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Enforcement Report - Week of August 29, 2012

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Biologics Devices Drugs Food / Cosmetics Veterinary

Class I Veterinary Event

Event ID	61897
Status	Ongoing
Product Type	Veterinary
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-May-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Diamond Pet Foods
City	Meta
State	MO
Country	US
Distribution Pattern	Distribution was made to AR, CO, IL, KY, LA, MI, MN, MO, OK, NE, PA, SD, TN, TX, and WI,

Associated Products

Product Description	Diamond 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 Info	Best Before 26Aug2012, 27-Sept 2012, 18-Oct-2012 and 20-Oct-2012
Classification	Class I
Reason for Recall	Contaminated with Salmonella
Product Quantity	4,218/6-lb., 1,802/18-lb., and 7,020/6-oz. bags
Recall Number	V-200-2012

Class I Drugs Event

Event ID	61957
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-May-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	The Menz Club, LLC
City	Ridgeland
State	MS
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	V 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
Classification	Class I
Reason for Recall	Marketed 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 Quantity	585,000 Capsules
Recall Number	D-1657-2012

Class I Veterinary Event

Event ID	62469
Status	Ongoing
Product Type	Veterinary
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-Jun-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Mars Petcare USA
City	Franklin
State	TN
Country	US
Distribution Pattern	Product 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 Description	PEDIGREE+® 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 Info	UPC 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.
Classification	Class I
Reason for Recall	Product 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 Quantity	18,877 cs/12/13.2 oz cans = 226,524 cans
Recall Number	V-201-2012

Product Description	PEDIGREE® 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 Info	UPC 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.
Classification	Class I
Reason for Recall	Product 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 Quantity	23,897 cs/24/13.2 oz cans = 573,528 cans
Recall Number	V-202-2012

Product Description	PEDIGREE® 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 Info	UPC 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.
Classification	Class I
Reason for Recall	Product 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 Quantity	35,551 cs/24/13.2 oz cans = 853,224 cans
Recall Number	V-203-2012

Class I Food/Cosmetics Event

Event ID	62549
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Peoples Bakery Inc
City	Trenton
State	NJ
Country	US
Distribution Pattern	Mercer/Burlington counties in NJ

Associated Products

Product Description	Dinner Rolls, 12 oz. net weight,, manufactured by Italian Peoples Bakery, 61-63 Butler Street, Trenton, NJ 08611;
Code Info	UPC 53277101246
Classification	Class I
Reason for Recall	Product 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	Unknown
Recall Number	F-1944-2012

Product Description	Kaiser Roll, 12 oz. net weight,, manufactured by Italian Peoples Bakery, 61-63 Butler Street, Trenton, NJ 08611;
Code Info	UPC 53277101253
Classification	Class I
Reason for Recall	Product 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 Number	F-1945-2012

Product Description	Torps Rolls 12 oz. net weight,, manufactured by Italian Peoples Bakery, 61-63 Butler Street, Trenton, NJ 08611;
Code Info	UPC 5327710125
Classification	Class I
Reason for Recall	Product 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 Number	F-1946-2012

Class I Devices Event

Event ID	62642
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	CareFusion 303, Inc.
City	San Diego
State	CA
Country	US
Distribution Pattern	Worldwide Distribution-USA (nationwide) and the countries of Australia, European Union, and South Africa.

Associated Products

Product Description	Alaris 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 Info	Model 8100; Lot/Serial numbers-various
Classification	Class I
Reason for Recall	The 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 Quantity	43,862 units total (40,780 units in the US)
Recall Number	Z-2205-2012

Class I Food/Cosmetics Event

Event ID	62669
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Jul-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Cool Creations, LLC
City	North Kansas City
State	MO
Country	US
Distribution Pattern	Direct distribution was made to KS, MO, and OK.

Associated Products

Product Description	Yellow 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 Info	Lot numbers 12201 thru 12207 (last use by date affected is 8/30/2012)
Classification	Class I
Reason for Recall	Products may be contaminated with Listeria monocytogenes
Product Quantity
Recall Number	F-1995-2012

Product Description	Yellow 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 Info	Lot numbers 12201 thru 12207 (last use by date affected is 8/30/2012)
Classification	Class I
Reason for Recall	Products may be contaminated with Listeria monocytogenes
Product Quantity
Recall Number	F-1996-2012

Product Description	Yellow 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 Info	Lot numbers 12201 thru 12207 (last use by date affected is 8/30/2012)
Classification	Class I
Reason for Recall	Products may be contaminated with Listeria monocytogenes
Product Quantity
Recall Number	F-1997-2012

Product Description	Yellow 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 Info	Lot numbers 12201 thru 12207 (last use by date affected is 8/5/2012)
Classification	Class I
Reason for Recall	Products may be contaminated with Listeria monocytogenes
Product Quantity
Recall Number	F-1998-2012

Product Description	Cool 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 Info	Lot numbers 12201 thru 12207 (last use by date affected is 8/5/12)
Classification	Class I
Reason for Recall	Products may be contaminated with Listeria monocytogenes
Product Quantity	209/4/16-oz. container cases, 42/4/8-oz. container cases, and 6/2/5-lb. plastic tray cases
Recall Number	F-1999-2012

Product Description	Cool Creations Fajita Mix Deluxe packaged for food service in 5-lb. plastic trays, 4 per case (item #15741).
Code Info	Lot numbers 12201 thru 12207 (last affected use by date 8/4/12)
Classification	Class I
Reason for Recall	Products may be contaminated with Listeria monocytogenes
Product Quantity	11/4/5-lb. plastic tray cases
Recall Number	F-2000-2012

Product Description	Grillers 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 Info	Lot numbers 12201 thru 12207 (last use by date affected is 8/6/2012)
Classification	Class I
Reason for Recall	Products may be contaminated with Listeria monocytogenes
Product Quantity	59/4/10-oz. cases
Recall Number	F-2001-2012

Product Description	Grillers 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 Info	Lot numbers 12201 thru 12207 (last use by date affected is 8/6/2012)
Classification	Class I
Reason for Recall	Products may be contaminated with Listeria monocytogenes
Product Quantity	71/4/12-oz. tray cases
Recall Number	F-2002-2012

Product Description	Grillers 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 Info	Lot numbers 12201 thru 12207 (last use by date affected is 8/6/2012)
Classification	Class I
Reason for Recall	Products may be contaminated with Listeria monocytogenes
Product Quantity	102/4/10-oz. tray cases
Recall Number	F-2003-2012

Product Description	Grillers 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 Info	Lot numbers 12201 thru 12207 (last use by date affected is 8/6/2012)
Classification	Class I
Reason for Recall	Products may be contaminated with Listeria monocytogenes
Product Quantity	43/4/12-oz. tray cases
Recall Number	F-2004-2012

Product Description	Kabob 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 Info	Lot numbers 12201 thru 12207 (last use by date affected is 8/5/2012)
Classification	Class I
Reason for Recall	Products may be contaminated with Listeria monocytogenes
Product Quantity	95/2/24-oz. container cases
Recall Number	F-2005-2012

Product Description	Beef 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 Info	Lot numbers 12201 thru 12207 (last use by date affected is 8/5/2012)
Classification	Class I
Reason for Recall	Products may be contaminated with Listeria monocytogenes
Product Quantity	26/2/32-oz. container cases
Recall Number	F-2006-2012

Product Description	Vegetable 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 Info	Lot numbers 12201 thru 12207 (last use by date affected is 8/5/2012)
Classification	Class I
Reason for Recall	Products may be contaminated with Listeria monocytogenes
Product Quantity	39/2/20-oz. container cases
Recall Number	F-2007-2012

Product Description	Bean 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 Info	Lot numbers 12201 thru 12207 (last use by date affected is 8/5/2012)
Classification	Class I
Reason for Recall	Products may be contaminated with Listeria monocytogenes
Product Quantity	47/4/10-oz. bowl cases, 24/4/20-oz. bowl cases, 5/4/20-oz. pan cases, and 26/2/45-oz. tray cases
Recall Number	F-2008-2012

Product Description	Fiesta 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 Info	Lot numbers 12201 thru 12207 (last use by date affected is 8/30/2012)
Classification	Class I
Reason for Recall	Products may be contaminated with Listeria monocytogenes
Product Quantity	20/6/16-oz. container cases
Recall Number	F-2009-2012

Product Description	Fiesta garden Fresh Salsa, Garlic, packaged in 16-oz. plastic containers, 6 per case, UPC 829595000062. Distributed by Vanscoy Industries, Cedar Rapids, IA.
Code Info	Lot numbers 12201 thru 12207 (last use by date affected is 8/30/2012)
Classification	Class I
Reason for Recall	Products may be contaminated with Listeria monocytogenes
Product Quantity	30/6/16-oz. container cases
Recall Number	F-2010-2012

Product Description	Fiesta garden Fresh Salsa, Hot, packaged in 16-oz. plastic containers, 12 per case, UPC 829595000048. Distributed by Vanscoy Industries, Cedar Rapids, IA.
Code Info	Lot numbers 12201 thru 12207 (last use by date affected is 8/30/2012)
Classification	Class I
Reason for Recall	Products may be contaminated with Listeria monocytogenes
Product Quantity	60/12/16-oz. container cases
Recall Number	F-2011-2012

Product Description	Fiesta garden Fresh Salsa, Mild, packaged in 16-oz. plastic containers, 12 per case, UPC 829595000017. Distributed by Vanscoy Industries, Cedar Rapids, IA.
Code Info	Lot numbers 12201 thru 12207 (last use by date affected is 8/30/2012)
Classification	Class I
Reason for Recall	Products may be contaminated with Listeria monocytogenes
Product Quantity	160/12/16-oz. container cases
Recall Number	F-2012-2012

Product Description	Fiesta garden Fresh Salsa, Pineapple, packaged in 16-oz. plastic containers, 6 per case, UPC 829595000079. Distributed by Vanscoy Industries, Cedar Rapids, IA.
Code Info	Lot numbers 12201 thru 12207 (last use by date affected is 8/30/2012)
Classification	Class I
Reason for Recall	Products may be contaminated with Listeria monocytogenes
Product Quantity	30/6/16-oz. container cases
Recall Number	F-2013-2012

Class I Food/Cosmetics Event

Event ID	62671
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Jul-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Wimberger's Old World Bakery, Inc.
City	Colorado Springs
State	CO
Country	US
Distribution Pattern	The product was distributed to retailers located in Colorado and Kansas.

Associated Products

Product Description	Kaiser 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 Info	UPC 7960540012.
Classification	Class I
Reason for Recall	Wimberger'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 Quantity	4,874 x 12 units
Recall Number	F-1994-2012

Class I Food/Cosmetics Event

Event ID	62685
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Jul-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Freshpoint Atlanta, Inc.
City	Forest Park
State	GA
Country	US
Distribution Pattern	AL, GA, NC, SC & TN.

Associated Products

Product Description	Processed Yellow Onions - Yellow Sliced 1/8", 1/4" and 3/16"
Code Info	Julian Date 12188 through Julian Date 12206 - Item No. 900258, 801459, 900253, 801103, 501083, 501459, 500258, 900569,
Classification	Class I
Reason for Recall	Product may be contaminated with Listeria monocytogenes.
Product Quantity	142 cases
Recall Number	F-1971-2012

Product Description	Processed Yellow Onions - Yellow Julienne 1/8", 1/4", 3/4" and 3/8"
Code Info	Julian Date 12188 through Julian Date 12206 - Item No. 900540, 500245, 901329, 900215, 901081, 501081, 801329, 700245, 500206, 900245, 501329, 501699, 901699
Classification	Class I
Reason for Recall	Product may be contaminated with Listeria monocytogenes.
Product Quantity	154 cases
Recall Number	F-1972-2012

Product Description	Processed Yellow Onions -Yellow Diced 1/4", 1/2" 3/4", 3/8", and 1/8"
Code Info	Julian 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
Classification	Class I
Reason for Recall	Product may be contaminated with Listeria monocytogenes.
Product Quantity	1635 cases
Recall Number	F-1973-2012

Product Description	Processed Yellow Onions Veg. Ratatouille Mix
Code Info	Julian Date 12188 through Julian Date 12206 - Item No. 900776, 500776
Classification	Class I
Reason for Recall	Product may be contaminated with Listeria monocytogenes.
Product Quantity	17 cases
Recall Number	F-1974-2012

Product Description	Processed Yellow Onions Cubed 1"
Code Info	Julian Date 12188 through Julian Date 12206 - Item No. 500236, 800236
Classification	Class I
Reason for Recall	Product may be contaminated with Listeria monocytogenes.
Product Quantity	2 cases
Recall Number	F-1975-2012

Product Description	Processed Yellow Onions - Veg. Harvest Hash Mix
Code Info	Julian Date 12188 through Julian Date 12206 - Item No. 901786, 501786
Classification	Class I
Reason for Recall	Product may be contaminated with Listeria monocytogenes.
Product Quantity	4 cases
Recall Number	F-1976-2012

Product Description	Processed Yellow Onions - Veg. Mirepoix
Code Info	Julian Date 12188 through Julian Date 12206 - Item No. 901041, 501205
Classification	Class I
Reason for Recall	Product may be contaminated with Listeria monocytogenes.
Product Quantity	70 cases
Recall Number	F-1977-2012

Product Description	Processed Yellow Onions - Veg. Mix Asp/On/Ryg Pep Jul
Code Info	Julian Date 12188 through Julian Date 12206 - Item No. 501441
Classification	Class I
Reason for Recall	Product may be contaminated with Listeria monocytogenes.
Product Quantity	3 cases
Recall Number	F-1978-2012

Product Description	Processed Yellow Onions - Whole Peeled
Code Info	Julian Date 12188 through Julian Date 12206 - Item No. 500557, 500267, 501884, 800267, 900267
Classification	Class I
Reason for Recall	Product may be contaminated with Listeria monocytogenes.
Product Quantity	62 cases
Recall Number	F-1979-2012

Product Description	Processed Yellow Onions - Veg. Fajita Mix II & III Julienne
Code Info	Julian Date 12188 through Julian Date 12206 - Item No. 500619, 900619, 901393
Classification	Class I
Reason for Recall	Product may be contaminated with Listeria monocytogenes.
Product Quantity	17 cases
Recall Number	F-1980-2012

Product Description	Processed Yellow Onions - Yellow Slivered
Code Info	Julian Date 12188 through Julian Date 12206 - Item No. 501200
Classification	Class I
Reason for Recall	Product may be contaminated with Listeria monocytogenes.
Product Quantity	3425 cases
Recall Number	F-1981-2012

Product Description	Processed Yellow Onions - Veg. Asian Bias Mix
Code Info	Julian Date 12188 through Julian Date 12206 - Item No. 501204
Classification	Class I
Reason for Recall	Product may be contaminated with Listeria monocytogenes.
Product Quantity	153 cases
Recall Number	F-1982-2012

Product Description	Processed Yellow Onions - Yellow Colossal Ring
Code Info	Julian Date 12188 through Julian Date 12206 - Item No. 901375
Classification	Class I
Reason for Recall	Product may be contaminated with Listeria monocytogenes.
Product Quantity	16 cases
Recall Number	F-1983-2012

Class I Food/Cosmetics Event

Event ID	62686
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Jul-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Huxtable's Kitchen Inc
City	Vernon
State	CA
Country	US
Distribution Pattern	Distributed to Trader Joes market stores CA, AZ, NV and NM.

Associated Products

Product Description	Trader 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 Info	Use by date 7/28/12 and 7/30/12
Classification	Class I
Reason for Recall	Recall initiated by firm because the onions uses as an ingredient have the potential to be contaminated by Listeria monocytogenes.
Product Quantity	3639 units
Recall Number	F-1986-2012

Class I Food/Cosmetics Event

Event ID	62694
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Jul-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Reshmi's Group Inc.
City	Kent
State	WA
Country	US
Distribution Pattern	Product was further distributed to consignees in Alaska, Colorado, Oregon, and Washington

Associated Products

Product Description	Crispy 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 FoodsIngredients: Wheat Flour, soybean oil, margarine, sugar, semolina, baking powder, ammonium carbonate*".
Code Info	USE BYE DATE JULY 31ST 2012.
Classification	Class I
Reason for Recall	Crispy Just Baked Punjabi Cookies contain milk but the label does not declare milk.
Product Quantity	estimated 228 cases
Recall Number	F-1988-2012

Class I Food/Cosmetics Event

Event ID	62701
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	23-Jul-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Mother India foods LLC
City	Portland
State	OR
Country	US
Distribution Pattern	Distributed in Oregon and Washington

Associated Products

Product Description	Crispy 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 FoodsNet Wt. 800 g/1.76 lbsIngredients: Wheat Flour, soybean oil, margarine, sugar, semolina, baking powder, ammonium carbonate**".
Code Info	All lots and all codes
Classification	Class I
Reason for Recall	Crispy Just Baked Punjabi Cookies contain milk but the label does not declare milk.
Product Quantity	69 cases (14 packages/800 gram)
Recall Number	F-1989-2012

Class I Food/Cosmetics Event

Event ID	62777
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	2 Moms in the Raw, LLC
City	Lafayette
State	CO
Country	US
Distribution Pattern	National US distribution only: OR, NY, KS, PA, CA, TX, NH, WA.

Associated Products

Product Description	Two 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 Info	Lot numbers: 1008, 1016, 1027, 1055, 1067.
Classification	Class I
Reason for Recall	Two 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 Quantity	4618 x 4 oz bags
Recall Number	F-1991-2012

Class I Food/Cosmetics Event

Event ID	62778
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	02-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Deep Foods Inc
City	Union
State	NJ
Country	US
Distribution Pattern	Nationwide.

Associated Products

Product Description	Crispy 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 Info	All lots shipped to customers between August 1, 2011 to current date (8/2/2012).
Classification	Class I
Reason for Recall	This 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 Quantity	391 cases
Recall Number	F-1987-2012

Class I Food/Cosmetics Event

Event ID	62782
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Aug-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Specialty Commodities, Inc.
City	Fargo
State	ND
Country	US
Distribution Pattern	CA, MN NJ, NY, OR, PA, SC, and Canada

Associated Products

Product Description	Organic Pinenut, 25 kg, Product of China
Code Info	Mfg Lot No: 97638
Classification	Class I
Reason for Recall	A customer of Specialty Commodities reported that they found peanuts in a container of pine nuts.
Product Quantity	541 - 25kg containers
Recall Number	F-1990-2012

Class I Food/Cosmetics Event

Event ID	62793
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Aug-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Menno Beachy
City	Cresco
State	IA
Country	US
Distribution Pattern	Distribution 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 Description	Menno 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 Info	Lot numbers MB725GT0, MB725GT3, and MB725GT8. These lot numbers only appear on the case label, not on the clamshell label.
Classification	Class I
Reason for Recall	Salmonella Montevideo was isolated in one lot of the grape tomatoes
Product Quantity	20/12/1-pt. container cases
Recall Number	F-1992-2012

Class I Food/Cosmetics Event

Event ID	62802
Status	Completed
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Aug-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Essential Living Foods, Inc
City	Culver City
State	CA
Country	US
Distribution Pattern	CA

Associated Products

Product Description	Pine Nuts, 5lbs, Item 40476-214, UPC 8 12986 01288.
Code Info	Lot #21712
Classification	Class I
Reason for Recall	Essential Living is recalling Pine Nuts because it has undeclared peanuts.
Product Quantity	1 unit
Recall Number	F-1993-2012

Class I Food/Cosmetics Event

Event ID	62806
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Aug-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Fresco Green Farms, Inc.
City	Winchester
State	CA
Country	US
Distribution Pattern	CA

Associated Products

Product Description	Cilantro, 2.5 dozens, 30 bunches/case
Code Info	Produt is not coded.
Classification	Class I
Reason for Recall	Fresco Green Farms Inc. is recalling cilantro because it has the potential to be contaminated with Salmonella.
Product Quantity	1,643 cases
Recall Number	F-2014-2011

Class II Biologics Event

Event ID	38681
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Mar-07
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Belle Bonfils Memorial Blood Center
City	Denver
State	CO
Country	US
Distribution Pattern	AZ

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	6731694
Classification	Class II
Reason for Recall	Blood product, negative for the Fyb-antigen but typed as Fyb-antigen positive, was distributed.
Product Quantity	1 unit
Recall Number	B-1748-12

Class II Biologics Event

Event ID	38689
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Jun-07
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Belle Bonfils Memorial Blood Center
City	Denver
State	CO
Country	US
Distribution Pattern	Colorado, Switzerland

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	2143525
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity	1 unit
Recall Number	B-1738-12

Product Description	Red Blood Cells
Code Info	2143525
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity	1 unit
Recall Number	B-1739-12

Class II Biologics Event

Event ID	40124
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-May-05
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Community Blood Center of Greater Kansas City
City	Kansas City
State	MO
Country	US
Distribution Pattern	MO

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W045005005778
Classification	Class II
Reason for Recall	Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity	1 unit
Recall Number	B-2052-12

Class II Biologics Event

Event ID	40693
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Aug-05
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Biomat USA, Inc.
City	Los Angeles
State	CA
Country	US
Distribution Pattern	Spain

Associated Products

Product Description	Source Plasma
Code Info	380017145, 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
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was previously deferred, were distributed.
Product Quantity	49 units
Recall Number	B-1287-12

Class II Biologics Event

Event ID	40833
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Aug-05
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	American Red Cross Blood Services
City	Wichita
State	KS
Country	US
Distribution Pattern	OK, KY

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	02LH75991
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-1799-12

Product Description	Blood and Blood Products for Reprocessing
Code Info	02LH75991
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-1800-12

Class II Biologics Event

Event ID	40870
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Oct-05
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	American National Red Cross (The)
City	Oakland
State	CA
Country	US
Distribution Pattern	Blood products were released for distribution to consignees located in CA.

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
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084T15988, 084T16024, 084T16029, 084T16063, 084T16069, 084T16076, 084T16084, 084T16110, 084T16113, 084T16244, 084T16262, 084T16355, 084T16483, 084T16484, 084T16486, 084T16490, 084T16494, 084T16510, 084T16515, 084T16525, 084T17057, 084T17062, 084T17446, 084T17562, 084T18567, 084T18568, 084T19296, 084T19507, 084T19562, 084T19581, 084T19942, 084T19944, 084T19963, 084T20058, 084T20132, 084T20590, 084T20891, 084T20903, 084T20913, 084T20914, 084T20994, 084T21128, 084T21165, 084T21265, 084T21300, 084T21311, 084T21318, 084T21404, 084T21664, 084T21678, 084T21855, 084T21857, 084T21867, 084T21911, 084T22224, 084T22271, 084T22275, 084T22577, 084T22677, 084T22790, 084T22947, 084T23189, 084T23223, 084T23229, 084T23231, 084T23890, 084T23899, 084T24112, 084T24136, 084T24145, 084T24173, 084T24396 , 084T24506, 084T24573, 084T24925, 084T24957, 084T25012, 084T25095, 084T25367, 084W61337, 084W61342, 084W61718, 084W61722, 084W61944, 084W61951, 084W61964, 084W61978, 084W62039, 084W62054, 084W62062, 084W62272, 084W62288, 084W62331, 084W62393, 084W62394, 084W62396, 084W62404, 084W62416, 084W62418, 084W62552, 084W62555, 084W62706, 084W62869, 084W62872, 084W62893, 084W62980, 084W63133, 084W63886, 084W63931, 084W63959, 084W64007, 084W64175, 084W64182, 084W64340, 084W64386, 084W64401, 084W64558, 084W64580, 084W64950, 084W65141, 084W65393, 084W65458, 084W65475, 084W65851, 084W65885, 084W66026, 084W66191, 084W66283, 084W66311, 084W66353, 084W66417, 084W66805, 084W66817, 084W66821, 084W66825, 084W66887, 084W66889, 084W66922, 084W66938, 084W66958, 084W67003, 084W67021, 084W67025, 084W67363, 084W67369, 084W67372, 084W67565, 084W67643, 084W67652, 084W67653, 084W67699, 084W67781, 084W67791, 084W68377, 084W68384, 084W68425, 084W68436, 084W68483 , 084W68521 , 084W68616 , 084W68626 , 084W68717, 084W68830, 084W68987, 084W68996, 084W68999, 084W69048, 084W69058, 084W69313, 084W69342, 084W69352, 084W69511, 084W69570, 084W69626, 084W69789, 084W69825, 084W69865, 084W70224, 084Z83316, 084Z83353, 084Z84246, 084Z84585, 084Z84598, 084Z84614, 084Z84672, 084Z84687, 084Z84688, 084Z84697, 084Z84703, 084Z84742, 084Z84754, 084Z84756, 084Z84862, 084Z84878, 084Z85046, 084Z85056, 084Z85201, 084Z85259, 084Z85324, 084Z85512, 084Z85573, 084Z85626, 084Z86198, 084Z86358, 084Z86651, 084Z86693, 084Z86727, 084Z86728, 084Z86731, 084Z86763, 084Z86906, 084Z86994, 084Z87308, 084Z87351, 084Z87550, 084Z87580, 084Z87679, 084Z87715, 084Z87819, 084Z87871, 084Z87964, 084Z87989, 084Z88001, 084Z88037, 084Z88043, 084Z88091, 084Z88182, 084Z88225, 084Z88244, 084Z88251, 084Z88337, 084Z88344, 084Z88463, 084Z88553, 084Z88569, 084Z88604, 084Z89320 , 084Z89397, 084Z89432 , 084Z89499, 084Z89537, 084Z89573, 084Z89589, 084Z89746, 084Z89759, 084Z89835, 084Z89869, 084Z89886, 084Z89979, 084Z90070, 084Z90155, 084Z90224, 084Z90864, 211LE53095, 211LE54987, 211LE55166, 211LE55504, 211LE62607
Classification	Class II
Reason for Recall	Blood products, lacking proper documentation of antigen phenotyping, were distributed.
Product Quantity	960
Recall Number	B-2289-12

Product Description	Red Blood Cells
Code Info	084LT31329, P-2; 084LT31329, P-I; 084LT31600, P-1; 084LT31600, P-2
Classification	Class II
Reason for Recall	Blood products, lacking proper documentation of antigen phenotyping, were distributed.
Product Quantity	4
Recall Number	B-2290-12

Product Description	Red Blood Cells Deglycerolized Leukocytes Reduced
Code Info	021KC66135, 084FT77211, 084FT78046, 084FT81909, 084J90862, 084J93534, 084KM43545, 084LP37814, 084Q20379 084T15992 084T18414 084T21858 084Z84403 084Z88455
Classification	Class II
Reason for Recall	Blood products, lacking proper documentation of antigen phenotyping, were distributed.
Product Quantity	14
Recall Number	B-2291-12

Product Description	Red Blood Cells Deglycerolized Leukocytes Reduced
Code Info	084FT82947, 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
Classification	Class II
Reason for Recall	Blood products, lacking proper documentation of antigen phenotyping, were distributed.
Product Quantity	32
Recall Number	B-2292-12

Product Description	Red Blood Cells Deglycerolized Leukocytes Reduced
Code Info	084FT72445, 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
Classification	Class II
Reason for Recall	Blood products, lacking proper documentation of antigen phenotyping, were distributed.
Product Quantity	31
Recall Number	B-2293-12

Product Description	Red Blood Cells Leukocytes Reduced Frozen
Code Info	084FT80048, 084FT80056, 084K59787, 084Q14901, 084T20919
Classification	Class II
Reason for Recall	Blood products, lacking proper documentation of antigen phenotyping, were distributed.
Product Quantity	5
Recall Number	B-2294-12

Class II Biologics Event

Event ID	41015
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Oct-05
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Community Blood Center of Greater Kansas City
City	Kansas City
State	MO
Country	US
Distribution Pattern	MO

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W045005057009
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity	1 unit
Recall Number	B-2046-12

Class II Biologics Event

Event ID	41141
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Oct-05
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Community Blood Center of Greater Kansas City
City	Kansas City
State	MO
Country	US
Distribution Pattern	MO

Associated Products

Product Description	Red Blood Cells
Code Info	W045005063760
Classification	Class II
Reason for Recall	Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity	1 unit
Recall Number	B-2053-12

Class II Biologics Event

Event ID	41550
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Jan-06
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Community Blood Center of Greater Kansas City
City	Kansas City
State	MO
Country	US
Distribution Pattern	MO

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W045005101342
Classification	Class II
Reason for Recall	Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity	1 unit
Recall Number	B-2153-12

Class II Biologics Event

Event ID	42583
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Jul-06
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Mississippi Valley Reg Bld Ctr
City	Davenport
State	IA
Country	US
Distribution Pattern	Kentucky

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	GK12345
Classification	Class II
Reason for Recall	Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity	1 Unit
Recall Number	B-1635-12

Class II Biologics Event

Event ID	42718
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Jul-06
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Belle Bonfils Memorial Blood Center
City	Denver
State	CO
Country	US
Distribution Pattern	CO, CA, Switzerland

Associated Products

Product Description	Red Blood Cells
Code Info	6921760, 6417894, 6613297
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity	3 units
Recall Number	B-1786-12

Product Description	Fresh Frozen Plasma
Code Info	6419927, 6417894
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity	2 units
Recall Number	B-1787-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	6731967, 6920467, 6915184, 6419927, 6910371, 6179510.
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity	6 units
Recall Number	B-1788-12

Product Description	Blood and Blood Products for Reprocessing
Code Info	6731967, 6921760, 6920467, 6915184, 6910371, 6613297, 6179510.
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity	7 units
Recall Number	B-1789-12

Class II Biologics Event

Event ID	42875
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	23-Aug-06
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Community Blood Bank of Lancaster County Medical Society
City	Lincoln
State	NE
Country	US
Distribution Pattern	NE

Associated Products

Product Description	Red Blood Cells (Apheresis) Leukocytes Reduced
Code Info	6040735(Part A): 6040735(Part B)
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity	2 units
Recall Number	B-2024-12

Class II Biologics Event

Event ID	43441
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Nov-06
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Mississippi Valley Regional Blood Center
City	Davenport
State	IA
Country	US
Distribution Pattern	Iowa

Associated Products

Product Description	Red Blood Cells
Code Info	Y53727
Classification	Class II
Reason for Recall	Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity
Recall Number	B-2143-12

Class II Biologics Event

Event ID	43734
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Dec-06
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Mississippi Valley Regional Blood Center
City	Davenport
State	IA
Country	US
Distribution Pattern	Missouri, Iowa

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced Irradiated
Code Info	K41143(Part A); K41143(Part B)
Classification	Class II
Reason for Recall	Blood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity	2 Units
Recall Number	B-2207-12

Class II Biologics Event

Event ID	43919
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Jan-07
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Mississippi Valley Regional Blood Center
City	Davenport
State	IA
Country	US
Distribution Pattern	Washington, D.C.

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	KW07812
Classification	Class II
Reason for Recall	Blood product, which did not meet acceptable product specifications, was distributed.
Product Quantity	1 unit
Recall Number	B-2201-12

Class II Biologics Event

Event ID	44403
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Feb-07
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Community Blood Bank of Lancaster County Medical Society
City	Lincoln
State	NE
Country	US
Distribution Pattern	FL

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	3732972
Classification	Class II
Reason for Recall	Blood product, which was collected from a donor who lived in a malarial endemic area, was distributed.
Product Quantity	1 unit
Recall Number	B-2040-12

Class II Biologics Event

Event ID	45109
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Sep-07
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Mississippi Valley Reg Bld Ctr
City	Davenport
State	IA
Country	US
Distribution Pattern	Iowa

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	E26323
Classification	Class II
Reason for Recall	Blood product, which did not meet acceptable product specifications, was distributed.
Product Quantity	1 Unit
Recall Number	B-2197-12

Class II Biologics Event

Event ID	45110
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Sep-07
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Community Blood Bank of Lancaster County Medical Society
City	Lincoln
State	NE
Country	US
Distribution Pattern	NE

Associated Products

Product Description	Red Blood Cells (Apheresis) Leukocytes Reduced
Code Info	6074434(Part A); 6074434(Part B)
Classification	Class II
Reason for Recall	Blood products, collection bag with pin size hole under the label were distributed.
Product Quantity	2 units
Recall Number	B-2067-12

Class II Biologics Event

Event ID	45130
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Jul-07
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Belle Bonfils Memorial Blood Center
City	Denver
State	CO
Country	US
Distribution Pattern	MI, Switzerland

Associated Products

Product Description	Red Blood Cells
Code Info	3713775
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity	1 unit
Recall Number	B-1797-12

Product Description	Recovered Plasma
Code Info	3713775
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity	1 unit
Recall Number	B-1798-12

Class II Biologics Event

Event ID	45717
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Sep-07
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Mississippi Valley Reg Bld Ctr
City	Davenport
State	IA
Country	US
Distribution Pattern	Pennsylvania

Associated Products

Product Description	Platelets
Code Info	GP02952
Classification	Class II
Reason for Recall	Blood product, which was collected in a collection system that had product integrity compromised during component preparation, was distributed.
Product Quantity	1 Unit
Recall Number	B-2198-12

Class II Biologics Event

Event ID	46547
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Dec-07
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	American Red Cross Blood Services
City	Omaha
State	NE
Country	US
Distribution Pattern	NE

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	09FF23771; 09FF25553
Classification	Class II
Reason for Recall	Blood products, in which testing for Jka antigen was interpreted, or incorrectly documented were distributed
Product Quantity	2 units
Recall Number	B-1964-12

Class II Biologics Event

Event ID	46972
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Nov-07
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Mississippi Valley Reg Bld Ctr
City	Davenport
State	IA
Country	US
Distribution Pattern	Iowa, Illinois

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced Irradiated
Code Info	KW09237
Classification	Class II
Reason for Recall	Blood products, which did not meet acceptable product specifications, were distributed.
Product Quantity	1 Unit
Recall Number	B-2199-12

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	KW09237
Classification	Class II
Reason for Recall	Blood products, which did not meet acceptable product specifications, were distributed.
Product Quantity	1 Unit
Recall Number	B-2200-12

Class II Biologics Event

Event ID	46988
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Oct-07
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Delta Blood Bank
City	Stockton
State	CA
Country	US
Distribution Pattern	CA.

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	V80168
Classification	Class II
Reason for Recall	Blood product, collected from a donor who traveled to a malaria endemic area, was distributed.
Product Quantity	1
Recall Number	B-1773-12

Class II Biologics Event

Event ID	47198
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Jan-08
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Belle Bonfils Memorial Blood Center
City	Denver
State	CO
Country	US
Distribution Pattern	CO, Switzerland

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	6559105
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity	1 unit
Recall Number	B-1793-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	6559105
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity	1 unit
Recall Number	B-1794-12

Class II Biologics Event

Event ID	47662
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Dec-07
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Delta Blood Bank
City	Stockton
State	CA
Country	US
Distribution Pattern	CA and Austria

Associated Products

Product Description	Red Blood Cells
Code Info	H24693
Classification	Class II
Reason for Recall	Blood products, collected from a donor taking the drug methotrexate, were distributed.
Product Quantity	1
Recall Number	B-1806-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	H24295
Classification	Class II
Reason for Recall	Blood products, collected from a donor taking the drug methotrexate, were distributed.
Product Quantity	1
Recall Number	B-1807-12

Product Description	Blood and Blood Products for Reprocessing
Code Info	H24693, H24295
Classification	Class II
Reason for Recall	Blood products, collected from a donor taking the drug methotrexate, were distributed.
Product Quantity	2
Recall Number	B-1808-12

Class II Biologics Event

Event ID	47979
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Apr-08
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Mississippi Valley Regional Blood Center
City	Davenport
State	IA
Country	US
Distribution Pattern	California, Missouri and Maryland

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced Irradiated
Code Info	K47326; K47326; K47326
Classification	Class II
Reason for Recall	Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
Product Quantity	3 Units
Recall Number	B-2209-12

Class II Biologics Event

Event ID	49692
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Aug-08
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	BioLife Plasma Services L.P.
City	Deerfield
State	IL
Country	US
Distribution Pattern	CA

Associated Products

Product Description	Source Plasma
Code Info	07DIAF9913
Classification	Class II
Reason for Recall	Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1 unit
Recall Number	B-1744-12

Class II Biologics Event

Event ID	50383
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Oct-08
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Plasma Care, Inc. dba Marion Blood Plasma, Inc.
City	Indianapolis
State	IN
Country	US
Distribution Pattern	California.

Associated Products

Product Description	Source Plasma.
Code Info	2010162630 , 2010162088.
Classification	Class II
Reason for Recall	Blood products, which were not quarantined subsequent to receiving disqualifying post donation information, were distributed.
Product Quantity	2
Recall Number	B-1803-12

Class II Biologics Event

Event ID	50403
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Oct-08
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Belle Bonfils Memorial Blood Center
City	Denver
State	CO
Country	US
Distribution Pattern	CO, Switzerland

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	W036208303073
Classification	Class II
Reason for Recall	Blood products, collected from a donor with a history of Hepatitis A, were distributed.
Product Quantity	1 unit
Recall Number	B-1795-12

Product Description	Red Blood Cells, Leukocytes Reduced.
Code Info	W036208303073
Classification	Class II
Reason for Recall	Blood products, collected from a donor with a history of Hepatitis A, were distributed.
Product Quantity	1 unit
Recall Number	B-1796-12

Class II Biologics Event

Event ID	50626
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	31-Oct-08
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	American National Red Cross (The)
City	Louisville
State	KY
Country	US
Distribution Pattern	KY, IN

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	24KS91773
Classification	Class II
Reason for Recall	Blood products, manufactured from overweight whole blood unit, were distributed.
Product Quantity	1 unit
Recall Number	B-1235-12

Product Description	Cryoprecipitated AHF
Code Info	24KS91773
Classification	Class II
Reason for Recall	Blood products, manufactured from overweight whole blood unit, were distributed.
Product Quantity	1 unit
Recall Number	B-1236-12

Class II Biologics Event

Event ID	50669
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Dec-08
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Blood Center of Northcentral Wisconsin, Inc.
City	Wausau
State	WI
Country	US
Distribution Pattern	WI, NY

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	F01615
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity	1
Recall Number	B-2054-12

Product Description	Plasma Frozen
Code Info	F01615
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity	1
Recall Number	B-2055-12

Class II Biologics Event

Event ID	54896
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-Dec-09
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	CSL Plasma, Inc.
City	Boca Raton
State	FL
Country	US
Distribution Pattern	IL, NC, CA.

Associated Products

Product Description	Source Plasma
Code Info	6160249894; 6160249295; 6160247737; 6160246995; 01266146; 01222340; 01101348; 85399372; 85308510; 85296886 85284470 80754343 80750888 0540414653 0540414348
Classification	Class II
Reason for Recall	Blood products, collected from a donor regarding multiple high-risk behaviors, were distributed.
Product Quantity	15 units
Recall Number	B-1734-12

Class II Biologics Event

Event ID	55395
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Dec-09
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Csl Plasma Inc
City	Boca Raton
State	FL
Country	US
Distribution Pattern	Illinois

Associated Products

Product Description	Source Plasma
Code Info	15 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
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was permanently deferred, were distributed.
Product Quantity	14 units
Recall Number	B-2142-12

Class II Biologics Event

Event ID	57772
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Dec-10
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Delta Blood Bank
City	Stockton
State	CA
Country	US
Distribution Pattern	CA.

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W128710220363
Classification	Class II
Reason for Recall	Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity	1
Recall Number	B-2041-12

Class II Devices Event

Event ID	61671
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Stryker Medical Division of Stryker Corporation
City	Portage
State	MI
Country	US
Distribution Pattern	Worldwide 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 Description	Powered 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 Info	Model 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.
Classification	Class II
Reason for Recall	Paramed 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 Quantity	159 units
Recall Number	Z-2246-2012

Product Description	Powered 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 Info	Model: EMS24 with serial codes: 100346, 100348, 100355, 100356, 100357, 100358, 100359, 100360, 100362, 100363, and 100364.
Classification	Class II
Reason for Recall	Paramed 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 Quantity	159 units
Recall Number	Z-2247-2012

Product Description	Powered 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 Info	Model: 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.
Classification	Class II
Reason for Recall	Paramed 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 Quantity	159 units
Recall Number	Z-2248-2012

Product Description	Powered 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 Info	Model: 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.
Classification	Class II
Reason for Recall	Paramed 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 Quantity	159 units
Recall Number	Z-2249-2012

Class II Biologics Event

Event ID	61861
Status	Ongoing
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Siemens Healthcare Diagnostics Inc.
City	Berkeley
State	CA
Country	US
Distribution Pattern	Product 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 Description	Siemens 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 Info	Lot Numbers: U080A1, U080A2
Classification	Class II
Reason for Recall	Trugene HIV-1 Genotype kits, not meeting current performance claims due to variation during manufacture, were distributed.
Product Quantity	2 lots
Recall Number	B-2263-12

Class II Devices Event

Event ID	62134
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Oct-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Exactech, Inc.
City	Gainesville
State	FL
Country	US
Distribution Pattern	Nationwide 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 Description	OPTETRAK 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 Info	Catalog Number: 02-012-42-2508.
Classification	Class II
Reason for Recall	Exactech, 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 Quantity	70
Recall Number	Z-2234-2012

Class II Biologics Event

Event ID	62305
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-May-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	SightLife
City	Seattle
State	WA
Country	US
Distribution Pattern	One cornea was shipped to each of 2 physicians in Japan.

Associated Products

Product Description	Corneas
Code Info	AAG744ODCN; AAG744OSCN
Classification	Class II
Reason for Recall	Human Corneas, recovered from a donor with evidence of infection due to a communicable disease agent, were distributed.
Product Quantity	2 corneas, (1 right, 1 left)
Recall Number	B-2312-12

Class II Devices Event

Event ID	62410
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Mar-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Abbott Point Of Care Inc.
City	Princeton
State	NJ
Country	US
Distribution Pattern	Worldwide Distribution - US Nationwide, International

Associated Products

Product Description	i-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 Info	510(K)K031739 List Number 06F15-03, 06F15-04, 03P90-25, 600-9009-25 All lots
Classification	Class II
Reason for Recall	Abbott 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 Quantity	7,057675 cartridges US; 772,400 cartridges OUS
Recall Number	Z-2237-2012

Class II Devices Event

Event ID	62460
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Siemens Healthcare Diagnostics, Inc.
City	Newark
State	DE
Country	US
Distribution Pattern	Worldwide Distribution-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 Description	EasyLink 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 Info	Part Number: 1000034805, Version 5.0 and Version 5.0 Service Pack 1 through 4
Classification	Class II
Reason for Recall	When 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 Quantity	637
Recall Number	Z-2242-2012

Class II Food/Cosmetics Event

Event ID	62521
Status	Terminated
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Jun-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Breadfarm
City	Bow
State	WA
Country	US
Distribution Pattern	Distributed to retailers and direct accounts in Washington State.

Associated Products

Product Description	Whiskey 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.
Classification	Class II
Reason for Recall	The 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 Quantity	46, 9.6oz packages
Recall Number	F-1966-2012

Product Description	Wheat 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.
Classification	Class II
Reason for Recall	The 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 Quantity	163, 6.4oz packages
Recall Number	F-1967-2012

Product Description	Fig 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.
Classification	Class II
Reason for Recall	The 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 Quantity	Approximately 50 to 60 pounds.
Recall Number	F-1968-2012

Class II Drugs Event

Event ID	62530
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Noven Pharmaceuticals, Inc.
City	Miami
State	FL
Country	US
Distribution Pattern	Nationwide and Puerto Rico.

Associated Products

Product Description	Daytrana (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 Info	Lot # 55302, Exp 12/12
Classification	Class II
Reason for Recall	Miscalibrated 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 Quantity	177,900 patches
Recall Number	D-1653-2012

Product Description	Daytrana (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 Info	Lot # 56506, Exp 12/12
Classification	Class II
Reason for Recall	Miscalibrated 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 Quantity	121,530 patches
Recall Number	D-1654-2012

Product Description	Daytrana (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 Info	Lot #53823, Exp 08/12
Classification	Class II
Reason for Recall	Miscalibrated 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 Quantity	231,270 patches
Recall Number	D-1655-2012

Class II Food/Cosmetics Event

Event ID	62539
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-Jul-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	KT Specialty Foods Inc.
City	Portland
State	OR
Country	US
Distribution Pattern	Products are distributed in Oregon and Washington

Associated Products

Product Description	Cheese Pizza. Label is not provided. Product is packaged and delivered in bulk.
Code Info	None
Classification	Class II
Reason for Recall	Cheese Pizza is recalled due to the lack of temperature control to prevent pathogens growth.
Product Quantity	20-25 units
Recall Number	F-1947-2012

Product Description	Pizza Bagel. Label is not provided. Product is packaged and delivered in bulk.
Code Info	None
Classification	Class II
Reason for Recall	Pizza Bagel is recalled due to the lack of temperature control to prevent pathogens growth.
Product Quantity	50-100 units
Recall Number	F-1948-2012

Product Description	Veggie Pizza. Label is not provided. Product is packaged and delivered in bulk.
Code Info	None
Classification	Class II
Reason for Recall	Veggie Pizza is recalled due to the lack of temperature control to prevent pathogens growth.
Product Quantity	20 units
Recall Number	F-1949-2012

Class II Drugs Event

Event ID	62541
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Nov-11
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Victus, Inc.
City	Miami
State	FL
Country	US
Distribution Pattern	FL

Associated Products

Product Description	Hipoglos 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 Info	Lot #/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
Classification	Class II
Reason for Recall	Misbranded
Product Quantity	1,535 Tubes
Recall Number	D-1652-2012

Class II Devices Event

Event ID	62567
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Mckesson Medical Imaging Group
City	Richmond
State	BC
Country	CA
Distribution Pattern	Worldwide Distribution - U.S. Nationwide and the countries of: Canada, France, Ireland and United Kingdom.

Associated Products

Product Description	Horizon 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 Info	Horizon Medial Imaging (HMI) versions 11.5, 11.5.1, 11.5.2, 11.6 and 11.7.
Classification	Class II
Reason for Recall	There is a potential to save reports in RadReport with an Incorrect Final Status.
Product Quantity	516 units
Recall Number	Z-2238-2012

Class II Devices Event

Event ID	62571
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Medtronic Navigation, Inc.
City	Littleton
State	MA
Country	US
Distribution Pattern	Worldwide 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 Description	Medtronic 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 Info	Serial Numbers: 109R, 118R, 124, 136, 159 ,170, 218, 222, 223, 236, 239 , 299, 309R, 402, 410, 412, 414.
Classification	Class II
Reason for Recall	A fault in a high voltage relay in the 0-arm® Imaging System might cause the relay to overheat and burn.
Product Quantity	17 units
Recall Number	Z-2244-2012

Class II Devices Event

Event ID	62576
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Conformis Inc
City	Burlington
State	MA
Country	US
Distribution Pattern	Worldwide Distribution - US Nationwide and the country of Germany

Associated Products

Product Description	Conformis 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 Info	All serial numbers
Classification	Class II
Reason for Recall	Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique
Product Quantity	1427 units
Recall Number	Z-2222-2012

Class II Devices Event

Event ID	62581
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Siemens Medical Solutions, USA, Inc
City	Ann Arbor
State	MI
Country	US
Distribution Pattern	Nationwide Distribution -- MA, GA, MO, IA, CA, PA, OR, CO, NY, NJ, WA, UT, OH, WI, MI, KY, and NC.

Associated Products

Product Description	syngo Dynamics Version 9.5
Code Info	10091862 and 10091863
Classification	Class II
Reason for Recall	If 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 Quantity	30
Recall Number	Z-2219-2012

Class II Food/Cosmetics Event

Event ID	62623
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-May-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	LD Amory & Company
City	Hampton
State	VA
Country	US
Distribution Pattern	The products were distributed to AZ, NC, and VA.

Associated Products

Product Description	Oysters, Frozen IQF, packaged in 5 lb bags, 6x5 lb/cartons, labeled in part *Product of Korea*
Code Info	All codes
Classification	Class II
Reason for Recall	Molluscan shellfish may have been exposed to human fecal waste and are potentially contaminated with norovirus.
Product Quantity	60,000 lbs
Recall Number	F-1950-2012

Class II Devices Event

Event ID	62640
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Siemens Healthcare Diagnostics, Inc
City	East Walpole
State	MA
Country	US
Distribution Pattern	Worldwide Distribution - US Nationwide and the countries of: Foreign: Brazil, China, Denmark, Hong Kong, Malaysia, and New Zealand Viet Nam

Associated Products

Product Description	Siemens 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 Info	US 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.
Classification	Class II
Reason for Recall	Syphilis Assay Interference with HBsAg Assay
Product Quantity	2050 Kits
Recall Number	Z-2228-2012

Class II Devices Event

Event ID	62649
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	DePuy Orthopaedics, Inc.
City	Warsaw
State	IN
Country	US
Distribution Pattern	Worldwide Distribution - USA including PA and the country of Canada

Associated Products

Product Description	Altrx" 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 Info	Catalog number: 1221-36-054 and Lot Number: 231859
Classification	Class II
Reason for Recall	In 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 Quantity	20 liners
Recall Number	Z-2220-2012

Class II Devices Event

Event ID	62663
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Apr-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Stryker Spine
City	Allendale
State	NJ
Country	US
Distribution Pattern	Distributed in Atlanta, Georgia.

Associated Products

Product Description	Stryker 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 Info	Code 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
Classification	Class II
Reason for Recall	The 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 Quantity	40 units.
Recall Number	Z-2235-2012

Class II Devices Event

Event ID	62684
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Terumo Cardiovascular Systems Corporation
City	Ann Arbor
State	MI
Country	US
Distribution Pattern	Worldwide Distribution - 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 Description	Serial 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 Info	catalog 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.
Classification	Class II
Reason for Recall	Terumo 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 Quantity	579 units
Recall Number	Z-2230-2012

Product Description	Serial 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 Info	catalog number: 803518 and serial numbers:00007-00038, 00041, and 00043.
Classification	Class II
Reason for Recall	Terumo 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 Quantity	34 units
Recall Number	Z-2231-2012

Product Description	Interface 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 Info	catalog number: 802558 and serial numbers:00008-00013, and 00015-00241.
Classification	Class II
Reason for Recall	Terumo 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 Quantity	232 units
Recall Number	Z-2232-2012

Product Description	Interface 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 Info	catalog number: 803479 and serial numbers:00009-00122, 00124-00210, 00213-00365, 00367-00458, and 00461-00596.
Classification	Class II
Reason for Recall	Terumo 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 Quantity	582 units
Recall Number	Z-2233-2012

Class II Devices Event

Event ID	62691
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Nov-09
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	GE OEC Medical Systems, Inc
City	Salt Lake City
State	UT
Country	US
Distribution Pattern	Worldwide Distribution -- USA (nationwide)

Associated Products

Product Description	892.1650 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 Info	Model Number HDS721616PLAT80; GE Healthcare part number 5304649.
Classification	Class II
Reason for Recall	GE 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 Quantity	3,595 units
Recall Number	Z-2240-2012

Class II Food/Cosmetics Event

Event ID	62697
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Authentic Gourmet
City	Miami
State	FL
Country	US
Distribution Pattern	CA

Associated Products

Product Description	Strawberry Filled Cake, 21.9 oz (1lb 6oz) (620g), UPC 3 760147 195867
Code Info	Lot # FR110803DD
Classification	Class II
Reason for Recall	The 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 Quantity	2560 units total
Recall Number	F-1969-2012

Product Description	Raspberry Filled Cake, 21.9 oz (1lb 6oz) (620g), UPC 3 760147 195881
Code Info	Lot # FR110801BB
Classification	Class II
Reason for Recall	The 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 Quantity	2560 units total
Recall Number	F-1970-2012

Class II Devices Event

Event ID	62706
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Oct-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Beckman Coulter Inc.
City	Brea
State	CA
Country	US
Distribution Pattern	Worldwide 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 Description	UniCel 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 Info	Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285.
Classification	Class II
Reason for Recall	The 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 Quantity	2442 units total (784 units in US)
Recall Number	Z-2257-2012

Product Description	UniCel 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 Info	Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460.
Classification	Class II
Reason for Recall	The 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 Quantity	2442 units total (784 units in US)
Recall Number	Z-2258-2012

Product Description	UniCel 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 Info	Part Numbers: DxC 660i: A64871; DxC 680i: A64903; DxC 860i: A64935; DxC 880i: A59102
Classification	Class II
Reason for Recall	The 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 Quantity	2442 units total (784 units in US)
Recall Number	Z-2259-2012

Class II Devices Event

Event ID	62729
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Apr-10
Initial Firm Notification of Consignee or Public	Visit

Recalling Firm	GE OEC Medical Systems, Inc
City	Salt Lake City
State	UT
Country	US
Distribution Pattern	Worldwide and Nationwide (USA) distribution.

Associated Products

Product Description	GE 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 Info	Serial 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.
Classification	Class II
Reason for Recall	GE 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 Quantity	845 units
Recall Number	Z-2241-2012

Class II Devices Event

Event ID	62744
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-Oct-06
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	GE OEC Medical Systems, Inc
City	Salt Lake City
State	UT
Country	US
Distribution Pattern	Nationwide Distribution.

Associated Products

Product Description	OEC 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 Info	Model number A857680 with various serial numbers (refer to consignee list).
Classification	Class II
Reason for Recall	GE 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 Quantity	99 units
Recall Number	Z-2236-2012

Class II Devices Event

Event ID	62745
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Biomet U.K., Ltd.
City	Bridgend, South Wales
State
Country	GB
Distribution Pattern	Worldwide 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 Description	Oxford 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 Info	Catalog Number: 32-422801 and Lot Number Identification: ZB111101, ZBll1201, ZB120101, ZB120501, ZB111102, and ZB120201.
Classification	Class II
Reason for Recall	A 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 Quantity	119 units
Recall Number	Z-2224-2012

Class II Devices Event

Event ID	62746
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Oct-08
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	GE OEC Medical Systems, Inc
City	Salt Lake City
State	UT
Country	US
Distribution Pattern	Nationwide distribution.

Associated Products

Product Description	GEHC 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 Info	Serial 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.
Classification	Class II
Reason for Recall	GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye.
Product Quantity	149 units
Recall Number	Z-2262-2012

Class II Devices Event

Event ID	62755
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Dec-11
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Beckman Coulter Inc.
City	Brea
State	CA
Country	US
Distribution Pattern	Worldwide 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 Description	UniCel 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 Info	Part 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
Classification	Class II
Reason for Recall	The 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 Quantity	41 units (15 units in the US)
Recall Number	Z-2225-2012

Product Description	UniCel 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 Info	Part 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
Classification	Class II
Reason for Recall	The 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 Quantity	41 units (15 units in the US)
Recall Number	Z-2226-2012

Class II Drugs Event

Event ID	62772
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Prometheus Laboratories Inc.
City	San Diego
State	CA
Country	US
Distribution Pattern	Nationwide and Puerto Rico.

Associated Products

Product Description	Mercaptopurine 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 Info	Lot #s: a) 11A003, 11A004, 11A005, Exp 01/13; 11L071, 11L072, Exp 10/13; b) 11B009, Exp 01/13; 11L073, Exp 10/13
Classification	Class II
Reason for Recall	Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
Product Quantity	a) 25,516 bottles; b) 2,569 bottles
Recall Number	D-1659-2012

Class II Drugs Event

Event ID	62775
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	23-Jul-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Custom Medical Specialties, Inc.
City	Pine Level
State	NC
Country	US
Distribution Pattern	GA, MD, MA

Associated Products

Product Description	Custom 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 Info	Lot #: 25744-1111, Exp 09/2012
Classification	Class II
Reason for Recall	Lack 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 Quantity	35 Trays
Recall Number	D-1649-2012

Product Description	CMS-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 Info	Lot #: 25915-1111, Exp 12/2012
Classification	Class II
Reason for Recall	Lack 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 Quantity	20 Trays
Recall Number	D-1650-2012

Product Description	CMS-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 Info	Lot #: 26124-1112, Exp 12/2012
Classification	Class II
Reason for Recall	Lack 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 Quantity	25 Trays
Recall Number	D-1651-2012

Class II Food/Cosmetics Event

Event ID	62783
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Jul-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Flywheel's Pies
City	Prescott
State	AR
Country	US
Distribution Pattern	Arkansas

Associated Products

Product Description	Apple 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 Info	All product on market.
Classification	Class II
Reason for Recall	Undeclared soy lecithin, partially hydrogenated soybean oil and wheat.
Product Quantity
Recall Number	F-1952-2012

Product Description	Peach 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 Info	All product on market.
Classification	Class II
Reason for Recall	Undeclared soy lecithin, partially hydrogenated soybean oil and wheat.
Product Quantity
Recall Number	F-1953-2012

Product Description	Cherry 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 Info	All product on market.
Classification	Class II
Reason for Recall	Undeclared soy lecithin, partially hydrogenated soybean oil and wheat.
Product Quantity
Recall Number	F-1954-2012

Product Description	Blueberry 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 Info	All product on market.
Classification	Class II
Reason for Recall	Undeclared partially hydrogenated soybean oil and wheat.
Product Quantity
Recall Number	F-1955-2012

Product Description	Raisin 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 Info	All product on market.
Classification	Class II
Reason for Recall	Undeclared partially hydrogenated soybean oil and wheat.
Product Quantity
Recall Number	F-1956-2012

Product Description	Strawberry 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 Info	All product on market.
Classification	Class II
Reason for Recall	Undeclared partially hydrogenated soybean oil and wheat.
Product Quantity
Recall Number	F-1957-2012

Product Description	Sweet 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 Info	All product on market.
Classification	Class II
Reason for Recall	Undeclared partially hydrogenated soybean oil and wheat.
Product Quantity
Recall Number	F-1958-2012

Product Description	Apricot 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 Info	All product on market.
Classification	Class II
Reason for Recall	Undeclared soy lecithin, partially hydrogenated soybean oil and wheat.
Product Quantity
Recall Number	F-1959-2012

Product Description	Chocolate 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 Info	All product on market.
Classification	Class II
Reason for Recall	Undeclared soy lecithin, partially hydrogenated soybean oil and wheat.
Product Quantity
Recall Number	F-1960-2012

Product Description	Coconut 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 Info	All product on market.
Classification	Class II
Reason for Recall	Undeclared soy lecithin, partially hydrogenated soybean oil and wheat.
Product Quantity
Recall Number	F-1961-2012

Product Description	Lemon 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 Info	All product on market.
Classification	Class II
Reason for Recall	Undeclared partially hydrogenated soybean oil and wheat.
Product Quantity
Recall Number	F-1962-2012

Product Description	Pineapple 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 Info	All product on market.
Classification	Class II
Reason for Recall	Undeclared partially hydrogenated soybean oil and wheat.
Product Quantity
Recall Number	F-1963-2012

Product Description	Blackberry 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 Info	All product on market.
Classification	Class II
Reason for Recall	Undeclared partially hydrogenated soybean oil and wheat.
Product Quantity
Recall Number	F-1964-2012

Product Description	Sugar 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 Info	All product on market.
Classification	Class II
Reason for Recall	Undeclared soy lecithin, partially hydrogenated soybean oil and wheat.
Product Quantity
Recall Number	F-1965-2012

Class II Devices Event

Event ID	62790
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Philips Medical Systems (Cleveland) Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	Worldwide 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 Description	The 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 Info	System 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.
Classification	Class II
Reason for Recall	The patient support may move in an unintended manner if the foot switch cover becomes damaged and impinges on the foot switch.
Product Quantity	126 units
Recall Number	Z-2245-2012

Class II Devices Event

Event ID	62796
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	AGFA Corp.
City	Greenville
State	SC
Country	US
Distribution Pattern	USA Nationwide, Virgin Islands and Canada

Associated Products

Product Description	AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device
Code Info	All software versions of DICOMstore in combination with Media Purge Daemon (MPD) or Cardiovascular Purge Services (CPS).
Classification	Class II
Reason for Recall	Loss 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 Quantity	535
Recall Number	Z-2252-2012

Class II Devices Event

Event ID	62798
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Oct-07
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	GE OEC Medical Systems, Inc
City	Salt Lake City
State	UT
Country	US
Distribution Pattern	Worldwide 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 Description	GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.
Code Info	Serial 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.
Classification	Class II
Reason for Recall	X-ray units did not meet manufacturer's specification for linearity.
Product Quantity	175 units
Recall Number	Z-2221-2012

Class II Devices Event

Event ID	62870
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Hitachi Medical Systems America Inc
City	Twinsburg
State	OH
Country	US
Distribution Pattern	US 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 Description	Hitachi 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 Info	Echelon, V001 through V061, inclusive. Oasis, M001 through M105, inclusive, M951
Classification	Class II
Reason for Recall	Hitachi 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 Quantity	165 units
Recall Number	Z-2254-2012

Class II Devices Event

Event ID	62871
Status	Completed
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Galil Medical, Inc.
City	Arden Hills
State	MN
Country	US
Distribution Pattern	Worldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands

Associated Products

Product Description	Visual-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 Info	VL0004 VL0014 VL0015 VL0016
Classification	Class II
Reason for Recall	Galil 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 Quantity	4
Recall Number	Z-2261-2012

Class II Devices Event

Event ID	62892
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Philips Medical Systems (Cleveland) Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	Nationwide Distribution-including the states of CO, FL, MD, MN, NE and PA.

Associated Products

Product Description	Positron 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 Info	GEMINI 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
Classification	Class II
Reason for Recall	Philips 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 Quantity	7 units
Recall Number	Z-2239-2012

Class II Drugs Event

Event ID	62893
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Apr-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	VistaPharm, Inc.
City	Largo
State	FL
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Xactdose 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 Info	Lot 202800, NDC 66689-035-50
Classification	Class II
Reason for Recall	Defective 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 Number	D-1658-2012

Class II Food/Cosmetics Event

Event ID	62901
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Aug-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Winn Dixie Stores, Inc.
City	Jacksonville
State	FL
Country	US
Distribution Pattern	SC

Associated Products

Product Description	Southern 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 Info	Item Code: 627888, UPC 6-07880-03039.
Classification	Class II
Reason for Recall	Undeclared allergen, soy lecithin.
Product Quantity	232 Cases/6 packages per case
Recall Number	F-1984-2012

Class II Food/Cosmetics Event

Event ID	62941
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	J&S Group
City	Fullerton
State	CA
Country	US
Distribution Pattern	CA, IL

Associated Products

Product Description	Frozen Oysters (IQF), Net Weight: 30 lbs (6/5lbs).
Code Info	none
Classification	Class II
Reason for Recall	J&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 Quantity	779 cases
Recall Number	F-2015-2012

Class II Food/Cosmetics Event

Event ID	62951
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Spartan Central Kitchen
City	Grand Rapids
State	MI
Country	US
Distribution Pattern	MI distribution only

Associated Products

Product Description	Spartan/Fresh Selections Wedge Sandwich W/Sandwich Spread 4oz
Code Info	LOT NUMBER: All dates up to and including 8/12/12 UPC: 011213-900001 SPARTAN CODE: 744
Classification	Class II
Reason for Recall	During an FDA inspection, the investigation found the 4oz sandwich spread label did not declare Yellow # 5 as an ingredient.
Product Quantity	288 units
Recall Number	F-2016-2012

Class III Biologics Event

Event ID	41766
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-Dec-05
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	American National Red Cross (The)
City	Louisville
State	KY
Country	US
Distribution Pattern	IN

Associated Products

Product Description	Fresh Frozen Plasma
Code Info	24FC35223- part 1; 24FC35223- part 2; 24FC35223- part 3
Classification	Class III
Reason for Recall	Blood components, processed more than 8 hours after collection, were distributed.
Product Quantity	3 units
Recall Number	B-1790-12

Class III Biologics Event

Event ID	42223
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-May-06
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Mississippi Valley Reg Bld Ctr
City	Davenport
State	IA
Country	US
Distribution Pattern	Illinois

Associated Products

Product Description	Red Blood Cells
Code Info	C79023
Classification	Class III
Reason for Recall	Blood product, manufactured without the entire quantity of additive solution, was distributed.
Product Quantity	1 Unit
Recall Number	B-2141-12

Class III Biologics Event

Event ID	42916
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Aug-06
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Bio-Blood Components, Inc.
City	Columbus
State	OH
Country	US
Distribution Pattern	California.

Associated Products

Product Description	Source Plasma
Code Info	06BOHA4075
Classification	Class III
Reason for Recall	Blood product, which tested initially reactive for the hepatitis C virus, was distributed.
Product Quantity	1 unit
Recall Number	B-1581-12

Class III Biologics Event

Event ID	43405
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-Nov-06
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Community Blood Center Of Gtr KC
City	Kansas City
State	MO
Country	US
Distribution Pattern	KS.

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W045006104362 Part A, W045006104362 Part B
Classification	Class III
Reason for Recall	Blood products, which did not meet acceptable product specifications, were distributed.
Product Quantity	2 units
Recall Number	B-1560-12

Class III Biologics Event

Event ID	49164
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-May-08
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Blood Centers of the Pacific
City	San Francisco
State	CA
Country	US
Distribution Pattern	CA.

Associated Products

Product Description	Platelets Apheresis Leukoreduced
Code Info	7354767, 9348475,7354764,7354767, 9348475
Classification	Class III
Reason for Recall	Blood products, which were exposed to unacceptable temperature during transport, were distributed.
Product Quantity	5
Recall Number	B-1801-12

Product Description	Platelets Apheresis Leukoreduced (Irradiated)
Code Info	7354764, 9348470, 9348470
Classification	Class III
Reason for Recall	Blood products, which were exposed to unacceptable temperature during transport, were distributed.
Product Quantity	3
Recall Number	B-1802-12

Class III Biologics Event

Event ID	60098
Status	Ongoing
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Aug-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Allograft Innovations, LLC
City	Gainesville
State	FL
Country	US
Distribution Pattern	Products were distributed domestically to hospitals nationwide and internationally to Israel, South Korea, United Kingdom, and Turkey.

Associated Products

Product Description	Products: .5-1mm 2cc Cancellous Chips; .5-1mm 15cc Cancellous Chips; .5-1mm 30cc Cancellous Chips. Cancellous Chips. Product s are labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED 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 Info	Tissue 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
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	37 Tissues
Recall Number	B-2227-12

Product Description	Product: .25-.5mm 15cc Cancellous Chips. Cancellous Chips Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" . Donor ID # - NLGIN10-0016.
Code Info	Tissue ID #: AI1000162018
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	1 Tissue
Recall Number	B-2228-12

Product Description	Products: 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 INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED 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 Info	Tissue 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
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	104 Tissues
Recall Number	B-2229-12

Product Description	Products: 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 INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED 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 Info	Tissue 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
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	77 Tissues
Recall Number	B-2230-12

Product Description	Products: .5-1mm 1cc Cortical Cancellous Chips, .5-1mm 2cc Cortical Cancellous Chips. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0013 NLGIN10-0024 NLGIN10-0025 NLGIN10-0035 NLGIN10-0038 NLGIN10-0066
Code Info	Tissue 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
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	101 Tissues
Recall Number	B-2231-12

Product Description	Products: 1-2mm 1cc Cortical Cancellous Chips, 1-2mm 2cc Cortical Cancellous Chips,1-2mm 5cc Cortical Cancellous Chips. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0020 NLGIN10-0031 NLGIN10-0035 NLGIN10-0038 NLGIN10-0047
Code Info	Tissue 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
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	68 units
Recall Number	B-2232-12

Product Description	Products: 100mm Femur Shaft Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0038 NLGIN10-0047
Code Info	Tissue ID #: AI1000380105, AI1000380106, AI1000470105, AI1000470106
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	4 Tissues
Recall Number	B-2233-12

Product Description	Products: 150mm Femur Shaft. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0047
Code Info	Tissue ID #: AI1000470107
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	1 Tissue
Recall Number	B-2234-12

Product Description	Products: 10x10x18 Ilium Tricortical Block. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0004 NLGIN10-0038
Code Info	Tissue ID #: AI1000045005, AI1000045008, AI1000045011, AI1000385007
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	4 Tissues
Recall Number	B-2235-12

Product Description	Products: 11-13x10x18 Ilium Tricortical Block Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0004 NLGIN10-0038
Code Info	Tissue ID #: AI1000045006, AI1000045009, AI1000385009, AI1000385012, AI1000385015, AI1000385017, AI1000385018
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	7 Tissues
Recall Number	B-2236-12

Product Description	Products: 14-17x11x25 Ilium Tricortical Block. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0004 NLGIN10-0038
Code Info	Tissue ID #: AI1000045007, AI1000045010, AI1000385005, AI1000385006, AI1000385008, AI1000385010, AI1000385011, AI1000385013, AI1000385014 AI1000385016
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	10 Tissues
Recall Number	B-2237-12

Product Description	Products: 150mm x 20mm Cortical Plate. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0047
Code Info	Tissue ID #: AI1000470205, AI1000470206, AI1000470207
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	3 Tissues
Recall Number	B-2238-12

Product Description	Products: 200mm Tibia Shaft Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0033
Code Info	Tissue ID #: AI10110400105
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	1 Tissue
Recall Number	B-2239-12

Product Description	Products: 5mm 30cc Cancellous Cubes. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0025
Code Info	Tissue ID #: AI1000252019, AI1000252020, AI1000252021 AI1000252023, AI1000252024, AI1000252025
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	6 Tissues
Recall Number	B-2240-12

Product Description	Products: 8mm Cancellous Block. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0004
Code Info	Tissue ID #: AI1000040753, AI1000040754, AI1000040755, AI1000040756, AI1000040757, AI1000040758, AI1000040759, AI1000040760, AI1000040761, AI1000040762, AI1000040763, AI1000040771
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	12 Tissues
Recall Number	B-2241-12

Product Description	Products: 9mm Cancellous Block. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0004
Code Info	Tissue ID #: AI1000040776, AI1000040777, AI1000040778, AI1000040779
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	4 Tissues
Recall Number	B-2242-12

Product Description	Products: 5mm Lordotic Cervical Cancellous Spacer Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0016
Code Info	Tissue ID #: AI1000163005
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	1 Tissue
Recall Number	B-2243-12

Product Description	Products: 6mm Lordotic Cervical Cancellous Spacer. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0001 NLGIN10-0007 NLGIN10-0013 NLGIN10-0016
Code Info	Tissue ID #: AI1000013007, AI1000073006, AI1000073007, AI1000073010, AI1000073011, AI1000073013, AI1000073014, AI1000073016, AI1000073018, AI1000133008, AI1000133009, AI1000133010, AI1000163006, AI1000163007
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	14 Tissues
Recall Number	B-2244-12

Product Description	Products: 7mm Lordotic Cervical Cancellous Spacer. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0007 NLGIN10-0013 NLGIN10-0016
Code Info	Tissue ID #: AI1000073024, AI1000073026, AI1000073028, AI1000133011, AI1000163008, AI1000163009, AI1000163010, AI1000163011, AI1000163012
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	9 Tissues
Recall Number	B-2245-12

Product Description	Products: 5mm Lordotic Cervical Spacer. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0024
Code Info	Tissue ID #: AI1000244006, AI1000244015, AI1000244016, AI1000244017, AI1000244018
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	5 Tissues
Recall Number	B-2246-12

Product Description	Products: 6mm Lordotic Cervical Spacer. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0012 NLGIN10-0024 NLGIN10-0069
Code Info	Tissue 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
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	27 Tissues
Recall Number	B-2247-12

Product Description	Products: 7mm Lordotic Cervical Spacer. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0012 NLGIN10-0069
Code Info	Tissue ID #: AI1000124009, AI1000124010, AI1000124011, AI1000124012, AI1000124013, AI1000124014, AI1000124015, AI10110034029, AI10110034030, AI10110034031, AI10110034032
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	11 Tissues
Recall Number	B-2248-12

Product Description	Products: Achilles with Bone Block. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0021
Code Info	Tissue ID #: AI1000210005, AI1000210006
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	2 Tissues
Recall Number	B-2249-12

Product Description	Products: Achilles with Bone Block Pre-sized. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED 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 Info	Tissue ID #: AI1000040006, AI1000090005, AI1000090006, AI1000120005, AI1000160005, AI1000160006, AI1000380015, AI1000380016, AI10110030006, AI10110400005, AI10110400006
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	11 Tissues
Recall Number	B-2250-12

Product Description	Products: Achilles without Bone Block.. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0005
Code Info	Tissue ID #: AI1000050005, AI1000050006
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	2 Tissues
Recall Number	B-2251-12

Product Description	Products: Medial Femur Hemi-Condyle. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0038
Code Info	Tissue ID #: AI1000380030
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	1 Tissue
Recall Number	B-2252-12

Product Description	Products: Patella Tendon - Hemi Presized. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED 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 Info	Tissue ID #: AI1000160007, AI1000160008, AI1000160009, AI1000160010, AI1000210007, AI1000210008, AI1000210009, AI1000240007, AI1000240008, AI1000250007, AI1000250008, AI1000380017, AI1000380018, AI1000660002, AI1000660003, AI10110030007, AI10110030008, AI10110030009, AI10110400007
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	19 Tissues
Recall Number	B-2253-12

Product Description	Products: Patella Whole. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0004 NLGIN10-0009 NLGIN10-0012
Code Info	Tissue ID #: AI1000040007, AI1000040008, AI1000090007, AI1000090008
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	4 Tissues
Recall Number	B-2254-12

Product Description	Products: Peroneus Longus Tendon. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED 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 Info	Tissue ID #: AI1000040013, AI1000040014, AI1000050012, AI1000090013, AI1000090014, AI1000120013, AI1000120014, AI1000160015, AI1000160016, AI1000240012, AI1000380010, AI1000470013, AI10110030014, AI10110030015, AI11060010013
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	15 Tissues
Recall Number	B-2255-12

Product Description	Products: Semitendinosus/Gracilis Tendon . Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0033 NLGIN10-0047
Code Info	Tissue ID #: AI10110400014, AI1000470014
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	2 Tissues
Recall Number	B-2256-12

Product Description	Products: Semitendinosus Tendon . Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN09-0024C NLGIN10-0033 NLGIN10-0047 NLGIN10-0066
Code Info	Tissue ID #: AI090024C0011, AI1000470015, AI1000660009, AI1000660010, AI10110400015
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	5 Tissues
Recall Number	B-2257-12

Product Description	Products: Tibialis Tendon - Anterior. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED 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 Info	Tissue 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
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	28 Tissues
Recall Number	B-2258-12

Product Description	Products: Tibialis Tendon - Posterior. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED 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 Info	Tissue 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
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	25 Tissues
Recall Number	B-2259-12

Product Description	Products: 5mm Cancellous Block Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous BlockSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0004 NLGIN10-0021 NLGIN10-0024
Code Info	Tissue ID #: AI1000040705, AI1000040706, AI1000210705, AI1000210706, AI1000210707, AI1000210708, AI1000210709, AI1000210710, AI1000210711, AI1000210712, AI1000240705, AI1000240706, AI1000240707, AI1000240708, AI1000240709, AI1000240710
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	16 Tissues
Recall Number	B-2260-12

Product Description	Products: 6mm Cancellous Block Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous BlockSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0004
Code Info	Tissue 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
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	25 Tissues
Recall Number	B-2261-12

Product Description	Products: 7mm Cancellous Block Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous BlockSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" Donor ID #: NLGIN10-0004
Code Info	Tissue ID #: AI1000040732, AI1000040733, AI1000040734, AI1000040735, AI1000040736, AI1000040737, AI1000040738, AI1000040739, AI1000040740, AI1000040741, AI1000040742, AI1000040743, AI1000040744, AI1000040750, AI1000040751, AI1000040752
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	16 Tissues
Recall Number	B-2262-12

Class III Biologics Event

Event ID	60914
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Dec-11
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Delta Blood Bank
City	Stockton
State	CA
Country	US
Distribution Pattern	CA, IN.

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	W128711161270
Classification	Class III
Reason for Recall	Blood products, collected from a donor for whom there was no documentation on the donor record of an arm inspection, were distributed.
Product Quantity	1 unit
Recall Number	B-2220-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W128711161270
Classification	Class III
Reason for Recall	Blood products, collected from a donor for whom there was no documentation on the donor record of an arm inspection, were distributed.
Product Quantity	1 unit
Recall Number	B-2221-12

Class III Biologics Event

Event ID	60915
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Nov-11
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Delta Blood Bank
City	Stockton
State	CA
Country	US
Distribution Pattern	CA, IN.

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W128711016818
Classification	Class III
Reason for Recall	Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-2219-12

Class III Biologics Event

Event ID	61567
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Mar-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	San Antonio Eye Bank
City	San Antonio
State	TX
Country	US
Distribution Pattern	CA, TX, FL

Associated Products

Product Description	Cornea
Code Info	SA20120362, SA201203451, SA20120361
Classification	Class III
Reason for Recall	Human Corneas, processed in a manner that may cause the introduction, transmission, or spread of communicable disease, were distributed.
Product Quantity	3 corneas
Recall Number	B-2269-12

Class III Drugs Event

Event ID	61818
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Morton Salt Co.
City	Chicago
State	IL
Country	US
Distribution Pattern	Nationwide & PR & Ireland.

Associated Products

Product Description	Morton, 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 Info	Lot #: OCT251BC01, NOV041BA01 & NOV071BA01.
Classification	Class III
Reason for Recall	Impurities/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 Quantity	531,950 lbs
Recall Number	D-1656-2012

Class III Devices Event

Event ID	62452
Status	Completed
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Aug-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Sunquest Information Systems, Inc.
City	Tucson
State	AZ
Country	US
Distribution Pattern	US Nationwide Distribution

Associated Products

Product Description	Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
Code Info	Version 6.4.2
Classification	Class III
Reason for Recall	In 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 Quantity	47 sites
Recall Number	Z-2229-2012

Class III Devices Event

Event ID	62751
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Apr-09
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Sunquest Information Systems, Inc.
City	Tucson
State	AZ
Country	US
Distribution Pattern	Worldwide distribution: USA (nationwide) and country of: Bahamas.

Associated Products

Product Description	Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.
Code Info	versions 2.4 and later
Classification	Class III
Reason for Recall	Sunquest 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 Quantity	23 clients
Recall Number	Z-2243-2012

Class III Devices Event

Event ID	62791
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-Oct-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Beckman Coulter Inc.
City	Brea
State	CA
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide), Canada, and internationally.

Associated Products

Product Description	Access 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 Info	All Lots
Classification	Class III
Reason for Recall	A 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 Quantity	117,385 units total (33,918 units in US)
Recall Number	Z-2227-2012

Mixed Classification Food/Cosmetics Event

Event ID	62710
Status	Completed
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Jul-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Tomales Bay Foods, Inc.
City	Petaluma
State	CA
Country	US
Distribution Pattern	Part 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 Description	Tomales 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 Info	All product cut and wrapped on July 24 and 25, 2012.
Classification	Class II
Reason for Recall	Firm received a positive environmental for Listeria Monocytogenes from their internal testing samples.
Product Quantity	562.74 pounds original recall, 101.1 pounds of Pondhopper and 31.41 pounds of Big Woods Blue
Recall Number	F-1985-2012

Mixed Classification Biologics Event

Event ID	49306
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Jul-08
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	American Red Cross Blood Services
City	Wichita
State	KS
Country	US
Distribution Pattern	TX, CA

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	02GC00390
Classification	Class II
Reason for Recall	Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-2211-12

Product Description	Recovered Plasma
Code Info	02GC00390
Classification	Class III
Reason for Recall	Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-2212-12

Mixed Classification Biologics Event

Event ID	59719
Status	Ongoing
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Aug-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	New Life Generation, INC.
City	Indianapolis
State	IN
Country	US
Distribution Pattern	IN, CA, VA

Associated Products

Product Description	Human Skin for Transplant
Code Info	NLGIL100017002, 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
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	619
Recall Number	B-1578-12

Product Description	Human Skin for Transplant
Code Info	NLGIN100003001, NLGIN100003002, NLGIN100003003, NLGIN100003004, NLGIN100003005, NLGIN100003006, NLGIN100003007, NLGIN100003008, NLGIN100003009, NLGIN100003010, NLGIN100003011, NLGIN100003012, NLGIN100003013, NLGIN100003014, NLGIN100003015, NLGIN100003016, NLGIN100003017, NLGIN100003018, NLGIN100003019, NLGIN100003020, NLGIN100003021
Classification	Class II
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	21
Recall Number	B-1579-12

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