Plasma Inc
CityBoca Raton
StateFL
CountryUS
Distribution PatternIL
 

Associated Products

Product DescriptionSource Plasma
Code Info4100390029, 4100388970, 4100388493, 4100387277, 4100386693, 4100384472, 4100382876, 4100381825, 4100380949, 4100379320, 4100378814, 4100377047, 4100376495, 4100374637, 4100374066, 4100372123, 4100371499, 4100367023, 4100366099, 4100364569, 4100363343, 4100361829, 4100360661, 4100359312, 4100357701, 4100356440, 4100355151, 4100354324, 4100352193, 4100351244, 4100349719, 4100348960, 4100347312, 4100346498, 4100344650, 4100343847, 4100342040, 4100341196, 4100339642, 4100338055, 4100337306, 4100335571, 4100334696, 4100332958, 4100332137, 4100330514, 4100329685, 4100328112, 4100327320, 4100325907, 4100323557, 4100322764, 4100321304, 4100320369, 4100319028, 4100317970, 4100316746, 4100315642, 4100313416, 4100311769, 4100310871, 4100309219, 4100307559, 4100306536, 4100304555, 4100303355, 4100302051, 4100301021, 4100298987, 4100297752, 4100296643, 4100295022, 4100294463, 4100292817, 4100291830, 4100290225
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity76 units
Recall NumberB-2216-12

Class II Biologics Event

Event ID54209
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Nov-09
Initial Firm Notification of Consignee or Public Other
Recalling FirmCsl Plasma Inc
CityBoca Raton
StateFL
CountryUS
Distribution PatternIL
 

Associated Products

Product DescriptionSource Plasma
Code Info4100392051, 4100391500, 4100389118, 4100388452, 4100387385, 4100386645, 4100385652, 4100384768, 4100382850, 4100382474, 4100380926, 4100380407, 4100378762, 4100378159, 4100376439, 4100375784, 4100373987, 4100373333, 4100371396, 4100370969, 4100369129, 4100368322, 4100366367, 4100365648, 4100363580, 4100362777, 4100360899, 4100360181, 4100358258, 4100357376, 4100355646, 4100354819, 4100352727, 4100351938, 4100350267, 4100349445, 4100347445, 4100346605, 4100344801, 4100343970, 4100342162, 4100341325, 4100339782, 4100339283, 4100337032, 4100336269, 4100334446, 4100333691, 4100332065, 4100331442
ClassificationClass II
Reason for RecallBlood products, collected from a donor who did not have a complete physical examination, were distributed.
Product Quantity50 units
Recall NumberB-2214-12

Class II Devices Event

Event ID54705
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Feb-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSteris Corporation
CityMentor
StateOH
CountryUS
Distribution PatternWorldwide Distribution - US Nationwide including District of Columbia and Puerto Rico and the following countries: American Samoa, Argentina, Australia, Bahrain, Bangladesh, Bermuda, Brazil, Canada, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Germany, Greece, Guam, Hong Kong, India, Indonesia, Israel, Italy, Japa, Jordan, Kazakhstan, Korea, Kuwait, Lebanon , Libya , Malaysia , Mexico, Morocco, New Zealand, Panama, Peru, Philippines , Poland, Portugal, Qatar, Russia, Saudi Arabia , Singapore, South Africa, Spain, Sri Lanka, Taiwan, Thailand, Trinidad and Tobago, Turkey & United Kingdom.
 

Associated Products

Product DescriptionA mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. Product Usage: Product provides a flexible, easy-to-use, articulated posturing of a patient for either general, I.A., or specialized surgical procedures. There are movable components and accessories intended for use during diagnostic examinations or surgical procedures to support and position a patient.
Code InfoB420702032 to 0402110097
ClassificationClass II
Reason for RecallCustomers may be storing objects on the base and/or around the column of the surgical table. This prohibited practice and misuse known by the customers can damage the override switch assembly located at the top of the column cover. Depending upon the nature and severity of the damage to the electronics of the table, it is possible that the table could move without prompting by an operator .
Product Quantity11,044 Units
Recall NumberZ-2402-2012

Class II Biologics Event

Event ID61097
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jan-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmUpstate New York Transplant Services, Inc.
CityBuffalo
StateNY
CountryUS
Distribution PatternAlabama, Venezuela
 

Associated Products

Product DescriptionCornea
Code Info110112OS; 110112OD
ClassificationClass II
Reason for RecallCorneas, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity2
Recall NumberB-2432-12

Class II Biologics Event

Event ID62300
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Apr-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBlood Systems, Inc
CityBillings
StateMT
CountryUS
Distribution PatternProducts were distributed to four domestic consignees including blood bank and health care facilities, located in Montana State. One of the four consignees responded that the unit was transfused.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW0423110455999
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of malaria, were distributed.
Product Quantity1 unit
Recall NumberB-2357-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW042311056937V; W0423110503973; W042311040445E
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of malaria, were distributed.
Product Quantity3 units
Recall NumberB-2358-12

Class II Drugs Event

Event ID62320
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Jun-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmDukal Corp.
CityRonkonkoma
StateNY
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective concentration), over the counter; supplied in 10 (item 2633), 50 (items 0204 and 02040 [sold in Canada only]) and 100 (item 0271) wipes per box distributed by ZEE MEDICAL, INC., Irvine, CA
Code InfoAntiseptic wipes shipped since July 02, 2009. Lots: JT14509, JT15209, JT20609, JT20909, JT23709, JT27809, JT32809, JT00710, JT15810, JT18310, JT18810, JT23210, JT25810, JT27610, JT31510, JT35610, JT35911, JT04811, JT05311, JT11811, JT15211, JT15911, JT18211, JT18211, JT21511-1, JT26311, JT30711, JT22011-1, JT01012, JT04112, JT06512, JT07512, JT07710, JT14509, JT15209, JT21409, JT20609, JT33009, JT00710, JT18810, JT23210, JT35911, JT05311, JT11811, JT26311, JT01012, JT14509, JT15209, JT20609, JT15209, JT23709, JT27809, JT00710, JT00710, JT18310, JT18810, JT23210, JT23210, JT27610, JT31510, JT05809, JT14509, JT15209, JT21209, JT27809, JT12510, JT15810, JT18310, JT11811, JT13211, JT15911, JT35911, JT01012, JT30711
ClassificationClass II
Reason for RecallMicrobial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)
Product Quantity
Recall NumberD-1675-2012
Product DescriptionDukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.133% w/v, Item 854-1000 contains 1000 individually packaged swabs per box. Item 854 contains 200 individually packaged swabs per box. Packaging labeled with Dukal Corporation, Hauppauge, NY 11788 --- NDC 65517-00031
Code InfoAntiseptic wipes shipped since July 02, 2009. Lots: JT34808, JT08209, JT15209, JT32809, JT00610, JT27610, JT05311, JT18211, JT22711-1, JT26411, JT01012, JT00610, JT14511, JT22011, JT30711
ClassificationClass II
Reason for RecallMicrobial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)
Product Quantity
Recall NumberD-1676-2012

Class II Biologics Event

Event ID62358
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMemorial Blood Centers
CitySaint Paul
StateMN
CountryUS
Distribution PatternMinnesota
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info1427905
ClassificationClass II
Reason for RecallBlood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-2131-12

Class II Biologics Event

Event ID62361
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Mar-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmHCSC-Blood Center
CityBethlehem
StatePA
CountryUS
Distribution PatternPennsylvania
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW050912009497
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2128-12
Product DescriptionFresh Frozen Plasma
Code InfoW050912009497
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2129-12

Class II Devices Event

Event ID62391
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmBiomet, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternNationwide Distribution-including the states of WA, IN, AK, PA, GA, SD, KS, NY, VA, AR, AL, OH, WI, MA, and CA.
 

Associated Products

Product DescriptionJUGGERKNOT IN·GUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the JuggerKnot 2.9mm Suture Anchor is to be placed. The JuggerKnot 2.9mm Suture Anchor is intended to be used to attach soft tissue to bone.
Code InfoREF. 912064 LOT 121040, 497540, 839530
ClassificationClass II
Reason for Recall Investigation found that the current design of the product allows the press-fit of the knob/shaft interface to be overcome by the impaction force of a mallet, causing the knob to potentially unfasten and slide down the shaft.
Product Quantity62
Recall NumberZ-2399-2012

Class II Drugs Event

Event ID62459
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternNationwide, including Puerto Rico and Guam. Product was also distributed internationally to Australia, Belgium, Canada, France, Germany, Korea, Malaysia, New Zealand, Norway, Pakistan, Philippines, Portugal, Singapore, Sweden, Thailand and Vietnam
 

Associated Products

Product DescriptionCarboplatin Injection, 10 mg/mL, 45 mL Multi-Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-50 (Hospira label), NDC 61703-360-50 (Novoplus label)
Code Infolot numbers Y061711AA, exp FEB 2013 and Y061711AB, exp FEB 2013 rest of world lots being recalled: list M1685A001, lots numbers Y151686AB, exp MAY 2013 and Y131686AA, exp MAR 2013; list M1723A001, lot number Y121686AF, exp SEP 2013; list M1686ADE1, lot numbers Y121686AA, exp SEP 2013 and Y151686AC, exp NOV 2013; list M1686AFR1, lot numbers Y121686AG, exp SEP 2013 and Y131686AB, exp SEP 2013; list M1714A001, lot number Y121686AC, exp SEP 2013; list M1686ANO3, lot number Y121686AE, exp SEP 2013; list M1686ASE2, lot number Y121686AB, exp SEP 2013
ClassificationClass II
Reason for RecallThe affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Product Quantity30,582 vials
Recall NumberD-1679-2012
Product DescriptionCytarabine Injection, 20 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; NDC 61703-303-46
Code Infolot numbers Y131994AA, exp AUG 2013; Y141994AA, exp SEP 2013; Y151994AA, exp SEP 2013; Y161994AA, exp NOV 2013; Y171994AA, exp NOV 2013 and Y181994AA, exp NOV 2013
ClassificationClass II
Reason for RecallThe affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Product Quantity210 vials
Recall NumberD-1680-2012
Product DescriptionMethotrexate Injection, USP, 25 mg/mL, 40 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; NDC 61703-408-41
Code Infolot number Y064457AA, exp OCT 2013 Rest of world lot numbers: list M4457A001, lot number Y054457AB, exp SEP 2013
ClassificationClass II
Reason for RecallThe affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Product Quantity34,572 vials
Recall NumberD-1681-2012
Product DescriptionPaclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; N DC 61703-342-50
Code Infolot numbers Y096865AA, exp AUG 2013; Y106865AA, exp AUG 2013; Y116865AA, exp AUG 2013; Y126865AA, exp SEP 2013; Y136865AA, exp SEP 2013; Y146865AA, exp SEP 2013; Y156865AA, exp OCT 2013; Y166865AA, exp NOV 2013; Y176865AA, exp NOV 2013; and Y186865AA, exp DEC 2013
ClassificationClass II
Reason for RecallThe affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Product Quantity131,264 vials
Recall NumberD-1682-2012

Class II Biologics Event

Event ID62468
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLife Technologies, Inc.
CityBrown Deer
StateWI
CountryUS
Distribution PatternNationwide and CANADA
 

Associated Products

Product DescriptionB17 SSP UniTray® Kit, REF 472303 and 472313; B Locus High Res SSP UniTray® Kit , REF 4730010 and 4730110; AllSet Gold SSP HLA-B17 High Res Kit, Prod.no. 541120D, AllSet Gold SSP HLA-B Locus High Res Kit , Prod.no. 54020D.
Code Info. 472303 (B17 SSP UniTray Kit): 004743203, 004825654, 004904114, 004944916, 0041047204 472313 (B17 SSP UniTray Kit with Taq Polymerase) 004743203794936, 004743203824725, 004743203867126, 004825654862612, 004825654902239, 004825654903448, 004825654908705, 004825654933983 004904114936659, 004904114943927, 004904114989957, 004904114991724 0049449161006545, 0049449161029905, 0049449161036926, 00410472041097465 4730010 (B Locus High Res SSP UniTray Kit) 008709385, 008757730, 008800850, 008839301, 008873000, 009910766, 009984375 0101103786 4730110 (B Locus High Res SSP UniTray Kit with Taq Polymerase) 008709385760267, 008709385764018, 008709385764321, 008709385770871, 008839301892884, 008839301895965, 008839301900752, 008839301903610, 008709385786802, 008709385790179, 008709385791195, 008709385791779, 008709385792235, 008709385794392, 008709385799832, 008757730812167, 008757730825400, 008757730826478, 008757730827309, 008757730832868, 008757730835072, 008800850838882, 008800850842278, 008800850845743, 008800850849098, 008800850853960, 008800850857260, 008 800850 859419 008800850864238, 008800850874250, 008839301884136, 008839301891810, 008839301907862, 008839301923305, 008873000925324, 008873000940462, 008873000942042, 009910766979658, 009910766990558, 0099107661007232, 0099107661013361, 0099107661016456, 0099107661029333, 0099107661032390, 0099107661038471, 0099107661046552, 0099107661048423, 0099107661070124, 0099843751071655, 0099843751077181, 0099843751112028, 0099843751112356, 0099843751113862, 01011037861143513, 01011037861148166 541120D (AllSet Gold SSP HLA-B17 High Res Kit - 10 Tests) 004744187, 004841439, 0041030324 54020D (AllSet Gold SSP HLA-B Locus High Res Kit - 10 Tests) 008707067, 008775767, 008796669, 008839303, 009910772, 009979631
ClassificationClass II
Reason for RecallHLA typing assay, associated with false negative results, was distributed.
Product Quantity6 Units
Recall NumberB-2385-12

Class II Devices Event

Event ID62494
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBD Biosciences, Systems & Reagents
CitySan Jose
StateCA
CountryUS
Distribution PatternWorldwide Distribution -- USA (nationwide) including the countries of Australia, Belgium, Canada, Chile, Korea, Mexico, Singapore and Taiwan.
 

Associated Products

Product DescriptionBD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention.
Code InfoCatalog number: 335775; Lot number 33412.
ClassificationClass II
Reason for RecallIncorrect version of the CD was included with BD FACS 7 Color Setup Beads.
Product Quantity96 kits
Recall NumberZ-2397-2012

Class II Food Event

Event ID62565
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jan-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAtico International USA, Inc.
CityFt Lauderdale
StateFL
CountryUS
Distribution PatternMilwaukee, WI
 

Associated Products

Product DescriptionRoundy's Rich Fields Butter Cookies. Product is labeled in part: Side of tin: "***RICH FIELDS*** Butter Cookies***NET WT 12 OZ (340g)***See Bottom Panel for Nutritional Information***" Bottom of tin: "***Nutrition Facts Serving Size 4 Cookies (30g)***INGREDIENTS: Wheat Flour, Sugar, Butter, Eggs, Salt, Soy Lecithin (Emulsifier) Leavening Agent (Sodium bicarbonate), Artificial Flavor.***Contains Egg, Milk, Wheat, Soy***Manufactured in a facility that process peanuts and tree nuts.***Distributed By: ATICO INTERNATIONAL USA, INC. FT. LAUDERDALE, FL 33301***MADE IN CHINA*** ROUNDY'S***205049***8 84118 12366 6***"
Code InfoBest by Date Jun 24, 2012 and Batch #047 06 25
ClassificationClass II
Reason for RecallAtico International USA, Inc. is recalling Roundy's Rich Fields Butter Cookies due to Toxigenic Bacillus cereus found in a sample tested by FDA.
Product Quantity22068
Recall NumberF-2298-2012

Class II Food Event

Event ID62737
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jul-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmSan Francisco Herb & Natural Food Company
CityFremont
StateCA
CountryUS
Distribution PatternNationwide and Canada.
 

Associated Products

Product DescriptionCarob Raw Powder Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoP351, Lot 120056.
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityxx
Recall NumberF-2299-2012
Product DescriptionChicory Root Roasted Granules Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoG440, Lot 120056.
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityxx
Recall NumberF-2300-2012
Product DescriptionGreen Tea, Gunpowder C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoC837, lot 100181.
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityxx
Recall NumberF-2301-2012
Product DescriptionFennel Seed, Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoW170, Lot 110155
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityxx
Recall NumberF-2302-2012
Product DescriptionHops Flower; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoW890, Lot 110020
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityxx
Recall NumberF-2303-2012
Product DescriptionMarigold Petals Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoW1087, Lot 100196.
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityxx
Recall NumberF-2304-2012
Product DescriptionLavender Flower Medium Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoW985, Lot 120033; Also lot 110200 and 120004. W980, Lot 110200
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityxx
Recall NumberF-2305-2012
Product DescriptionOlive Leaf Organic Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoW01119, Lot 090286.
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityxx
Recall NumberF-2306-2012
Product DescriptionPaprika Sweet Powder; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoP1251, Lot 090048
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityxx
Recall NumberF-2307-2012
Product DescriptionParsley Leaf C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoC1255, Lot 110107.
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityxx
Recall NumberF-2308-2012
Product DescriptionPau D'Arco Bark C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoC1270, Lot 100266.
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityxx
Recall NumberF-2309-2012
Product DescriptionRose Hips Organic Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoW01430, Lot 090324.
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityxx
Recall NumberF-2310-2012
Product DescriptionRosemary Leaf Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoProduct No. W1445, Lot 010017. Product No. A330, Lot 110197, 110226, 120004.
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityxx
Recall NumberF-2311-2012
Product DescriptionSenna Pods Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoW1520, Lot 110220.
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityxx
Recall NumberF-2312-2012
Product DescriptionSpearmint Leaf Organic C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoCO1565, Lot 110171.
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityxx
Recall NumberF-2313-2012
Product DescriptionThyme Leaf C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoC1631, Lot 110197.
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityxx
Recall NumberF-2314-2012
Product DescriptionOlive Leaf Organic; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoLot 100275.
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityxx
Recall NumberF-2315-2012
Product DescriptionPaprika Sweet Flakes; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoLot 100032.
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityxx
Recall NumberF-2316-2012
Product DescriptionLicorice Root, WHL; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoLot 120019.
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityxx
Recall NumberF-2317-2012
Product DescriptionPeppermint lf, org C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoLot 110171.
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityxx
Recall NumberF-2318-2012
Product DescriptionTea green, Gun Powder, C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoLot 100101.
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityxx
Recall NumberF-2319-2012
Product DescriptionTea black, China T/B Cut; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoLot 100981.
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityall
Recall NumberF-2320-2012
Product DescriptionOrganic Yerba Mate; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoLot GTA10-01/12..
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityall
Recall NumberF-2321-2012
Product DescriptionPeppermint Leaf Organic, Large Cut; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoLot 100275.
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityall
Recall NumberF-2322-2012
Product DescriptionSpearmint LF/CS; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoLot 110125.
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityall
Recall NumberF-2323-2012
Product DescriptionMullein Leaf, Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoLot 110200.
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityall
Recall NumberF-2324-2012
Product DescriptionPeppermint Leaf Organic C/S Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoLot 110171, Product No. CO1310
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityall
Recall NumberF-2325-2012
Product DescriptionSpearmint Leaf C/S Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code InfoProduct No. C1565, Lot No. 110128
ClassificationClass II
Reason for RecallCA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantityall
Recall NumberF-2326-2012

Class II Devices Event

Event ID62738
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Apr-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRoche Molecular Systems, Inc.
CityBranchburg
StateNJ
CountryUS
Distribution PatternNationwide (USA) Distribution
 

Associated Products

Product DescriptionAmplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.
Code Info05666678001
ClassificationClass II
Reason for RecallWhen using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK software v3.2 series (AL v3.2) there is a potential for wrong results to be assigned to an order.
Product Quantity1292 instruments
Recall NumberZ-2403-2012

Class II Devices Event

Event ID62765
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDePuy Orthopaedics, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternNationwide Distribution including the states of MA, TX, OH, CA, and NC.
 

Associated Products

Product DescriptionS-Rom® Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch are placed into a nylon outer pouch and sealed. This is then placed into a folding carton, labeled, and shrink-wrapped. Description: Total Hip System Poly Dial® Liner is part of the S-ROM® Total Hip System. The Liner is fitted inside the acetabular shell; and is the bearing surface for the Head on the S-ROM® stem. The S-ROM liner is used for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Intended Use: Total Hip System Poly Dial Liner is part of the S-Rom Total Hip System. The Liner is fitted inside the acetabular shell; and is the bearing surface for the Head on the S-Rom® stem. The S Rom liner is used for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Code InfoCatalogue Lot Number 87-5987 3189424 3312166 3340992 3402685
ClassificationClass II
Reason for RecallOrthopaedics, Inc. (DePuy) is issuing a voluntary recall of four lots of the S-ROM" liner because the Carton label has an Incorrect Color Code Series Designation. We have received one complaint regarding this issue.
Product Quantity12 liners
Recall NumberZ-2414-2012

Class II Food Event

Event ID62786
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Dec-09
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGMP Laboratories of America Inc
CityAnaheim
StateCA
CountryUS
Distribution PatternUS States nationwide.
 

Associated Products

Product DescriptionDietary supplement. Product is labeled as :" Rescue Me***911 Damage Control***brantley living herbal formulas***HERBAL SUPPLEMENT 15 INDIVIDUAL PACKETS 4 VEGAN CAPSULES PER PACKET (2-368mg/2-584mg Each)***DISTRIBUTED EXCLUSIVELY BY: Living Herbal Pharmacy, LLC PO Box 56-2410, Miami, FL 33256-2410***".
Code InfoLOT 2448 BEST BY 10/12
ClassificationClass II
Reason for RecallThe firm recalled because the product lot contained mispackaged product wherein some capsules were missing from the finished packaged product.
Product Quantity1027 boxes
Recall NumberF-2297-2012

Class II Devices Event

Event ID62850
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBio-Rad Laboratories
CityRedmond
StateWA
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and countries of: Canada, South Africa, and Zimbabwe.
 

Associated Products

Product DescriptionThe Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.
Code InfoAll lots distributed from May 5, 2007
ClassificationClass II
Reason for RecallProlonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result in elevated Optical Densities (OD) in some samples such that a negative sample could elevate to a grey zone or low positive result.
Product Quantity7,400 (approximately)- All lots since distribution date May 9, 2007
Recall NumberZ-2398-2012

Class II Devices Event

Event ID62867
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCovidien LLC
CitySunnyvale
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Israel, Jordan, Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Venezuela and UK.
 

Associated Products

Product DescriptionHALO Flex Energy Generators Manufactured by BÂRRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085. The HALO Flex Energy Generator is indicated for use for the coagulation of soft tissue. The HALO Flex System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus, including Barrett's Esophagus.
Code InfoModel numbers 1190A-115A and 1190A-230A; all serial numbers.
ClassificationClass II
Reason for RecallPotential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore can not be used for patient care.
Product Quantity617 generators
Recall NumberZ-2379-2012

Class II Food Event

Event ID62873
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Apr-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmR & S Mexican Food Products, Inc
CityGlendale
StateAZ
CountryUS
Distribution Pattern4 direct accounts in AZ. No international or outside states.
 

Associated Products

Product DescriptionR&S Mexican Food Products, Inc. Tomato/Basil Pressed Tortillas, 1 Dozen. Packaged in sealed flexible plastic bag.
Code InfoNo UPC or manufacturing code used.
ClassificationClass II
Reason for RecallProduct contains undeclared FD&C Yellow # 6.
Product Quantityunknown
Recall NumberF-2348-2012

Class II Devices Event

Event ID62884
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Aug-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPhilips Healthcare Inc.
CityAndover
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA including OH and WA and the country of Canada
 

Associated Products

Product DescriptionPhilips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
Code InfoLot or Serial Numbers With affected M-cabinet CXA; Serial number; 11-K0003; 12-B0001, 12-B0002; 12-B0003
ClassificationClass II
Reason for RecallCreepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm.
Product Quantity4 systems
Recall NumberZ-2384-2012

Class II Devices Event

Event ID62894
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmInstrumentation Laboratory Co.
CityBedford
StateMA
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, REPUBLIC OF LUXEMBOURG, MACAU, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SLOVAKIA (Slovak Republic), SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TURKEY, UNITED KINGDOM, URUGUAY and VIETNAM.
 

Associated Products

Product DescriptionInstrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Code InfoSerial Number range:03110101 through 11111174 Distributed from: Nov 2003 to Nov 2011
ClassificationClass II
Reason for RecallLow Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
Product Quantity1074 units
Recall NumberZ-2387-2012
Product DescriptionInstrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Code InfoSerial Number range: 09080100 through12060403 Distributed between: Aug 2009 to Jun 2012
ClassificationClass II
Reason for RecallLow Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
Product Quantity304 units
Recall NumberZ-2388-2012
Product DescriptionInstrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Code InfoSerial Number range: 06020101 through 10080662 Distributed between: Feb 2006 to Aug 2010
ClassificationClass II
Reason for RecallLow Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
Product Quantity562 units
Recall NumberZ-2389-2012
Product DescriptionInstrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Code InfoSerial Number range: 08120100 through 12060145 Distributed between: Dec 2008 to Jun 2012
ClassificationClass II
Reason for RecallLow Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
Product Quantity46 units
Recall NumberZ-2390-2012
Product DescriptionInstrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Code InfoSerial Number range: 08010100 through 12062270 Distributed between: Jan 2008 to Jun 2012
ClassificationClass II
Reason for RecallLow Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
Product Quantity2171 units
Recall NumberZ-2391-2012
Product DescriptionInstrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Code InfoSerial Number range: 09120101 through 12060240 Distributed between: Dec 2009 to Jun 2012
ClassificationClass II
Reason for RecallLow Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
Product Quantity140 units
Recall NumberZ-2392-2012

Class II Devices Event

Event ID62899
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTedan Surgical Innovations Llc
CitySugar Land
StateTX
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and countries of : Australia and Taiwan.
 

Associated Products

Product DescriptionSterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction Screws are intended for the distraction in the anterior approach to the cervical spine. Sterile XL Screws are intended for the fixation of the blade to the vertebral body to prohibit drifting in the extreme lateral approach to the lumbar spine.
Code InfoLot numbers: 019715, 019716, 019942, 019943, 019977, 019978, 020102, 020103, 020104, 020105, 020106, 020107, 020108, 020609, 020782, 021539, 021663, 022097, 022098, 022099, 022122, 022123, 022124, 022371, 022372, 022790, 022791, 022792, 022794, 022795, 022796, 022827, 022828, and 023266.
ClassificationClass II
Reason for RecallThis letter is to notify you that several of our sterile screw products are being voluntarily recalled. Product sterility may be compromised due to a mechanical failure of the protective packaging tube. Tube end plugs may dislodge creating the potential for the screw to come out of the protective tube and then the sharp end of the screw pierce the outer sterile barrier pouch.
Product Quantity12,065 Sterile Distraction Screws (2413 boxes); 384 Sterile XL Screws (128 boxes) in distribution
Recall NumberZ-2385-2012

Class II Devices Event

Event ID62917
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Aug-12
Initial Firm Notification of Consignee or Public Other
Recalling FirmElekta, Inc.
CityNorcross
StateGA
CountryUS
Distribution PatternNationwide Distribution including AL, AZ, CA, CO, CT, FL, GA, IL, IA, MD, MA, MI, MN, NE, NV, NJ, NM, NY, ND, OH, OK, OR, PA, VA, SC, TN TX, WA, WV, WI and Puerto
 

Associated Products

Product DescriptionPrecise Digital Accelerator Delivery of radiation to defined target volumes
Code Info151587, 105932, 151574, 151363, 151076, 151110, 151369, 151504, 105941, 151418, 151674, 151566, 151259, 151636, 151568, 151390, 151258, 151584, 151391, 151317, 151522, 151055, 151423, 151507, 151623, 151627, 151640, 151479, 151340, 151178, 151467, 151514, 151051, 151411, 151216, 151430, 151173, 151616, 151595, 151141, 151433, 151611, 151151, 151653, 151515, 151360, 151675, 151538, 151024, 151523, 151521, 151260, 151519, 151432, 151410, 151371, 151084, 151435, 151387, 151530, 151328, 151176, 151080, 151626, 151567, 151598, 151601, 151269, 151396, 151557, 151558, 105982, 151160, 151634, 151394, 151398, 151540, 151632, 151446, 151301, 151038, 151441, 151256, 151168, 151156, 151157, 151155, 151579, 151412, 105984, 151053, 151359, 151585, 151326, 151327, 151443, 151250, 151130, 151245, 151416, 151664, 151672, 151074, 151352, 151298, 151545, 151628, 105803, 151362, 151073
ClassificationClass II
Reason for RecallThere have been a small number of instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.
Product Quantity110
Recall NumberZ-2405-2012

Class II Devices Event

Event ID62939
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmZoe Medical Incorporated
CityTopsfield
StateMA
CountryUS
Distribution PatternNationwide distribution: WA only.
 

Associated Products

Product DescriptionSpacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature.
Code InfoSerial Numbers: FFD3291, FFD3292, FFD3293, FFD3294, FFD3295, FFD3296, FFD3297, FFD3298, FFD3299, FFD3300, FFD3301, FFD3302, FFD3303, FFD3304, FFD3306, FFD3307, FFD3308, FFD3309, FFD3310, FFD3312, FFD3313, FFD3314, FFD3315, FFD3316,FFD3317, FFD3318, FFD3319, FFD3320, FFD3321, FFD3579, FFD3771, FFD3772, FFD3814, FFD3815, FFD3817
ClassificationClass II
Reason for RecallUnit fails to power up, resulting in an equipment alarm
Product Quantity35 units
Recall NumberZ-2380-2012

Class II Food Event

Event ID62962
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmProtica, Inc
CityWhitehall
StatePA
CountryUS
Distribution PatternNationwide distribution - product was distributed to direct accounts in AL, AZ, FL, IL, IN, KY, MN, MO, MS, NY OH, OK, RI, SC, TX and VA.
 

Associated Products

Product DescriptionProBalance Protein To Go(TM), Milk Chocolate Shake, Dietary Supplement, Net Wt 2.5 fl oz (Responsible firm on labeling: Pro Balance LLC, 4070 Tampa Road, Oldsmar, FL 34677)
Code InfoLot numbers PP04024109A, PP04024109B, PP04024109C, PP04024109D, PP04024109E, PP04024109F, PP04024109G, PP04424113, PP04724115, PP08924121, PP10324131A, PP10324131B, PP11624134B, PP11624134C, PP11624134A, PP12424139, PP12924140, PP15924145B, and PP15924145A.
ClassificationClass II
Reason for RecallProduct not sufficiently acidified (equilibrium pH higher than 4.6), therefore it has the potential to be contaminated with Clostridium botulinum
Product Quantity233,114 bottles
Recall NumberF-2349-2012
Product DescriptionProBalance Protein To Go(TM), Caffeinated French Vanilla Latte, Dietary Supplement, Net Wt 2.5 fl oz (Responsible firm on labeling: Pro Balance LLC, 4070 Tampa Road, Oldsmar, FL 34677)
Code InfoLot numbers PP25114066A, PP25114066B, PP28414079, PP29114086, PP34014103, PP04424112, PP09324122, PP09524125, PP10224129, PP11524133A, PP11524133B, PP11524133C, PP12224138A, PP12224138B, PP12224138, PP12924141, PP15924146A, and PP16024146B.
ClassificationClass II
Reason for RecallProduct not sufficiently acidified (equilibrium pH higher than 4.6), therefore it has the potential to be contaminated with Clostridium botulinum
Product Quantity230,000 bottles
Recall NumberF-2350-2012
Product DescriptionProtein Wave 15 grams of protein, Tropical Fruit Gelatin (Responsible firm on label: Nutritional Resources, Inc., 5003 Wrightsboro Road, Grovetown, GA 30813)
Code InfoLot number PP12426123
ClassificationClass II
Reason for RecallProduct not sufficiently acidified (equilibrium pH higher than 4.6), therefore it has the potential to be contaminated with Clostridium botulinum
Product Quantity2,928 cups
Recall NumberF-2351-2012
Product DescriptionProtein Shots, Orange Sunshine Flavor, 2.9 fl oz (Responsible firm on label: Body Choice Nutrition, Inc., 1595 Peachtree Park Way, Suite 204, Cumming, GA 30041)
Code InfoLot number PP35412924
ClassificationClass II
Reason for RecallProduct not sufficiently acidified (equilibrium pH higher than 4.6), therefore it has the potential to be contaminated with Clostridium botulinum
Product Quantity6,912 vials
Recall NumberF-2352-2012

Class II Drugs Event

Event ID62971
StatusCompleted
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Nov-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCarefusion 213, Llc
CityEl Paso
StateTX
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA
Code InfoProduct code 260415, Lot#: 48225
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
Product Quantity67,775 Applicators
Recall NumberD-1674-2012

Class II Devices Event

Event ID62978
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmIntegra LifeSciences Corporation
CityPlainsboro
StateNJ
CountryUS
Distribution PatternWorldwide distribution: USA (Nationwide) and countries of: Argentina, Australia, Belgium, Canada, China, Czec, Denmark, France, Hong Kong, Hungary, Italy, Japan, Malaysia, Philippines, Singapore, Spain, South Africa, and UK.
 

Associated Products

Product DescriptionIntegra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CTIMR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes
Code InfoAll lot numbers from 2002 to current
ClassificationClass II
Reason for RecallT-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. When the T-handle on the HRAIM intubation hoop is tightened, the T-handle could stop in a vertical position that prevents the CRWPRECISE and certain models of the CRW-ASL from seating properly on the head ring although it appears to be fully seated
Product Quantity175 units
Recall NumberZ-2428-2012
Product DescriptionIntegra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CT/MR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes
Code InfoAll lot numbers from 2002 to current
ClassificationClass II
Reason for RecallT-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. When the T-handle on the HRAIM intubation hoop is tightened, the T-handle could stop in a vertical position that prevents the CRWPRECISE and certain models of the CRW-ASL from seating properly on the head ring although it appears to be fully seated
Product Quantity188 units
Recall NumberZ-2429-2012

Class II Food Event

Event ID62980
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTunnel Farms
CitySwanquarter
StateNC
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionWatermelon, labeled IT'S WATERMELON TIME!, Produce of USA, Seedless, #4032.
Code InfoPLU 4032, Bill of Lading numbers: 8601, 8492, 27541, 27542, 27543, 27544 and 9276.
ClassificationClass II
Reason for RecallUnapproved pesticide residue was detected.
Product Quantity7 loads (15,750 melons)
Recall NumberF-2358-2012

Class II Food Event

Event ID62984
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Aug-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmAmerican Licorice Co
CityUnion City
StateCA
CountryUS
Distribution PatternNationwide distribution.
 

Associated Products

Product DescriptionRed Vines Black Licorice Twists; No preservatives and Always Fat Free Packaged in the following configurations: One Pound Pac: Red and white Plastic bag with a window to display licorice twists. UPC 0 41364 00283 5; 5 oz Black Licorice Tray Pack; UPC 4136451277 and 4136450277; 7 oz Black Licorice Laydown Bag: UPC 4136454347: 8 oz Jumbo Black twists hanging bag; UPC 4136400231; 2.5 oz Black Licorice Bar; 4 lb Black Licorice Jar, UPC 413400103; Ingredients: Molasses, Wheat Flour, corn Syrup, Caramel Coloring, Licorice Extract, Salt and Anise Flavor. American Licorice Company Union City, CA
Code InfoAll candy
ClassificationClass II
Reason for RecallCA Dept. of Public Health collected random samples of Red Vines Black Licorice and found elevated levels of lead in the product.
Product Quantity`1.5 million pounds, all varieties
Recall NumberF-2148-2012
Product DescriptionRED VINES Mixed Bites; Red and Black licorice mixed bites. UPC: 4136400288 and 4136451277. Family Mix Half Pallet; UPD 4136421697; Family Mix PDQ; UPC 4136455297; Mixed Original Red/Black Licorice Bag Pallet; UPC 413466283; Family Mix 1/4 pallet; UPC 4136424097; 96/5 ox mixed floor display; UPC 4136454279; Mixed 4 lb Jar Pallet 120 original Red/30 Black licorice; UPC 4136421543; Family Mix Pallet: UPC 3146436097; American Licorice Company Union City, CA
Code InfoAll candy
ClassificationClass II
Reason for RecallCA Dept. of Public Health collected random samples of Red Vines Black Licorice and found elevated levels of lead in the product.
Product Quantity~1.5 million pounds- all varieties
Recall NumberF-2154-2012
Product DescriptionOriginal Snaps Classic Chewy Candy; packed in 5.5 oz bags, 4.5 oz theatre box and 12 oz. tins. UPC 5.5 oz - 4136408300; 4.5 oz Theatre Box UPC 4136408302; Theatre box shipper UPC 4136408295. 12 oz tin UPC 4136408299; American Licorice Company Union City, CA
Code InfoAll candy
ClassificationClass II
Reason for RecallCA Dept. of Public Health collected random samples of Red Vines Black Licorice and found elevated levels of lead in the product.
Product Quantity~1,5 million pounds, all products
Recall NumberF-2167-2012

Class II Food Event

Event ID62985
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Aug-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmFriendly Ice Cream Corp.
CityWilbraham
StateMA
CountryUS
Distribution PatternMaine, New Hampshire, Vermont, Connecticut, Massachusetts, Rhode Island, New York, New Jersey, Pennsylvania, Delaware, Maryland, Virginia, Florida
 

Associated Products

Product DescriptionFriendly's Sundae Nut Football Limited Edition, 48 oz. carton UPC :0-29839-00530-7
Code InfoLot Codes: WC5 06/20/13 XXXX XXXXXX and WC5 07/08/13 XXXX XXXXXX
ClassificationClass II
Reason for RecallProduct contains foreign material
Product Quantity59, 052 cartons
Recall NumberF-2353-2012
Product DescriptionFriendly's Fudge Nut Brownie Sundae Extreme, 48 oz. carton UPC: 0-29839-00657-1
Code InfoLot Code: WC5 06/01/13 XXXX XXXXXX
ClassificationClass II
Reason for RecallProduct contains foreign material
Product Quantity19,860 cartons
Recall NumberF-2354-2012
Product DescriptionFriendly's Brand Nutty Caramel Crunch Sundae, 6 0z. UPC: 0-29839-00050 Weis Crunchy Caramel Nut Sundae, 6 0z cup UPC 0-41497-01573-3
Code InfoLot Code: 06/11/13
ClassificationClass II
Reason for RecallProduct contains foreign material
Product Quantity86,136 cups
Recall NumberF-2355-2012

Class II Devices Event

Event ID63001
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Jun-10
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmKimberly-Clark Corporation
CityRoswell
StateGA
CountryUS
Distribution PatternNationwide Distribution including AL, AK, AZ, CA, CO, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, ME, MA, MI, MN, MS, MO, NE, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WI.
 

Associated Products

Product DescriptionKimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk.
Code InfoLots AW916102A
ClassificationClass II
Reason for RecallThe placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube.
Product Quantity277 units
Recall NumberZ-2415-2012
Product DescriptionKimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk.
Code InfoLots AW916002A, AW916102D
ClassificationClass II
Reason for RecallThe placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube.
Product Quantity766 units
Recall NumberZ-2416-2012

Class II Devices Event

Event ID63004
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmZOLL Medical Corporation
CityChelmsford
StateMA
CountryUS
Distribution PatternWorldwide Distribution - US Nationwide including the states of: LA, MA, ME, NC, ND, NE, OH and the country of Germany.
 

Associated Products

Product DescriptionZoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in synchronized mode to terminate certain atrial and ventricular tachycardias and other arrhythmias resistant to drug therapy. The X Series may be used for cardiac pacing in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The X Series may be used for the monitoring a patients electrocardiogram (ECG).
Code InfoSerial Numbers: AR11J000164, AR12E000853, AR12E000856, AR12E000868, AR12E000920, AR12E000922, AR12E000923, AR12E000931, AR12E000944 AR12F001100, AR12F001298,
ClassificationClass II
Reason for RecallShipped with incorrect software
Product Quantity11 units
Recall NumberZ-2401-2012

Class II Devices Event

Event ID63007
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSpacelabs Healthcare, Llc
CityIssaquah
StateWA
CountryUS
Distribution PatternWorldwide Distribution.
 

Associated Products

Product DescriptionUltraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission. Through this network, a patient's data may be displayed at the bedside monitor, central station or clinical information system.
Code InfoDomestic - 1493-000275, 1493-000276, 1493-000277, 1493-002469, 1493-002616, 1493-003358, 1493-003359, 1493-003667, 1493-003668, 1493-003669, 1493-003670, 1493-003671, 1493-003672, 1493-003673, 1493-003674, 1493-003675, 1493-003676, 1493-003677, 1493-003678, 1493-003679, 1493-003680, 1493-003681, 1493-003682, 1493-003683, 1493-003684, 1493-003685, 1493-003686, 1493-003687, 1493-003688, 1493-003693, 1493-003694, 1493-003695, 1493-003696, 1493-003697, 1493-003879, 1493-003880, 1493-003881, 1493-003882, 1493-003883, 1493-003884, 1493-003885, 1493-003886, 1493-003887, 1493-003888, 1493-003889, 1493-003890, 1493-003891, 1493-003892, 1493-003893, 1493-003894, 1493-003895, 1493-003896, 1493-003897, 1493-003898, 1493-003899, 1493-003900, 1493-003901, 1493-003902, 1493-003903, 1493-003904, 1493-003905, 1493-003906, 1493-003907, 1493-003908, 1493-003909, 1493-003914, 1493-003915, 1493-003916, 1493-003917, 1493-003918, 1493-003919, 1493-003920, 1493-003921, 1493-003922, 1493-003923, 1493-003924, 1493-003925, 1493-003926, 1493-003927, 1493-003928, 1493-003929, 1493-003930, 1493-003931, 1493-003932, 1493-003933, 1493-003934, 1493-003935, 1493-003936, 1493-003937, 1493-003938, 1493-003939, 1493-003940, 1493-003941, 1493-003942, 1493-003943, 1493-003944, 1493-003945, 1493-003957, 1493-003958, 1493-003959, 1493-003960, 1493-003961, 1493-003962, 1493-003963, 1493-003964, 1493-003965, 1493-003985, 1493-004007, 1493-004011, 1493-004023, 1493-004026, 1493-004027, 1493-004028, 1493-004029, 1493-004030, 1493-004031, 1493-004032, 1493-004033, 1493-004034, 1493-004043, 1493-004044, 1493-004047, 1493-004048, 1493-004050, 1493-004051, 1493-004052, 1493-004053, 1493-004054, 1493-004055, 1493-004056, 1493-004058, 1493-004060, 1493-004064, 1493-004067, 1493-004068, 1493-004069, 1493-004070, 1493-004071, 1493-004075, 1493-004084, 1493-004085, 1493-004086, 1493-004106, 1493-004112, 1493-004113, 1493-004114, 1493-004115, 1493-004116, 1493-004117, 1493-004118, 1493-004119, 1493-004120, 1493-004121, 1493-004122, 1493-004123, 1493-004124, 1493-004125, 1493-004126, 1493-004127, 1493-004128, 1493-004130, 1493-004158, 1493-004159, 1493-004160, 1493-004161, 1493-004162, 1493-004163, 1493-004164, 1493-004172, 1493-004173, 1493-004174, 1493-004175, 1493-004176, 1493-004177, 1493-004178, 1493-004179, 1493-004180, 1493-004181, 1493-004182, 1493-004183, 1493-004184, 1493-004185, 1493-004205, 1493-004206, 1493-004207, 1493-004208, 1493-004209, 1493-004210, 1493-004211, 1493-004212, 1493-004214, 1493-004215, 1493-004216, 1493-004217, 1493-004218, 1493-004219, 1493-004220, 1493-004221, 1493-004222, 1493-004223, 1493-004224, 1493-004225, 1493-004226, 1493-004227, 1493-004228, 1493-004229, 1493-004230, 1493-004231, 1493-004232, 1493-004233, 1493-004234, 1493-004235, 1493-004236, 1493-004237, 1493-004238, 1493-004239, 1493-004240, 1493-004241, 1493-004242, 1493-004243, 1493-004256, 1493-004257, 1493-004258, 1493-004259, 1493-004260, 1493-004261, 1493-004262, 1493-004263, 1493-004264, 1493-004265, 1493-004266, 1493-004267, 1493-004268, 1493-004269, 1493-004270, 1493-004271, 1493-004272, 1493-004273, 1493-004274, 1493-004275, 1493-004276, 1493-004277, 1493-004278, 1493-004279, 1493-004280, 1493-004281, 1493-004282, 1493-004283, 1493-004284, 1493-004285, 1493-004286, 1493-004287, 1493-004288, 1493-004289, 1493-004290, 1493-004291, 1493-004292, 1493-004293, 1493-004294, 1493-004295, 1493-004296, 1493-004297, 1493-004298, 1493-004299, 1493-004301, 1493-004302, 1493-004306, 1493-004307, 1493-004308, 1493-004309, 1493-004310, 1493-004311, 1493-004312, 1493-004313, 1493-004314, 1493-004315, 1493-004316, 1493-004317, 1493-004318, 1493-004319, 1493-004320, 1493-004321, 1493-004322, 1493-004323, 1493-004324, 1493-004325, 1493-004326, 1493-004327, 1493-004328, 1493-004329, 1493-004330, 1493-004331, 1493-004332, 1493-004333, 1493-004334, 1493-004335, 1493-004336, 1493-004337, 1493-004338, 1493-004339, 1493-004340, 1493-004341, 1493-004342, 1493-004343, 1493-004344, 1493-004345, 1493-004346, 1493-004347, 1493-004348, 1493-004349, 1493-004350, 1493-004351, 1493-004352, 1493-004353, 1493-004354, 1493-004355, 1493-004356, 1493-004357, 1493-004358, 1493-004359, 1493-004360, 1493-004361, 1493-004362, 1493-004363, 1493-004364, 1493-004365, 1493-004366, 1493-004367, 1493-004368, 1493-004369, 1493-004370, 1493-004371, 1493-004372, 1493-004373, 1493-004374, 1493-004375, 1493-004376, 1493-004377, 1493-004378, 1493-004379, 1493-004380, 1493-004381, 1493-004382, 1493-004383, 1493-004384, 1493-004385, 1493-004405, 1493-004406, 1493-004407, and 1493-004408. International - 1493-002941, 1493-003666, 1493-003689, 1493-003690, 1493-003691, 1493-003692, 1493-003910, 1493-003911, 1493-003912, 1493-003913, 1493-003946, 1493-003947, 1493-003948, 1493-003949, 1493-003950, 1493-003951, 1493-003952, 1493-003953, 1493-003954, 1493-003955, 1493-003956, 1493-003966, 1493-003967, 1493-003968, 1493-003969, 1493-003970, 1493-003971, 1493-003972, 1493-003973, 1493-003974, 1493-003975, 1493-003976, 1493-003977, 1493-003978, 1493-003979, 1493-003980, 1493-003981, 1493-003982, 1493-003983, 1493-003984, 1493-003986, 1493-003987, 1493-003988, 1493-003989, 1493-003990, 1493-003991, 1493-003992, 1493-003993, 1493-003994, 1493-003995, 1493-003996, 1493-003997, 1493-003998, 1493-003999, 1493-004000, 1493-004001, 1493-004002, 1493-004003, 1493-004004, 1493-004005, 1493-004008, 1493-004009, 1493-004010, 1493-004012, 1493-004013, 1493-004014, 1493-004015, 1493-004016, 1493-004017, 1493-004018, 1493-004019, 1493-004020, 1493-004021, 1493-004022, 1493-004024, 1493-004025, 1493-004035, 1493-004036, 1493-004037, 1493-004038, 1493-004039, 1493-004040, 1493-004041, 1493-004042, 1493-004045, 1493-004046, 1493-004065, 1493-004066, 1493-004072, 1493-004073, 1493-004074, 1493-004076, 1493-004078, 1493-004079, 1493-004080, 1493-004081, 1493-004083, 1493-004087, 1493-004088, 1493-004089, 1493-004090, 1493-004091, 1493-004092, 1493-004093, 1493-004094, 1493-004095, 1493-004096, 1493-004097, 1493-004098, 1493-004099, 1493-004100, 1493-004101, 1493-004102, 1493-004103, 1493-004104, 1493-004105, 1493-004107, 1493-004108, 1493-004109, 1493-004110, 1493-004111, 1493-004129, 1493-004131, 1493-004132, 1493-004133, 1493-004134, 1493-004135, 1493-004136, 1493-004137, 1493-004138, 1493-004139, 1493-004140, 1493-004141, 1493-004142, 1493-004143, 1493-004144, 1493-004145, 1493-004146, 1493-004147, 1493-004148, 1493-004149, 1493-004150, 1493-004151, 1493-004152, 1493-004153, 1493-004154, 1493-004155, 1493-004165, 1493-004166, 1493-004167, 1493-004168, 1493-004169, 1493-004170, 1493-004171, 1493-004186, 1493-004187, 1493-004188, 1493-004189, 1493-004190, 1493-004191, 1493-004192, 1493-004193, 1493-004194, 1493-004195, 1493-004196, 1493-004197, 1493-004198, 1493-004199, 1493-004200, 1493-004201, 1493-004202, 1493-004203, 1493-004204, 1493-004300, 1493-004304, 1493-004305, and 670-1350-00.
ClassificationClass II
Reason for RecallThere is a potential failure of the Integrated Module Housing causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing.
Product Quantity527 units total; 350 US and 177 International
Recall NumberZ-2382-2012

Class II Devices Event

Event ID63011
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmHaag-Streit USA Inc
CityMason
StateOH
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) including states of: AR, CA, CT, FL, GA, IA, IL, LA, MA, MI, MN, MS, NJ, NV, NY, OH, OR, PA, SC, SD, WA, WI, and WV; and to the countries of Jamaica, Puerto Rico, and Mexico.
 

Associated Products

Product DescriptionOctopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.
Code InfoModel Octopus 101. SN: 119, 136, 165, 166, 221, 222, 225, 236, 243, 273, 277, 279, 370, 371, 392, 507, 541, 553, 570, 602, 603, 611, 620, 622, 661, 667, 668, 687, 690, 726, 741, 744, 794, 796, 1054, 1214, 1275, 1276, 1277, 1313, 1322, 1326, 1380, 1402, 1404, 1413, 1414, 1436, 1437, 1459, 1460, 1489, 1490, 1491, 1492, 1560, 1561, 1607, 1608, 1625, 1626, 1706, 1710, 1852
ClassificationClass II
Reason for RecallThe firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101.
Product Quantity64 units
Recall NumberZ-2411-2012

Class II Devices Event

Event ID63014
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Medical Systems (Cleveland) Inc
CityCleveland
StateOH
CountryUS
Distribution PatternWorldwide distribution, Nationwide (US) including the states AL, AR, CA, FL, GA, IL, IN, MS, NJ, NV, NY, OH, PA, and VA and the countries of Albania, Argentina, Australia, Belgium, Brazil, Chile, China, Colombia, Dominican Republic, Ecuador, France, Germany, Greece, India, Indonesia, Ireland, Italy, Jordan, Lebanon, Malawi, Mexico, Nepal, Netherlands, Oman, Palestine, Philippines, Poland, Romania, Russia, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Turkey, Uganda, and Venezuela.
 

Associated Products

Product DescriptionMX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system.
Code InfoSystem Code #, 728131, Serial #: EP16E090001-EP16E090004, EP16E090006-EP16E090015, EP16E100001- EP16E100004, EP16E100006, EP16E100008- EP16E100063, EP16E100067, EP16E100069- EP16E100113, EP16E110001- EP16E110065, EP16E110067-EP16E110070, EP16E110074-EP16E110075, EP16E110077-EP16E110078, EP16E110080, EP16E110083- EP16E110085, EP16E110088- EP16E110112, EP16E110115- EP16E110119, EP16E120001- EP16E120014, EP16E120016, EP16EB110003- EP16ER100007, EP16ER110003, EP16ER110006, P16C080001, P16C080002, P16C090001, P16C100001-P16C100015, P16C100017, P16C100018, P16C110001- P16C110008, P16C110011-P16C110037, P16C120001-P16C120003, P16C120006, P16C120007, P16E080005, P16E080007, P16E080008, P16E080012, P16E090002-P16E090021, P16E090024-P16E090028, P16E100002, P16EF80010, P16EM08003, and P16EM09002-P16EM09004. System Code #, 728132, Serial #: EP16E100005, EP16E100007, EP16E110066, EP16ER100003-EP16ER100005, EP16ER100008, EP16ER110004, EP16ER110005, and EP16ER110007-EP16ER110024.
ClassificationClass II
Reason for RecallOn August 24, 2012 the firm recalled the MX 16-slice after discovering that a bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
Product Quantity328 units
Recall NumberZ-2386-2012

Class II Devices Event

Event ID63016
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSekisui Diagnostics Llc
CityStamford
StateCT
CountryUS
Distribution PatternNationwide distribution: USA including states of: FL, IN, IL, and WA.
 

Associated Products

Product DescriptionSekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. Catalog Number: 101201 For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use.
Code InfoLot Numbers: 120425 and 120601
ClassificationClass II
Reason for RecallSPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This will reduce the slope of the standard curve requiring the user to make more frequent sample dilutions.
Product Quantity699 kits
Recall NumberZ-2431-2012

Class II Devices Event

Event ID63033
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmVarian Medical Systems, Inc. Oncology Systems
CityPalo Alto
StateCA
CountryUS
Distribution PatternWorldwide Distribution.
 

Associated Products

Product DescriptionVarian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Code InfoLIST OF SERIAL NUMBERS: H140863 ,H294608 ,H294669 ,H294732 ,H140865 ,H294610 ,H294670 ,H294733 ,H140866 ,H294611 ,H294671 ,H294734 ,H140867 ,H294612 ,H294672 ,H294735 ,H140868 ,H294613 ,H294673 ,H294736 ,H140869 ,H294614 ,H294674 ,H294737 ,H140870 ,H294615 ,H294675 ,H294738 ,H140871 ,H294616 ,H294676 ,H294739 ,H140872 ,H294617 ,H294677 ,H294740 ,H140873 ,H294618 ,H294678 ,H294741 ,H140874 ,H294619 ,H294679 ,H294742 ,H140875 ,H294620 ,H294680 ,H294743 ,H140876 ,H294621 ,H294681 ,H294744 ,H140877 ,H294622 ,H294682 ,H294745 ,H140878 ,H294623 ,H294683 ,H294746 ,H140879 ,H294624 ,H294684 ,H294747 ,H140880 ,H294625 ,H294685 ,H294748 ,H140881 ,H294626 ,H294686 ,H294749 ,H140882 ,H294627 ,H294687 ,H294750 ,H140883 ,H294628 ,H294688 ,H294751 ,H140884 ,H294629 ,H294689 ,H294752 ,H140885 ,H294630 ,H294690 ,H294753 ,H140886 ,H294631 ,H294691 ,H294754 ,H140887 ,H294632 ,H294692 ,H294755 ,H140888 ,H294633 ,H294693 ,H294756 ,H140889 ,H294634 ,H294694 ,H294757 ,H140890 ,H294635 ,H294695 ,H294758 ,H140891 ,H294636 ,H294696 ,H294759 ,H140892 ,H294637 ,H294697 ,H294760 ,H140893 ,H294638 ,H294698 ,H294761 ,H140895 ,H294639 ,H294699 ,H294762 ,H140896 ,H294640 ,H294700 ,H294763 ,H140897 ,H294641 ,H294701 ,H294764 ,H140898 ,H294642 ,H294702 ,H294765 ,H140899 ,H294643 ,H294704 ,H294766 ,H140900 ,H294644 ,H294705 ,H294767 ,H181175 ,H294645 ,H294706 ,H294768 ,H181176 ,H294646 ,H294707 ,H294769 ,H181177 ,H294647 ,H294708 ,H294770 ,H181178 ,H294648 ,H294709 ,H294771 ,H181179 ,H294649 ,H294710 ,H294772 ,H181180 ,H294650 ,H294711 ,H181181 ,H294651 ,H294712 ,H181182 ,H294652 ,H294713 ,H181183 ,H294653 ,H294714 ,H181184 ,H294654 ,H294715 ,H181185 ,H294655 ,H294716 ,H181186 ,H294656 ,H294717 ,H181187 ,H294657 ,H294718 ,H181188 ,H294658 ,H294719 ,H181189 ,H294659 ,H294720 ,H181190 ,H294660 ,H294722 ,H181191 ,H294661 ,H294723 ,H181192 ,H294662 ,H294724 ,H182000 ,H294663 ,H294726 ,H182001 ,H294664 ,H294727 ,H182002 ,H294665 ,H294728 ,H182003 ,H294666 ,H294729 ,H182005 ,H294667 ,H294730 ,H294607 ,H294668 ,H294731
ClassificationClass II
Reason for RecallSome X-jaws (lower collimator jaw) carriers were manufactured with the incorrect metal alloy, which can potentially cause the jaw carrier to crack. If both jaw carriers on the same X-jaw were to crack, the jaw would be able to move freely in the closed direction. In this case, the deviation of the jaw position will not be detected by the position readout interlock circuitry; Treatment after such a failure occurs may lead to an under-dose of the intended target volume. This condition was found on some machines.
Product Quantity
Recall NumberZ-2383-2012

Class II Devices Event

Event ID63069
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDavol, Inc., Subs. C. R. Bard, Inc.
CityWarwick
StateRI
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionBard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
Code InfoLot # HUWE1779
ClassificationClass II
Reason for RecallMislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh product
Product Quantity49 units
Recall NumberZ-2412-2012
Product DescriptionBard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
Code InfoLot # HUWE1780
ClassificationClass II
Reason for RecallMislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh
Product Quantity49 units
Recall NumberZ-2413-2012

Class II Devices Event

Event ID63078
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of Saudi Arabia, Canada and Barbados.
 

Associated Products

Product DescriptionEmpty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections.
Code Info250 mL size - Lot 11179DW, Exp, Date 1NOV2013, 11195DW, Exp. Date 1NOV2013 and 93854DW, Exp. Date 1SEP2012 - 1000 mL size - Lot 92835DW, Exp. Date 1AUG2012, Lot 96090DW, Exp. Date 1DEC2012, and Lot 96098DW, Exp. Date 1DEC2012
ClassificationClass II
Reason for RecallEmbedded iron oxide glass defect which may have the potential to break off into the solution.
Product Quantity191,094 units
Recall NumberZ-2395-2012

Class II Devices Event

Event ID63089
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSmith & Nephew Inc
CityMemphis
StateTN
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including the states of CA, FL, GA, IL, IN, MA, NC, NJ, NY, OH, OK, PA, TN, TX, and WA, and the country of Canada.
 

Associated Products

Product Description12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS.
Code InfoLot Numbers: 12FTM0017A, 12FTM0017B, 12FTM0017C, 12FTM0019A. 12FTM0019B, 12FTM0019C, 12FTM0019D, 12FTM0020A, 12FTM0020B, 12FTM0020C, 12FTM0021A, 12FTM0021B, and 12FTM0021C
ClassificationClass II
Reason for RecallModular necks were manufactured out of specification by a vendor; the taper provide is undersized.
Product Quantity70 units
Recall NumberZ-2427-2012

Class II Devices Event

Event ID63098
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmVascular Solutions, Inc.
CityMaple Grove
StateMN
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) including states of: AZ, AR, CA, CT, DE, FL, GA, ID, IL IN , KY, LA,MD, MN, MO, NV, NM, NY, OH, PA, SC, TN, TX, VA, WA, and WV; and countries of: Italy and Korea. Italy, Korea
 

Associated Products

Product DescriptionGuardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.
Code Infolots 27686, 27293, 22446
ClassificationClass II
Reason for RecallVascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal from Guardian II (Model 8210) and Guardian II NC (Model FH102) Hemostasis Valve which poses a risk of product contamination.
Product Quantity3500 units
Recall NumberZ-2400-2012

Class II Devices Event

Event ID63110
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-May-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRAYSEARCH LABORATORIES AB
CityStockholm
State
CountrySE
Distribution PatternWorldwide Distribution - USA including CA, KY, MI, NY, OK, and OR. Internationally to Canada, Belgium, United Kingdom, Australia, France, Germany, and Poland.
 

Associated Products

Product DescriptionThe product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10. Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists
Code InfoSharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10).
ClassificationClass II
Reason for RecallThis field notice concerns two behaviors of the SharePlan (Multiple Fraction Groups and Depth Offset) that may be unexpected and are not clearly described in the user manual. None of these behaviors have caused patient mistreatment or other incidents. However, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivered treatment.
Product Quantity15 units
Recall NumberZ-2378-2012

Class II Devices Event

Event ID63129
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSteris Corporation
CityMentor
StateOH
CountryUS
Distribution PatternWorldwide Distribution--USA (nationwide) including the states of AL, CA, CO, CT, FL, GA, IA, IN, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK,OR, PA, RI, SC, TX, UT, VA, WA, WI, WV and WY. and the country of Canada.
 

Associated Products

Product DescriptionVerify® Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor, OH 44060 The Verify Bowie-Dick Test Card consists of a card printed on one side with bars of chemical indicator ink. On the opposite side of the card, space is provided for critical cycle information to be recorded. The card is laminated inside a thin clear plastic enclosure. The enclosure has two holes in it to allow air removal and steam penetration. The preassembled test is used to evaluate the effectiveness of air removal from the sterilizer chamber during prevacuum pulse steam sterilizer cycle. Following a prevacuum cycle, the chemical bars of the Bowie-Dick Test card uniformly darken indicating that residual air has been sufficiently removed to allow complete steam penetration into the test card. If air is trapped in the card during the exposure phase of the cycle, the color change of the bars will be incomplete or uneven. Thus the card can provide an immediate indication of inadequate removal of air during a cycle. The Bowie-Dick Type test is performed in an empty chamber each day the sterilizer is to be used, usually before the first sterilization cycle.
Code InfoModel #S3098, Serial #"s: H20013, H20014, and H20016.
ClassificationClass II
Reason for RecallSTERIS has learned that the Verify Bowie Dick Test Cards are not performing to product specifications. Specifically, test cards have resulted in false fail results when sterilizer performance is within acceptable ranges.
Product Quantity629 cards
Recall NumberZ-2417-2012

Class II Devices Event

Event ID63142
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Apr-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSteris Corporation
CityMentor
StateOH
CountryUS
Distribution PatternWorldwide Distribution - US Nationwide including the states of: AL, AR, CA, CO, CT, FL, HI, ID, IL, IN, IA, KY, LA, MA, MD, ME, MI, MN, MO, MS, NV, NYH, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WI & WV and countries of: Australia, Canada, China, India, Korea, Mexico, Panama and Thailand.
 

Associated Products

Product DescriptionSTERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. It accommodates all general surgical procedures including but not limited to, cardiac and vascular, endoscopic, gynecology, urology, nephrectomy, neurology, ophthalmologic, orthopedics and other procedures requiring intraoperative fluoroscopic C-arm imaging and also supports laparoscopic surgical technique for the largest surgical patients. The 5085SRT table is a variation of the 5085 table that enables patient transport on hard level surfaces within the surgical suite (from pre-operative areas to the operating room and again from the operating room to post operative recovery).
Code InfoSerial numbers from 0403809001 to 0408612102
ClassificationClass II
Reason for RecallSTERIS has learned from Customer feedback and field service experience that damage from external impact to the table hydraulic column can cause the stainless steel shroud sections covering the table hydraulic column to become misaligned; if the damage is severe, the up/down movement of the table may be impeded. In addition, the table hand control may indicate that the table floor locks are unlocked when in fact the floor locks are engaged.
Product Quantity379 tables
Recall NumberZ-2426-2012

Class II Devices Event

Event ID63146
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAsahi Kasei Medical Co., Ltd., Okatomi Plant
CityNobeoka-shi
State
CountryJP
Distribution PatternREXEED SX: Worldwide Distribution - USA including TN and the countries of Japan and Germany REXEED LX: Worldwide Distribution - USA including TN and Germany
 

Associated Products

Product DescriptionAsahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter
Code InfoLot numbers: 194349, 193T45, 193U46, 194H4R, 294S59, 295V68, 295Z5L, 29626X, and 296J6U
ClassificationClass II
Reason for RecallAsahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products.
Product Quantity55,632 units
Recall NumberZ-2418-2012
Product DescriptionAsahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter
Code InfoLot numbers: 193S43, 193V47, 193W48, 1948E, 19494F, 194J4S, 194K4T, 294N4U, 296F6Q, 29767F, 297J7U, 297U87, 299199, 29929X, 29939Y, and 299X9H
ClassificationClass II
Reason for RecallAsahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products.
Product Quantity152,016 units
Recall NumberZ-2419-2012
Product DescriptionAsahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter
Code InfoLot numbers: 193J3R, 193M3T, and 294Q57
ClassificationClass II
Reason for RecallAsahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products.
Product Quantity30,408 units
Recall NumberZ-2420-2012
Product DescriptionAsahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter
Code InfoLot numbers: 295W67, 295Y5K, 29656B, 296E6P, 296N72, and 296Y6J
ClassificationClass II
Reason for RecallAsahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products.
Product Quantity80,208 units
Recall NumberZ-2421-2012
Product DescriptionAsahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter
Code InfoLot number: 296S77
ClassificationClass II
Reason for RecallAsahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products.
Product Quantity1,536 units
Recall NumberZ-2422-2012
Product DescriptionAsahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter
Code InfoLot number: 296T78
ClassificationClass II
Reason for RecallAsahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products.
Product Quantity24 units
Recall NumberZ-2423-2012
Product DescriptionAsahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter
Code InfoLot numbers: 193P3V and 295P62
ClassificationClass II
Reason for RecallAsahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products.
Product Quantity5184 units
Recall NumberZ-2424-2012

Class III Biologics Event

Event ID40008
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Mar-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternMO
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info11GW59870, 11GW59871, 11GW59874, 11GW59876
ClassificationClass III
Reason for RecallBlood products, tested using the Hematastat equipment that was missing the daily quality control records, were distributed.
Product Quantity4 units
Recall NumberB-2494-12

Class III Biologics Event

Event ID42282
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-May-06
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCSL Plasma
CityLexington
StateKY
CountryUS
Distribution PatternIL, Germany
 

Associated Products

Product DescriptionSource Plasma
Code Info4040029292, 4040029296, 4040029301, 4040029294, 4040029304, 4040029297, 4040029289, 4040029298, 4040029299, 4040029305, 4040035505, 4040035512, 4040035517, 4040035522, 4040035523, 4040030105, 4040029306, 4040030109, 4040030111, 4040030114, 4040030115, 4040030116, 4040030117, 4040030118, 4040030225, 4040030228, 4040030232, 4040030302, 4040030306, 4040030308, 4040030309, 4040030310, 4040030311, 4040030312, 4040030313, 4040030314, 4040030315, 4040030316, 4040030317, 4040030318, 4040030319, 4040030320
ClassificationClass III
Reason for RecallBlood products, which may have reached unacceptable temperatures during storage, were distributed.
Product Quantity42 units
Recall NumberB-2121-12

Class III Biologics Event

Event ID44222
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Dec-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHoxworth Blood Center University of Cincinnati Medical Center
CityCincinnati
StateOH
CountryUS
Distribution PatternOH
 

Associated Products

Product DescriptionPlatelets Pooled
Code Info0090059
ClassificationClass III
Reason for RecallBlood product, for which the quality control testing was incomplete, was distributed.
Product Quantity1 unit
Recall NumberB-2328-12

Class III Biologics Event

Event ID44296
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jan-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBio-Blood Components, Inc.
CityColumbus
StateOH
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info06BOHA0323
ClassificationClass III
Reason for RecallBlood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-2327-12

Class III Biologics Event

Event ID44298
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Jan-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityToledo
StateOH
CountryUS
Distribution PatternOH
 

Associated Products

Product DescriptionPlasma Frozen
Code Info50LW55055
ClassificationClass III
Reason for RecallBlood products, manufactured from a whole blood unit that may have had an extended collection time, were distributed.
Product Quantity1 unit
Recall NumberB-2329-12

Class III Biologics Event

Event ID49625
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Jul-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CityWichita
StateKS
CountryUS
Distribution PatternKS, OK
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code Info02P96564, 02P96666, 02P96637, 02P96670, 02P96626, 02P96598, 02P96566, 02LS01159
ClassificationClass III
Reason for RecallBlood products, which may have reached an unacceptable temperature during storage, were distributed.
Product Quantity8 units
Recall NumberB-2210-12

Class III Biologics Event

Event ID50428
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jul-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info370060133, 370060924, 370061166, 370061723, 370063443, 370063689, 370064569, 370066763, 370069527, 370071330, 370072723, 370073353
ClassificationClass III
Reason for RecallBlood products, collected from a donor who was previously deferred, were distributed.
Product Quantity12 units
Recall NumberB-2496-12

Class III Biologics Event

Event ID62353
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-May-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmThe Blood Connection, Inc.
CityPiedmont
StateSC
CountryUS
Distribution PatternMichigan, South Carolina
 

Associated Products

Product DescriptionFresh Frozen Plasma (Apheresis)
Code InfoW121611912691, W121611907470
ClassificationClass III
Reason for RecallBlood products, which were not frozen within six hours of collection, were distributed.
Product Quantity2 units
Recall NumberB-2218-12

Class III Biologics Event

Event ID62363
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Apr-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmer. National Red Cross-Greater Chesapeake & Potomac Reg.
CityBaltimore
StateMD
CountryUS
Distribution PatternMaryland
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info53H10237
ClassificationClass III
Reason for RecallBlood product, which was incorrectly labeled as negative for the N red cell antigen, was distributed.
Product Quantity1 unit
Recall NumberB-2127-12

Class III Biologics Event

Event ID62376
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Apr-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRecovered Plasma
Code Info011LQ82629
ClassificationClass III
Reason for RecallBlood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-2120-12

Class III Devices Event

Event ID62577
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Dec-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmKimberly-Clark Corporation
CityRoswell
StateGA
CountryUS
Distribution PatternUS (nationwide) including the states of CA, CO, LA, NM, OK, TX and WA.
 

Associated Products

Product DescriptionULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Code InfoProduct Code: 95221-35, Unit Code: 90372
ClassificationClass III
Reason for RecallThe impacted product was not intended for commercial distribution to end users.
Product Quantity32 cases
Recall NumberZ-2425-2012

Class III Devices Event

Event ID62736
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Mar-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmImpact Instrumentation, Inc.
CityWest Caldwell
StateNJ
CountryUS
Distribution PatternNationwide distribution: USA including states of: FL and OH.
 

Associated Products

Product DescriptionModel 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers.
Code InfoModel 324JL S/N 120142 and S/N 120144
ClassificationClass III
Reason for RecallA shipment mix-up took place.
Product Quantity2 devices
Recall NumberZ-2430-2012

Class III Devices Event

Event ID62897
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics, Inc
CityEast Walpole
StateMA
CountryUS
Distribution PatternWorldwide Distribution - US Nationwide and the countries of: Canada, Argentina, Australia, Bangaldesh,Brazil, Chile, China, Columbia, Croatia, Ecuduar, Egypt, Hong Kong, India, Israel,Japan, Korea, Maylasia, New Zealand, Mexico, Peru, Philipines, Pakistan, Saudia Arabia, Singapore, Thailand, Taiwan, Viet Nam, South Africa and UK.
 

Associated Products

Product DescriptionADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP Prolactin assay: For in vitro diagnostic use in the quantitative determination of prolactin in serum using the ADVIA Centaur System. ADVIA Centaur Calibrator B: For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur® Systems: Digoxin, FSH, TotallgE, LH, LH2, Prolactin, Total hCG, and TSH
Code InfoUS: 2 Pack Ref: 00649625: Lot Numbers/Exp Date: Dec 2, 2012: 78813A30 79982A30 81013A30 82021B30 82767B30 83453C30 85447D30 87319A40 Exp Date:April 9, 2013 85598A40 85708A40 86098A40 87319A40 87979B40 88809B40 89351C40 91750C40 (6 pack) Ref. 00652707: Lot Numbers/Exp Date: Dec 2 2012 79354A30 80802A30 81892B30 82815B30 83741D30 84186A40 Exp. Date April, 8, 2013 85599A40 86191A40 88102B40 89717C40 91383C40 (6 Pack) Ref: 00654254 79714A30 Exp Date Dec 2, 2012 82370A30 84274A30 85512E30 OUS: 2 pack REF: 00650577 78319A29 Exp Dec 2, 2102 78487A29 79024A29 79403A29 79770B29 79981B29 82935B29 85735C29 00654130 Ref: 00654130 (6 pack) 78321A29 Exp Dec 2,2102 79197A29 83314C29
ClassificationClass III
Reason for RecallADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40
Product Quantity15, 455 kits
Recall NumberZ-2409-2012
Product DescriptionADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination of follicle-stimulating hormone (FSH) in serum using the ADVIA Centaur and ADVIA Centaur XP systems
Code InfoUS: 2 Pack Ref: 00649625: Lot Numbers/Exp Date: Dec 2, 2012: 78813A30 79982A30 81013A30 82021B30 82767B30 83453C30 85447D30 87319A40 Exp Date:April 9, 2013 85598A40 85708A40 86098A40 87319A40 87979B40 88809B40 89351C40 91750C40 (6 pack) Ref. 00652707: Lot Numbers/Exp Date: Dec 2 2012 79354A30 80802A30 81892B30 82815B30 83741D30 84186A40 Exp. Date April, 8, 2013 85599A40 86191A40 88102B40 89717C40 91383C40 (6 Pack) Ref: 00654254 79714A30 Exp Date Dec 2, 2012 82370A30 84274A30 85512E30 OUS: 2 pack REF: 00650577 78319A29 Exp Dec 2, 2102 78487A29 79024A29 79403A29 79770B29 79981B29 82935B29 85735C29 00654130 Ref: 00654130 (6 pack) 78321A29 Exp Dec 2,2102 79197A29 83314C29
ClassificationClass III
Reason for RecallADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40
Product Quantity15,445 kits
Recall NumberZ-2410-2012

Class III Devices Event

Event ID63006
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Medical Systems (Cleveland) Inc
CityCleveland
StateOH
CountryUS
Distribution PatternWorldwide Distribution - US Nationwide including the states of: AL, CA, GA, MA, MD, NC, OH, PA, TX, and WA; and to the following countries of: Algeria, Oman, Australia, Brazil, China, Saudi Arabia, United Arab Emirates, and India.
 

Associated Products

Product DescriptionThe Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Code InfoSystem Code #, 728246, Serial #, 6462, 6447, 6495, 6514, 6467, 6482, 6473, 6544, 6439, 6453, 6436, 6536, 6448, 6449, 6471, 6498, 6502, 6504, 6452, 6510, 6508, 6438, 6513, 6456, 6505, 6457, 6442, 6454, 6461, 6469, 6485, 6458, 6475, 6487, 6531, 6520, 6490, 6470, 6437, 6497, 6481, 6489, 6488, 6455, 6543, 6499, 6493, 6443, 6463, 6476, 6477, 6478, 6526, 6545, 6546, 6518, 6491, 6450, 6451, 6468, 6464, 6466, 6459, 6472, 6444, 6445, 6529, 6530, 6440, 6532, 6515, 6486, 6507, 6512, 6483, 6524, 6480, 6479, 6509, 6460, 6441, 6465, 6474, 6484, 6492, 6503, 6511, 6517, 6519, 6523, 6525, 6549, 6555
ClassificationClass III
Reason for RecallPhilips was notified that the system logout in software version 2.3.6 is now longer and may sometimes fail to logout, requiring a forced system restart or hard shutdown with the power button.
Product Quantity93 units
Recall NumberZ-2404-2012

Class III Drugs Event

Event ID63080
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmApace KY LLC
CityFountain Run
StateKY
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionEnalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30
Code InfoLot: DL11600 Exp Date: 06/13
ClassificationClass III
Reason for RecallLabeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.
Product Quantity81,516 bottles
Recall NumberD-1683-2012

Class III Devices Event

Event ID63105
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAmsino Medical USA
CityNashville
StateTN
CountryUS
Distribution PatternDistributed to one customer in Illinois.
 

Associated Products

Product Description0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.
Code InfoKH03752
ClassificationClass III
Reason for RecallOne lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL.
Product Quantity196,400 units
Recall NumberZ-2393-2012
Product Description0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.
Code InfoKH03752
ClassificationClass III
Reason for RecallOne lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL.
Product Quantityunknown
Recall NumberZ-2394-2012

Class III Drugs Event

Event ID63160
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSandoz Incorporated
CityBroomfield
StateCO
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionPramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781- 5249-92,
Code InfoLot numbers: BJ3338; BJ3339; BJ 3340; BJ3341; BJ3342; BJ6282; BJ7192; BM8498; BJ7202; BJ7203, Exp 12/12
ClassificationClass III
Reason for RecallImpurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Product Quantity43,060 x 90 count bottles
Recall NumberD-1677-2012
Product DescriptionPramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5248-92
Code InfoLot numbers: KW10J511, KW10J512, KW10J513, KW10J514, KW10J515, BJ3167, BJ3172, BJ3177, BJ3179, BJ3188, BJ3182. Exp. 09/12
ClassificationClass III
Reason for RecallImpurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Product Quantity41,761bottles.
Recall NumberD-1678-2012

Mixed Classification Biologics Event

Event ID48860
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-May-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CityWichita
StateKS
CountryUS
Distribution PatternTX, CA
 

Associated Products

Product DescriptionRecovered Plasma
Code Info02LP18662
ClassificationClass III
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2454-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info02LP18662
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2455-12

Mixed Classification Biologics Event

Event ID62064
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBlood Centers of the Pacific - Irwin Center
CitySan Francisco
StateCA
CountryUS
Distribution PatternSwitzerland; Austria; California
 

Associated Products

Product DescriptionPlasma Frozen Cryoprecipitated Reduced
Code InfoW117009159701N;
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history reactive results for HCV, were distributed.
Product Quantity1 unit
Recall NumberB-1941-12
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW117010196924W;
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history reactive results for HCV, were distributed.
Product Quantity1 unit
Recall NumberB-1942-12
Product DescriptionPlasma Frozen
Code InfoW117011455152N;
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history reactive results for HCV, were distributed.
Product Quantity1 unit
Recall NumberB-1943-12
Product DescriptionCryoprecipitated AHF, Pooled
Code InfoW117009159701N; W117010100874Y; W1170114435834;
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history reactive results for HCV, were distributed.
Product Quantity3 units
Recall NumberB-1944-12
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW117010196924W; W1170114417093;
ClassificationClass III
Reason for RecallBlood products, collected from a donor with a history reactive results for HCV, were distributed.
Product Quantity2 units
Recall NumberB-1945-12
Product DescriptionFresh Frozen Plasma
Code InfoW117009194370I; W117009125131Y; W117011426472Y; W1170101117358;
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history reactive results for HCV, were distributed.
Product Quantity4 units
Recall NumberB-1946-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW117009159701N; W117009125131Y; W117009194370I; W117011426472Y; W1170101117358; W117011455152N; W1170114417093;
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history reactive results for HCV, were distributed.
Product Quantity7 units
Recall NumberB-1947-12

Mixed Classification Biologics Event

Event ID62354
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-May-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBlood Assurance Inc
CityChattanooga
StateTN
CountryUS
Distribution PatternTennessee, Georgia, Indiana
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW043212033535 (2 units)
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-2135-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW043211081628
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2136-12
Product DescriptionRecovered Plasma
Code InfoW043211081628
ClassificationClass III
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2137-12

Mixed Classification Biologics Event

Event ID62362
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Feb-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHCSC-Blood Center
CityBethlehem
StatePA
CountryUS
Distribution PatternPennsylvania, Korea, New Jersey
 

Associated Products

Product DescriptionRecovered Plasma
Code InfoW050912012863
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2345-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW050912012863, W050912013540
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-2346-12
Product DescriptionFresh Frozen Plasma
Code InfoW050912009254
ClassificationClass III
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2347-12
Product DescriptionRed Blood Cells
Code InfoW050912010131
ClassificationClass III
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2348-12
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW050912013552
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2349-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW050912011703, W050912009254
ClassificationClass III
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-2350-12

Mixed Classification Biologics Event

Event ID62412
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Apr-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmAmerican National Red Cross
CityColumbus
StateOH
CountryUS
Distribution PatternOhio, California
 

Associated Products

Product DescriptionRecovered Plasma
Code Info16GR73221
ClassificationClass III
Reason for RecallBlood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-2112-12
Product DescriptionCryoprecipitated AHF, Pooled
Code Info16GR73221 (pool ID: 16N54970)
ClassificationClass II
Reason for RecallBlood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-2113-12
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