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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Class I Veterinary Event

Event ID61897
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-May-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmDiamond Pet Foods
CityMeta
StateMO
CountryUS
Distribution PatternDistribution was made to AR, CO, IL, KY, LA, MI, MN, MO, OK, NE, PA, SD, TN, TX, and WI,
 

Associated Products

Product DescriptionDiamond Pet Foods Naturals Small Breed Adult Dog Lamb & Rice Formula, packaged in 6-lb. (6/case) and 18-lb. bags, and 6-oz. sample-size bags (30/case). The firm name on the label is Diamond Pet Foods, Meta, MO.
Code InfoBest Before 26Aug2012, 27-Sept 2012, 18-Oct-2012 and 20-Oct-2012
ClassificationClass I
Reason for RecallContaminated with Salmonella
Product Quantity4,218/6-lb., 1,802/18-lb., and 7,020/6-oz. bags
Recall NumberV-200-2012

Class I Drugs Event

Event ID61957
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-May-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmThe Menz Club, LLC
CityRidgeland
StateMS
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionV Maxx Rx, All Natural Male Enhancement, a) 1-count blister pack UPC Code 2802803561; b) 5-count blister pack UPC Code 0972859402; c) 10-count bottle UPC code 0913251017 bottles, Manufactured by The Menz Club, LLC, 103 W. Washington Street, Suite B5, Ridgeland, MS 39157, Phone: 601-866-6746
Code Info Lot #s: a) 101108, 101009, 101010, 101011; b) 101108, 101109, 101110; c) 301000, 301001
ClassificationClass I
Reason for RecallMarketed Without An Approved NDA/ANDA: Samples tested by FDA were found to contain sulfoaildenafil, an analogue of sildenafil, an FDA approved drug used in the treatment of male erectile dysfunction, making these products unapproved new drugs.
Product Quantity585,000 Capsules
Recall NumberD-1657-2012

Class I Veterinary Event

Event ID62469
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Jun-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmMars Petcare USA
CityFranklin
StateTN
CountryUS
Distribution PatternProduct was shipped to the following states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI & WV.
 

Associated Products

Product DescriptionPEDIGREE+® Healthy Weight Premium Ground Entrée in Meaty Juices, 375 g (13.2 oz) cans, FOOD FOR DOGS, Ingredients: Sufficient Water For Processing: Chicken, Meat By-Products, Liver, Chicken By-Products, chicken Breast, Carrots, Spinach, Brewers Rice***1-800-525-5273 Distributed by Mars Petcare US, Inc., P. O. Box 683006, Franklin, TN 37068-3006***, UPC 0 23100 34974 9
Code InfoUPC 0 23100 34974 9, Each product will have a lot code printed on the end of the can that begins with 209, 210, 211 or 212 and a Best Before date that falls between 2/24/2014 and 3/23/2014.
ClassificationClass I
Reason for RecallProduct is being recalled because it may contain small pieces (2/3 x 2/3 x 2/5) of blue plastic. These pieces may represent a choking hazard to dogs.
Product Quantity18,877 cs/12/13.2 oz cans = 226,524 cans
Recall NumberV-201-2012
Product DescriptionPEDIGREE® Weight Management Meaty Ground Dinner Beef & Liver Dinner in Meaty Juices, 375 g (13.2 oz) cans, Ingredients: Sufficient Water for Processing, Meat By-Products, Chicken, Beef, Liver, Brewers Rice***1-800-525-5273 Distributed by Mars Petcare US PO Box 683006, Franklin, TN 37068-3006***, UPC 0 23100 01913 0
Code InfoUPC 0 23100 01913 0, Each product will have a lot code printed on the end of the can that begins with 209, 210, 211 or 212 and a Best Before date that falls between 2/24/2014 and 3/23/2014.
ClassificationClass I
Reason for RecallProduct is being recalled because it may contain small pieces (2/3 x 2/3 x 2/5) of blue plastic. These pieces may represent a choking hazard to dogs.
Product Quantity23,897 cs/24/13.2 oz cans = 573,528 cans
Recall NumberV-202-2012
Product DescriptionPEDIGREE® Weight Management Meaty Ground Dinner Chicken & Rice Dinner in Meaty Juices, 375 g (13.2 oz) cans, Ingredients: Sufficient Water for Processing, Chicken, Meat By-Products, Chicken By-Products (Source of Linoleic Acid), Liver, Brewers Rice***1-800-525-5273 Distributed by Mars Petcare US P. O. Box 683006, Franklin, TN 37068-3006***, UPC 0 23100 23045 9
Code InfoUPC UPC 0 23100 23045 9, Each product will have a lot code printed on the end of the can that begins with 209, 210, 211 or 212 and a Best Before date that falls between 2/24/2014 and 3/23/2014.
ClassificationClass I
Reason for RecallProduct is being recalled because it may contain small pieces (2/3 x 2/3 x 2/5) of blue plastic. These pieces may represent a choking hazard to dogs.
Product Quantity35,551 cs/24/13.2 oz cans = 853,224 cans
Recall NumberV-203-2012

Class I Food Event

Event ID62549
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPeoples Bakery Inc
CityTrenton
StateNJ
CountryUS
Distribution PatternMercer/Burlington counties in NJ
 

Associated Products

Product DescriptionDinner Rolls, 12 oz. net weight,, manufactured by Italian Peoples Bakery, 61-63 Butler Street, Trenton, NJ 08611;
Code InfoUPC 53277101246
ClassificationClass I
Reason for RecallProduct has an error on the ingredient listing of the packaging for product produced by Italian Peoples Bakery. The listing should include whey, but it is not included.
Product QuantityUnknown
Recall NumberF-1944-2012
Product DescriptionKaiser Roll, 12 oz. net weight,, manufactured by Italian Peoples Bakery, 61-63 Butler Street, Trenton, NJ 08611;
Code InfoUPC 53277101253
ClassificationClass I
Reason for RecallProduct has an error on the ingredient listing of the packaging for product produced by Italian Peoples Bakery. The listing should include whey, but it is not included.
Product Quantity
Recall NumberF-1945-2012
Product DescriptionTorps Rolls 12 oz. net weight,, manufactured by Italian Peoples Bakery, 61-63 Butler Street, Trenton, NJ 08611;
Code InfoUPC 5327710125
ClassificationClass I
Reason for RecallProduct has an error on the ingredient listing of the packaging for product produced by Italian Peoples Bakery. The listing should include whey, but it is not included.
Product Quantity
Recall NumberF-1946-2012

Class I Devices Event

Event ID62642
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCareFusion 303, Inc.
CitySan Diego
StateCA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of Australia, European Union, and South Africa.
 

Associated Products

Product DescriptionAlaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.
Code InfoModel 8100; Lot/Serial numbers-various
ClassificationClass I
Reason for RecallThe recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door keypad overlay may separate from the keypad assembly
Product Quantity43,862 units total (40,780 units in the US)
Recall NumberZ-2205-2012

Class I Food Event

Event ID62669
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jul-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmCool Creations, LLC
CityNorth Kansas City
StateMO
CountryUS
Distribution PatternDirect distribution was made to KS, MO, and OK.
 

Associated Products

Product DescriptionYellow onions Diced 3/8", packaged in 25-lb. plastic bags, 1 per case (item 19551); Diced 1/4", packaged in 5-lb. bags, 2 per case (item #19516), 4 per case (item 19510), and 1 per case (item 19515). Diced yellow onion packaged in 5-oz. plastic containers, 4 per case, UPC 815970010153, and 10-oz. plastic containers, 4 per case, UPC 815970011082, for retail sale. The firm name on the label is Cool Creations, LLC, North Kansas City, MO.
Code InfoLot numbers 12201 thru 12207 (last use by date affected is 8/30/2012)
ClassificationClass I
Reason for RecallProducts may be contaminated with Listeria monocytogenes
Product Quantity
Recall NumberF-1995-2012
Product DescriptionYellow onions: Julienne 1/4", packaged in 5-lb. plastic bags, 4 per case (item 19540) The firm name on the label is Cool Creations, LLC, North Kansas City, MO.
Code InfoLot numbers 12201 thru 12207 (last use by date affected is 8/30/2012)
ClassificationClass I
Reason for RecallProducts may be contaminated with Listeria monocytogenes
Product Quantity
Recall NumberF-1996-2012
Product DescriptionYellow onions: Sliced 1/4", packaged in 5-lb. plastic bags, 4 per case (item 19500) and 1 per case (item 19505) The firm name on the label is Cool Creations, LLC, North Kansas City, MO.
Code InfoLot numbers 12201 thru 12207 (last use by date affected is 8/30/2012)
ClassificationClass I
Reason for RecallProducts may be contaminated with Listeria monocytogenes
Product Quantity
Recall NumberF-1997-2012
Product DescriptionYellow onions: Whole peeled, packaged in 10-lb. plastic bags, 1 per case (item 19530). The firm name on the label is Cool Creations, LLC, North Kansas City, MO.
Code InfoLot numbers 12201 thru 12207 (last use by date affected is 8/5/2012)
ClassificationClass I
Reason for RecallProducts may be contaminated with Listeria monocytogenes
Product Quantity
Recall NumberF-1998-2012
Product DescriptionCool Creations Pico de Gallo packaged for food service in 5-lb. trays, 2 per case (item 17502), and Pico de Gallo packaged for retail sale in 16-oz plastic containers, 4 per case, UPC 815970011013; and 8-oz. plastic containers, 4 per case, UPC 815970010252. The firm name on the label is Cool Creations, LLC, North Kansas City, MO.
Code InfoLot numbers 12201 thru 12207 (last use by date affected is 8/5/12)
ClassificationClass I
Reason for RecallProducts may be contaminated with Listeria monocytogenes
Product Quantity209/4/16-oz. container cases, 42/4/8-oz. container cases, and 6/2/5-lb. plastic tray cases
Recall NumberF-1999-2012
Product DescriptionCool Creations Fajita Mix Deluxe packaged for food service in 5-lb. plastic trays, 4 per case (item #15741).
Code InfoLot numbers 12201 thru 12207 (last affected use by date 8/4/12)
ClassificationClass I
Reason for RecallProducts may be contaminated with Listeria monocytogenes
Product Quantity11/4/5-lb. plastic tray cases
Recall NumberF-2000-2012
Product DescriptionGrillers Fajita Mix, packaged in 10-oz. foil trays, 4 trays per case, UPC 815970011341. The firm name on the label is Cool Creations, LLC, North Kansas City, MO.
Code InfoLot numbers 12201 thru 12207 (last use by date affected is 8/6/2012)
ClassificationClass I
Reason for RecallProducts may be contaminated with Listeria monocytogenes
Product Quantity59/4/10-oz. cases
Recall NumberF-2001-2012
Product DescriptionGrillers Potato & Mushroom, packaged in 12-oz. foil trays, 4 trays per case, UPC 815970011334. The firm name on the label is Cool Creations, LLC, North Kansas City, MO.
Code InfoLot numbers 12201 thru 12207 (last use by date affected is 8/6/2012)
ClassificationClass I
Reason for RecallProducts may be contaminated with Listeria monocytogenes
Product Quantity71/4/12-oz. tray cases
Recall NumberF-2002-2012
Product DescriptionGrillers Asparagus Medley, packaged in 10-oz. foil trays, 4 trays per case, UPC 815970011440. The firm name on the label is Cool Creations, LLC, North Kansas City, MO.
Code InfoLot numbers 12201 thru 12207 (last use by date affected is 8/6/2012)
ClassificationClass I
Reason for RecallProducts may be contaminated with Listeria monocytogenes
Product Quantity102/4/10-oz. tray cases
Recall NumberF-2003-2012
Product DescriptionGrillers Squash Medley, packaged in 12-oz. foil trays, 4 trays per case, UPC 815970011389. The firm name on the label is Cool Creations, LLC, North Kansas City, MO.
Code InfoLot numbers 12201 thru 12207 (last use by date affected is 8/6/2012)
ClassificationClass I
Reason for RecallProducts may be contaminated with Listeria monocytogenes
Product Quantity43/4/12-oz. tray cases
Recall NumberF-2004-2012
Product DescriptionKabob Kit, packaged in 24-oz. plastic containers, 2 containers per case, UPC 815970011792. The firm name on the label is Cool Creations, LLC, North Kansas City, MO.
Code InfoLot numbers 12201 thru 12207 (last use by date affected is 8/5/2012)
ClassificationClass I
Reason for RecallProducts may be contaminated with Listeria monocytogenes
Product Quantity95/2/24-oz. container cases
Recall NumberF-2005-2012
Product DescriptionBeef Stew Kit, packaged in 32-oz. plastic containers, 2 containers per case, UPC 815970011150. The firm name on the label is Cool Creations, LLC, North Kansas City, MO.
Code InfoLot numbers 12201 thru 12207 (last use by date affected is 8/5/2012)
ClassificationClass I
Reason for RecallProducts may be contaminated with Listeria monocytogenes
Product Quantity26/2/32-oz. container cases
Recall NumberF-2006-2012
Product DescriptionVegetable Medley, packaged in 20-oz. plastic containers, 2 containers per case, UPC 815970011259. The firm name on the label is Cool Creations, LLC, North Kansas City, MO.
Code InfoLot numbers 12201 thru 12207 (last use by date affected is 8/5/2012)
ClassificationClass I
Reason for RecallProducts may be contaminated with Listeria monocytogenes
Product Quantity39/2/20-oz. container cases
Recall NumberF-2007-2012
Product DescriptionBean dip packaged in the following configurations: 1. Bean Dip Bowl, packaged in 10-oz. plastic bowls, 4 bowls per case, UPC 815970011198; 2. Bean Dip Bowl, packaged in 20-oz. plastic bowls, 4 bowls per case, UPC 815970010368; 3. Bean Dip Tray, packaged in 20-oz. foil pans, 4 per case, UPC 815970011648; and 4. Bean Dip Platter, packaged in 45-oz. trays, 2 per case, UPC 815970010375. The firm name on the label is Cool Creations, LLC, North Kansas City, MO.
Code InfoLot numbers 12201 thru 12207 (last use by date affected is 8/5/2012)
ClassificationClass I
Reason for RecallProducts may be contaminated with Listeria monocytogenes
Product Quantity47/4/10-oz. bowl cases, 24/4/20-oz. bowl cases, 5/4/20-oz. pan cases, and 26/2/45-oz. tray cases
Recall NumberF-2008-2012
Product DescriptionFiesta garden Fresh Salsa, Black Beans & Corn, packaged in 16-oz. plastic containers, 6 per case, UPC 829595000055. Distributed by Vanscoy Industries, Cedar Rapids, IA.
Code InfoLot numbers 12201 thru 12207 (last use by date affected is 8/30/2012)
ClassificationClass I
Reason for RecallProducts may be contaminated with Listeria monocytogenes
Product Quantity20/6/16-oz. container cases
Recall NumberF-2009-2012
Product DescriptionFiesta garden Fresh Salsa, Garlic, packaged in 16-oz. plastic containers, 6 per case, UPC 829595000062. Distributed by Vanscoy Industries, Cedar Rapids, IA.
Code InfoLot numbers 12201 thru 12207 (last use by date affected is 8/30/2012)
ClassificationClass I
Reason for RecallProducts may be contaminated with Listeria monocytogenes
Product Quantity30/6/16-oz. container cases
Recall NumberF-2010-2012
Product DescriptionFiesta garden Fresh Salsa, Hot, packaged in 16-oz. plastic containers, 12 per case, UPC 829595000048. Distributed by Vanscoy Industries, Cedar Rapids, IA.
Code InfoLot numbers 12201 thru 12207 (last use by date affected is 8/30/2012)
ClassificationClass I
Reason for RecallProducts may be contaminated with Listeria monocytogenes
Product Quantity60/12/16-oz. container cases
Recall NumberF-2011-2012
Product DescriptionFiesta garden Fresh Salsa, Mild, packaged in 16-oz. plastic containers, 12 per case, UPC 829595000017. Distributed by Vanscoy Industries, Cedar Rapids, IA.
Code InfoLot numbers 12201 thru 12207 (last use by date affected is 8/30/2012)
ClassificationClass I
Reason for RecallProducts may be contaminated with Listeria monocytogenes
Product Quantity160/12/16-oz. container cases
Recall NumberF-2012-2012
Product DescriptionFiesta garden Fresh Salsa, Pineapple, packaged in 16-oz. plastic containers, 6 per case, UPC 829595000079. Distributed by Vanscoy Industries, Cedar Rapids, IA.
Code InfoLot numbers 12201 thru 12207 (last use by date affected is 8/30/2012)
ClassificationClass I
Reason for RecallProducts may be contaminated with Listeria monocytogenes
Product Quantity30/6/16-oz. container cases
Recall NumberF-2013-2012

Class I Food Event

Event ID62671
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jul-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmWimberger's Old World Bakery, Inc.
CityColorado Springs
StateCO
CountryUS
Distribution PatternThe product was distributed to retailers located in Colorado and Kansas.
 

Associated Products

Product DescriptionKaiser Rolls, Seeded Rolls, Brat Buns, French Bread, Pretzel Rolls, Pretzels, Pizza Dough, Hoagie Rolls and French Baguettes each packaged in identical semi-transparent plastic bags identified as fresh from the OVEN SOUR DOUGH 12 KAISER ROLLS, NET WT 20 OZ, WIMBERGER'S OLD WORLD BAKERY 2321 Bott St., Colorado Springs, Colo 80904. The labeling is yellow, white, and brown, with black print writing bearing the UPC 7960540012. These items are also distributed in 10 oz.
Code InfoUPC 7960540012.
ClassificationClass I
Reason for RecallWimberger's Old World Bakery is recalling various baked bread products due to the omission of major allergens milk, soy, and wheat from their finished product labeling.
Product Quantity4,874 x 12 units
Recall NumberF-1994-2012

Class I Food Event

Event ID62685
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jul-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmFreshpoint Atlanta, Inc.
CityForest Park
StateGA
CountryUS
Distribution PatternAL, GA, NC, SC & TN.
 

Associated Products

Product DescriptionProcessed Yellow Onions - Yellow Sliced 1/8", 1/4" and 3/16"
Code InfoJulian Date 12188 through Julian Date 12206 - Item No. 900258, 801459, 900253, 801103, 501083, 501459, 500258, 900569,
ClassificationClass I
Reason for RecallProduct may be contaminated with Listeria monocytogenes.
Product Quantity142 cases
Recall NumberF-1971-2012
Product DescriptionProcessed Yellow Onions - Yellow Julienne 1/8", 1/4", 3/4" and 3/8"
Code InfoJulian Date 12188 through Julian Date 12206 - Item No. 900540, 500245, 901329, 900215, 901081, 501081, 801329, 700245, 500206, 900245, 501329, 501699, 901699
ClassificationClass I
Reason for RecallProduct may be contaminated with Listeria monocytogenes.
Product Quantity154 cases
Recall NumberF-1972-2012
Product DescriptionProcessed Yellow Onions -Yellow Diced 1/4", 1/2" 3/4", 3/8", and 1/8"
Code InfoJulian Date 12188 through Julian Date 12206 - Item No. 500200, 500656, 900262, 500262, 900200, 901597, 901957, 901926, 900201, 901059, 901076, 501059, 700656, 900656, 501076, 501622, 500448, 500209, 500569, 900264, 500201, 501461, 500264
ClassificationClass I
Reason for RecallProduct may be contaminated with Listeria monocytogenes.
Product Quantity1635 cases
Recall NumberF-1973-2012
Product DescriptionProcessed Yellow Onions Veg. Ratatouille Mix
Code InfoJulian Date 12188 through Julian Date 12206 - Item No. 900776, 500776
ClassificationClass I
Reason for RecallProduct may be contaminated with Listeria monocytogenes.
Product Quantity17 cases
Recall NumberF-1974-2012
Product DescriptionProcessed Yellow Onions Cubed 1"
Code InfoJulian Date 12188 through Julian Date 12206 - Item No. 500236, 800236
ClassificationClass I
Reason for RecallProduct may be contaminated with Listeria monocytogenes.
Product Quantity2 cases
Recall NumberF-1975-2012
Product DescriptionProcessed Yellow Onions - Veg. Harvest Hash Mix
Code InfoJulian Date 12188 through Julian Date 12206 - Item No. 901786, 501786
ClassificationClass I
Reason for RecallProduct may be contaminated with Listeria monocytogenes.
Product Quantity4 cases
Recall NumberF-1976-2012
Product DescriptionProcessed Yellow Onions - Veg. Mirepoix
Code InfoJulian Date 12188 through Julian Date 12206 - Item No. 901041, 501205
ClassificationClass I
Reason for RecallProduct may be contaminated with Listeria monocytogenes.
Product Quantity70 cases
Recall NumberF-1977-2012
Product DescriptionProcessed Yellow Onions - Veg. Mix Asp/On/Ryg Pep Jul
Code InfoJulian Date 12188 through Julian Date 12206 - Item No. 501441
ClassificationClass I
Reason for RecallProduct may be contaminated with Listeria monocytogenes.
Product Quantity3 cases
Recall NumberF-1978-2012
Product DescriptionProcessed Yellow Onions - Whole Peeled
Code InfoJulian Date 12188 through Julian Date 12206 - Item No. 500557, 500267, 501884, 800267, 900267
ClassificationClass I
Reason for RecallProduct may be contaminated with Listeria monocytogenes.
Product Quantity62 cases
Recall NumberF-1979-2012
Product DescriptionProcessed Yellow Onions - Veg. Fajita Mix II & III Julienne
Code InfoJulian Date 12188 through Julian Date 12206 - Item No. 500619, 900619, 901393
ClassificationClass I
Reason for RecallProduct may be contaminated with Listeria monocytogenes.
Product Quantity17 cases
Recall NumberF-1980-2012
Product DescriptionProcessed Yellow Onions - Yellow Slivered
Code InfoJulian Date 12188 through Julian Date 12206 - Item No. 501200
ClassificationClass I
Reason for RecallProduct may be contaminated with Listeria monocytogenes.
Product Quantity3425 cases
Recall NumberF-1981-2012
Product DescriptionProcessed Yellow Onions - Veg. Asian Bias Mix
Code InfoJulian Date 12188 through Julian Date 12206 - Item No. 501204
ClassificationClass I
Reason for RecallProduct may be contaminated with Listeria monocytogenes.
Product Quantity153 cases
Recall NumberF-1982-2012
Product DescriptionProcessed Yellow Onions - Yellow Colossal Ring
Code InfoJulian Date 12188 through Julian Date 12206 - Item No. 901375
ClassificationClass I
Reason for RecallProduct may be contaminated with Listeria monocytogenes.
Product Quantity16 cases
Recall NumberF-1983-2012

Class I Food Event

Event ID62686
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Jul-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmHuxtable's Kitchen Inc
CityVernon
StateCA
CountryUS
Distribution PatternDistributed to Trader Joes market stores CA, AZ, NV and NM.
 

Associated Products

Product DescriptionTrader Joe's Roasted Butternut Squash, Red Quinoa and Wheatberr Salad, 9.5 oz. Product packaged in plastic tray with plastic lid. 18 units/basket.
Code InfoUse by date 7/28/12 and 7/30/12
ClassificationClass I
Reason for RecallRecall initiated by firm because the onions uses as an ingredient have the potential to be contaminated by Listeria monocytogenes.
Product Quantity3639 units
Recall NumberF-1986-2012

Class I Food Event

Event ID62694
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmReshmi's Group Inc.
CityKent
StateWA
CountryUS
Distribution PatternProduct was further distributed to consignees in Alaska, Colorado, Oregon, and Washington
 

Associated Products

Product DescriptionCrispy Just Baked Punjabi Cookies, packaged in clear clam shell container and sealed in clear plastic wrap. Net weight is 800 gram (1.76 lb). The UPC is 6 27265 00152 0. The product is labeled in parts: "***CRISPY PUNJABI COOKIES Just Baked!***By TWI Foods***Ingredients: Wheat Flour, soybean oil, margarine, sugar, semolina, baking powder, ammonium carbonate***".
Code InfoUSE BYE DATE JULY 31ST 2012.
ClassificationClass I
Reason for RecallCrispy Just Baked Punjabi Cookies contain milk but the label does not declare milk.
Product Quantityestimated 228 cases
Recall NumberF-1988-2012

Class I Food Event

Event ID62701
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMother India foods LLC
CityPortland
StateOR
CountryUS
Distribution PatternDistributed in Oregon and Washington
 

Associated Products

Product DescriptionCrispy Just Baked Punjabi Cookies, packaged in clear clam shell container and sealed in clear plastic wrap. Net weight is 800 gram (1.76 lb). The UPC is 6 27265 00152 0. The product is labeled in parts: "***CRISPY PUNJABI COOKIES Just Baked!***By TWI Foods***Net Wt. 800 g/1.76 lbs***Ingredients: Wheat Flour, soybean oil, margarine, sugar, semolina, baking powder, ammonium carbonate***".
Code InfoAll lots and all codes
ClassificationClass I
Reason for RecallCrispy Just Baked Punjabi Cookies contain milk but the label does not declare milk.
Product Quantity69 cases (14 packages/800 gram)
Recall NumberF-1989-2012

Class I Food Event

Event ID62777
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling Firm2 Moms in the Raw, LLC
CityLafayette
StateCO
CountryUS
Distribution PatternNational US distribution only: OR, NY, KS, PA, CA, TX, NH, WA.
 

Associated Products

Product DescriptionTwo Moms in the Raw, Gluten-Free Pesto Sea Cracker enclosed in brown semi-synthetic packaging with a transparent section displaying the contents. Labeling on the product is green, white, and blue with blue, green, and red print writing.
Code InfoLot numbers: 1008, 1016, 1027, 1055, 1067.
ClassificationClass I
Reason for RecallTwo Moms in the Raw is issuing a voluntary recall for Pesto Sea Cracker, 4 oz, because they were notified by their raw material supplier that the pine nuts used in the product may contain peanuts.
Product Quantity4618 x 4 oz bags
Recall NumberF-1991-2012

Class I Food Event

Event ID62778
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDeep Foods Inc
CityUnion
StateNJ
CountryUS
Distribution PatternNationwide.
 

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 InfoAll lots shipped to customers between August 1, 2011 to current date (8/2/2012).
ClassificationClass I
Reason for RecallThis recall has been initiated due to Non-Declared Milk. This product may have traces that can cause an allergic reaction and is not declared on certain labels.
Product Quantity391 cases
Recall NumberF-1987-2012

Class I Food Event

Event ID62782
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSpecialty Commodities, Inc.
CityFargo
StateND
CountryUS
Distribution PatternCA, MN NJ, NY, OR, PA, SC, and Canada
 

Associated Products

Product DescriptionOrganic Pinenut, 25 kg, Product of China
Code InfoMfg Lot No: 97638
ClassificationClass I
Reason for RecallA customer of Specialty Commodities reported that they found peanuts in a container of pine nuts.
Product Quantity541 - 25kg containers
Recall NumberF-1990-2012

Class I Food Event

Event ID62793
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMenno Beachy
CityCresco
StateIA
CountryUS
Distribution PatternDistribution was made to a food distributor in MN who further distributed the product to retail stores located in MN, WI, and MI.
 

Associated Products

Product DescriptionMenno Beachy, Cresco, IA Certified Organic Grape Tomato packaged in 1-pint square-shaped clear plastic clamshell containers, UPC 044419310176, 12/1-pint. containers per case.
Code InfoLot numbers MB725GT0, MB725GT3, and MB725GT8. These lot numbers only appear on the case label, not on the clamshell label.
ClassificationClass I
Reason for RecallSalmonella Montevideo was isolated in one lot of the grape tomatoes
Product Quantity20/12/1-pt. container cases
Recall NumberF-1992-2012

Class I Food Event

Event ID62802
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmEssential Living Foods, Inc
CityCulver City
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionPine Nuts, 5lbs, Item 40476-214, UPC 8 12986 01288.
Code InfoLot #21712
ClassificationClass I
Reason for RecallEssential Living is recalling Pine Nuts because it has undeclared peanuts.
Product Quantity1 unit
Recall NumberF-1993-2012

Class I Food Event

Event ID62806
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Aug-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmFresco Green Farms, Inc.
CityWinchester
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionCilantro, 2.5 dozens, 30 bunches/case
Code InfoProdut is not coded.
ClassificationClass I
Reason for RecallFresco Green Farms Inc. is recalling cilantro because it has the potential to be contaminated with Salmonella.
Product Quantity1,643 cases
Recall NumberF-2014-2012

Class II Biologics Event

Event ID38681
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Mar-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBelle Bonfils Memorial Blood Center
CityDenver
StateCO
CountryUS
Distribution PatternAZ
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info6731694
ClassificationClass II
Reason for RecallBlood product, negative for the Fyb-antigen but typed as Fyb-antigen positive, was distributed.
Product Quantity1 unit
Recall NumberB-1748-12

Class II Biologics Event

Event ID38689
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jun-07
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBelle Bonfils Memorial Blood Center
CityDenver
StateCO
CountryUS
Distribution PatternColorado, Switzerland
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info2143525
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-1738-12
Product DescriptionRed Blood Cells
Code Info2143525
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-1739-12

Class II Biologics Event

Event ID40124
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-May-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center of Greater Kansas City
CityKansas City
StateMO
CountryUS
Distribution PatternMO
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045005005778
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-2052-12

Class II Biologics Event

Event ID40693
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Aug-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomat USA, Inc.
CityLos Angeles
StateCA
CountryUS
Distribution PatternSpain
 

Associated Products

Product DescriptionSource Plasma
Code Info380017145, 380016941, 380016754, 380016610, 380016394, 380016226, 380015934, 380015846, 380015692, 380015570, 380015308, 380015112, 380014344, 380013925, 380013756, 380013475, 380013131, 380012882, 380012613, 380012361, 380012134, 380011958, 380011604, 380011323, 380010943, 380010817, 380010306, 380010299, 380009793, 380009785, 380009266, 380008811, 380008710, 380008281, 380008184, 380007743, 380007677, 380007001, 380006596, 380006435, 380006007, 380005874, 380005430, 380005279, 380004898, 380004255, 380003648, 380003044, 380002818
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred, were distributed.
Product Quantity49 units
Recall NumberB-1287-12

Class II Biologics Event

Event ID40833
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Aug-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CityWichita
StateKS
CountryUS
Distribution PatternOK, KY
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info02LH75991
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1799-12
Product DescriptionBlood and Blood Products for Reprocessing
Code Info02LH75991
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1800-12

Class II Biologics Event

Event ID40870
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Oct-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityOakland
StateCA
CountryUS
Distribution PatternBlood products were released for distribution to consignees located in CA.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info006GG69748, 006LM40904, 006LQ64474, 084FT72355, 084FT72408, 084FT73012, 084FT73025, 084FT73593, 084FT73801, 084FT73906, 084FT73920, 084FT73945, 084FT73954, 084FT74138, 084FT74145, 084FT74193, 084FT74371, 084FT74399, 084FT74407, 084FT74422, 084FT74426, 084FT74476, 084FT74486, 084FT74491, 084FT74494, 084FT74505, 084FT74507, 084FT74508, 084FT74512, 084FT74520, 084FT74544, 084FT74574, 084FT74638, 084FT74642, 084FT74650, 084FT74692, 084FT74704, 084FT74780, 084FT74831, 084FT74928, 084FT74935, 084FT74936, 084FT74958, 084FT75074, 084FT75138, 084FT75166, 084FT75212, 084FT75218, 084FT75241, 084FT75248, 084FT75275, 084FT75439, 084FT75465, 084FT75551, 084FT75572, 084FT75708, 084FT75884, 084FT75885, 084FT75946, 084FT75962, 084FT76060, 084FT76101, 084FT76218, 084FT76222, 084FT76278, 084FT76284, 084FT76318, 084FT76373, 084FT76448, 084FT76449, 084FT76465, 084FT76468, 084FT76578, 084FT76593, 084FT76921, 084FT77010, 084FT77029, 084FT77040, 084FT77045, 084FT77196, 084FT77201, 084FT77206, 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ClassificationClass II
Reason for RecallBlood products, lacking proper documentation of antigen phenotyping, were distributed.
Product Quantity960
Recall NumberB-2289-12
Product DescriptionRed Blood Cells
Code Info084LT31329, P-2; 084LT31329, P-I; 084LT31600, P-1; 084LT31600, P-2
ClassificationClass II
Reason for RecallBlood products, lacking proper documentation of antigen phenotyping, were distributed.
Product Quantity4
Recall NumberB-2290-12
Product DescriptionRed Blood Cells Deglycerolized Leukocytes Reduced
Code Info021KC66135, 084FT77211, 084FT78046, 084FT81909, 084J90862, 084J93534, 084KM43545, 084LP37814, 084Q20379 084T15992 084T18414 084T21858 084Z84403 084Z88455
ClassificationClass II
Reason for RecallBlood products, lacking proper documentation of antigen phenotyping, were distributed.
Product Quantity14
Recall NumberB-2291-12
Product DescriptionRed Blood Cells Deglycerolized Leukocytes Reduced
Code Info084FT82947, 084FT83618, 084J96023, 084J96301, 084J97023, 084J98141, 084K55016, 084K58706, 084K60043, 084K60194, 084K62037, 084K62556, 084KM48320, 084Q13262, 084Q13611, 084Q13772, 084Q15707, 084Q17490, 084Q20457, 084Q22541, 084T21666, 084T21812, 084T21893, 084T22978, 084W62556, 084W62563, 084W66330, 084W69575, 084Z84745, 084Z86429, 084Z88735, 084Z90229
ClassificationClass II
Reason for RecallBlood products, lacking proper documentation of antigen phenotyping, were distributed.
Product Quantity32
Recall NumberB-2292-12
Product DescriptionRed Blood Cells Deglycerolized Leukocytes Reduced
Code Info084FT72445, 084FT74945, 084FT75422, 084FT76207, 084FT76466, 084FT76787, 084FT79582, 084J88571, 084K56474, 084K57952, 084KM45730, 084KM47908, 084KM47958, 084LP37808, 084LP39576, 084LP39785, 084LP40062, 084Q13430, 084Q14912, 084Q18636, 084Q18827, 084T16406, 084T16514, 084T17835, 084T18403, 084T22494, 084T23219, 084W62702, 084W62726, 084W64387, 084W65869
ClassificationClass II
Reason for RecallBlood products, lacking proper documentation of antigen phenotyping, were distributed.
Product Quantity31
Recall NumberB-2293-12
Product DescriptionRed Blood Cells Leukocytes Reduced Frozen
Code Info084FT80048, 084FT80056, 084K59787, 084Q14901, 084T20919
ClassificationClass II
Reason for RecallBlood products, lacking proper documentation of antigen phenotyping, were distributed.
Product Quantity5
Recall NumberB-2294-12

Class II Biologics Event

Event ID41015
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Oct-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center of Greater Kansas City
CityKansas City
StateMO
CountryUS
Distribution PatternMO
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045005057009
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity1 unit
Recall NumberB-2046-12

Class II Biologics Event

Event ID41141
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Oct-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center of Greater Kansas City
CityKansas City
StateMO
CountryUS
Distribution PatternMO
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW045005063760
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-2053-12

Class II Biologics Event

Event ID41550
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jan-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center of Greater Kansas City
CityKansas City
StateMO
CountryUS
Distribution PatternMO
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045005101342
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-2153-12

Class II Biologics Event

Event ID42583
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jul-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternKentucky
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoGK12345
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 Unit
Recall NumberB-1635-12

Class II Biologics Event

Event ID42718
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jul-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBelle Bonfils Memorial Blood Center
CityDenver
StateCO
CountryUS
Distribution PatternCO, CA, Switzerland
 

Associated Products

Product DescriptionRed Blood Cells
Code Info6921760, 6417894, 6613297
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity3 units
Recall NumberB-1786-12
Product DescriptionFresh Frozen Plasma
Code Info6419927, 6417894
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity2 units
Recall NumberB-1787-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info6731967, 6920467, 6915184, 6419927, 6910371, 6179510.
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity6 units
Recall NumberB-1788-12
Product DescriptionBlood and Blood Products for Reprocessing
Code Info6731967, 6921760, 6920467, 6915184, 6910371, 6613297, 6179510.
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity7 units
Recall NumberB-1789-12

Class II Biologics Event

Event ID42875
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Aug-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Bank of Lancaster County Medical Society
CityLincoln
StateNE
CountryUS
Distribution PatternNE
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info6040735(Part A): 6040735(Part B)
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity2 units
Recall NumberB-2024-12

Class II Biologics Event

Event ID43441
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Nov-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMississippi Valley Regional Blood Center
CityDavenport
StateIA
CountryUS
Distribution PatternIowa
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoY53727
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity
Recall NumberB-2143-12

Class II Biologics Event

Event ID43734
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Dec-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMississippi Valley Regional Blood Center
CityDavenport
StateIA
CountryUS
Distribution PatternMissouri, Iowa
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoK41143(Part A); K41143(Part B)
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity2 Units
Recall NumberB-2207-12

Class II Biologics Event

Event ID43919
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jan-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMississippi Valley Regional Blood Center
CityDavenport
StateIA
CountryUS
Distribution PatternWashington, D.C.
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoKW07812
ClassificationClass II
Reason for RecallBlood product, which did not meet acceptable product specifications, was distributed.
Product Quantity1 unit
Recall NumberB-2201-12

Class II Biologics Event

Event ID44403
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Feb-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Bank of Lancaster County Medical Society
CityLincoln
StateNE
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info3732972
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who lived in a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-2040-12

Class II Biologics Event

Event ID45109
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Sep-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternIowa
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoE26323
ClassificationClass II
Reason for RecallBlood product, which did not meet acceptable product specifications, was distributed.
Product Quantity1 Unit
Recall NumberB-2197-12

Class II Biologics Event

Event ID45110
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Sep-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Bank of Lancaster County Medical Society
CityLincoln
StateNE
CountryUS
Distribution PatternNE
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info6074434(Part A); 6074434(Part B)
ClassificationClass II
Reason for RecallBlood products, collection bag with pin size hole under the label were distributed.
Product Quantity2 units
Recall NumberB-2067-12

Class II Biologics Event

Event ID45130
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jul-07
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBelle Bonfils Memorial Blood Center
CityDenver
StateCO
CountryUS
Distribution PatternMI, Switzerland
 

Associated Products

Product DescriptionRed Blood Cells
Code Info3713775
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-1797-12
Product DescriptionRecovered Plasma
Code Info3713775
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-1798-12

Class II Biologics Event

Event ID45717
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Sep-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternPennsylvania
 

Associated Products

Product DescriptionPlatelets
Code InfoGP02952
ClassificationClass II
Reason for RecallBlood product, which was collected in a collection system that had product integrity compromised during component preparation, was distributed.
Product Quantity1 Unit
Recall NumberB-2198-12

Class II Biologics Event

Event ID46547
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Dec-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican Red Cross Blood Services
CityOmaha
StateNE
CountryUS
Distribution PatternNE
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info09FF23771; 09FF25553
ClassificationClass II
Reason for RecallBlood products, in which testing for Jka antigen was interpreted, or incorrectly documented were distributed
Product Quantity2 units
Recall NumberB-1964-12

Class II Biologics Event

Event ID46972
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Nov-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternIowa, Illinois
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoKW09237
ClassificationClass II
Reason for RecallBlood products, which did not meet acceptable product specifications, were distributed.
Product Quantity1 Unit
Recall NumberB-2199-12
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoKW09237
ClassificationClass II
Reason for RecallBlood products, which did not meet acceptable product specifications, were distributed.
Product Quantity1 Unit
Recall NumberB-2200-12

Class II Biologics Event

Event ID46988
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Oct-07
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmDelta Blood Bank
CityStockton
StateCA
CountryUS
Distribution PatternCA.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoV80168
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to a malaria endemic area, was distributed.
Product Quantity1
Recall NumberB-1773-12

Class II Biologics Event

Event ID47198
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Jan-08
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBelle Bonfils Memorial Blood Center
CityDenver
StateCO
CountryUS
Distribution PatternCO, Switzerland
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info6559105
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-1793-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info6559105
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-1794-12

Class II Biologics Event

Event ID47662
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Dec-07
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmDelta Blood Bank
CityStockton
StateCA
CountryUS
Distribution PatternCA and Austria
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoH24693
ClassificationClass II
Reason for RecallBlood products, collected from a donor taking the drug methotrexate, were distributed.
Product Quantity1
Recall NumberB-1806-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoH24295
ClassificationClass II
Reason for RecallBlood products, collected from a donor taking the drug methotrexate, were distributed.
Product Quantity1
Recall NumberB-1807-12
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoH24693, H24295
ClassificationClass II
Reason for RecallBlood products, collected from a donor taking the drug methotrexate, were distributed.
Product Quantity2
Recall NumberB-1808-12

Class II Biologics Event

Event ID47979
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Apr-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMississippi Valley Regional Blood Center
CityDavenport
StateIA
CountryUS
Distribution PatternCalifornia, Missouri and Maryland
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoK47326; K47326; K47326
ClassificationClass II
Reason for RecallBlood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
Product Quantity3 Units
Recall NumberB-2209-12

Class II Biologics Event

Event ID49692
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Aug-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services L.P.
CityDeerfield
StateIL
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info07DIAF9913
ClassificationClass II
Reason for RecallBlood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-1744-12

Class II Biologics Event

Event ID50383
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Oct-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmPlasma Care, Inc. dba Marion Blood Plasma, Inc.
CityIndianapolis
StateIN
CountryUS
Distribution PatternCalifornia.
 

Associated Products

Product DescriptionSource Plasma.
Code Info2010162630 , 2010162088.
ClassificationClass II
Reason for RecallBlood products, which were not quarantined subsequent to receiving disqualifying post donation information, were distributed.
Product Quantity2
Recall NumberB-1803-12

Class II Biologics Event

Event ID50403
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Oct-08
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBelle Bonfils Memorial Blood Center
CityDenver
StateCO
CountryUS
Distribution PatternCO, Switzerland
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036208303073
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of Hepatitis A, were distributed.
Product Quantity1 unit
Recall NumberB-1795-12
Product DescriptionRed Blood Cells, Leukocytes Reduced.
Code InfoW036208303073
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of Hepatitis A, were distributed.
Product Quantity1 unit
Recall NumberB-1796-12

Class II Biologics Event

Event ID50626
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Oct-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityLouisville
StateKY
CountryUS
Distribution PatternKY, IN
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info24KS91773
ClassificationClass II
Reason for RecallBlood products, manufactured from overweight whole blood unit, were distributed.
Product Quantity1 unit
Recall NumberB-1235-12
Product DescriptionCryoprecipitated AHF
Code Info24KS91773
ClassificationClass II
Reason for RecallBlood products, manufactured from overweight whole blood unit, were distributed.
Product Quantity1 unit
Recall NumberB-1236-12

Class II Biologics Event

Event ID50669
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Dec-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBlood Center of Northcentral Wisconsin, Inc.
CityWausau
StateWI
CountryUS
Distribution PatternWI, NY
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoF01615
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1
Recall NumberB-2054-12
Product DescriptionPlasma Frozen
Code InfoF01615
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1
Recall NumberB-2055-12

Class II Biologics Event

Event ID54896
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Dec-09
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCSL Plasma, Inc.
CityBoca Raton
StateFL
CountryUS
Distribution PatternIL, NC, CA.
 

Associated Products

Product DescriptionSource Plasma
Code Info6160249894; 6160249295; 6160247737; 6160246995; 01266146; 01222340; 01101348; 85399372; 85308510; 85296886 85284470 80754343 80750888 0540414653 0540414348
ClassificationClass II
Reason for RecallBlood products, collected from a donor regarding multiple high-risk behaviors, were distributed.
Product Quantity15 units
Recall NumberB-1734-12

Class II Biologics Event

Event ID55395
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Dec-09
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCsl Plasma Inc
CityBoca Raton
StateFL
CountryUS
Distribution PatternIllinois
 

Associated Products

Product DescriptionSource Plasma
Code Info15 BKNGFX;15 BKNDPJ;15 BKMCMC;15 BKMBTN 15 BKLZNS;15 BKLZFX;15 BKLYQT;15 BKLXRS 15 BKLXFQ;15 BKLCPJ;15 BKLBMV;15 BKKZPJ 15 BKKXZM;15 BKKRWP
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was permanently deferred, were distributed.
Product Quantity14 units
Recall NumberB-2142-12

Class II Biologics Event

Event ID57772
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Dec-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDelta Blood Bank
CityStockton
StateCA
CountryUS
Distribution PatternCA.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW128710220363
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-2041-12

Class II Devices Event

Event ID61671
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Medical Division of Stryker Corporation
CityPortage
StateMI
CountryUS
Distribution PatternWorldwide Distribution -- USA (nationwide) including the states of AK, AL, AZ, CA, FL, ID, IN, KS, KY, LA, MA, MD, MN, MO, NC, NJ, NY, OR, PA, TN, TX, UT, UT, VA, WA, WI, and WV, and the country of Canada.
 

Associated Products

Product DescriptionPowered Mobility Offers Versatility (MÖV)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs.
Code InfoModel number: EMS with serial codes: 100393, 100395, 100400, 100402, 100410, 100451, 100460, 100499, 100500, 100502, 100503, 100504, 100506, 100507, 100508, 100509, 100510, 100511, 100512, 100513, 100514, 100515, 100516, 100517, 100518, 100519, 100522, 100523, 100524, 100525, 100533, 100537, 100538, 100541, 100542, 100544, 100545, 100548, 100549, 100553, 100554, 100555, 100556, 100557, 100559, 100610, 100611, 100612, 100615, 100616, and 100723.
ClassificationClass II
Reason for RecallParamed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Paramed's powered Mobility Offers Versatility (MÖV) chair was reviewed to identify potential compliance issues in relation to product documentation and classification.
Product Quantity159 units
Recall NumberZ-2246-2012
Product DescriptionPowered Mobility Offers Versatility (MÖV)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs.
Code InfoModel: EMS24 with serial codes: 100346, 100348, 100355, 100356, 100357, 100358, 100359, 100360, 100362, 100363, and 100364.
ClassificationClass II
Reason for RecallParamed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Paramed's powered Mobility Offers Versatility (MÖV) chair was reviewed to identify potential compliance issues in relation to product documentation and classification.
Product Quantity159 units
Recall NumberZ-2247-2012
Product DescriptionPowered Mobility Offers Versatility (MÖV)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs
Code InfoModel: HHC with serial codes: 100391, 100394, 100397, 100401, 100403, 100404, 100405, 100407, 100408, 100409, 100411, 100413, 100414, 100416, 100417, 100418, 100419, 100420, 100421, 100422, 100423, 100424, 100425, 100426, 100427, 100428, 100430, 100430, 100431, 100433, 100434, 100435, 100436, 100437, 100438, 100439, 100440, 100441, 100442, 100443, 100444, 100445, 100446, 100447, 100448, 100449, 100450, 100452, 100453, 100454, 100455, 100456, 100457, 100458, 100459, 100461, 100462, 100463, 100464, 100465, 100466, 100467, 100468, 100469, 100470, 100471, 100472, 100473, 100540, and 100543.
ClassificationClass II
Reason for RecallParamed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Paramed's powered Mobility Offers Versatility (MÖV) chair was reviewed to identify potential compliance issues in relation to product documentation and classification.
Product Quantity159 units
Recall NumberZ-2248-2012
Product DescriptionPowered Mobility Offers Versatility (MÖV)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs.
Code InfoModel: IND with serial codes: 100546, 100547, 100558, 100560, 100561, 100562, 100563, 100564, 100565, 100567, 100568, 100569, 100570, 100571, 100572, 100573, 100574, 100575, 100576, 100577, 100585, 100589, 100592, 100594, 100596, 100620, and 100638.
ClassificationClass II
Reason for RecallParamed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Paramed's powered Mobility Offers Versatility (MÖV) chair was reviewed to identify potential compliance issues in relation to product documentation and classification.
Product Quantity159 units
Recall NumberZ-2249-2012

Class II Biologics Event

Event ID61861
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics Inc.
CityBerkeley
StateCA
CountryUS
Distribution PatternProduct was released for distribution in US and Internationally. The firm stated that National Competent Authorities notified in affected countries: Brazil, Thailand, and South Africa.
 

Associated Products

Product DescriptionSiemens brand Trugene HIV-1, Genotyping Kit, Box 1 and Box 2, Catalog Numbers: 10336823 10336826; Product is manufactured and distributed by Siemens Healthcare Diagnostics Inc., Berkeley, CA
Code InfoLot Numbers: U080A1, U080A2
ClassificationClass II
Reason for RecallTrugene HIV-1 Genotype kits, not meeting current performance claims due to variation during manufacture, were distributed.
Product Quantity2 lots
Recall NumberB-2263-12

Class II Devices Event

Event ID62134
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Oct-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmExactech, Inc.
CityGainesville
StateFL
CountryUS
Distribution PatternNationwide distribution: USA including states of: AL, AZ, CO, FL, GA, IL, LA, MD, MN, NC, NJ, NY, OH, OK, PA, PR, TN, VA, and WA.
 

Associated Products

Product DescriptionOPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC Tibial Components. REF 02--012-42-2508. The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. The Optetrak Comprehensive Knee Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, patients with either mental or neuromuscular disorders that do not allow control of the knee joint, and patients whose weight, age, or activity level might cause extreme loads and early failure of the system.
Code InfoCatalog Number: 02-012-42-2508.
ClassificationClass II
Reason for RecallExactech, Inc. of Gainesville, FL recalled their Optetrak Proximal Tibial Spacer after the devices were determined to be dimensionally incompatible to mate as intended with the Logic Tibial Tray.
Product Quantity70
Recall NumberZ-2234-2012

Class II Biologics Event

Event ID62305
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-May-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSightLife
CitySeattle
StateWA
CountryUS
Distribution PatternOne cornea was shipped to each of 2 physicians in Japan.
 

Associated Products

Product DescriptionCorneas
Code InfoAAG744ODCN; AAG744OSCN
ClassificationClass II
Reason for RecallHuman Corneas, recovered from a donor with evidence of infection due to a communicable disease agent, were distributed.
Product Quantity2 corneas, (1 right, 1 left)
Recall NumberB-2312-12

Class II Devices Event

Event ID62410
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Mar-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAbbott Point Of Care Inc.
CityPrinceton
StateNJ
CountryUS
Distribution PatternWorldwide Distribution - US Nationwide, International
 

Associated Products

Product Descriptioni-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measurement cane be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
Code Info510(K)K031739 List Number 06F15-03, 06F15-04, 03P90-25, 600-9009-25 All lots
ClassificationClass II
Reason for RecallAbbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit incorrectly elevated cardiac troponin I results. This recall was expanded on July 19 2012 to include additional information regarding user documentation.
Product Quantity7,057675 cartridges US; 772,400 cartridges OUS
Recall NumberZ-2237-2012

Class II Devices Event

Event ID62460
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics, Inc.
CityNewark
StateDE
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of Canada, France, Germany, Spain, Portugal, Italy, Japan, Norway, Australia, Austria, New Zealand, Belgium, Switzerland, Netherlands, Malaysia, Slovenia, South Korea, Denmark, Saudi Arabia, Slovakia, Taiwan, Philippines, Czech Republic, and Singapore.
 

Associated Products

Product DescriptionEasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended tot duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. The EasyLink Informatics System is classified as a data calculator and processing module for use with in vitro diagnostic devices. The EasyLink is included with the Dimension Vista System and may be used with other Siemens analyzers as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.
Code InfoPart Number: 1000034805, Version 5.0 and Version 5.0 Service Pack 1 through 4
ClassificationClass II
Reason for RecallWhen using the EasyLink Quality Control Package the system may not perform as intended for Multi-Rule QC violations [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions send with the Urgent Field Safety Notice. When this situation occurs, QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the patient results will not be held as expected.
Product Quantity637
Recall NumberZ-2242-2012

Class II Food Event

Event ID62521
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jun-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBreadfarm
CityBow
StateWA
CountryUS
Distribution PatternDistributed to retailers and direct accounts in Washington State.
 

Associated Products

Product DescriptionWhiskey Pecan Cookies, packaged in cellophane sleeve wrap, 9.6 oz each. Sold in individual sleeves or in a case of 6 packages (cello sleeves).
Code Info"135", "141", "146", "148", "154", "155", "157", "160", "163", "166", and "173". These are the julian dates that the dough was baked and packaged. The dough was made on 4/29/12 and 5/28/12 and frozen.
ClassificationClass II
Reason for RecallThe wheat germ used by the firm to make their products was recalled by the wheat germ manufacturer because it was potentially contaminated with metal fragments approximately 05.mm in diameter and 3-15 mm in length. The contamination occurred at the raw ingredient manufacturer.
Product Quantity46, 9.6oz packages
Recall NumberF-1966-2012
Product DescriptionWheat Crackers, packaged in cellophane sleeve wrap, 6.4 oz each. Sold in individual sleeves or in a case of 12 packages (cello sleeves).
Code Info"122", "130", "137", "148", "165". These are the julian dates that the dough was made,baked and packaged.
ClassificationClass II
Reason for RecallThe wheat germ used by the firm to make their products was recalled by the wheat germ manufacturer because it was potentially contaminated with metal fragments approximately 05.mm in diameter and 3-15 mm in length. The contamination occurred at the raw ingredient manufacturer.
Product Quantity163, 6.4oz packages
Recall NumberF-1967-2012
Product DescriptionFig Bars (Fig Newton style), bulk packed and refrigerated for individual sales.
Code Info"128" and "149". These are the julian dates that the dough was baked and packaged. The dough was produced on 5/5/12 and 5/26/12.
ClassificationClass II
Reason for RecallThe wheat germ used by the firm to make their products was recalled by the wheat germ manufacturer because it was potentially contaminated with metal fragments approximately 05.mm in diameter and 3-15 mm in length. The contamination occurred at the raw ingredient manufacturer.
Product QuantityApproximately 50 to 60 pounds.
Recall NumberF-1968-2012

Class II Drugs Event

Event ID62530
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNoven Pharmaceuticals, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternNationwide and Puerto Rico.
 

Associated Products

Product DescriptionDaytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3.
Code InfoLot # 55302, Exp 12/12
ClassificationClass II
Reason for RecallMiscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Product Quantity177,900 patches
Recall NumberD-1653-2012
Product DescriptionDaytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5555-3.
Code InfoLot # 56506, Exp 12/12
ClassificationClass II
Reason for RecallMiscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Product Quantity121,530 patches
Recall NumberD-1654-2012
Product DescriptionDaytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.
Code InfoLot #53823, Exp 08/12
ClassificationClass II
Reason for RecallMiscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Product Quantity231,270 patches
Recall NumberD-1655-2012

Class II Food Event

Event ID62539
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmKT Specialty Foods Inc.
CityPortland
StateOR
CountryUS
Distribution PatternProducts are distributed in Oregon and Washington
 

Associated Products

Product DescriptionCheese Pizza. Label is not provided. Product is packaged and delivered in bulk.
Code InfoNone
ClassificationClass II
Reason for RecallCheese Pizza is recalled due to the lack of temperature control to prevent pathogens growth.
Product Quantity20-25 units
Recall NumberF-1947-2012
Product DescriptionPizza Bagel. Label is not provided. Product is packaged and delivered in bulk.
Code InfoNone
ClassificationClass II
Reason for RecallPizza Bagel is recalled due to the lack of temperature control to prevent pathogens growth.
Product Quantity50-100 units
Recall NumberF-1948-2012
Product DescriptionVeggie Pizza. Label is not provided. Product is packaged and delivered in bulk.
Code InfoNone
ClassificationClass II
Reason for RecallVeggie Pizza is recalled due to the lack of temperature control to prevent pathogens growth.
Product Quantity20 units
Recall NumberF-1949-2012

Class II Drugs Event

Event ID62541
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Nov-11
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmVictus, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionHipoglos Ointment (zinc oxide and lanolin), Helps prevent and treat diaper rash, skin irritation, Manufactured by Laboratorios Andromaco S.A. Av. Quilin 5273, Penalolen, Santiago. www.hipoglos.cl, www.laboratoriosandromaco.cl, Made in Chile, Net wt. per Tube: a) 0.18 oz (5 g), NDC: 50145-111-05; b) 2.2 oz (60 g), NDC: 50145-111-04; c) 2.5 oz (72 g), NDC: 50145-111-03; d) 3.5 oz (100 g), NDC: 50145-111-02; e) 4.2 oz (120 g), NDC: 50145-111-01.
Code InfoLot #/Product #: a) C1557B/MM26306, Exp 03/31/2014; b) C1387B/PV16856, Exp 03/31/2014, G0288C/PV16856, Exp 07/31/2013; c) G0288A/PV16855, Exp 07/31/2013; d) G0289B/PV16854, Exp 07/31/2013; e) C1387A/PV16853, Exp 03/31/2014, G0288B/PV16853, Exp 07/31/2013
ClassificationClass II
Reason for RecallMisbranded
Product Quantity1,535 Tubes
Recall NumberD-1652-2012

Class II Devices Event

Event ID62567
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMckesson Medical Imaging Group
CityRichmond
StateBC
CountryCA
Distribution PatternWorldwide Distribution - U.S. Nationwide and the countries of: Canada, France, Ireland and United Kingdom.
 

Associated Products

Product DescriptionHorizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medial technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medial images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images).
Code InfoHorizon Medial Imaging (HMI) versions 11.5, 11.5.1, 11.5.2, 11.6 and 11.7.
ClassificationClass II
Reason for RecallThere is a potential to save reports in RadReport with an Incorrect Final Status.
Product Quantity516 units
Recall NumberZ-2238-2012

Class II Devices Event

Event ID62571
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMedtronic Navigation, Inc.
CityLittleton
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA, including the states of AL, CO, FL, IA, MI, IA, NC, NE, NY and the countries of South Africa, Italy, and Spain.
 

Associated Products

Product DescriptionMedtronic O-arm® Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.
Code InfoSerial Numbers: 109R, 118R, 124, 136, 159 ,170, 218, 222, 223, 236, 239 , 299, 309R, 402, 410, 412, 414.
ClassificationClass II
Reason for RecallA fault in a high voltage relay in the 0-arm® Imaging System might cause the relay to overheat and burn.
Product Quantity17 units
Recall NumberZ-2244-2012

Class II Devices Event

Event ID62576
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmConformis Inc
CityBurlington
StateMA
CountryUS
Distribution PatternWorldwide Distribution - US Nationwide and the country of Germany
 

Associated Products

Product DescriptionConformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Right Knee Product Usage : Usage: The iTotal CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patello-femoral or bi-compartmental prosthesis.
Code InfoAll serial numbers
ClassificationClass II
Reason for RecallAddendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique
Product Quantity1427 units
Recall NumberZ-2222-2012

Class II Devices Event

Event ID62581
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions, USA, Inc
CityAnn Arbor
StateMI
CountryUS
Distribution PatternNationwide Distribution -- MA, GA, MO, IA, CA, PA, OR, CO, NY, NJ, WA, UT, OH, WI, MI, KY, and NC.
 

Associated Products

Product Descriptionsyngo Dynamics Version 9.5
Code Info10091862 and 10091863
ClassificationClass II
Reason for RecallIf multiple uncompressed images/clips are sent to the syngo Dynamics server, around the same time, it is possible for an image from a patient to be placed in another patient's study.
Product Quantity30
Recall NumberZ-2219-2012

Class II Food Event

Event ID62623
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-May-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmLD Amory & Company
CityHampton
StateVA
CountryUS
Distribution PatternThe products were distributed to AZ, NC, and VA.
 

Associated Products

Product DescriptionOysters, Frozen IQF, packaged in 5 lb bags, 6x5 lb/cartons, labeled in part ***Product of Korea***
Code InfoAll codes
ClassificationClass II
Reason for RecallMolluscan shellfish may have been exposed to human fecal waste and are potentially contaminated with norovirus.
Product Quantity60,000 lbs
Recall NumberF-1950-2012

Class II Devices Event

Event ID62640
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jul-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: Foreign: Brazil, China, Denmark, Hong Kong, Malaysia, and New Zealand Viet Nam
 

Associated Products

Product DescriptionSiemens ADVIA Centaur® Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (SYPH) assay is an in vitro diagnostic immunoassay for the qualitative determination of antibodies to Treponema pallidum in human serum or plasma (EDTA, lithium or sodium heparinized, citrate) using the ADVIA Centaur and ADVIA Centaur XP systems as an aid in the diagnosis of syphilis
Code InfoUS Lot Number/Exp. Date 85456003 2012-10-13; 86036003 2012-10-13; 87129003 2012-10-13; 88440003 2012-10-13; 90054004 2013-04-09; 90422004 2013-04-09. Outside the US: Kit lots, 77749002, 80615003, 82640003, 84120003, 85456003, 86036003, 87129003,88440003,90054004,90422004.
ClassificationClass II
Reason for RecallSyphilis Assay Interference with HBsAg Assay
Product Quantity2050 Kits
Recall NumberZ-2228-2012

Class II Devices Event

Event ID62649
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDePuy Orthopaedics, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternWorldwide Distribution - USA including PA and the country of Canada
 

Associated Products

Product DescriptionAltrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the damaged hip joint to help increase patient mobility and to reduce pain. Packaging: Product is placed into a PETG tray, sealed with a Tyvek lid. This is placed into a second PETG tray and sealed with a Tyvek lid. This package is placed into a paperboard carton, labeled, and shrink-wrapped. Intended Use: An acetabular liner is used in combination with other implants 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 InfoCatalog number: 1221-36-054 and Lot Number: 231859
ClassificationClass II
Reason for RecallIn the recalled lot, the products were not machined according to the production router, a size 52 cup (122136052) was machined instead. This resulted in a size 52 liner being etched and labeled as a size 54 liner.
Product Quantity20 liners
Recall NumberZ-2220-2012

Class II Devices Event

Event ID62663
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Apr-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Spine
CityAllendale
StateNJ
CountryUS
Distribution PatternDistributed in Atlanta, Georgia.
 

Associated Products

Product DescriptionStryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 55 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 60 mm STANDARD POST SCREW Manufactured by: STRYKER Spine SAS, Z.I. Marticot - 33610 - Cestas-France +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct., Allendale, NJ 07401-1677 USA +1-201-750-8000. The Stryker Spine Trio/Trio+ Spinal Fixation Systems are comprised of spinal screws, rods, and connectors. The components are available in a variety of lengths in order to accommodate patient anatomy. The system is intended for posterior, non-cervical pedicle and non-pedicle pedicle fixation of the spine. It is indicated for: degenerative disc disease (DDD), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis kyphosis, lordosis, spinal tumor, pseudarthrosis, and failed previous fusion.
Code InfoCode information listed in the following format: Manufacturer Part Number/Prodcut Description/Corresponding IFU Part Number/Affected Lot #s are as follows: 48900445/Trio Standard Post Screw 5.5x55mm/#NOLI135B03Rev02/57281 and 57201 48900450/Trio Standard Post Screw 5.5x60mm/#NOLI135B03Rev02/57197 48900455/Trio Standard Post Screw 4.5x45mm/#NOLI135B03Rev02/57198 48900555/Trio Standard Post Screw 4.5x50mm/#NOLI135B03Rev02/56599 48900560/Trio Standard Post Screw 4.5x55mm/#NOLI135B03Rev02/57192
ClassificationClass II
Reason for RecallThe front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly marked with a "Sterile" logo in the lower right corner. The products these IFUs were packed with are sold as "Non-Sterile" and require sterilization before use in surgery.
Product Quantity40 units.
Recall NumberZ-2235-2012

Class II Devices Event

Event ID62684
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTerumo Cardiovascular Systems Corporation
CityAnn Arbor
StateMI
CountryUS
Distribution PatternWorldwide Distribution - US Nationwide including the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, and WV and the countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Germany, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Singapore, South Africa, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam
 

Associated Products

Product DescriptionSerial interface module RS-232 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between the TLink Data Management ystem or Sarns CCPro Data Perfusion oftware and the system. The data collected and exported by the data transfer module includes physiological data and device events to record the progress and events during a procedure.
Code Infocatalog number: 802113 and serial numbers: 00007-00036, 00038-00045, 00047-00064, 00066-00077, 00080-00121, 00123-00214,00216-00283, 00285-00363, 00366-00498, 00500-00548, and 00550-00597.
ClassificationClass II
Reason for RecallTerumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the odor of smoke was as associated with the failures. The malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the module. Terumo CVS's investigation has determined that the the malfunctions are caused by a circuit board that failed. There have been no reports of patient injury as a result of this issue.
Product Quantity579 units
Recall NumberZ-2230-2012
Product DescriptionSerial interface module RS-485 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between the TLink Data Management ystem or Sarns CCPro Data Perfusion oftware and the system. The data collected and exported by the data transfer module includes physiological data and device events to record the progress and events during a procedure.
Code Infocatalog number: 803518 and serial numbers:00007-00038, 00041, and 00043.
ClassificationClass II
Reason for RecallTerumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the odor of smoke was as associated with the failures. The malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the module. Terumo CVS's investigation has determined that the the malfunctions are caused by a circuit board that failed. There have been no reports of patient injury as a result of this issue.
Product Quantity34 units
Recall NumberZ-2231-2012
Product DescriptionInterface module for CDl System 100/101 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data from the CDl 500
Code Infocatalog number: 802558 and serial numbers:00008-00013, and 00015-00241.
ClassificationClass II
Reason for RecallTerumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the odor of smoke was as associated with the failures. The malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the module. Terumo CVS's investigation has determined that the the malfunctions are caused by a circuit board that failed. There have been no reports of patient injury as a result of this issue.
Product Quantity232 units
Recall NumberZ-2232-2012
Product DescriptionInterface module for CDl System 500 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data from the CDl 500
Code Infocatalog number: 803479 and serial numbers:00009-00122, 00124-00210, 00213-00365, 00367-00458, and 00461-00596.
ClassificationClass II
Reason for RecallTerumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the odor of smoke was as associated with the failures. The malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the module. Terumo CVS's investigation has determined that the the malfunctions are caused by a circuit board that failed. There have been no reports of patient injury as a result of this issue.
Product Quantity582 units
Recall NumberZ-2233-2012

Class II Devices Event

Event ID62691
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Nov-09
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE OEC Medical Systems, Inc
CitySalt Lake City
StateUT
CountryUS
Distribution PatternWorldwide Distribution -- USA (nationwide)
 

Associated Products

Product Description892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fluoroscopic and spot film imaging of the patient during diagnostic surgical and interventional procedures. The systems include features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and are also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures. The systems may be used for other imaging applications at the physician's discretion.
Code InfoModel Number HDS721616PLAT80; GE Healthcare part number 5304649.
ClassificationClass II
Reason for RecallGE OEC is recalling certain 9800 Image Intensified Flouroscopic x-ray systems due to customer complaint analysis showing that a replacement Hitachi 160 GB Hard Drive, when installed on certain models is susceptible of causing unanticipated system shut downs, no boots, data loss or data mix, or unexpected hard drive corruption.
Product Quantity3,595 units
Recall NumberZ-2240-2012

Class II Food Event

Event ID62697
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAuthentic Gourmet
CityMiami
StateFL
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionStrawberry Filled Cake, 21.9 oz (1lb 6oz) (620g), UPC 3 760147 195867
Code InfoLot # FR110803DD
ClassificationClass II
Reason for RecallThe recall was initiated because Authentic Gourmet was alerted by FDA sample analysis that the Strawberry Cake and the Raspberry Cake has non-permitted color additive and allergen, cochineal red A (also known as ponceau 4R).
Product Quantity2560 units total
Recall NumberF-1969-2012
Product DescriptionRaspberry Filled Cake, 21.9 oz (1lb 6oz) (620g), UPC 3 760147 195881
Code Info Lot # FR110801BB
ClassificationClass II
Reason for RecallThe recall was initiated because Authentic Gourmet was alerted by FDA sample analysis that the Strawberry Cake and the Raspberry Cake has non-permitted color additive and allergen, cochineal red A (also known as ponceau 4R).
Product Quantity2560 units total
Recall NumberF-1970-2012

Class II Devices Event

Event ID62706
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Oct-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBeckman Coulter Inc.
CityBrea
StateCA
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and countries of: Algeria, Angola, Argentina, Australia, Austria, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea,Republic of; Kuwait, Liechtenstein, Malaysia, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.
 

Associated Products

Product DescriptionUniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Code InfoPart Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285.
ClassificationClass II
Reason for RecallThe recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results.
Product Quantity2442 units total (784 units in US)
Recall NumberZ-2257-2012
Product DescriptionUniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Code InfoPart Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460.
ClassificationClass II
Reason for RecallThe recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results.
Product Quantity2442 units total (784 units in US)
Recall NumberZ-2258-2012
Product DescriptionUniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Numbers: DxC 660i: A64871; DxC 680i: A64903; DxC 860i: A64935; DxC 880i: A59102. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Code InfoPart Numbers: DxC 660i: A64871; DxC 680i: A64903; DxC 860i: A64935; DxC 880i: A59102
ClassificationClass II
Reason for RecallThe recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results.
Product Quantity2442 units total (784 units in US)
Recall NumberZ-2259-2012

Class II Devices Event

Event ID62729
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Apr-10
Initial Firm Notification of Consignee or Public Visit
Recalling FirmGE OEC Medical Systems, Inc
CitySalt Lake City
StateUT
CountryUS
Distribution PatternWorldwide and Nationwide (USA) distribution.
 

Associated Products

Product DescriptionGE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.
Code InfoSerial numbers: 69-0128, 82-0157, 82-0158, 82-0185, 82-0191, 82-0210, 82-0215, 82-0223, 82-0229, 82-0266, 82-0324, 82-0328, 82-0464, 82-0477, 82-0484, 82-0505-RC, 82-0507, 82-0542, 82-0544, 82-0546, 82-0551, 82-0604, 82-0648, 82-0673, 82-0680, 82-0714, 82-0733, 82-0779, 82-0858, 82-0869, 82-0884, 82-0906, 82-0918, 82-0965, 82-1004, 82-1009, 82-1057-RC, 82-1070, 82-1139, 82-1191, 82-1194, 82-1225, 82-1247, 82-1303, 82-1405, 82-1434, 82-1458, 82-1480, 82-1534, 82-1547-RC, 82-1564, 82-1585, 82-1588, 82-1601, 82-1604, 82-1621, 82-1694, 82-1695, 82-1699, 82-1797, 82-1798, 82-1842, 82-1850, 82-1921, 82-1959, 82-2015, 82-2120, 82-2192, 82-2245, 82-2247, 82-2274, 82-2277, 82-2306, 82-2386, 82-2487, 82-2661, 82-2662, 82-2716, 82-2721, 82-2741, 82-2745, 82-2797, 82-2846, 82-2905, 82-2965, 82-3102, 82-3107, 82-3122, 82-3135, 82-3151, 82-3351, 82-3366, 82-3403, 82-3431, 82-3492, 82-3498, 82-3563, 82-3570, 82-3614, 82-3634, 82-3762, 82-3815, 82-3819, 82-3824, 82-3839, 82-3851, 82-3882, 82-3884, 82-3887, 82-3888, 82-3890, 82-3894, 82-3895, 82-3896, 82-3898, 82-3899, 82-3901, 82-3903, 82-3904, 82-3910, 82-3911, 82-3912, 82-3913, 82-3914, 82-3915, 82-3917, 82-3919, 82-3920, 82-3921, 82-3922, 82-3923, 82-3925, 82-3928, 82-3929, 82-3930, 82-3931, 82-3933, 82-3934, 82-3935, 82-3936, 82-3937, 82-3938, 82-3939, 82-3941, 82-3942, 82-3943, 82-3944, 82-7011-MH, 82-7024-MH, 82-7154-CMH, 82-7189-MH, 82-7190-MH, 82-7191-MH, 82-7197-MH, 82-7200-MH, 82-7206-MH, 89-0100, 89-0128, 89-0135-RC, 89-0210, 89-0248, 89-0315, 89-0362, 89-0385, 89-0401, 89-0416, 89-0457, 89-0464, 89-0467, 89-0505, 89-0506, 89-0537, 89-0556, 89-0559, 89-0577, 89-0612, 89-0643, 89-0660, 89-0662, 89-0729, 89-0738, 89-0780, 89-0781, 89-0832, 89-0853, 89-0868, 89-0876, 89-0882, 89-0922, 89-0954-RC, 89-0963, 89-1040, 89-1071, 89-1172, 89-1195, 89-1228, 89-1245, 89-1248, 89-1255, 89-1262, 89-1268, 89-1271, 89-1274, 89-1286, 89-1295, 89-1308, 89-1343, 89-1373, 89-1400-RC, 89-1408, 89-1426, 89-1494, 89-1531, 89-1576, 89-1598, 89-1606, 89-1612, 89-1640, 89-1663, 89-1673, 89-1721, 89-1729, 89-1739, 89-1749, 89-1868, 89-2121, 89-2259, 89-2264, 89-2275, 89-2309, 89-2315, 89-2350, 89-2354, 89-2456, 89-2464, 89-2500, 89-2680, 89-2866, 89-3211, 89-3294, 89-3312, 89-3349, 89-3352, 89-3355, 89-3377, 89-3420, 89-3433, 89-3461, 89-3479, 89-3483, 89-3488, 89-3490, 89-3494, 89-3495, 89-3499, 89-3501, 89-3504, 89-3508, 89-3509, 89-3511, 89-3512, 89-3513, 89-3514, 89-3515, 89-3519, 89-3520, 89-3522, 89-3524, 89-3527, 89-3529, 89-3530, 89-3533, 89-3537, 89-3538, 89-3539, 89-3543, 89-3544, 89-3545, 89-3546, 89-3547, 89-3548, 89-3549, 89-3551, 89-3552, 89-3553, 89-3554, 89-3555, 89-3556, 89-3557, 89-3558, 89-3559, 89-3560, 89-3561, 89-3562, 89-3563, 89-3564, 89-3565, 89-3567, 89-3568, 89-3569, 89-3570, 89-3571, 89-3572, 89-3573, 89-3574, 89-3578, 89-3579, 8S-0027, 8S-0076-RC, 8S-0086, 8S-0121-C, 8S-0158, 8S-0165, 8S-0245, 8S-0291, 8S-0301-C, 8S-0315, 8S-0413-C, 8S-0494, 8S-0615-C, 8S-0642, 8S-0691, 8S-0707, 8S-0711, 8S-0735, 8S-0747, 8S-0776, 8S-0840, 8S-0844-RC, 8S-0858, 8S-0867, 8S-0872, 8S-0921, 8S-0974, 8S-1013-C, 8S-1046, 8S-1056, 8S-1058, 8S-1065-C, 8S-1174, 8S-1203, 8S-1224-C-RC, 8S-1285-RC, 8S-1360, 8S-1445, 8S-1644, 8S-1856, 8S-1930-N, 8S-1954, 8S-1959, 8S-1961, 8S-2052, 8S-2053, 8S-2063, 8S-2063, 8S-2113, 8S-2145, 8S-2164, 8S-2170, 8S-2207, 8S-2256, 8S-2329, 8S-2439, 8S-2451, 8S-2452, 8S-2452, 8S-2462, 8S-2532, 8S-2622, 8S-2865, 8S-2956, 8S-2985, 8S-3002, 8S-3108, 8S-3111, 8S-3112, 8S-3130, 8S-3179, 8S-3183, 8S-3197, 8S-3205, 8S-3207, 8S-3211-CH, 8S-3216, 8S-3222, 8s-3231, 8S-3233, 8S-3243, 8S-3245, 8S-3246, 8S-3247, 8S-3248, 8S-3249, 8S-3253, 8S-3254, 8S-3255, 8S-3256-H, 8S-3257, 8S-3258-CH, 8S-3259, 8S-3260, 8S-3261, 8S-3262, 8S-3263, 8S-3264, 8S-3265, 8S-3266, 8S-3267, 8S-3268, 8S-3269-H, 8S-3270-H, 8S-3271-H, 8S-3272-H, 8S-3273-CH, 8S-3274-CH, 8S-3275, 8S-3276, 8S-3278, 8S-3279, 8S-3280, 8S-3281, 8S-3282, 8S-3283, 8S-3285, 8S-3286, 8S-3287, 8S-3288-H, 8S-3289-H, 8S-3291, 8S-3292, 8S-3296, 8S-3299, 8S-3301-H, 8S-3302, 8S-3305, 8S-3306, 8S-3307, 8S-3308, 8S-3309, 8S-3310-H, 8S-3311, 8S-3315, 8S-7094-CMH, 8S-7228-CMH, 8S-7229-CMH, 8S-7230-CMH, 8S-7231-MH, 8S-7232-MH, 8S-7233-MH, E2-0001, E2-0015, E2-0026, E2-0028, E2-0034, E2-0078, E2-0084, E2-0085, E2-0108, E2-0110, E2-0111, E2-0117, E2-0120, E2-0122, E2-0130, E2-0142, E2-0143, E2-0148, E2-0151, E2-0152, E2-0153, E2-0154, E2-0155, E2-0156, E2-0157, E2-0158, E2-0159, E2-0160, E2-0161, E2-0162, E2-0163, E2-0164, E2-0165, E2-0167, E2-0168, E2-0169, E2-0171, E2-0172, E2-0173, E2-0174, E2-0175, E2-0176, E2-0177, E2-0178, E2-0179, E2-0180, E2-0181, E2-0182, E2-0183, E2-0184, E2-0185, E2-0186, E2-0187, E2-0188, E2-0189, E2-0190, E2-0191, E2-0192, E2-0193, E2-0194, E2-0195, E2-0196, E2-0197, E2-0198, E2-0199, E2-0200, E2-0201, E2-0202, E2-0203, E2-0204, E2-0205, E2-0206, E2-0207, E2-0208, E2-0209, E2-0210, E2-0211, E2-0212, E2-0213, E2-0215, E2-0216, E2-0217, E2-0222, E2-0224, E2-0225, E2-0230, E2-0231, E2-0232, E2-0233, E2-0234, E2-0235-C, E2-0237, E2-0238, E2-0239, E2-0240, E2-0241, E2-0242, E2-0243, E2-0244, E2-0245, E2-0246, E2-0247, E2-0248, E2-0250, E2-0251, E2-0252, E2-0253, E2-0254, E2-0255, E2-0256, E2-0257, E2-0258, E2-0259, E2-0260, E2-0261, E2-0262, E2-0263, E2-0264, E2-0265, E2-0266, E2-0267, E2-0268, E2-0269, E2-0270, E2-0271, E2-0272, E2-0273, E2-0274, E2-0275, E2-7014-MH, E2-7020-MH, E2-7048-MH, E2-7050-MH, E2-7051-MH, E2-7057-MH, E2-7058-MH, E2-7059-MH, E2-7060-MH, E2-7061-MH, E2-7062-MH, E2-7063-MH, E2-7064-MH, E2-7065-MH, E2-7066-MH, E2-7067-MH, E2-7068-MH, E2-7069-CMH, E2-7070-MH, E2-7071-MH, E2-7072-MH, E2-7074-MH, E2-7075-MH, E2-7076-MH, E2-7077-CMH, E2-7078-MH, E2-7079-MH, E9-0008, E9-0025, E9-0031, E9-0035-G, E9-0037, E9-0050, E9-0083, E9-0085, E9-0086, E9-0088, E9-0089-G, E9-0090, E9-0091, E9-0092, E9-0093, E9-0094, E9-0095, E9-0098, E9-0099, E9-0100, E9-0101, E9-0102, E9-0103, E9-0108, E9-0109, E9-0110, E9-0111, E9-0112, E9-0113, E9-0114, E9-0115, E9-0116, E9-0118, E9-0119, E9-0120, E9-0121, E9-0122, E9-0123, E9-0124, E9-0125, E9-0126, E9-0127, E9-0128, E9-0129, E9-0129, E9-0130, E9-0139, E9-0141, E9-0142, E9-0143, E9-0144, E9-0145, E9-0146, E9-0147, E9-0148, E9-0149, E9-0150, E9-0151, E9-0152, E9-0153, E9-0155, E9-0157, E9-0158, E9-0159, E9-0162, E9-0163, E9-0164, E9-0165, E9-0166, E9-0169, E9-0170, E9-0171, E9-0172, E9-0173, E9-0177, E9-0178, E9-0179, E9-0180, E9-0181, E9-0183, E9-0184, E9-0185, E9-0188, E9-0249, E9-0253, ES-0005, ES-0006, ES-0007-C, ES-0022-CH, ES-0029-CH, ES-0034-G, ES-0056, ES-0069, ES-0071, ES-0072, ES-0076, ES-0078, ES-0084-G, ES-0086-G, ES-0087, ES-0088, ES-0089, ES-0090, ES-0091-H, ES-0092-CH, ES-0096, ES-0097, ES-0098, ES-0099-CH, ES-0101-CH, ES-0102-CH, ES-0103, ES-0104, ES-0105, ES-0106, ES-0107, ES-0108, ES-0109, ES-0110, ES-0111, ES-0112, ES-0113, ES-0114, ES-0115, ES-0116, ES-0117, ES-0118, ES-0119, ES-0120, ES-0121, ES-0122, ES-0123, ES-0124, ES-0125, ES-0126, ES-0127, ES-0128, ES-0129, ES-0130, ES-0131-H, ES-0132, ES-0133, ES-0134, ES-0135, ES-0136, ES-0138, ES-0139, ES-0140, ES-0141, ES-0142, ES-0147, ES-0152, ES-0155-H, ES-0156, ES-0158, ES-0159, ES-0160, ES-0163-G, ES-0169-CH, ES-0170, ES-0171, ES-0172, ES-0176, ES-0178, ES-0180, ES-0181, ES-0182, ES-0184-CH, ES-0185-H, ES-0186-H, ES-0187-H, ES-0190-CH, ES-0191-H, ES-0192-H, ES-7010-CMH, ES-7015-MH, ES-7018-MH, ES-7021-MH, ES-7028-CMH, ES-7029-MH, ES-7030-CMH, ES-7031-CMH, ES-7033-CMH, ES-7034-CMH, ES-7035-CMH, ES-7036-CMH, ES-7037-CMH, ES-7039-MH.
ClassificationClass II
Reason for RecallGE OEC recalled certain 9800 Fluoroscope & 9900 Elite Models because the Snubber Board did not conform to the IEC 60601-1 standard for clearance and creepage of voltage isolation.
Product Quantity845 units
Recall NumberZ-2241-2012

Class II Devices Event

Event ID62744
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Oct-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE OEC Medical Systems, Inc
CitySalt Lake City
StateUT
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionOEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray.
Code InfoModel number A857680 with various serial numbers (refer to consignee list).
ClassificationClass II
Reason for RecallGE Healthcare had recalled certain OEC InstaTrak 3500 Carts due to the potential for the cart to tip over when the arm of the imaging device is extended during use.
Product Quantity99 units
Recall NumberZ-2236-2012

Class II Devices Event

Event ID62745
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomet U.K., Ltd.
CityBridgend, South Wales
State
CountryGB
Distribution PatternWorldwide Distribution-USA-including the states of IN, SD, and TX and the countries of Austria, China, Japan, Netherlands, Sweden, Turkey, and UK.
 

Associated Products

Product DescriptionOxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps when preparing the femur to accept the femoral component.
Code InfoCatalog Number: 32-422801 and Lot Number Identification: ZB111101, ZBll1201, ZB120101, ZB120501, ZB111102, and ZB120201.
ClassificationClass II
Reason for RecallA drafting error during an unrelated design change has led to 4 misleading dimensions on the drawing. The CAD model remained the same thickness but the problem dimensions were accidentally struck from an incorrect point result in an increase of 1.0mm in the value of each dimension
Product Quantity119 units
Recall NumberZ-2224-2012

Class II Devices Event

Event ID62746
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Oct-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE OEC Medical Systems, Inc
CitySalt Lake City
StateUT
CountryUS
Distribution PatternNationwide distribution.
 

Associated Products

Product DescriptionGEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers include 00-902260-01 and 00-883654-01.
Code InfoSerial Numbers: 82-1138, 82-1586, 82-2089, 82-2117, 82-2182, 82-2214, 82-2226, 82-2262, 82-2264, 82-2308, 82-2312, 82-2314, 82-2321, 82-2328, 82-2380, 82-2391, 82-2438, 82-2483, 82-2512, 82-2516, 82-2535, 82-2722, 82-2796, 82-2821, 82-2846, 82-2848, 82-3052, 82-3055, 82-3129, 82-3144, 82-3170, 82-3171, 82-3201, 82-3256, 82-3267, 82-3314, 82-3350, 82-3361, 82-3377, 82-3467, 82-3468, 82-3659, 82-3709, 82-3722, 82-3859, 82-7016-MH, 82-7022-MH, 82-7037-MH, 82-7055-MH, 82-7062-MH, 82-7080-MH, 82-7086-MH, 82-7105-MH, 82-7114-MH, 82-7124-MH, 82-7131-MH, 82-7133-MH, 82-7137-MH, 82-7141-MH, 82-7154-CMH, 82-7155-MH, 82-7156-MH, 82-7161-MH, 82-7175-MH, 82-7189-MH, 82-7190-MH, 89-1441, 8S-1053, 8S-1436, 8S-2059-C, 8S-7021-CMH, 8S-7023-CMH, 8S-7040-CMH, 8S-7087-CMH, 8S-7164-CMH, DEMO/8S-1355-N, DEMO/E3-7002-MH, E2-0049, E2-0088, E2-0111, E2-0262, E2-7001-MH, E2-7007-MH, E2-7010-MH, E2-7014-MH, E2-7015-MH, E2-7031-MH, E2-7032-MH, E2-7035-MH, E2-7043-MH, E2-7059-MH, E2-7061-MH, E2-7067-MH, E2-7075-MH, E2-7076-MH, E2-7015-MH, & rENTAL/82-7004-MH.
ClassificationClass II
Reason for RecallGE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye.
Product Quantity149 units
Recall NumberZ-2262-2012

Class II Devices Event

Event ID62755
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Dec-11
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBeckman Coulter Inc.
CityBrea
StateCA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including the states GA, NY, IL, TX, WA, PA, IN, MS, NC, and MO and the countries of Belgium, France, Hong Kong, Italy, Spain, and Switzerland.
 

Associated Products

Product DescriptionUniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: " Allows for the differentiation of white blood cells " Facilitates the characterization of red blood cells and platelets " Aids in the identification of blood components and cellular abnormalities The optional floor stand has four drawers for storing the reagent and waste containers currently in use in the DxH Slidemaker Stainer.
Code InfoPart Number(s) 775222 and A96152; Serial #s-MP010, MP023, MP026, AS23001, AS23002, AS25003, AS25004, AS25005, AS33008, AS33009, AS33010, AS33011, AS37013, AS38014, AS38015, AS39016, AS39017, AS40018, AS44012, AT04001, AT04002, AT04003, AT04004, AT04005, AT22010, AT22011, AT22012, AT35013, AT35014, AT35015, AT35016, AT35017, AT35018, AT40019, AT40020, AT40021, AT40022, AT40023, AT40024, AT40025, AT40026, AT40027, AT40028, AT40029, AT40030, AT45031, AT45032, AT45033, AT45034, AT45035
ClassificationClass II
Reason for RecallThe recall was initiated because Beckman Coulter has confirmed that the DxH Slidemaker Stainer Floor Stand shipped with Slidemaker Stainer instruments were missing vinyl caps, exposing sharpt edges on the DxH Slidemaker Stainer Reagent Cabinet (Floor Stand) drawer slides. The sharp edges on the drawer slides may expose operators to physical injury when replacing reagents and waste containers which potentially poses a risk to operator safety.
Product Quantity41 units (15 units in the US)
Recall NumberZ-2225-2012
Product DescriptionUniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152. The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: " Allows for the differentiation of white blood cells " Facilitates the characterization of red blood cells and platelets " Aids in the identification of blood components and cellular abnormalities The optional floor stand has four drawers for storing the reagent and waste containers currently in use in the DxH Slidemaker Stainer.
Code InfoPart Number(s) 775222 and A96152; Serial #s-MP010, MP023, MP026, AS23001, AS23002, AS25003, AS25004, AS25005, AS33008, AS33009, AS33010, AS33011, AS37013, AS38014, AS38015, AS39016, AS39017, AS40018, AS44012, AT04001, AT04002, AT04003, AT04004, AT04005, AT22010, AT22011, AT22012, AT35013, AT35014, AT35015, AT35016, AT35017, AT35018, AT40019, AT40020, AT40021, AT40022, AT40023, AT40024, AT40025, AT40026, AT40027, AT40028, AT40029, AT40030, AT45031, AT45032, AT45033, AT45034, AT45035
ClassificationClass II
Reason for RecallThe recall was initiated because Beckman Coulter has confirmed that the DxH Slidemaker Stainer Floor Stand shipped with Slidemaker Stainer instruments were missing vinyl caps, exposing sharpt edges on the DxH Slidemaker Stainer Reagent Cabinet (Floor Stand) drawer slides. The sharp edges on the drawer slides may expose operators to physical injury when replacing reagents and waste containers which potentially poses a risk to operator safety.
Product Quantity41 units (15 units in the US)
Recall NumberZ-2226-2012

Class II Drugs Event

Event ID62772
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPrometheus Laboratories Inc.
CitySan Diego
StateCA
CountryUS
Distribution PatternNationwide and Puerto Rico.
 

Associated Products

Product DescriptionMercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottle (NDC 49884-922-02) and b) 250-count tablets per bottle (NDC 49884-922-04), Rx only, Distributed by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
Code InfoLot #s: a) 11A003, 11A004, 11A005, Exp 01/13; 11L071, 11L072, Exp 10/13; b) 11B009, Exp 01/13; 11L073, Exp 10/13
ClassificationClass II
Reason for RecallFailed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
Product Quantitya) 25,516 bottles; b) 2,569 bottles
Recall NumberD-1659-2012

Class II Drugs Event

Event ID62775
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCustom Medical Specialties, Inc.
CityPine Level
StateNC
CountryUS
Distribution PatternGA, MD, MA
 

Associated Products

Product DescriptionCustom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), Manufactured for KM Medical, Inc., 124 Jewett Street, Georgetown, MA 01833, the tray also contains other components not listed in this product description.
Code InfoLot #: 25744-1111, Exp 09/2012
ClassificationClass II
Reason for RecallLack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags
Product Quantity35 Trays
Recall NumberD-1649-2012
Product DescriptionCMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine level, NC 27568, the tray also contains other components not listed in this product description.
Code InfoLot #: 25915-1111, Exp 12/2012
ClassificationClass II
Reason for RecallLack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.
Product Quantity20 Trays
Recall NumberD-1650-2012
Product DescriptionCMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by: CMS Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine Level, NC 27568, the tray also contains other components not listed in this product description.
Code InfoLot #: 26124-1112, Exp 12/2012
ClassificationClass II
Reason for RecallLack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.
Product Quantity25 Trays
Recall NumberD-1651-2012

Class II Food Event

Event ID62783
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmFlywheel's Pies
CityPrescott
StateAR
CountryUS
Distribution PatternArkansas
 

Associated Products

Product DescriptionApple Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES, PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt. Pie Label: Apple
Code InfoAll product on market.
ClassificationClass II
Reason for RecallUndeclared soy lecithin, partially hydrogenated soybean oil and wheat.
Product Quantity
Recall NumberF-1952-2012
Product DescriptionPeach Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt Pie Label: Peach
Code InfoAll product on market.
ClassificationClass II
Reason for RecallUndeclared soy lecithin, partially hydrogenated soybean oil and wheat.
Product Quantity
Recall NumberF-1953-2012
Product DescriptionCherry Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE, FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt Pie Label: Cherry
Code InfoAll product on market.
ClassificationClass II
Reason for RecallUndeclared soy lecithin, partially hydrogenated soybean oil and wheat.
Product Quantity
Recall NumberF-1954-2012
Product DescriptionBlueberry Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE, FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt Pie Label: Blueberry
Code InfoAll product on market.
ClassificationClass II
Reason for RecallUndeclared partially hydrogenated soybean oil and wheat.
Product Quantity
Recall NumberF-1955-2012
Product DescriptionRaisin Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almon, Salt Pie Label: Raisin
Code InfoAll product on market.
ClassificationClass II
Reason for RecallUndeclared partially hydrogenated soybean oil and wheat.
Product Quantity
Recall NumberF-1956-2012
Product DescriptionStrawberry Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Egg Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt Pie Label: Strawberry
Code InfoAll product on market.
ClassificationClass II
Reason for RecallUndeclared partially hydrogenated soybean oil and wheat.
Product Quantity
Recall NumberF-1957-2012
Product DescriptionSweet Potato Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Nigeriense: Fruit, Sugar, Butter, Almond, Salt Pie Label: Sweet Potato
Code InfoAll product on market.
ClassificationClass II
Reason for RecallUndeclared partially hydrogenated soybean oil and wheat.
Product Quantity
Recall NumberF-1958-2012
Product DescriptionApricot Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt Pie Label: Apricot
Code InfoAll product on market.
ClassificationClass II
Reason for RecallUndeclared soy lecithin, partially hydrogenated soybean oil and wheat.
Product Quantity
Recall NumberF-1959-2012
Product DescriptionChocolate Pies: Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt. Pie Label: Chocolate
Code InfoAll product on market.
ClassificationClass II
Reason for RecallUndeclared soy lecithin, partially hydrogenated soybean oil and wheat.
Product Quantity
Recall NumberF-1960-2012
Product DescriptionCoconut Pies: Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt. Pie Label: Coconut
Code InfoAll product on market.
ClassificationClass II
Reason for RecallUndeclared soy lecithin, partially hydrogenated soybean oil and wheat.
Product Quantity
Recall NumberF-1961-2012
Product DescriptionLemon Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt Pie Label: Lemon
Code InfoAll product on market.
ClassificationClass II
Reason for RecallUndeclared partially hydrogenated soybean oil and wheat.
Product Quantity
Recall NumberF-1962-2012
Product DescriptionPineapple Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt Pie Label: Pineapple
Code InfoAll product on market.
ClassificationClass II
Reason for RecallUndeclared partially hydrogenated soybean oil and wheat.
Product Quantity
Recall NumberF-1963-2012
Product DescriptionBlackberry Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt
Code InfoAll product on market.
ClassificationClass II
Reason for RecallUndeclared partially hydrogenated soybean oil and wheat.
Product Quantity
Recall NumberF-1964-2012
Product DescriptionSugar Free Apple Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt
Code InfoAll product on market.
ClassificationClass II
Reason for RecallUndeclared soy lecithin, partially hydrogenated soybean oil and wheat.
Product Quantity
Recall NumberF-1965-2012

Class II Devices Event

Event ID62790
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-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, AR, AZ, CA, DC, FL, GA, KY, MD, MI, MN, MS, ND, NM, NY, OH, OK, SC, TN, TX, VT, WA, and WI and the countries of: Austria, China, Denmark, France, Germany, Iceland, Japan, Netherlands, South Africa, Sweden, Switzerland, United Kingdom. There were two government consignees. There were no Canadian consignees.
 

Associated Products

Product DescriptionThe Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Product Usage: The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories
Code InfoSystem Code # 728243, Serial #s: 7392, 7394, 7399, 7405, 7406, 7429, 7433, 7440, 7457, 7465, 7469, 7479, 7481, 7487, 7488, 7491, 7502, 7506, 7507, 7517, 7518, 7520, 7521, 7532, 7539, 7545, 7547, and 7556. System Code # 728244, Serial #s: 7190, 7195, 7318, 7383, 7427, 7430, 7510, and 7533. System Code #728256, Serial #s: 3163, 3500, 3500, 5623, 5655, 5655, 5666, 5670, 5715, 5724, 5747, 5773, 5776, 5813, 5836, 5855, 5862, 5868, 5877, 5897, 5911, 5911, 5916, 5935, 5969, and 5997. System Code #728251, Serial #: 4051. System Code # 728246, Serial #s: 5547, 5585, 5791, 5803, 5876, 5974. System Code # 728235, Serial #s: 9233, 9234, 9261, 95022. System Code # 728231, Serial #s: 9867, 9925, 9931, 9980, 9996, 10009, 10011, 10015, 10028, 10036, 10042, 10045, 10050, 10052, 10062, 10063, 10064, 10077, 10079, 10081, 10096, 10099, 10102, 10111, 10114, 10120, 10122, 10133, 10135, 10136, 10137, 10139, 10145, 10148, 10149, 10151, 10153, 10166, 10170, 10172, 10198, 10203, 95109, 95348, 95563.
ClassificationClass II
Reason for RecallThe patient support may move in an unintended manner if the foot switch cover becomes damaged and impinges on the foot switch.
Product Quantity126 units
Recall NumberZ-2245-2012

Class II Devices Event

Event ID62796
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling Firm AGFA Corp.
CityGreenville
StateSC
CountryUS
Distribution PatternUSA Nationwide, Virgin Islands and Canada
 

Associated Products

Product DescriptionAGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device
Code InfoAll software versions of DICOMstore in combination with Media Purge Daemon (MPD) or Cardiovascular Purge Services (CPS).
ClassificationClass II
Reason for RecallLoss of patient data can occur under certain circumstances due to misconfiguration of DICOMstore configured with Agfa's Medical Image Storage Devices - Media Purge Daemon (MPD) and Cardiovascular Purge Service (CPS).
Product Quantity535
Recall NumberZ-2252-2012

Class II Devices Event

Event ID62798
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Oct-07
Initial Firm Notification of Consignee or Public Other
Recalling FirmGE OEC Medical Systems, Inc
CitySalt Lake City
StateUT
CountryUS
Distribution PatternWorldwide Distribution - USA - Australia, Brazil, Cameroon, China, Colombia, Cyprus, The Czech Republic, Finland, France, Germany, Greece, Italy, Japan, Korea, Malaysia, The Netherlands, New Zealand, Norway, Russian Federation, Spain, Sweden, Taiwan, Turkey, UAE, UK, and Canada.
 

Associated Products

Product DescriptionGEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.
Code InfoSerial numbers: 2791PU2, 2797PU9, 2817PU5, 2824PU1, 2827PU4, 2899PU3, 2900PU9, 2901PU7, 2918PU1, 2919PU9, 2922PU3, 2939PU7, 3095PU7, 3103PU9, 3107PU0, 3219PU3, 3223PU5, 3224PU3, 3230PU0, 3233PU4, 3236PU7, 3358PU9, 3368PU8, 3500PU6, 3513PU9, 3514PU6, 3516PU2, 3523PU8, 3562PU6, 3580PU8, 3957PU8, 3973PU5, 3978PU4, 3994PU1, 4012PU1, 4018PU8, 4025PU3, 4029PU5, 4041PU0, 4043PU6, 4378PU6, 4394PU3, 4397PU6, 4446PU1, 4458PU6, 4767PU0, 4777PU9, 4782PU9, 4787PU8, 4793PU6, 4795PU1, 4797PU7, 4799PU3, 4800PU9, 4803PU3, 4806PU6, 4812PU4, 4813PU2, 4815PU7, 4818PU1, 4822PU3, 4827PU2, 4829PU8, 4830PU6, 4831PU4, 4835PU5, 4839PU7, 4840PU5, 4843PU9, 4844PU7, 4846PU2, 4847PU0, 4852PU0, 4853PU8, 5167PU2, 5169PU8, 5177PU1, 5179PU7, 5182PU1, 5188PU8, 5205PU0, 5208PU4, 5209PU2, 5211PU8, 5213PU4, 5216PU7, 5217PU5, 5219PU1, 5222PU5, 5224PU1, 5225PU8, 5227PU4, 5231PU6, 5233PU2, 5235PU7, 5236PU5, 5237PU3, 5239PU9, 5242PU3, 5244PU9, 5245PU6, 5246PU4, 5247PU2, 5249PU8, 5251PU4, 5260PU5, 5600PU2, 5602PU8, 5608PU5, 5610PU1, 5613PU5, 5621PU8, 5628PU3, 5643PU2, 5648PU1, 5664PU8, 5682PU0, 5683PU8, 5684PU6, 5687PU9, 5691PU1, 6002PU0, 6034PU3, 6036PU8, 6042PU6, 6046PU7, 6051PU7, 6060PU8, 6063PU2, 6093PU9, 6094PU7, 6410PU5, 6424PU6, 6438PU6, 6456PU8, 6474PU1, 6484PU0, 6495PU6, 6498PU0, 6941PU9, 6955PU9, 6959PU1, 6964PU1, 6973PU2, 6986PU4, 6994PU8, 6999PU7, 7307PU2, 7308PU0, 7315PU5, 7317PU1, 7318PU9, 7329PU6, 7330PU4, 7332PU0, 7336PU1, 7338PU7, 7373PU4, 7378PU3, 7379PU1, 7381PU7, 7395PU7, 7396PU5, 7399PU9, 7700PU8, 7719PU8, 7730PU5, 7739PU6, 7754PU5, FIB0033, FIB0046, FIB0048, FIB0051, FIB0058, FIB0065.
ClassificationClass II
Reason for RecallX-ray units did not meet manufacturer's specification for linearity.
Product Quantity175 units
Recall NumberZ-2221-2012

Class II Devices Event

Event ID62870
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHitachi Medical Systems America Inc
CityTwinsburg
StateOH
CountryUS
Distribution PatternUS Nationwide Distribution - including the states of:: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and Mexico.
 

Associated Products

Product DescriptionHitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and clinical information that can be useful in diagnosis determination.
Code InfoEchelon, V001 through V061, inclusive. Oasis, M001 through M105, inclusive, M951
ClassificationClass II
Reason for RecallHitachi discovered a software error with a feature called Multi-Planar Reconstruction (MPR). MPR takes an original volume dataset reconstructed in any plane view and creates a new image set from another view (i.e. axial to coronal, coronal to sagittal, etc.). The error causes the first image in the dataset to have a right/left reversed orientation. The software error can occur randomly when executing the MPR task.
Product Quantity165 units
Recall NumberZ-2254-2012

Class II Devices Event

Event ID62871
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGalil Medical, Inc.
CityArden Hills
StateMN
CountryUS
Distribution PatternWorldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands
 

Associated Products

Product DescriptionVisual-ICE® Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these procedures. The Visual-ICE System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts) by the application of extremely cold temperatures.
Code InfoVL0004 VL0014 VL0015 VL0016
ClassificationClass II
Reason for RecallGalil Medical is recalling a number of Visual Ice Cryoablation Systems because the gas regulators may fail to regulate the gas pressure, rendering the devices inoperable.
Product Quantity4
Recall NumberZ-2261-2012

Class II Devices Event

Event ID62892
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Medical Systems (Cleveland) Inc
CityCleveland
StateOH
CountryUS
Distribution PatternNationwide Distribution-including the states of CO, FL, MD, MN, NE and PA.
 

Associated Products

Product DescriptionPositron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16 PET/CT, GEMINI TF Big Bore PET/CT, Philips Medical Systems, Cleveland, OH. The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: " The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders. " The detection, localization, and staging of tumors and diagnosing cancer patients. " Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of with regional cerebral activity from PET images.
Code InfoGEMINI TF 16 System serial numbers: 7194, 7186, 7235, 7233 GEMINI GXL 16 System serial number: 4201 GEMINI TF Big Bore System serial numbers: 9022, 9201
ClassificationClass II
Reason for RecallPhilips became aware of an issue relating to a UPS battery cabinet that appeared to have burned a hole through the casing on one of the batteries. Supplier of the UPS, Chloride/Emerson, determined the batteries, housed within the UPS battery cabinet, entered thermal runaway causing the battery to overheat.
Product Quantity7 units
Recall NumberZ-2239-2012

Class II Drugs Event

Event ID62893
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Apr-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmVistaPharm, Inc.
CityLargo
StateFL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionXactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC 66689-035-50
Code InfoLot 202800, NDC 66689-035-50
ClassificationClass II
Reason for RecallDefective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume
Product Quantity
Recall NumberD-1658-2012

Class II Food Event

Event ID62901
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Aug-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmWinn Dixie Stores, Inc.
CityJacksonville
StateFL
CountryUS
Distribution PatternSC
 

Associated Products

Product DescriptionSouthern Home Cranberry Nut Antioxidant Blend, Trail Mix, Net Wt. 16oz. (1 LB) 454g, Distributed by Southern Home, P.O. Box 99, Mauldin, SC 29662.
Code InfoItem Code: 627888, UPC 6-07880-03039.
ClassificationClass II
Reason for RecallUndeclared allergen, soy lecithin.
Product Quantity232 Cases/6 packages per case
Recall NumberF-1984-2012

Class II Food Event

Event ID62941
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmJ&S Group
CityFullerton
StateCA
CountryUS
Distribution PatternCA, IL
 

Associated Products

Product DescriptionFrozen Oysters (IQF), Net Weight: 30 lbs (6/5lbs).
Code Infonone
ClassificationClass II
Reason for RecallJ&S Group is recalling Frozen Oysters because the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity779 cases
Recall NumberF-2015-2012

Class II Food Event

Event ID62951
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSpartan Central Kitchen
CityGrand Rapids
StateMI
CountryUS
Distribution PatternMI distribution only
 

Associated Products

Product DescriptionSpartan/Fresh Selections Wedge Sandwich W/Sandwich Spread 4oz
Code InfoLOT NUMBER: All dates up to and including 8/12/12 UPC: 011213-900001 SPARTAN CODE: 744
ClassificationClass II
Reason for RecallDuring an FDA inspection, the investigation found the 4oz sandwich spread label did not declare Yellow # 5 as an ingredient.
Product Quantity288 units
Recall NumberF-2016-2012

Class III Biologics Event

Event ID41766
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Dec-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityLouisville
StateKY
CountryUS
Distribution PatternIN
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code Info24FC35223- part 1; 24FC35223- part 2; 24FC35223- part 3
ClassificationClass III
Reason for RecallBlood components, processed more than 8 hours after collection, were distributed.
Product Quantity3 units
Recall NumberB-1790-12

Class III Biologics Event

Event ID42223
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-May-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternIllinois
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoC79023
ClassificationClass III
Reason for RecallBlood product, manufactured without the entire quantity of additive solution, was distributed.
Product Quantity1 Unit
Recall NumberB-2141-12

Class III Biologics Event

Event ID42916
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Aug-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBio-Blood Components, Inc.
CityColumbus
StateOH
CountryUS
Distribution PatternCalifornia.
 

Associated Products

Product DescriptionSource Plasma
Code Info06BOHA4075
ClassificationClass III
Reason for RecallBlood product, which tested initially reactive for the hepatitis C virus, was distributed.
Product Quantity1 unit
Recall NumberB-1581-12

Class III Biologics Event

Event ID43405
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Nov-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternKS.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045006104362 Part A, W045006104362 Part B
ClassificationClass III
Reason for RecallBlood products, which did not meet acceptable product specifications, were distributed.
Product Quantity2 units
Recall NumberB-1560-12

Class III Biologics Event

Event ID49164
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-May-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Centers of the Pacific
CitySan Francisco
StateCA
CountryUS
Distribution PatternCA.
 

Associated Products

Product DescriptionPlatelets Apheresis Leukoreduced
Code Info7354767, 9348475,7354764,7354767, 9348475
ClassificationClass III
Reason for RecallBlood products, which were exposed to unacceptable temperature during transport, were distributed.
Product Quantity5
Recall NumberB-1801-12
Product DescriptionPlatelets Apheresis Leukoreduced (Irradiated)
Code Info7354764, 9348470, 9348470
ClassificationClass III
Reason for RecallBlood products, which were exposed to unacceptable temperature during transport, were distributed.
Product Quantity3
Recall NumberB-1802-12

Class III Biologics Event

Event ID60098
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Aug-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAllograft Innovations, LLC
CityGainesville
StateFL
CountryUS
Distribution PatternProducts were distributed domestically to hospitals nationwide and internationally to Israel, South Korea, United Kingdom, and Turkey.
 

Associated Products

Product DescriptionProducts: .5-1mm 2cc Cancellous Chips; .5-1mm 15cc Cancellous Chips; .5-1mm 30cc Cancellous Chips. Cancellous Chips. Product s are labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID: NLGIN09-0024C NLGIN10-0004 NLGIN10-0005 NLGIN10-0009 NLGIN10-0012 NLGIN10-0016 NLGIN10-0018 NLGIN10-0020 NLGIN10-0024 NLGIN10-0033
Code InfoTissue ID #: AI090024C2013, AI090024C2014, AI090024C2015, AI090024C2016, AI090024C2017, AI090024C2018, AI1000042016, AI1000052013, AI1000052014, AI1000052015, AI1000052016, AI1000052017, AI1000092019, AI1000092020, AI1000122013, AI1000122014, AI1000122015, AI1000122016, AI1000122017, AI1000122018, AI1000122019, AI1000122020, AI1000122021, AI1000122022, AI1000162019, AI1000182005, AI1000202018, AI1000202019, AI1000202020, AI1000202021, AI1000242009, AI1000242010, AI1000242011, AI10110402005, AI10110402006, AI10110402007, AI10110402008
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity37 Tissues
Recall NumberB-2227-12
Product DescriptionProduct: .25-.5mm 15cc Cancellous Chips. Cancellous Chips Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" . Donor ID # - NLGIN10-0016.
Code InfoTissue ID #: AI1000162018
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity1 Tissue
Recall NumberB-2228-12
Product DescriptionProducts: 1-4mm 5cc Cancellous Chips; 1-4mm 10cc Cancellous Chips; 1-4mm 15cc Cancellous Chips; 1-4mm 30cc Cancellous Chips; 1-4mm 40cc Cancellous Chips; 1-4mm 60cc Cancellous Chips. Cancellous Chips Products are labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID#: NLGIN09-0024C NLGIN10-0001 NLGIN10-0004 NLGIN10-0005 NLGIN10-0007 NLGIN10-0009 NLGIN10-0012 NLGIN10-0013 NLGIN10-0016 NLGIN10-0018 NLGIN10-0020 NLGIN10-0021 NLGIN10-0024 NLGIN10-0025 NLGIN10-0031 NLGIN10-0033 NLGIN10-0038 NLGIN10-0040 NLGIN10-0047 NLGIN10-0052 NLGIN10-0066 NLGIN10-0069 NLGIN10-0076 NLGIN11-0014 NLGIN11-0051
Code InfoTissue ID: AI090024C2009, AI090024C2010, AI090024C2011, AI090024C2012, AI1000012005, AI1000012006, AI1000012007, AI1000012010, AI1000012011, AI1000042011, AI1000042012, AI1000042013, AI1000042014, AI1000042015, AI1000052010, AI1000052011, AI1000052012, AI1000072006, AI1000072007, AI1000072008, AI1000072009, AI1000072010, AI1000072011, AI1000092014, AI1000092015, AI1000092016, AI1000092017, AI1000092018, AI1000122010, AI1000122011, AI1000122012, AI1000132005, AI1000132006, AI1000132007, AI1000162020, AI1000162021, AI1000162022, AI1000162023, AI1000162024, AI1000182006, AI1000202005, AI1000202006, AI1000202007, AI1000202008, AI1000202009, AI1000202010, AI1000202022, AI1000202023, AI1000212014, AI1000212015, AI1000212016, AI1000212017, AI1000212018, AI1000212019, AI1000242006, AI1000242007, AI1000242008, AI1000252008, AI1000252009, AI1000252010, AI1000252011, AI1000312005, AI1000312006, AI1000312007, AI1000312008, AI1000382005, AI1000382006, AI1000382007, AI1000382008, AI1000382009, AI1000402005, AI1000402006, AI1000402007, AI1000402009, AI1000402010, AI1000402011, AI1000402012, AI1000472005, AI1000472006, AI1000472007, AI1000662005, AI1000662006, AI10110032005, AI10110032006, AI10110032007, AI10110172006, AI10110172007, AI10110172008, AI10110402010, AI10110402011, AI10110402012, AI10110402013, AI10110402014, AI10110402015, AI10110402016, AI11010032005, AI11010032006, AI11030032005, AI11030032006, AI11030032007, AI11030032008, AI11060012010, AI11060012011, AI11060012012
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity104 Tissues
Recall NumberB-2229-12
Product DescriptionProducts: 4-10mm 15cc Cancellous Chips; 4-10mm 30cc Cancellous Chips, 4-10mm 40cc Cancellous Chips, 4-10mm 60cc Cancellous Chips. Products are labeled in part: Cancellous Chips. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN09-0024C NLGIN10-0001 NLGIN10-0004 NLGIN10-0005 NLGIN10-0007 NLGIN10-0009 NLGIN10-0012 NLGIN10-0013 NLGIN10-0016 NLGIN10-0020 NLGIN10-0021 NLGIN10-0024 NLGIN10-0025 NLGIN10-0033 NLGIN10-0047 NLGIN10-0052 NLGIN10-0066
Code InfoTissue ID #: AI090024C2005, AI090024C2006, AI090024C2007, AI090024C2008, AI1000012008, AI1000012009, AI1000042005, AI1000042006, AI1000042007, AI1000042008, AI1000042009, AI1000042010, AI1000052005, AI1000052006, AI1000052007, AI1000052008, AI1000052009, AI1000072005, AI1000092005, AI1000092006, AI1000092007, AI1000092008, AI1000092009, AI1000092010, AI1000092011, AI1000092012, AI1000092013, AI1000122005, AI1000122006, AI1000122007, AI1000122008, AI1000122009, AI1000132008, AI1000132009, AI1000162005, AI1000162006, AI1000162007, AI1000162008, AI1000162009, AI1000162010, AI1000162011, AI1000162012, AI1000162013, AI1000162014, AI1000162015, AI1000162016, AI1000162017, AI1000202011, AI1000202012, AI1000202013, AI1000212005, AI1000212006, AI1000212007, AI1000212008, AI1000212009, AI1000212010, AI1000212011, AI1000212012, AI1000212013, AI1000242005, AI1000252005, AI1000252006, AI1000252007, AI1000472009, AI1000472010, AI1000472011, AI1000472012, AI1000472013, AI1000472014, AI1000472015, AI1000662007, AI1000662008, AI1000662009, AI10110172009, AI10110172010, AI10110172011, AI10110402017
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity77 Tissues
Recall NumberB-2230-12
Product DescriptionProducts: .5-1mm 1cc Cortical Cancellous Chips, .5-1mm 2cc Cortical Cancellous Chips. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0013 NLGIN10-0024 NLGIN10-0025 NLGIN10-0035 NLGIN10-0038 NLGIN10-0066
Code InfoTissue ID#: AI1000130505, AI1000130506, AI1000130507, AI1000130508, AI1000130516, AI1000130517, AI1000130518, AI1000130519, AI1000240509, AI1000240510, AI1000240511, AI1000240512, AI1000240513, AI1000240514, AI1000240515, AI1000240516, AI1000240517, AI1000240518, AI1000240519, AI1000240521, AI1000240522, AI1000240523, AI1000240524, AI1000240525, AI1000240526, AI1000240528, AI1000240529, AI1000240530, AI1000240531, AI1000240532, AI1000240533, AI1000240534, AI1000240535, AI1000240536, AI1000240537, AI1000240539, AI1000240540, AI1000240544, AI1000240545, AI1000250524, AI1000250525, AI1000250526, AI1000250527, AI1000250528, AI1000250529, AI1000350535, AI1000350536, AI1000350537, AI1000350538, AI1000350539, AI1000350552, AI1000350553, AI1000350554, AI1000350555, AI1000350556, AI1000350557, AI1000350558, AI1000350559, AI1000350560, AI1000350561, AI1000380506, AI1000380507, AI1000380508, AI1000380509, AI1000380510, AI1000380511, AI1000380512, AI1000380513, AI1000380515, AI1000380516, AI1000660505, AI1000660506, AI1000660507, AI1000660508, AI1000660509, AI1000660510, AI1000660511, AI1000660512, AI1000660513, AI1000660514, AI1000660515, AI1000660516, AI1000660517, AI1000660518, AI1000660519, AI1000660520, AI1000660521, AI1000660522, AI1000660523, AI1000660524, AI1000660525, AI1000660526, AI1000660527, AI1000660528, AI1000660529, AI1000660530, AI1000660531, AI1000660532, AI1000660533, AI1000660534, AI1000660535
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity101 Tissues
Recall NumberB-2231-12
Product DescriptionProducts: 1-2mm 1cc Cortical Cancellous Chips, 1-2mm 2cc Cortical Cancellous Chips,1-2mm 5cc Cortical Cancellous Chips. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0020 NLGIN10-0031 NLGIN10-0035 NLGIN10-0038 NLGIN10-0047
Code InfoTissue ID #: AI1000200536, AI1000200537, AI1000200538, AI1000200539, AI1000200540, AI1000310510, AI1000350505, AI1000350506, AI1000350507, AI1000350508, AI1000350509, AI1000350510, AI1000350511, AI1000350512, AI1000350513, AI1000350514, AI1000350515, AI1000350516, AI1000350517, AI1000350518, AI1000350519, AI1000350520, AI1000350521, AI1000350522, AI1000350523, AI1000350524, AI1000350525, AI1000350526, AI1000380518, AI1000380519, AI1000380520, AI1000380521, AI1000380522, AI1000380523, AI1000380525, AI1000380526, AI1000380527, AI1000380528, AI1000380529, AI1000380530, AI1000380531, AI1000380532, AI1000380533, AI1000380534, AI1000380535, AI1000380536, AI1000380537, AI1000380538, AI1000380539, AI1000380543, AI1000380544, AI1000380545, AI1000380546, AI1000380547, AI1000380549, AI1000380550, AI1000380552, AI1000380554, AI1000470508, AI1000470509, AI1000470510, AI1000470511, AI1000470512, AI1000470513, AI1000470514, AI1000470515, AI1000470516, AI1000470517
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity68 units
Recall NumberB-2232-12
Product DescriptionProducts: 100mm Femur Shaft Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0038 NLGIN10-0047
Code InfoTissue ID #: AI1000380105, AI1000380106, AI1000470105, AI1000470106
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity4 Tissues
Recall NumberB-2233-12
Product DescriptionProducts: 150mm Femur Shaft. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0047
Code InfoTissue ID #: AI1000470107
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity1 Tissue
Recall NumberB-2234-12
Product DescriptionProducts: 10x10x18 Ilium Tricortical Block. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0004 NLGIN10-0038
Code InfoTissue ID #: AI1000045005, AI1000045008, AI1000045011, AI1000385007
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity4 Tissues
Recall NumberB-2235-12
Product DescriptionProducts: 11-13x10x18 Ilium Tricortical Block Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0004 NLGIN10-0038
Code InfoTissue ID #: AI1000045006, AI1000045009, AI1000385009, AI1000385012, AI1000385015, AI1000385017, AI1000385018
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity7 Tissues
Recall NumberB-2236-12
Product DescriptionProducts: 14-17x11x25 Ilium Tricortical Block. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0004 NLGIN10-0038
Code InfoTissue ID #: AI1000045007, AI1000045010, AI1000385005, AI1000385006, AI1000385008, AI1000385010, AI1000385011, AI1000385013, AI1000385014 AI1000385016
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity10 Tissues
Recall NumberB-2237-12
Product DescriptionProducts: 150mm x 20mm Cortical Plate. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0047
Code InfoTissue ID #: AI1000470205, AI1000470206, AI1000470207
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity3 Tissues
Recall NumberB-2238-12
Product DescriptionProducts: 200mm Tibia Shaft Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0033
Code InfoTissue ID #: AI10110400105
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity1 Tissue
Recall NumberB-2239-12
Product DescriptionProducts: 5mm 30cc Cancellous Cubes. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0025
Code InfoTissue ID #: AI1000252019, AI1000252020, AI1000252021 AI1000252023, AI1000252024, AI1000252025
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity6 Tissues
Recall NumberB-2240-12
Product DescriptionProducts: 8mm Cancellous Block. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0004
Code InfoTissue ID #: AI1000040753, AI1000040754, AI1000040755, AI1000040756, AI1000040757, AI1000040758, AI1000040759, AI1000040760, AI1000040761, AI1000040762, AI1000040763, AI1000040771
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity12 Tissues
Recall NumberB-2241-12
Product DescriptionProducts: 9mm Cancellous Block. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0004
Code InfoTissue ID #: AI1000040776, AI1000040777, AI1000040778, AI1000040779
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity4 Tissues
Recall NumberB-2242-12
Product DescriptionProducts: 5mm Lordotic Cervical Cancellous Spacer Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0016
Code InfoTissue ID #: AI1000163005
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity1 Tissue
Recall NumberB-2243-12
Product DescriptionProducts: 6mm Lordotic Cervical Cancellous Spacer. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0001 NLGIN10-0007 NLGIN10-0013 NLGIN10-0016
Code InfoTissue ID #: AI1000013007, AI1000073006, AI1000073007, AI1000073010, AI1000073011, AI1000073013, AI1000073014, AI1000073016, AI1000073018, AI1000133008, AI1000133009, AI1000133010, AI1000163006, AI1000163007
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity14 Tissues
Recall NumberB-2244-12
Product DescriptionProducts: 7mm Lordotic Cervical Cancellous Spacer. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0007 NLGIN10-0013 NLGIN10-0016
Code InfoTissue ID #: AI1000073024, AI1000073026, AI1000073028, AI1000133011, AI1000163008, AI1000163009, AI1000163010, AI1000163011, AI1000163012
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity9 Tissues
Recall NumberB-2245-12
Product DescriptionProducts: 5mm Lordotic Cervical Spacer. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0024
Code InfoTissue ID #: AI1000244006, AI1000244015, AI1000244016, AI1000244017, AI1000244018
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity5 Tissues
Recall NumberB-2246-12
Product DescriptionProducts: 6mm Lordotic Cervical Spacer. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0012 NLGIN10-0024 NLGIN10-0069
Code InfoTissue ID #: AI1000124005, AI1000124006, AI1000124007, AI1000124008, AI1000244022, AI1000244023, AI1000244024, AI1000244025, AI1000244026, AI1000244027, AI10110034011, AI10110034012, AI10110034013, AI10110034014, AI10110034015, AI10110034016, AI10110034017, AI10110034018, AI10110034019, AI10110034020, AI10110034021, AI10110034022, AI10110034023, AI10110034024, AI10110034025, AI10110034026, AI10110034028
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity27 Tissues
Recall NumberB-2247-12
Product DescriptionProducts: 7mm Lordotic Cervical Spacer. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0012 NLGIN10-0069
Code InfoTissue ID #: AI1000124009, AI1000124010, AI1000124011, AI1000124012, AI1000124013, AI1000124014, AI1000124015, AI10110034029, AI10110034030, AI10110034031, AI10110034032
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity11 Tissues
Recall NumberB-2248-12
Product DescriptionProducts: Achilles with Bone Block. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0021
Code InfoTissue ID #: AI1000210005, AI1000210006
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity2 Tissues
Recall NumberB-2249-12
Product DescriptionProducts: Achilles with Bone Block Pre-sized. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0004 NLGIN10-0009 NLGIN10-0012 NLGIN10-0016 NLGIN10-0033 NLGIN10-0038 NLGIN10-0047 NLGIN10-0069
Code InfoTissue ID #: AI1000040006, AI1000090005, AI1000090006, AI1000120005, AI1000160005, AI1000160006, AI1000380015, AI1000380016, AI10110030006, AI10110400005, AI10110400006
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity11 Tissues
Recall NumberB-2250-12
Product DescriptionProducts: Achilles without Bone Block.. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0005
Code InfoTissue ID #: AI1000050005, AI1000050006
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity2 Tissues
Recall NumberB-2251-12
Product DescriptionProducts: Medial Femur Hemi-Condyle. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0038
Code InfoTissue ID #: AI1000380030
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity1 Tissue
Recall NumberB-2252-12
Product DescriptionProducts: Patella Tendon - Hemi Presized. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0016 NLGIN10-0016 NLGIN10-0016 NLGIN10-0016 NLGIN10-0021 NLGIN10-0021 NLGIN10-0021 NLGIN10-0024 NLGIN10-0024 NLGIN10-0025 NLGIN10-0025 NLGIN10-0033 NLGIN10-0038 NLGIN10-0038 NLGIN10-0066 NLGIN10-0066 NLGIN10-0069 NLGIN10-0069 NLGIN10-0069
Code InfoTissue ID #: AI1000160007, AI1000160008, AI1000160009, AI1000160010, AI1000210007, AI1000210008, AI1000210009, AI1000240007, AI1000240008, AI1000250007, AI1000250008, AI1000380017, AI1000380018, AI1000660002, AI1000660003, AI10110030007, AI10110030008, AI10110030009, AI10110400007
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity19 Tissues
Recall NumberB-2253-12
Product DescriptionProducts: Patella Whole. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0004 NLGIN10-0009 NLGIN10-0012
Code InfoTissue ID #: AI1000040007, AI1000040008, AI1000090007, AI1000090008
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity4 Tissues
Recall NumberB-2254-12
Product DescriptionProducts: Peroneus Longus Tendon. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0004 NLGIN10-0005 NLGIN10-0009 NLGIN10-0012 NLGIN10-0016 NLGIN10-0024 NLGIN10-0038 NLGIN10-0047 NLGIN10-0069 NLGIN11-0051
Code InfoTissue ID #: AI1000040013, AI1000040014, AI1000050012, AI1000090013, AI1000090014, AI1000120013, AI1000120014, AI1000160015, AI1000160016, AI1000240012, AI1000380010, AI1000470013, AI10110030014, AI10110030015, AI11060010013
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity15 Tissues
Recall NumberB-2255-12
Product DescriptionProducts: Semitendinosus/Gracilis Tendon . Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0033 NLGIN10-0047
Code InfoTissue ID #: AI10110400014, AI1000470014
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity2 Tissues
Recall NumberB-2256-12
Product DescriptionProducts: Semitendinosus Tendon . Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN09-0024C NLGIN10-0033 NLGIN10-0047 NLGIN10-0066
Code InfoTissue ID #: AI090024C0011, AI1000470015, AI1000660009, AI1000660010, AI10110400015
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity5 Tissues
Recall NumberB-2257-12
Product DescriptionProducts: Tibialis Tendon - Anterior. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN09-0024C NLGIN10-0004 NLGIN10-0005 NLGIN10-0009 NLGIN10-0012 NLGIN10-0013 NLGIN10-0016 NLGIN10-0021 NLGIN10-0024 NLGIN10-0025 NLGIN10-0033 NLGIN10-0038 NLGIN10-0047 NLGIN10-0066 NLGIN10-0069 NLGIN11-0051
Code InfoTissue ID #: AI090024C0007, AI090024C0008, AI1000040010, AI1000050007, AI1000050008, AI1000090009, AI1000090010, AI1000120009, AI1000120010, AI1000130008, AI1000130009, AI1000160011, AI1000160012, AI1000210010, AI1000210011, AI1000240009, AI1000240010, AI1000250009, AI1000250010, AI1000380005, AI1000380006, AI1000470008, AI1000660004, AI1000660005, AI10110030010, AI10110030011, AI10110400008, AI10110400009
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity28 Tissues
Recall NumberB-2258-12
Product DescriptionProducts: Tibialis Tendon - Posterior. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN09-0024C NLGIN10-0004 NLGIN10-0005 NLGIN10-0009 NLGIN10-0012 NLGIN10-0013 NLGIN10-0016 NLGIN10-0021 NLGIN10-0024 NLGIN10-0025 NLGIN10-0033 NLGIN10-0038 NLGIN10-0066 NLGIN10-0069
Code InfoTissue ID #: AI090024C0009, AI090024C0010, AI1000040011, AI1000040012, AI1000050009, AI1000050010, AI1000090011, AI1000090012, AI1000120011, AI1000120012, AI1000130010, AI1000160013, AI1000160014, AI1000210012, AI1000210013, AI1000240011, AI1000250011, AI1000250012, AI1000380007, AI1000380008, AI1000660006, AI10110030012, AI10110030013, AI10110400010, AI10110400011
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity25 Tissues
Recall NumberB-2259-12
Product DescriptionProducts: 5mm Cancellous Block Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Block***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0004 NLGIN10-0021 NLGIN10-0024
Code InfoTissue ID #: AI1000040705, AI1000040706, AI1000210705, AI1000210706, AI1000210707, AI1000210708, AI1000210709, AI1000210710, AI1000210711, AI1000210712, AI1000240705, AI1000240706, AI1000240707, AI1000240708, AI1000240709, AI1000240710
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity16 Tissues
Recall NumberB-2260-12
Product DescriptionProducts: 6mm Cancellous Block Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Block***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0004
Code InfoTissue ID #: AI1000040707, AI1000040708, AI1000040709, AI1000040710, AI1000040711, AI1000040712, AI1000040713, AI1000040714, AI1000040715, AI1000040716, AI1000040717, AI1000040718, AI1000040719, AI1000040720, AI1000040721, AI1000040722, AI1000040723, AI1000040724, AI1000040725, AI1000040726, AI1000040727, AI1000040728, AI1000040729, AI1000040730, AI1000040731
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity25 Tissues
Recall NumberB-2261-12
Product DescriptionProducts: 7mm Cancellous Block Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Block***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Donor ID #: NLGIN10-0004
Code InfoTissue ID #: AI1000040732, AI1000040733, AI1000040734, AI1000040735, AI1000040736, AI1000040737, AI1000040738, AI1000040739, AI1000040740, AI1000040741, AI1000040742, AI1000040743, AI1000040744, AI1000040750, AI1000040751, AI1000040752
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity16 Tissues
Recall NumberB-2262-12

Class III Biologics Event

Event ID60914
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Dec-11
Initial Firm Notification of Consignee or Public FAX
Recalling FirmDelta Blood Bank
CityStockton
StateCA
CountryUS
Distribution PatternCA, IN.
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW128711161270
ClassificationClass III
Reason for RecallBlood products, collected from a donor for whom there was no documentation on the donor record of an arm inspection, were distributed.
Product Quantity1 unit
Recall NumberB-2220-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW128711161270
ClassificationClass III
Reason for RecallBlood products, collected from a donor for whom there was no documentation on the donor record of an arm inspection, were distributed.
Product Quantity1 unit
Recall NumberB-2221-12

Class III Biologics Event

Event ID60915
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Nov-11
Initial Firm Notification of Consignee or Public FAX
Recalling FirmDelta Blood Bank
CityStockton
StateCA
CountryUS
Distribution PatternCA, IN.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW128711016818
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2219-12

Class III Biologics Event

Event ID61567
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Mar-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSan Antonio Eye Bank
CitySan Antonio
StateTX
CountryUS
Distribution PatternCA, TX, FL
 

Associated Products

Product DescriptionCornea
Code InfoSA20120362, SA201203451, SA20120361
ClassificationClass III
Reason for RecallHuman Corneas, processed in a manner that may cause the introduction, transmission, or spread of communicable disease, were distributed.
Product Quantity3 corneas
Recall NumberB-2269-12

Class III Drugs Event

Event ID61818
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMorton Salt Co.
CityChicago
StateIL
CountryUS
Distribution PatternNationwide & PR & Ireland.
 

Associated Products

Product DescriptionMorton, Sodium Chloride, USP, Granular, packaged in kraft paper bags, fiber drums, and semi-bulk bags. Product is shipped in 80 lb bags, 350 lb drums & 2000 lb semi-bulk sacks. Manufactured by Morton Salt, Inc., Chicago, Illinois 60606-1743.
Code InfoLot #: OCT251BC01, NOV041BA01 & NOV071BA01.
ClassificationClass III
Reason for RecallImpurities/Degradation Products: The product was found to contain a slightly out of specification level of bromides, exceeding the bromides limit for USP Sodium Chloride.
Product Quantity531,950 lbs
Recall NumberD-1656-2012

Class III Devices Event

Event ID62452
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Aug-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSunquest Information Systems, Inc.
CityTucson
StateAZ
CountryUS
Distribution PatternUS Nationwide Distribution
 

Associated Products

Product DescriptionSunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
Code InfoVersion 6.4.2
ClassificationClass III
Reason for RecallIn GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive.
Product Quantity47 sites
Recall NumberZ-2229-2012

Class III Devices Event

Event ID62751
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Apr-09
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSunquest Information Systems, Inc.
CityTucson
StateAZ
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and country of: Bahamas.
 

Associated Products

Product DescriptionSunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.
Code Infoversions 2.4 and later
ClassificationClass III
Reason for RecallSunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect time is displaying and printing one hour later than the actual collect time only when Daylight Saving Time is active.
Product Quantity23 clients
Recall NumberZ-2243-2012

Class III Devices Event

Event ID62791
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Oct-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBeckman Coulter Inc.
CityBrea
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide), Canada, and internationally.
 

Associated Products

Product DescriptionAccess Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function and diagnosis of thyroid disorders when T3 levels are between 0.1 and 8.0 ng/mL.
Code InfoAll Lots
ClassificationClass III
Reason for RecallA recall was initiated because Beckman Coulter has identified a negative bias in test results when comparing elevated Total T3 patient samples diluted with Sample Diluent A to samples diluted with Access Total T3 Calibrator S0.
Product Quantity117,385 units total (33,918 units in US)
Recall NumberZ-2227-2012

Mixed Classification Food Event

Event ID62710
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTomales Bay Foods, Inc.
CityPetaluma
StateCA
CountryUS
Distribution PatternPart One: CA, VA, VT, WI, OR, UT and Italy, Spain, Switzerland, France, Holland, Greece. Part Two: Dates of Distribution: 6/2512 - 7/27/12 Pattern: CA, NC, FL
 

Associated Products

Product DescriptionTomales Bay Foods brand Artisan Cheese in PARTIAL WHEELS of Cheese, from cheese makers in US (VA, VT, Ca, WI, OR, WA and UT) and Ireland, Italy, Switzerland, France, Holland and Greece. Varieties include Appalachian, Coolea, Cabot clothbound Cheddar, Big Rock Blue, Goat Gouda, Holey Cow, Big Woods Blue, Fiore Sardo,, Valdeon, Pecorino Romano, Sottocenere, Capriago, Capricious, Cave Aged Gruyere, Cave Aged Marisa, Fenacho, Pondhopper, Comte, L'Amuse Signature Gouda, Dante Waxed Rind, Dry Jack Special Reserve, Mezzo Secco, Extra Mature Bandage Cheddar, San Joaquin Gold, Flagship Reserve Truckle, Fontina Vallet Pietro, Grana Padano, Parmigiano Reggiano Organic, Taleggio Organic, Comte Reserve Ete, Loma Alta, Mt. Viko Barrel Aged Feta, Pepato, San Andreas Bellwether Farms, Reading, Tarentaise, Seahive, St. George, Toma and Wagon Wheel. Cheese is cut per order and wrapped in cheese paper and marked with a magic marker indicating the type of cheese, poundage and pack date as well as a Tomales Bay Foods label. There are no code numbers or expiration dates marked on the product. After positive findings of listeria in finished product of Pondhopper and Big Woods Blue, Tomales Bay recalled additional partial wheels of these cheeses cut between June 25 and July 27, 2012. Product is cut and packaged by Tomales Bay Foods, Petaluma, CA
Code InfoAll product cut and wrapped on July 24 and 25, 2012.
ClassificationClass II
Reason for RecallFirm received a positive environmental for Listeria Monocytogenes from their internal testing samples.
Product Quantity562.74 pounds original recall, 101.1 pounds of Pondhopper and 31.41 pounds of Big Woods Blue
Recall NumberF-1985-2012

Mixed Classification Biologics Event

Event ID49306
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jul-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CityWichita
StateKS
CountryUS
Distribution PatternTX, CA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info02GC00390
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-2211-12
Product DescriptionRecovered Plasma
Code Info02GC00390
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-2212-12

Mixed Classification Biologics Event

Event ID59719
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Aug-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNew Life Generation, INC.
CityIndianapolis
StateIN
CountryUS
Distribution PatternIN, CA, VA
 

Associated Products

Product DescriptionHuman Skin for Transplant
Code InfoNLGIL100017002, NLGIL100017003, NLGIL100017004, NLGIL100017005, NLGIL100017008, NLGIL100017012, NLGIL100017013, NLGIL100017014, NLGIL100017015, NLGIL100017017, NLGIL100017018, NLGIL100017019, NLGIL100017020, NLGIN100004001, NLGIN100004002, NLGIN100004003, NLGIN100004004, NLGIN100004005, NLGIN100004006, NLGIN100004007, NLGIN100004008, NLGIN100004009, NLGIN100004011, NLGIN100004012, NLGIN100004013, NLGIN100004014, NLGIN100004015, NLGIN100004016, NLGIN100004018, NLGIN100004019, NLGIN100004020, NLGIN100005001, NLGIN100005003, NLGIN100005004, NLGIN100005006, NLGIN100005007, NLGIN100005008, NLGIN100005009, NLGIN100005010, NLGIN100005011, NLGIN100005012, NLGIN100005013, NLGIN100005014, NLGIN100005015, NLGIN100005016, NLGIN100005017, NLGIN100005018, NLGIN100005019, NLGIN100006001, NLGIN100006002, NLGIN100006003, NLGIN100006004, NLGIN100006005, NLGIN100006006, NLGIN100006007, NLGIN100006008, NLGIN100006009, NLGIN100006010, NLGIN100006011, NLGIN100007001, NLGIN100007002, NLGIN100007003, NLGIN100007004, NLGIN100007005, NLGIN100007006, NLGIN100007007, NLGIN100007008, NLGIN100007009, NLGIN100007010, NLGIN100007011, NLGIN100007012, NLGIN100007014, NLGIN100007015, NLGIN100007017, NLGIN100007018, NLGIN100007019, NLGIN100007020, NLGIN100007022, NLGIN100007023, NLGIN100008001, NLGIN100008002, NLGIN100008003, NLGIN100008004, NLGIN100008005, NLGIN100008006, NLGIN100008007, NLGIN100008008, NLGIN100008009, NLGIN100008010, NLGIN100008011, NLGIN100008012, NLGIN100008013, NLGIN100008014, NLGIN100008015, NLGIN100008016, NLGIN100008017, NLGIN100008018, NLGIN100008019, NLGIN100008020, NLGIN100008021, NLGIN100008022, NLGIN100008023, NLGIN100008024, NLGIN100008025, NLGIN100009001, NLGIN100009003, NLGIN100009004, NLGIN100009005, NLGIN100009006, NLGIN100009008, NLGIN100009009, NLGIN100009010, NLGIN100009011, NLGIN100009012, NLGIN100009013, NLGIN100009014, NLGIN100009015, NLGIN100009016, NLGIN100012001, NLGIN100012004, NLGIN100012005, NLGIN100012006, NLGIN100012007, NLGIN100012008, NLGIN100012011, NLGIN100012012, NLGIN100012014, NLGIN100012015, NLGIN100014001, NLGIN100014003, NLGIN100014004, NLGIN100014009, NLGIN100014010, NLGIN100014012, NLGIN100014015, NLGIN100014016, NLGIN100018002, NLGIN100018007, NLGIN100018008, NLGIN100018009, NLGIN100018010, NLGIN100018011, NLGIN100018012, NLGIN100018013, NLGIN100018014, NLGIN100018015, NLGIN100018018, NLGIN100019001, NLGIN100019002, NLGIN100019003, NLGIN100019004, NLGIN100019005, NLGIN100019008, NLGIN100019009, NLGIN100019011, NLGIN100019012, NLGIN100019013, NLGIN100019015, NLGIN100019016, NLGIN100019017, NLGIN100019019, NLGIN100019020, NLGIN100019022, NLGIN100019023, NLGIN100019024, NLGIN100021001, NLGIN100021003, NLGIN100021004, NLGIN100021005, NLGIN100021006, NLGIN100021008, NLGIN100021009, NLGIN100021011, NLGIN100021012, NLGIN100021015, NLGIN100021017, NLGIN100022001, NLGIN100022002, NLGIN100022003, NLGIN100022005, NLGIN100022006, NLGIN100022007, NLGIN100022008, NLGIN100022009, NLGIN100022012, NLGIN100023001, NLGIN100023002, NLGIN100023005, NLGIN100023006, NLGIN100023009, NLGIN100023012, NLGIN100023014, NLGIN100023015, NLGIN100023016, NLGIN100023017, NLGIN100024002, NLGIN100024003, NLGIN100024004, NLGIN100024006, NLGIN100024008, NLGIN100024010, NLGIN100024011, NLGIN100024013, NLGIN100024014, NLGIN100024015, NLGIN100024016, NLGIN100024018, NLGIN100024019, NLGIN100024020, NLGIN100025001, NLGIN100025002, NLGIN100025003, NLGIN100025004, NLGIN100025006, NLGIN100025007, NLGIN100025009, NLGIN100025011, NLGIN100025014, NLGIN100025015, NLGIN100025016, NLGIN100027001, NLGIN100027002, NLGIN100027003, NLGIN100027004, NLGIN100027005, NLGIN100027006, NLGIN100027007, NLGIN100027008, NLGIN100027009, NLGIN100027010, NLGIN100027012, NLGIN100027013, NLGIN100027014, NLGIN100027015, NLGIN100027016, NLGIN100027017, NLGIN100027018, NLGIN100027019, NLGIN100027020, NLGIN100027021, NLGIN100027022, NLGIN100031002, NLGIN100031003, NLGIN100031004, NLGIN100031005, NLGIN100031008, NLGIN100032003, NLGIN100032004, NLGIN100032005, NLGIN100032006, NLGIN100032008, NLGIN100032010, NLGIN100032011, NLGIN100032012, NLGIN100032013, NLGIN100032016, NLGIN100032017, NLGIN100037002, NLGIN100037003, NLGIN100037004, NLGIN100037005, NLGIN100037006, NLGIN100037007, NLGIN100037008, NLGIN100037009, NLGIN100037010, NLGIN100037011, NLGIN100037013, NLGIN100037014, NLGIN100037015, NLGIN100038001, NLGIN100038002, NLGIN100038003, NLGIN100038004, NLGIN100038005, NLGIN100038006, NLGIN100038007, NLGIN100038009, NLGIN100038010, NLGIN100038011, NLGIN100039002, NLGIN100039004, NLGIN100039005, NLGIN100039008, NLGIN100039009, NLGIN100040001, NLGIN100040002, NLGIN100040003, NLGIN100040004, NLGIN100040005, NLGIN100040008, NLGIN100040009, NLGIN100040010, NLGIN100042001, NLGIN100042003, NLGIN100042005, NLGIN100042006, NLGIN100042007, NLGIN100042009, NLGIN100042010, NLGIN100042011, NLGIN100043001, NLGIN100043002, NLGIN100043003, NLGIN100043004, NLGIN100043005, NLGIN100043006, NLGIN100043009, NLGIN100043010, NLGIN100043011, NLGIN100043012, NLGIN100046002, NLGIN100046003, NLGIN100046005, NLGIN100046006, NLGIN100046007, NLGIN100046009, NLGIN100046010, NLGIN100046011, NLGIN100046012, NLGIN100046013, NLGIN100047001, NLGIN100047002, NLGIN100047003, NLGIN100047004, NLGIN100047005, NLGIN100047006, NLGIN100048003, NLGIN100048004, NLGIN100048005, NLGIN100048006, NLGIN100048007, NLGIN100048009, NLGIN100050002, NLGIN100050003, NLGIN100050004, NLGIN100050005, NLGIN100050006, NLGIN100050007, NLGIN100051001, NLGIN100051002, NLGIN100051003, NLGIN100051004, NLGIN100051005, NLGIN100051006, NLGIN100051007, NLGIN100051008, NLGIN100051010, NLGIN100052001, NLGIN100052002, NLGIN100052003, NLGIN100055001, NLGIN100055002, NLGIN100055003, NLGIN100055004, NLGIN100055005, NLGIN100056001, NLGIN100056002, NLGIN100056003, NLGIN100056004, NLGIN100056005, NLGIN100056006, NLGIN100056007, NLGIN100057001, NLGIN100057002, NLGIN100057003, NLGIN100057004, NLGIN100057005, NLGIN100057006, NLGIN100058001, NLGIN100058002, NLGIN100058003, NLGIN100058004, NLGIN100058008, NLGIN100058011, NLGIN100067002, NLGIN100067003, NLGIN100067004, NLGIN100067005, NLGIN100067006, NLGIN100068001, NLGIN100068002, NLGIN100068004, NLGIN100068005, NLGIN100068006, NLGIN100069001, NLGIN100069002, NLGIN100069003, NLGIN100069004, NLGIN100069005, NLGIN100069006, NLGIN100069008, NLGIN100072001, NLGIN100072002, NLGIN100072003, NLGIN100072004, NLGIN100072005, NLGIN100072006, NLGIN100072007, NLGIN100072008, NLGIN100074001, NLGIN100074002, NLGIN100074003, NLGIN100074004, NLGIN100074005, NLGIN100074006, NLGIN100074007, NLGIN100074008, NLGIN100076002, NLGIN100076003, NLGIN100076008, NLGIN100077001, NLGIN100077002, NLGIN100077003, NLGIN100077004, NLGIN100077005, NLGIN100077006, NLGIN100079001, NLGIN100079002, NLGIN100079003, NLGIN100079004, NLGIN100079005, NLGIN100079006, NLGIN100079007, NLGIN100079008, NLGIN100079009, NLGIN100079010, NLGIN100079011, NLGIN100081001, NLGIN100081003, NLGIN100081004, NLGIN100081005, NLGIN100081006, NLGIN100081007, NLGIN100081008, NLGIN100081009, NLGIN100081010, NLGIN100088001, NLGIN100088002, NLGIN100088003, NLGIN100090001, NLGIN100090002, NLGIN100090003, NLGIN100090004, NLGIN100090005, NLGIN100090006, NLGIN100090007, NLGIN110006001, NLGIN110006002, NLGIN110006003, NLGIN110006007, NLGIN110006008, NLGIN110007001, NLGIN110007002, NLGIN110007003, NLGIN110007004, NLGIN110007005, NLGIN110007008, NLGIN110007009, NLGIN110007010, NLGIN110007011, NLGIN110007012, NLGIN110007013, NLGIN110010003, NLGIN110010004, NLGIN110010005, NLGIN110011001, NLGIN110011003, NLGIN110011004, NLGIN110011005, NLGIN110011006, NLGIN110011007, NLGIN110011008, NLGIN110011009, NLGIN110014001, NLGIN110014002, NLGIN110014006, NLGIN110014007, NLGIN110015002, NLGIN110015003, NLGIN110015004, NLGIN110015005, NLGIN110015006, NLGIN110016001, NLGIN110016002, NLGIN110016003, NLGIN110016004, NLGIN110016005, NLGIN110016006, NLGIN110016007, NLGIN110016008, NLGIN110019001, NLGIN110019002, NLGIN110019003, NLGIN110019004, NLGIN110019005, NLGIN110019006, NLGIN110019007, NLGIN110019009, NLGIN110019010, NLGIN110019011, NLGIN110021001, NLGIN110021003, NLGIN110021004, NLGIN110021006, NLGIN110021007, NLGIN110021008, NLGIN110021009, NLGIN110021010, NLGIN110021012, NLGIN110021013, NLGIN110022003, NLGIN110022004, NLGIN110022005, NLGIN110022007, NLGIN110022008, NLGIN110022010, NLGIN110024001, NLGIN110024002, NLGIN110024003, NLGIN110024004, NLGIN110024005, NLGIN110024006, NLGIN110024007, NLGIN110024008, NLGIN110024009, NLGIN110026002, NLGIN110026003, NLGIN110026004, NLGIN110026005, NLGIN110026006, NLGIN110026007, NLGIN110031001, NLGIN110031002, NLGIN110031003, NLGIN110031004, NLGIN110031005, NLGIN110051001, NLGIN110051002, NLGIN110051003, NLGIN110051004, NLGIN110051005, NLGIN110052001, NLGIN110053001, NLGIN110053002, NLGIN110053003, NLGIN110053004, NLGIN110053005, NLGIN110053006, NLGIN110053007, NLGIN110056001, NLGIN110056002, NLGIN110056003, NLGIN110056004, NLGIN110056006, NLGIN110056007, NLGIN110056008, NLGIN110061001, NLGIN110061002, NLGIN110061003, NLGIN110061004, NLGIN110061005, NLGIN110061006, NLGIN110061007, NLGIN110061008, NLGIN110061009, NLGIN110062001, NLGIN110062002, NLGIN110062003, NLGIN110062004, NLGIN110062005, NLGIN110062006, NLGIN110062007, NLGIN110062008, NLGIN110062009, NLGIN110062010, NLGIN110070001, NLGIN110070002, NLGIN110070003, NLGIN110070004, NLGIN110070005, NLGIN110070006, NLGIN110074002, NLGIN110074003, NLGIN110074004, NLGIN110074005, NLGIN110074006, NLGIN110074008, NLGIN110076001, NLGIN110076002, NLGIN110076003, NLGIN110076005, NLGIN110076006, NLGIN110081001, NLGIN110081004, NLGIN110081006, NLGIN110081007, NLGIN110081008, NLGIN110082001, NLGIN110082002, NLGIN110082004, NLGIN110082005, NLGIN110084001, NLGIN110084002, NLGIN110084003, NLGIN110084004, NLGIN110084005, NLGIN110084006, NLGIN110084007, NLGIN110084008, NLGIN110084009, NLGIN110085002, NLGIN110085003, NLGIN110085004, NLGIN110093001, NLGIN110093002, NLGIN110093003, NLGIN110093004, NLGIN110093005
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity619
Recall NumberB-1578-12
Product DescriptionHuman Skin for Transplant
Code InfoNLGIN100003001, NLGIN100003002, NLGIN100003003, NLGIN100003004, NLGIN100003005, NLGIN100003006, NLGIN100003007, NLGIN100003008, NLGIN100003009, NLGIN100003010, NLGIN100003011, NLGIN100003012, NLGIN100003013, NLGIN100003014, NLGIN100003015, NLGIN100003016, NLGIN100003017, NLGIN100003018, NLGIN100003019, NLGIN100003020, NLGIN100003021
ClassificationClass II
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity21
Recall NumberB-1579-12
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