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Enforcement Report - Week of November 14, 2012

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Biologics Devices Drugs Food / Cosmetics Veterinary

Class I Veterinary Event

Event ID	62597
Status	Ongoing
Product Type	Veterinary
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Jul-12
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	Land O Lakes Purina LLC
City	Shoreview
State	MN
Country	US
Distribution Pattern	WI Expanded Recall: AL, AR, CA, CO,FL, GA, IA, IL, IN, KY, KS, MS, MI, MN, MO, NC, NE, NY, NM, OR, OH, OK, PA , SC, SD, TN, TX, WI.

Associated Products

Product Description	Land O Lakes, Pheasant Starter A Medicated, Type C Medicated Feed. Item # 1125000-301
Code Info	L633
Classification	Class I
Reason for Recall	Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted.
Product Quantity	23,824 lbs
Recall Number	V-092-2013

Product Description	EXPANDED RECALL: PURINA HONOR SHOW CHOW BROILER COMP AMP 0.0125% BMD50 MEDICATED, NET WEIGHT 50 LBS (22.67 KG), PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812, UPC 8 83576 01124 9, 0016637, 781B.
Code Info	Lot Codes: , 2MAY23MFI1, 2JUN11MFI3, 2JUN12MFI1, 2JUN14MFI3, 2JUN20MFI3, 2JUN28MFI3, 2JUL06MFI1, 2JUL16MFI3
Classification	Class I
Reason for Recall	Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D.
Product Quantity	2882 bags
Recall Number	V-093-2013

Product Description	EXPANDED RECALL: PURINA HONOR SHOW CHOW TURKEY GROW/FINISH BMD50 PELLET MEDICATED, NET WEIGHT 50 LBS (22.67 KG), PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812, UPC 8 83576 01182 9, 801R,0017095.
Code Info	Lot Codes: 2MAY23MFI1, 2MAY31MFI1, 2JUN12MFI3, 2JUN20MFI3, 2JUN27MFI1, 2JUL06MFI1, 2JUL11MF13, 2JUL18MFI1
Classification	Class I
Reason for Recall	Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D.
Product Quantity	353 bags
Recall Number	V-094-2013

Product Description	EXPANDED RECALL: PURINA HONOR SHOW CHOW TURKEY STARTER AMP .0125% BMD50 MEDICATED, NET WEIGHT 50 LBS (22.67 KG), PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812, UPC 8 83576 01183 6, 801T, 0017096.
Code Info	Lot Codes: 2MAY31MFI1, 2JUN06MFI3, 2JUN11MF13, 2JUN19MFI3, 2JUN22MFI3, 2JUL03MFI1, 2JUL11MF13, 2JUL13MFI1
Classification	Class I
Reason for Recall	Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D.
Product Quantity	936 bags
Recall Number	V-095-2013

Product Description	EXPANDED RECALL: DUMOR SHOW POULTRY AMP .0125% BMD 50 MEDICATED, TRACTOR SUPPLY COMPANY, 200 POWELL PLACE, BRENTWOOD, TN 37027-6812, NET WEIGHT 40 LB (18.14 KG), UPC 7 49394 01890 0, 60VA, 0045400.
Code Info	Lot Codes: 2JUN11MFI3, 2JUL11MFI3, 2JUL18MFI1
Classification	Class I
Reason for Recall	Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D.
Product Quantity	20 bags
Recall Number	V-096-2013

Product Description	EXPANDED RECALL: DUMOR CHICK STARTER 24%, TRACTOR SUPPLY COMPANY, 200 POWELL PLACE, BRENTWOOD, TN 37027-6812, NET WEIGHT 50 LB (22.67 KG), UPC 7 49394 05739 8, 60X7 , 0046443.
Code Info	Lot Codes: 2MAY30MFI1, 2JUN13NST1A1, 2MAY31STJ1, 2JUN13MFI1, 2JUN14NST1A1, 2MAY31STJ3, 2JUN22MFI1, 2JUN19NST2A1, 2JUN05STJ2, 2JUL11MFI3, 2JUN20NST2A1, 2JUN20STJ1, 2JUL02NST2A1, 2JUN26STJ2, 2JUL16NST2A1, 2JUL03STJ2, 2JUL16STJ2
Classification	Class I
Reason for Recall	Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D.
Product Quantity	4,491 bags
Recall Number	V-097-2013

Product Description	EXPANDED RECALL: DUMOR POULTRY GROWER/FINISHER 15%, TRACTOR SUPPLY COMPANY, 200 POWELL PLACE, BRENTWOOD, TN 37027-6812, NET WEIGHT 50 LB (22.67 KG), UPC 7 49394 05737 4, 60Y7, 0046444.
Code Info	Lot Codes: 2MAY23MFI1, 2JUN07NST1A1, 2MAY25STJ1, 2MAY29MFI1, 2JUN12NST1A1, 2MAY25STJ3, 2MAY31MFI1, 2JUN13NST2A1, 2JUN05STJ2, 2JUN01MFI1, 2JUN18NST1A1, 2JUN18STJ2, 2JUN05MFI1, 2JUN20NST1A1, 2JUN21STJ2, 2JUN08MFI1, 2JUN21NST2A1, 2JUL03STJ2, 2JUN13MFI1, 2JUN27NST1A1, 2JUN14MFI1, 2JUN28NST2A1, 2JUN18MFI3, 2JUL05NST2A1, 2JUN20MFI3, 2JUL06NST2A1, 2JUN22MFI1, 2JUL13NST2A1, 2JUN29MFI1, 2JUL18NST1A1, 2JUN29MFI3, 2JUL09MFI3, 2JUL09MFI1, 2JUL17MFI3, 2JUL20MFI3
Classification	Class I
Reason for Recall	Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D.
Product Quantity	18,588 bags
Recall Number	V-098-2013

Product Description	EXPANDED RECALL: PURINA DIAMOND MILLING 15% LAYER FEED 1.5 FLAX, 0041731, 60BQ, BULK NET WEIGHT, PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812.
Code Info	60BQ
Classification	Class I
Reason for Recall	Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D.
Product Quantity	11,820 lb
Recall Number	V-099-2013

Product Description	EXPANDED RECALL: PURINA CU PRIVETT BREEDER STARTER 60KK, 0044485, BULK NET WEIGHT AND PURINA CU PRIVETT BREEDER GROWER, 60KL, 0044484, BULK NET WEIGHT PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812
Code Info	60KK, 60KL
Classification	Class I
Reason for Recall	Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D.
Product Quantity	147,760 lb + 97,700 lb
Recall Number	V-100-2013

Product Description	EXPANDED RECALL: PURINA TURKEYMAX FINISHER 3 VMY 10 MEDICATED, 806G, 0045481, BULK NET WEIGHT, PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812
Code Info	806G
Classification	Class I
Reason for Recall	Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D.
Product Quantity	48,000 lb
Recall Number	V-101-2013

Product Description	EXPANDED RECALL: PURINA CS PHEASANT GROWER AMP 0.0175% MEDICATED, 804A, 0038560, BULK NET WEIGHT, PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812
Code Info	804A
Classification	Class I
Reason for Recall	Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D.
Product Quantity	254,040 lb
Recall Number	V-102-2013

Product Description	EXPANDED RECALL: PURINA CU LATHROP AN LAY 16 FLAX, 61XU, 0058755, BULK NET WEIGHT, PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812.
Code Info	61XU
Classification	Class I
Reason for Recall	Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D.
Product Quantity	19,882 lb
Recall Number	V-103-2013

Product Description	EXPANDED RECALL: PURINA LATHROP BROILER FINISHER, 783Z, 3000846-201, BULK NET WEIGHT, PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812
Code Info	783Z
Classification	Class I
Reason for Recall	Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D.
Product Quantity	85,518 lb
Recall Number	V-104-2013

Class I Food/Cosmetics Event

Event ID	63082
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Aug-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Giant Eagle
City	Pittsburgh
State	PA
Country	US
Distribution Pattern	Product was distributed within the US to select supermarkets (not under the Giant Eagle banner) in OH AND PA.

Associated Products

Product Description	Mango Medley, 16 oz (contains cantaloupe, honeydew, mango, grapes), distributed by Fresh Food Mfg, 2500 Love Road, Freedom, PA 15042, UPC 3003430338 (4 -16 oz clear plastic containers per case)
Code Info	UPC 3003430338, all product with expiration dates of 8/11/2012 through 8/31/2012
Classification	Class I
Reason for Recall	Recalling firm was notified the Mangoes used in production of product were recalled by supplier (Splendid Foods) for possible Salmonella contamination.
Product Quantity	28 cases of 4-16 oz containers
Recall Number	F-0635-2013

Class I Food/Cosmetics Event

Event ID	63291
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-Oct-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Fresh Express Incorporated
City	Salinas
State	CA
Country	US
Distribution Pattern	AZ, CA, CO, ID, MD, MN, MT, OR, TX, WA and Canada.

Associated Products

Product Description	Fresh Express, Hearts of Romaine, 18 oz, Fresh Express Incorporated, packed in clear flexible plastic package.
Code Info	Product Code: S270A24, UPC 71279-26201, Best Use By Date: Oct 11.
Classification	Class I
Reason for Recall	Sample of Fresh Express Hearts of Romaine tested positive for Salmonella.
Product Quantity	1176 cases
Recall Number	F-0599-2013

Class I Food/Cosmetics Event

Event ID	63292
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Sep-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	FreshPoint Central Florida
City	Orlando
State	FL
Country	US
Distribution Pattern	Florida

Associated Products

Product Description	Fruit Mango Peeled & Halved, Ready-To-Eat Product, 2, 2.5-lb trays per case
Code Info	Item Number 881262
Classification	Class I
Reason for Recall	Coast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & Vegetables are conducting a voluntary product recall of Kent's brand & Keitt's brand mangoes packed at Agricola Daniella due to salmonella associated with mangoes from this producer.
Product Quantity	123 trays / 2/2.5#
Recall Number	F-0604-2013

Product Description	Mixes, Salsa Mango Papaya, Ready-To-Eat Product, 2, 5-lb trays per case
Code Info	Item Number 480124
Classification	Class I
Reason for Recall	Coast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & Vegetables are conducting a voluntary product recall of Kent's brand & Keitt's brand mangoes packed at Agricola Daniella due to salmonella associated with mangoes from this producer.
Product Quantity	3 trays / 2/5#
Recall Number	F-0605-2013

Product Description	Fruit Mango Peeled & Diced 1/4, Ready-To-Eat Product, 2, 5-LB Trays per case
Code Info	Item Number 512544 & 812544
Classification	Class I
Reason for Recall	Coast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & Vegetables are conducting a voluntary product recall of Kent's brand & Keitt's brand mangoes packed at Agricola Daniella due to salmonella associated with mangoes from this producer.
Product Quantity	174 trays / 2/5LB
Recall Number	F-0606-2013

Product Description	Fruit Mango Peeled & Diced 1/2, Ready To Eat Product, 2, 5-LB Trays per case
Code Info	Item Number 480095, 481351, and 880095
Classification	Class I
Reason for Recall	Coast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & Vegetables are conducting a voluntary product recall of Kent's brand & Keitt's brand mangoes packed at Agricola Daniella due to salmonella associated with mangoes from this producer.
Product Quantity	40.5 trays / 2/5LB
Recall Number	F-0607-2013

Product Description	Fruit Mango Whole Peeled, Ready-To-Eat Product, 2, 5-LB Trays per case
Code Info	Item Number 481286
Classification	Class I
Reason for Recall	Coast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & Vegetables are conducting a voluntary product recall of Kent's brand & Keitt's brand mangoes packed at Agricola Daniella due to salmonella associated with mangoes from this producer.
Product Quantity	4 trays / 2/5LB
Recall Number	F-0608-2013

Product Description	Mixes, Salsa Mango Bucket, Ready To Eat Product, 1 Gal; & Salsa Mango packaged in 5-lb Trays with 2 trays per case.
Code Info	Item Number 513400, 880126 & 480126
Classification	Class I
Reason for Recall	Coast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & Vegetables are conducting a voluntary product recall of Kent's brand & Keitt's brand mangoes packed at Agricola Daniella due to salmonella associated with mangoes from this producer.
Product Quantity	1 gallon bucket & 35.5 Trays
Recall Number	F-0609-2013

Product Description	Fruit Mango Peeled and Sliced, Ready To Eat Product, 2, 5-lb Trays per case
Code Info	Item Number 482100 & 481274
Classification	Class I
Reason for Recall	Coast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & Vegetables are conducting a voluntary product recall of Kent's brand & Keitt's brand mangoes packed at Agricola Daniella due to salmonella associated with mangoes from this producer.
Product Quantity	2 trays / 5#
Recall Number	F-0610-2013

Product Description	Mixes Salsa/Mango Pineapple, Ready To Eat Product, 2, 5-lb Trays per case
Code Info	Item Number 481870
Classification	Class I
Reason for Recall	Coast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & Vegetables are conducting a voluntary product recall of Kent's brand & Keitt's brand mangoes packed at Agricola Daniella due to salmonella associated with mangoes from this producer.
Product Quantity	4 trays / 2/5#
Recall Number	F-0611-2013

Class I Food/Cosmetics Event

Event ID	63346
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Sep-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Jamba Juice
City	Emeryville
State	CA
Country	US
Distribution Pattern	Products were released for distribution in US.

Associated Products

Product Description	Jamba Juice brand Peanut Butter Moo'd Smoothie; All sizes (small, medium, large); A Blend Of: Nonfat Vanilla Yogurt (Contains Milk), Chocolate Moo'd Base (Contains Milk), Soymilk (Contains Soy), Ice, Bananas, Peanut Butter (Contains Peanuts); The product is processed and packaged by Jamba Juice Co.
Code Info	No codes (Stop sale date: September 24, 2012)
Classification	Class I
Reason for Recall	The products were manufactured using peanut butter recalled by Sunland Inc. because it may be contaminated with Salmonella.
Product Quantity	Unknown
Recall Number	F-0636-2013

Product Description	Jamba Juice brand Chunky Strawberry Topper; All sizes (small, medium, large); A Blend Of: Strawberries, Bananas, Nonfat Plain Yogurt (Contains Milk), Soymilk (Contains Soy), Organic Pumpkin Flax Seed Granola (Contains Soy & Wheat), Peanut Butter (Contains Peanuts); Product is processed and packaged by Jamba Juice Co.
Code Info	No codes (Stop sale date: September 24, 2012)
Classification	Class I
Reason for Recall	The products were manufactured using peanut butter recalled by Sunland Inc. because it may be contaminated with Salmonella.
Product Quantity	Unknown
Recall Number	F-0637-2013

Class I Food/Cosmetics Event

Event ID	63408
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Oct-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Clemmy's LLC
City	Rancho Mirage
State	CA
Country	US
Distribution Pattern	US States: CA, WA, NC, DE, HI, MN, OH, NH, NY, and IL. No international distribution.

Associated Products

Product Description	Clemmy's Brand Peanut Butter Chocolate Chip Ice Cream, Pint Size, 16 OZ (437mL), UPC 8 94509 00231 9. Labeling reads in part: "CLEMMY'S RICH AND CREAMY PEANUT BUTTER CHOCOLATE CHIP* 100% SUGAR FREE LACTOSE FREE GLUTEN FREE, 16 OZ (473mL)DIST BY: Clemmy's Ice Cream P.O.Box 1746, Rancho Mirage, CA 92270*". 8pints per case.
Code Info	UPC 8 94509 00231 9. Code Date Range 11038-12215. Firm's explanation of Best By date: The first production date of 11038 corresponds to 02/07/2011 and the most recent production date of 12215 corresponds to 08/02/2012. The product carries a 2-year best by print requirement, in the MM/YY format, so expiration date range to list would be: BB 02/13 through BB 08/14 BB 02/13 through BB 08/14
Classification	Class I
Reason for Recall	Clemmy's Ice Cream of Rancho Mirage, CA is initiating a voluntary recall of Peanut Butter Chocolate Chip 16 ounce containers of ice cream that contains peanut butter associated with the Sunland, Inc., recall. The peanut butter used in this product has the potential to be contaminated with Salmonella.
Product Quantity	12,000 cases
Recall Number	F-0596-2013

Class I Food/Cosmetics Event

Event ID	63411
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Oct-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Belfonte Ice Cream & Dairy Foods Co
City	Kansas City
State	MO
Country	US
Distribution Pattern	The products were distributed in MO, KS, OK, AR

Associated Products

Product Description	Belfonte Home Run Sundae Ice Cream, A Baseball Nut Blend of Chocolate Peanuts, Chocolate Coated Pretzels, and a Thick Fudge Swirl in Peanut Butter/Chocolate Ice Cream, 56 oz. (1.66L) Belonite Ice Cream Company, Kansas City, MO
Code Info	UPC 83057-91023 Best Used By Date: 04/08/2011; 05/07/2011; 06/03/2011; 06/08/2012; 03/13/2014; 04/26/2014; 06/21/2014; 07/27/2014
Classification	Class I
Reason for Recall	Products may contain peanut butter base with potentially contaminated with Salmonella.
Product Quantity	20,304/56oz-paper carton
Recall Number	F-0651-2013

Product Description	Belfonte Mama's Choice Premium Ice Cream, Reverse Peanut Butter Pie, Peanut Butter Coated Fudge Filled Cups, Peanut Butter Flakes and Swirled Chocolate Cookie Pie Crust Ribbon in Peanut Butter Ice Cream, 56 oz. (1.66L) Belonite Ice Cream Company, Kansas City, MO
Code Info	UPC 83057-17033 Best Used By Date: 07/15/2011; 10/02/2011; 12/02/2011; 02/09/2012; 04/06/2012; 06/02/2012
Classification	Class I
Reason for Recall	Products may contain peanut butter base with potentially contaminated with Salmonella.
Product Quantity	15,252/56-oz paper cartons
Recall Number	F-0652-2013

Class I Food/Cosmetics Event

Event ID	63413
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Oct-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Bliss Unlimited
City	Eugene
State	OR
Country	US
Distribution Pattern	Product was distributed to California, Illinois, New Hampshire, New York, Washington, and Wisconsin.

Associated Products

Product Description	Chocolate Peanut Butter Non-Dairy Frozen Dessert is sold under brand Luna & Larry's Organic Coconut Bliss. It is packaged in One Pint (473ml) StanPac paperboard container, 8 cups per case. The UPC code 8 96767 00121 9. The product is labeled in parts: "*CHOCOLATE PEANUT BUTTER NON-DAIRY FROZEN DESSERTLuna & Larry's ORGANIC COCONUT BLISS1 PINT 473mL*".
Code Info	The product is stamped with 41-61 and a date range of Nov 11 2012 through Oct 24 2013 printed on the bottom of the container
Classification	Class I
Reason for Recall	Luna & Larry's Coconut Bliss Chocolate Peanut Butter Non-Dairy Frozen Dessert is recalled because it has the potential to be contaminated with Salmonella. The peanut butter used in the product is supplied and recalled by Sunland, Inc.
Product Quantity	8,628 cases/8 units/1 pint
Recall Number	F-0598-2013

Class I Food/Cosmetics Event

Event ID	63437
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Oct-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Danielle Livolsi Jagrma
City	San Diego
State	CA
Country	US
Distribution Pattern	CA & NH

Associated Products

Product Description	Organic NuttZo Omega-3 SEVEN Nut & Seed Butter, Net Wt. 16 oz (1lb) 454 g, UPC 894697002030.
Code Info	Best By Dates 10/7/12-12/31/12
Classification	Class I
Reason for Recall	JagRma LLC is recalling NuttZo Original Nut and Seed Butter because it may be contaminated with Salmonella. The affected products contain a peanut butter ingredient supplied by Sunland, Inc who is recalling due to Salmonella.
Product Quantity	1510 cases
Recall Number	F-0638-2013

Class I Food/Cosmetics Event

Event ID	63438
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Oct-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	PureFit Inc
City	Irvine
State	CA
Country	US
Distribution Pattern	Nationwide in the US and worldwide: Australia, Canada, Norway, New Zealand, Ireland, Italy, and United Kingdom.

Associated Products

Product Description	PureFit Peanut Butter Bars, size 2 oz (56.7g) and box of 15 bars in 1 box/carton. UPC 812787001008, 812787002005
Code Info	01MAR13 and 12JUL13
Classification	Class I
Reason for Recall	PureFit is recalling PureFit Peanut Butter Crunch Bars because of possible Salmonella. The peanut butter in the crunch bars was supplied by Sunland Inc., and it is on recall because it may be contaminated with Salmonella.
Product Quantity	128,160 units
Recall Number	F-0597-2013

Class I Food/Cosmetics Event

Event ID	63440
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Oct-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Flying Food Group, Inc.
City	Newark
State	NJ
Country	US
Distribution Pattern	CT, MA, NY, NJ, PA, DE, MD, DC, VA, GA, FL, IL, WI, MN, IN, TX, AZ, NV, and CA

Associated Products

Product Description	Starbucks Protein Bistro Box, Net Wt 6.8 OZ (193g), Contains Cage-free egg, white Cheddar Cheese, multigrain muesli bread with honey peanut butter spread and fruit.
Code Info	Enjoy by Dates: 8/10/212-10/06/12 Best By Dates of Peanut Butter: 7/14/13; 7/26/13; 7/27/13; 7/28/13; 7/29/13; 8/9/13; 8/10/13; 8/13/13; 8/14/13; 8/15/13; 8/26/13; 8/27/13; 8/28/13; 8/29/13; 8/30/13
Classification	Class I
Reason for Recall	Starbucks Protein Bistro Boxes contain Honey Peanut Butter Squeeze Packs which are involved in Justin's Nut Butter expanded recall.
Product Quantity	955,541 units
Recall Number	F-0632-2013

Class I Food/Cosmetics Event

Event ID	63441
Status	Terminated
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-Oct-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Hannaford Bros.
City	Scarborough
State	ME
Country	US
Distribution Pattern	New York, Maine, New Hampshire, Massachusetts and Vermont

Associated Products

Product Description	Hannaford Red Velvet Cake Truffle, 6 count UPC #20335800000
Code Info	All sell by dates
Classification	Class I
Reason for Recall	Product labels fails to declare allergens: egg, milk, peanuts, wheat, soy and tree nuts
Product Quantity
Recall Number	F-0621-2013

Product Description	Hannaford Triple Chocolate Cake Truffle, 6 count UPC # 20335700000
Code Info	All sell by dates
Classification	Class I
Reason for Recall	Product labels fails to declare allergens: egg, milk, peanuts, wheat, soy and tree nuts
Product Quantity
Recall Number	F-0622-2013

Class I Food/Cosmetics Event

Event ID	63444
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Oct-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	S & P Company Limited
City	Paramount
State	CA
Country	US
Distribution Pattern	US states: AZ, CA, IL, NE, and TX. No international distribution.

Associated Products

Product Description	Su-Nun Crushed Roasted Thai Red Pepper, 10.58 oz. 12 jars/case. Packaged in clear plastic jars, red plastic screw on lid, with a red and yellow label. The principal display label has a red background with a yellow oval that reads in part:"SU-NUN*BRANDHOTCRUSHED ROASTED THAI RED PEPPER". Label on the back reads in part:"MANUFACTURED BY KHUN NAN CURRY PASTE FACTORY 149/375 Moo 13, Soi Pacific, Settakit Road, omm-Noi, Kratumband, Samutsakhon, 74130, Thailand*". No expiration date listed.
Code Info	No lot codes. Only UPC code: 659613000770. Distribution dates July 2012 to October 2012. No expiration date listed.
Classification	Class I
Reason for Recall	The recall was initiated in response to positive Salmonella resuts during FDA routine import sampling of the product.
Product Quantity	150 cases/1800 jars
Recall Number	F-0618-2013

Class I Food/Cosmetics Event

Event ID	63450
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Mondelez Global Llc
City	East Hanover
State	NJ
Country	US
Distribution Pattern	Nationwide.

Associated Products

Product Description	Green & Black's Organic Peanut & Sea Salt Milk Chocolate Bar NET WT. 3.5 oz (100g). UPC 708656 100562.
Code Info	UPC - 708656 100562; Code Dates: Oct 26, 2012; Oct 27, 2012; Oct 30, 2012; Nov 1, 2012.
Classification	Class I
Reason for Recall	Mondelez Global LLC (Mondelez Global) is voluntarily recalling the U.S. Green & Black's Organic Peanut & Sea Salt Milk Chocolate Bar (3.5 oz.) in response to the recently expanded recall of certain peanut products by Sunland Inc., Portales, NM (Sunland). This product contains peanuts supplied by Sunland. According to Sunland, the peanuts may be contaminated with Salmonella.
Product Quantity	558 cases (120 bars in each case)
Recall Number	F-0653-2013

Class I Food/Cosmetics Event

Event ID	63453
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Creative Energy Foods, Inc. LLC
City	Oakland
State	CA
Country	US
Distribution Pattern	Product was only sold on the internet.

Associated Products

Product Description	Ridgebar Peanut Butter Crunch, 40 grams
Code Info	UPC : 855468003052, Best by dates: 022413, 042813
Classification	Class I
Reason for Recall	Creative Energy Foods manufactured nutrition bars with peanuts from Sunland, Inc which are under recall for the potential to be contaminated with salmonella.
Product Quantity	1269
Recall Number	F-0613-2013

Class I Food/Cosmetics Event

Event ID	63469
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-Oct-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Velvet Ice Cream Company
City	Utica
State	OH
Country	US
Distribution Pattern	IN, KY, OH, and WV

Associated Products

Product Description	Peanut Butter Cup Ice Cream: 1) Velvet Supreme Peanut Butter Cup 1/2 gallon MFD BY VELVET ICE CREAM CO., INC UTICA, OHIO 43080 1-800-589-5000; UPC #70682-10119; 2) Velvet Peanut Butter Cup, 3 gal, UPC #70682-10539
Code Info	1 and 2 - Code Number #10181, MFD Date: 6/30/2010
Classification	Class I
Reason for Recall	The product was manufactured using peanut butter ingredient recalled by Sunland Inc. due to potential Salmonella contamination.
Product Quantity	1) 494 units; 2) 30 units
Recall Number	F-0619-2013

Product Description	Velvet Buckeye Classic MFD BY VELVET ICE CREAM CO., INC UTICA, OHIO 43080 1-800-589-5000 56 oz (UPC #70682-10038), 3 gallon (UPC #70682-10519) and pints (UPC #70682-10423)
Code Info	UPC #70682-10038 Code Number # 10193 MFD Date: 7/12/2010--56oz UPC #70682-10519 Code Number #10193 MFD Date: 7/12/2010- 3 gallon UPC #70682-10519 Code Number #12207 MFD Date: 7/25/2010--3 gallon UPC #70682-10519 Code Number #12227 MFD Date: 8/14/2010-- 3 gallon UPC #70682-10423 Code Number #12251 MFD Date: 9/07/2010--pints
Classification	Class I
Reason for Recall	The product was manufactured using peanut butter ingredient recalled by Sunland Inc. due to potential Salmonella contamination.
Product Quantity	56oz- 801 units; 3 gal 585 units; Pints- 548 units
Recall Number	F-0620-2013

Class I Food/Cosmetics Event

Event ID	63473
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Oct-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Think Thin, LLC
City	Ventura
State	CA
Country	US
Distribution Pattern	US states nationwide. No international distribution.

Associated Products

Product Description	Nutrition bar. Crunch® thinkThin Brand, Mixed Nuts, 40 grams. Packaged in plastic, labeled as:"Distributed by thinkproducts*Ventura, CA 93003*". 10 bars/carton, 12 cartons/case. 120 bars per case
Code Info	UPC Code: 7 53656 70840 9 Best by Dates: 101812, 110912, 120112, 022813, 040413, 041913, 050913, 051513, 052313, 060113, 060813, 061313. 062713, 070913 AND expired lots prior to Best By 101012
Classification	Class I
Reason for Recall	The firm inititated the recall of Crunch® thinkThin nutrition bars which may contain blanched roasted peanuts supplied by Sunland , Inc and have the potential to be contaminated with Salmonella.
Product Quantity	7,683 cases
Recall Number	F-0623-2013

Product Description	Nutrition bar. Crunch® thinkThin Brand, White Chocolate Dipped Mixed Nuts, 40 grams. Packaged in plastic, labeled as:"Distributed by thinkproducts*Ventura, CA 93003*". 10 bars/carton, 12 cartons/case. 120 bars per case
Code Info	UPC Code: 7 53656 70861 4 Best by Dates: 030113 ,032513, 042013, 052213, 060113, 061513, 062213 AND expired lots prior to Best By 101012
Classification	Class I
Reason for Recall	The firm inititated the recall of Crunch® thinkThin nutrition bars which may contain blanched roasted peanuts supplied by Sunland , Inc and have the potential to be contaminated with Salmonella.
Product Quantity	14,435 cases
Recall Number	F-0624-2013

Product Description	Nutrition bar. Crunch® thinkThin Brand, Chocolate Dipped Mixed Nuts, 40 grams. Packaged in plastic, labeled as:"Distributed by thinkproducts*Ventura, CA 93003*". 10 bars/carton, 12 cartons/case. 120 bars per case
Code Info	UPC Code: 7 53656 70843 0 Best by Dates: 101812, 102612, 110812, 110912, 120312, 030713, 030813, 031613, 032513, 041213, 041313, 042113, 042513, 042813, 051213, 052313, 052413, 060713, 061413, 062613, 062813, 071813 AND expired lots prior to Best By 101012
Classification	Class I
Reason for Recall	The firm inititated the recall of Crunch® thinkThin nutrition bars which may contain blanched roasted peanuts supplied by Sunland , Inc and have the potential to be contaminated with Salmonella.
Product Quantity	3,112 cases
Recall Number	F-0625-2013

Product Description	Nutrition bar. Crunch® thinkThin Brand, Caramel Chocolate Dipped Mixed Nuts, 40 grams. Packaged in plastic, labeled as:"Distributed by thinkproducts*Ventura, CA 93003*". 10 bars/carton, 12 cartons/case. 120 bars per case
Code Info	UPC Code: 7 53656 70879 9 Best by Dates: 112812, 030813, 040513, 042113, 051013, 060113, 061513, 071313 AND expired lots prior to Best By 101012
Classification	Class I
Reason for Recall	The firm inititated the recall of Crunch® thinkThin nutrition bars which may contain blanched roasted peanuts supplied by Sunland , Inc and have the potential to be contaminated with Salmonella.
Product Quantity	2,408 cases
Recall Number	F-0626-2013

Product Description	Nutrition bar. Crunch® thinkThin Brand, Cherry & Mixed Nuts, 40 grams. Packaged in plastic, labeled as:"Distributed by thinkproducts*Ventura, CA 93003*". 10 bars/carton, 12 cartons/case. 120 bars per case
Code Info	UPC Code: 7 53656 70915 4 Best by Dates: 022313, 032513, 041913, 042513, 061113 AND expired lots prior to Best By 101012
Classification	Class I
Reason for Recall	The firm inititated the recall of Crunch® thinkThin nutrition bars which may contain blanched roasted peanuts supplied by Sunland , Inc and have the potential to be contaminated with Salmonella.
Product Quantity	1,099 cases
Recall Number	F-0627-2013

Product Description	Nutrition bar. Crunch® thinkThin Brand, Blueberry & Mixed Nuts, 40 grams. Packaged in plastic, labeled as:"Distributed by thinkproducts*Ventura, CA 93003*". 10 bars/carton, 12 cartons/case. 120 bars per case
Code Info	UPC Code: 7 53656 70906 2 Best by Dates: 111812, 022313, 022413, 032813, 040413, 042113, 051813, 051913, 060813, 062713, 062813, 071913 AND expired lots prior to Best By 101012
Classification	Class I
Reason for Recall	The firm inititated the recall of Crunch® thinkThin nutrition bars which may contain blanched roasted peanuts supplied by Sunland , Inc and have the potential to be contaminated with Salmonella.
Product Quantity	1,775 cases
Recall Number	F-0628-2013

Product Description	Nutrition bar. Crunch® thinkThin Brand, Cranberry Apple & Mixed Nuts, 40 grams. Packaged in plastic, labeled as:"Distributed by thinkproducts*Ventura, CA 93003*". 10 bars/carton, 12 cartons/case. 120 bars per case
Code Info	UPC Code: 7 53656 70909 3 Best by Dates: 030813, 041113, 052913, 062213 AND expired lots prior to Best By 101012
Classification	Class I
Reason for Recall	The firm inititated the recall of Crunch® thinkThin nutrition bars which may contain blanched roasted peanuts supplied by Sunland , Inc and have the potential to be contaminated with Salmonella.
Product Quantity	1221 cases
Recall Number	F-0629-2013

Class I Food/Cosmetics Event

Event ID	63483
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Oct-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Dole Fresh Vegetables Inc
City	Monterey
State	CA
Country	US
Distribution Pattern	IL, IN, ME,. MO, NJ, NY, OH, PA, TN and WI

Associated Products

Product Description	Dole American Blend; Iceberg, Romaine, Red Cabbage, Carrots and Radishes. Net Wt. 12 oz. (340g) UPC 0 71430 00933 8 Distributed by Dole Fresh Vegetables, Monterey, CA 93940
Code Info	Code: A275208A or B275208B; Enjoy by Date: 10-17-12.
Classification	Class I
Reason for Recall	Tennessee Department of Agriculture collected a random sample of Dole American Blen and had a positive result for Listeria Monocytogenes.
Product Quantity	922 cases
Recall Number	F-0615-2013

Class I Food/Cosmetics Event

Event ID	63484
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Oct-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Natural Selection Foods LLC dba Earthbound Farm
City	San Juan Bautista
State	CA
Country	US
Distribution Pattern	CA, FL, HI, LA, MA, MT, NE, NJ, NY, OH, OR, PA, TX and Canada

Associated Products

Product Description	Earthbound Farms Organic Baby Spinach Grab & Go Salad; with sesame, soy vinaigrette and peanuts. USDA Organic 3.5 oz. Clamshell package. UPC 0 32601 08875 0 Natural Selection Foods San Juan Bautista, CA.
Code Info	Best if Used by Dates: 10/17-12 through 10/28/12.
Classification	Class I
Reason for Recall	Peanuts packaged with EarthBound Baby Spinach Grab & Go Salad were provided by Sunland through a third party and are under recall due to potential Salmonella contamination.
Product Quantity	362 cases
Recall Number	F-0614-2013

Class I Food/Cosmetics Event

Event ID	63487
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Oct-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Energy Club Inc
City	Pacoima
State	CA
Country	US
Distribution Pattern	nationwide in the US

Associated Products

Product Description	Peanuts in Shell, R&S, 8oz, Item#304, 12pk/case, UPC 070334003046. Peanuts in Shell, R&S, 8oz, Item#304P, 12pk/case, UPC 170334003046. Peanuts in Shell, R&S, 8oz, Item#307, 36pk/case, UPC 070334003046. Peanuts in Shell, R&S, 16oz, Item#317, 24pk/case, UPC 070334003176. Peanuts in Shell, R&S Clip Strips, Item#327, 8oz, 4/12 pk/case, UPC 070334003046. Peanuts in Shell, R&S, 4.5oz, Item#334, 12pk/case, UPC 070334003305. Peanuts in Shell, R&S, Display Ready, 8oz, Item#360, 12pk/case, UPC 070334003046. Peanuts in Shell, R&S, 3lbs, Item#383, 8pk/case, UPC 070334003831. Peanuts in Shell, R&S, 3lbs, Item#530, 60pk/case, UPC 170334005309. Peanuts in Shell, R&S, 3lbs, Item#530V, 60pk/case, UPC 070334005309. Peanuts in Shell, R&S, 3lbs, Item#530VP, 60pk/case, UPC 070334005309. Peanuts in Shell, R&S, 7.5lbs, Item#1950, 24pk/case, UPC 052679019500.
Code Info	Best By Date 11/23/2012 to 04/10/2013
Classification	Class I
Reason for Recall	Trifecta Foods, LLC in Pacoima, CA is voluntarily recalling products containing In-Shell Roasted Salted and Unsalted Peanuts supplied to Trifecta Foods by Sunland, Inc. because they may be contaminated with Salmonella.
Product Quantity	22,271 units total
Recall Number	F-0616-2013

Product Description	Peanuts in Shell, R Unsalted, 8oz, Item#305, 12pk/case, UPC 070334003053. Peanuts in Shell, R Unsalted, 8oz, Item#308, 36pk/case, UPC 070334003053. Peanuts in Shell, R Unsalted, 16oz, Item#318, 24pk/case, UPC 070334003189. Peanuts in Shell, R Unsalted-Display Ready, 8oz, Item#361, 12pk/case, UPC 070334003053. Peanuts in Shell, R Unsalted, 3lbs, Item#384, 8pk/case, UPC 070334003848. Peanuts in Shell, R Unsalted-Caddies, 3oz, Item#535, 8/12pk/case, UPC 070334005354.
Code Info	Best by Date 11/23/12 to 4/10/13.
Classification	Class I
Reason for Recall	Trifecta Foods, LLC in Pacoima, CA is voluntarily recalling products containing In-Shell Roasted Salted and Unsalted Peanuts supplied to Trifecta Foods by Sunland, Inc. because they may be contaminated with Salmonella.
Product Quantity	22,271 units total
Recall Number	F-0617-2013

Class I Food/Cosmetics Event

Event ID	63501
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Oct-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	The Nut Factory Inc.
City	Spokane Valley
State	WA
Country	US
Distribution Pattern	Product was distributed in Washington state. There are no Canadian consignees.

Associated Products

Product Description	Fiesta Mix 25 pound bags, with UPC 032491208597. The product is labeled in part: "*Fiesta Mix A Blend of the Sweet Crunchy and Salty Ingredient: Peanuts, honey, chili bits, corn, goldfish, nacho flavoring, vegetable oil, salt. * 25 pounds (11.34 kg) net weight * The Nut Factory 19425 East Broadway Avenue Greenacress, WA 99016*".
Code Info	Dates of distribution: 1/1/12 thorugh and including 10/17/12 Fiesta Mix label Date Manuactured: In format of date, first three letters of the month and year (2012).
Classification	Class I
Reason for Recall	Fiesta Mix product is recalled due to undeclared soy, milk, wheat, and FD& C Yellow #6 on finished product label.
Product Quantity	13-25 pound bags (325 lbs of product total).
Recall Number	F-0634-2013

Class I Food/Cosmetics Event

Event ID	63519
Status	Terminated
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Oct-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Honolulu Baking Company, Ltd.
City	Honolulu
State	HI
Country	US
Distribution Pattern	HI distribution only on island of Oahu.

Associated Products

Product Description	Starbucks brand Protein Bistro Box. cage free egg, white cheddar cheese, multigrain muesli bread, apple slices, red grapes and peanut butter packet. Net weight: 6.8 oz. Starbucks Bistro box UPC 762111881502; Justin's honey Peanut Butter blend UPC 894455000391. Honolulu Baking Co. Honolulu, HI 96813
Code Info	Enjoy By Dates of 9-2-10 - 3-28-12 and 9-1-12 - 10-1-12. for Bistro Boxes. Best Buy Dates for peanut packets: 4/11/11 _ 12/7/12; 7/27/13 and 7/29/13.
Classification	Class I
Reason for Recall	Firm used recalled 0.5 oz., single serve squeeze packs of Honey Peanut Butter in their Starbucks Brand Protein Bistro Packs which have been implicated in the Sunland Inc recall.
Product Quantity	146,311 boxes since 9/1/2010
Recall Number	F-0633-2013

Class I Food/Cosmetics Event

Event ID	63534
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-Oct-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Southern Belle, Inc.
City	Murfreesboro
State	TN
Country	US
Distribution Pattern	TN

Associated Products

Product Description	Peanut brittle, 2 lbs packaged in plastic bags (bulk product)
Code Info	all date codes between 09/30/2012 - 10/04/2012
Classification	Class I
Reason for Recall	Products were manufactured using peanuts recalled by Sunland
Product Quantity	41 units
Recall Number	F-0630-2013

Product Description	Bacon Brittle, 2 lbs packaged in plastic bags (bulk product)
Code Info	all date codes between 09/30/2012 - 10/04/2012
Classification	Class I
Reason for Recall	Products were manufactured using peanuts recalled by Sunland
Product Quantity	27 units
Recall Number	F-0631-2013

Class I Food/Cosmetics Event

Event ID	63587
Status	Completed
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Oct-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Williams and Company Inc dba The Nut Shop
City	Tuscaloosa
State	AL
Country	US
Distribution Pattern	AL and MS

Associated Products

Product Description	The Nut Shop (brand) Roasted Peanuts, 3.0 oz MIN Wt.
Code Info	The product is not coded. All product on the shelf as of October 18, 2012
Classification	Class I
Reason for Recall	Product manufactured using peanuts which were recalled by Sunland.
Product Quantity	3000 units
Recall Number	F-0612-2013

Class II Devices Event

Event ID	52796
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Aug-08
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Sechrist Industries Inc
City	Anaheim
State	CA
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada

Associated Products

Product Description	Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures.
Code Info	Serial Numbers: 330001-330069, 330071, 330072, 330074, 330075.
Classification	Class II
Reason for Recall	Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of the chamber.
Product Quantity	73 units
Recall Number	Z-0208-2013

Product Description	Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures
Code Info	Serial Numbers: 360001-360049, 360051-360064, 360068.
Classification	Class II
Reason for Recall	Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of the chamber.
Product Quantity	65 units total (61 units in the US)
Recall Number	Z-0209-2013

Class II Devices Event

Event ID	53337
Status	Completed
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Oct-08
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Medacta Usa Inc
City	Camarillo
State	CA
Country	US
Distribution Pattern	Worldwide Distribution -- US including the states of Texas, Nevada and Colorado., and the country of Belgium.

Associated Products

Product Description	Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.
Code Info	Ref: 01.10.10.122 (Lot # 085119), Ref: 01.10.10.123 (Lot # 085120), Ref: 01.10.10.124 (Lot # 085244), Ref: 01.10.10.125 (Lot # 085243)
Classification	Class II
Reason for Recall	Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potential of the rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to lock/unlock the broaches.
Product Quantity	12 units
Recall Number	Z-0267-2013

Class II Drugs Event

Event ID	62113
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Mar-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Aurobindo Pharma LTD
City	Mehbubnagar
State
Country	IN
Distribution Pattern	Nationwide

Associated Products

Product Description	Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC Memphis, TN 38141. Manufactured by Aurobindo Pharma Limited, Unit VII, Mahaboob Dagar, 509302, India
Code Info	Batch Number ZPSB11054-A Exp. 05/13
Classification	Class II
Reason for Recall	Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labeled Zolpidem Tartrate tables USP 10 mg
Product Quantity	23,616 bottles
Recall Number	D-041-2013

Class II Devices Event

Event ID	62271
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Oct-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Shimadzu Medical Systems
City	Torrance
State	CA
Country	US
Distribution Pattern	US Nationwide Distribution

Associated Products

Product Description	R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-ray tubes 0.6/1.2P364DK-85, 0.6/1.2P324DK-125, 0.6/1.2P324DK-85, 0.6/1.2P38DE-85 Device Model # R-30H. Subsequent Product Code: IZX Product Usage: The device is the beam-limiting device for X-ray Radiography.
Code Info	Device Model #R-30H
Classification	Class II
Reason for Recall	Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
Product Quantity	665 units
Recall Number	Z-0260-2013

Product Description	R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK-85, 0.6/1.2P324DK-125, 06/1.2P324DK-85, 0.6/1.2P38DE-85. Product Usage: The device is the beam-limiting device for X-ray Radiography.
Code Info	Device Model #R-20J
Classification	Class II
Reason for Recall	Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
Product Quantity	308 units
Recall Number	Z-0261-2013

Product Description	0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H. Classification Name: Mobile x-ray system. Device Model#MUX-100H. Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
Code Info	S/N of X-ray tube: 63049 63048 63074 63081 63082 63077 63350 63349 63629 63647 63909 62729 64214 66033 66032 70070 70065 70364 66327 66331 70058 66325 70955 71241 70920 71848 72472 72462 73056 73058 73341 73675 74577 74563 74565 74557 74558 74846 74845 75455 75452 75457 75728 75737 75736 76059 76057 76060 76054 76062 76360 76366 76612 76636 76336 76916 76655 76647 76938 76940 2XY080646 2XY0081249 2XY0081245 2XY0081543 2XY0081858 2XY0081849 2XY0081855 2XY0081856 2XY0081865 2XY0081862 2XY0082746 2XY0082764 2XY0083055 2XY0083052 2XY0083064 2XY0083051 2XY0083053 2XY0083038 2XY0083063 2XY0083063 2XY0083065 2XY0083343 2XY0083340 2XY0083349 2XY0083354 2XY0083360 2XY0083355 2XY0083646 2XY0083359 2XY0083652 2XY0083670 2XY0083674 2XY0083655 2XY0083673 2XY0083675 2XY0083665 2XY0083645 2XY0083643 2XY0083629 2XY0074577 2XY0083638 2XY0083943 2XY0083671 2XY0083933 2XY0083930 2XY0083925 2XY0084532 2XY0084558 2XY0084546 2XY0084553 2XY0084538 2XY0084846 2XY0084565 2XY0084845 2XY0085124 2XY0085137 2XY0085127 2XY0084578 2XY0085140 2XY0085143 2XY0085141 2XY0086351 2XY0084860 2XY0084856 2XY0084851 2XY0084859 2XY0086344 2XY0084852 2XY0086365 2XY0086364 2XY0086373 2XY0086368 2XY0086665 2XY0086674 2XY0087077 2XY0087371 2XY0087044 2XY0087036 2XY0087041
Classification	Class II
Reason for Recall	Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
Product Quantity	288 units
Recall Number	Z-0262-2013

Product Description	0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
Code Info	S/N of X-ray tube: 64510 66036 66026 66027 71866 70641 72470 72740 72735 73360 73365 2XY0084531 73372 73679 73671 73966 74248 74258 74546 74548 74291 74556 74832 74834 74833 74829 74837 76058 76326 76069 76355 76364 76361 76356 76358 76363 76367 2XY0080666 80666 2XY0080650 2XY0080345 2XY0080649 2XY0080656 2XY0082453 2XY0082456 2XY0082461 2XY0082748 2XY0083039 2XY0075448 2XY0082750 2XY0083070 2XY0082778 2XY0083047 2XY0083058 2XY0083680 2XY0083627 2XY0083633 2XY0083951 2XY0084556
Classification	Class II
Reason for Recall	Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
Product Quantity	133 units
Recall Number	Z-0263-2013

Product Description	0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
Code Info	MobileArt Evolution (12.5 kW) S/N of X-ray tube: 2XY0090049 2XY0090052 2XY0090062 2XY0090388 2XY0092824 2XY0092822 2XY0094944 2XY0094940 2XY0095628 2XY0095975 2XY0095996 2XY0097550 2XY0097539 2XY0000035 2XY0090058 MobileArt Evolution (32 kW) S/N of X-ray tube: 2XY0092847 2XY0092851 2XY0092850 2XY0093893 2XY0093890 2XY0093561 2XY0096822 2XY0096828 2XY0097579 2XY0000834 2XY0001079 2XY0001215 2XY0001200 2XY0001311 2XY0001216 2XY0001312 2XY0001214 2XY0001377 2XY0001374 2XY0001383 2XY0001488 2XY0001653 2XY0001478 2XY0001657 2XY0001658 2XY0001674 2XY0001672 2XY0001644 2XY0002081 2XY0002281 2XY0002088 2XY0002083 2XY0002289 2XY0001827 CM74B3012026 2XY0003774 2XY0004043
Classification	Class II
Reason for Recall	Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
Product Quantity	5 units
Recall Number	Z-0264-2013

Product Description	0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
Code Info	S/N of X-ray tube: 2XY0084725 2XY0084724 2XY0084723 2XY0099698 2XY0084726 2XY0084736 2XY0084739 2XY0084869 2XY0084729 2XY0084868 2XY0085162 2XY0085175 2XY0086383 2XY0086395 2XY0086726 2XY0086725 2XY0086724 2XY0087086 2XY0087088 2XY0087090 2XY0087421 2XY0087423 2XY0087427 2XY0087765 2XY0090747 2XY0091075 2XY0093894 2XY0096298 2XY0096820 2XY0096821 2XY0096832 2XY0096292 2XY0098245 2XY0098240 2XY0001064 2XY0001195 2XY0001088 2XY0001208 2XY0001077 2XY0001086 2XY0001198 2XY0001321 2XY0001204 2XY0001336 2XY0001337 2XY0001352 2XY0001388 2XY0001315 2XY0001370 2XY0001380 2XY0001464 2XY0001482 2XY0001484 2XY0001485 2XY0002730 2XY0003042 2XY0003037 2XY0003759 CM74B3016024 CM74B3017067 CM74B301201A CM74B3012018 CM74B3012017 CM74B301201C CM74B3012020 CM74B3012034 CM74B3012032 CM74B3013002 CM74B3016073 CM74B3016109 CM74B3015010
Classification	Class II
Reason for Recall	Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
Product Quantity	3 units
Recall Number	Z-0265-2013

Class II Devices Event

Event ID	62580
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Sysmex America, Inc.
City	Mundelein
State	IL
Country	US
Distribution Pattern	Nationwide distribution: USA including Puerto Rico.

Associated Products

Product Description	Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #983-1341-1 The Sysmex XE-2100 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-2100 performs hematology analyses according to the RF/DC detection method, HydroDynamic Focusing (DC Detection), flow cytometry method (using a semiconductor laser), and SLS-hemoglobin method.
Code Info	catalog #983-1341-1, all serial numbers
Classification	Class II
Reason for Recall	There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the XE-Series because of a low bias.
Product Quantity	1,099 units
Recall Number	Z-0254-2013

Product Description	Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-7591-7 The Sysmex XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-5000 performs analyses using the following methods: RF/DC Detection Method, Sheath Row DC Detection Method, and Flow Cytometry Methods using a Semiconductor Laser. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using the same reagents as the XE-2100, the XE-5000 automatically classifies cells from blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results.
Code Info	catalog #063-7591-7, all serial numbers
Classification	Class II
Reason for Recall	There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the XE-Series because of a low bias.
Product Quantity	763 units
Recall Number	Z-0255-2013

Product Description	Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #053-2311-4 The Sysmex XE-2100C is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Code Info	catalog ##053-2311-4, all serial numbers
Classification	Class II
Reason for Recall	There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the XE-Series because of a low bias.
Product Quantity	69 units
Recall Number	Z-0256-2013

Class II Biologics Event

Event ID	62820
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Community Blood Centers of Florida, Inc.
City	Miami
State	FL
Country	US
Distribution Pattern	Florida

Associated Products

Product Description	Red Blood Cells
Code Info	W036811144281;
Classification	Class II
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-2487-12

Product Description	Platelets Pooled Leukocytes Reduced
Code Info	W036811807521;
Classification	Class II
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-2488-12

Product Description	Fresh Frozen Plasma
Code Info	W036811144281;
Classification	Class II
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-2489-12

Class II Biologics Event

Event ID	62821
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Jul-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Central Jersey Blood Center, Inc.
City	Eatontown
State	NJ
Country	US
Distribution Pattern	New Jersey

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W053512009319; W053512000355; W053512002729; W053511145005;
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	4 units
Recall Number	B-2490-12

Class II Biologics Event

Event ID	62822
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Mar-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Community Blood Centers of Florida, Inc.
City	Lauderhill
State	FL
Country	US
Distribution Pattern	Florida

Associated Products

Product Description	Red Blood Cells
Code Info	W036811002671;
Classification	Class II
Reason for Recall	Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity	1 unit
Recall Number	B-2491-12

Class II Biologics Event

Event ID	62823
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Jun-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Hoxworth Blood Center UC Medical Center
City	Cincinnati
State	OH
Country	US
Distribution Pattern	Ohio

Associated Products

Product Description	Cryoprecipitated AHF, Pooled
Code Info	W037711502217;
Classification	Class II
Reason for Recall	Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Product Quantity	1 unit
Recall Number	B-2492-12

Class II Biologics Event

Event ID	62825
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Jun-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Mississippi Blood Services Inc.
City	Flowood
State	MS
Country	US
Distribution Pattern	Mississippi

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W069112124734(Part A); W069112124734(Part B)
Classification	Class II
Reason for Recall	Blood product, which did not meet the acceptable product specifications, were distributed.
Product Quantity	2 units
Recall Number	B-2501-12

Class II Biologics Event

Event ID	62837
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Aug-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	LifeSouth Community Blood Centers Inc - Birmingham Region
City	Birmingham
State	AL
Country	US
Distribution Pattern	Alabama

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W1151121920405;
Classification	Class II
Reason for Recall	Blood product, which did not meet acceptable product specifications, was distributed.
Product Quantity	1 unit
Recall Number	B-2499-12

Class II Biologics Event

Event ID	62838
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Jul-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	LifeSouth Community Blood Centers, Inc.
City	Gainesville
State	FL
Country	US
Distribution Pattern	Alabama

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W115112242560G;
Classification	Class II
Reason for Recall	Blood product, which did not meet the acceptable product specifications, was distributed.
Product Quantity	1 unit
Recall Number	B-2500-12

Class II Biologics Event

Event ID	62839
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Apr-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	LifeSouth Community Blood Centers Inc - Birmingham Region
City	Birmingham
State	AL
Country	US
Distribution Pattern	Alabama

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W1151121581200;
Classification	Class II
Reason for Recall	Blood product, which did not meet acceptable product specifications, was distributed.
Product Quantity	1 unit
Recall Number	B-2502-12

Class II Biologics Event

Event ID	62840
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Jul-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Walter L. Shepeard Community Blood Center, Inc.
City	Augusta
State	GA
Country	US
Distribution Pattern	Georgia

Associated Products

Product Description	Red Blood Cells
Code Info	W038509323445;
Classification	Class II
Reason for Recall	Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed
Product Quantity	1 unit
Recall Number	B-2503-12

Product Description	Cryoprecipitated AHF
Code Info	W038509323445;
Classification	Class II
Reason for Recall	Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed
Product Quantity	1 unit
Recall Number	B-2504-12

Class II Biologics Event

Event ID	62861
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Jun-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Florida's Blood Centers, Inc.
City	Orlando
State	FL
Country	US
Distribution Pattern	Florida

Associated Products

Product Description	Red Blood Cells (Apheresis)
Code Info	W038112098387;
Classification	Class II
Reason for Recall	Blood product, labeled 'leukoreduced', but which had not undergone leukoreduction, was distributed.
Product Quantity	1 unit
Recall Number	B-2543-12

Class II Biologics Event

Event ID	62862
Status	Completed
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Jul-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Community Blood Centers of Florida, Inc.
City	Lauderhill
State	FL
Country	US
Distribution Pattern	Florida; New York

Associated Products

Product Description	Red Blood Cells
Code Info	2621030;
Classification	Class II
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-2611-12

Product Description	Platelets Pooled Leukocytes Reduced Irradiated
Code Info	2926630;
Classification	Class II
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-2612-12

Product Description	Fresh Frozen Plasma
Code Info	2621030;
Classification	Class II
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-2613-12

Class II Biologics Event

Event ID	62863
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Jul-12
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W333612044123; W333612010664; W333611093208;
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed.
Product Quantity	3 units
Recall Number	B-2562-12

Class II Biologics Event

Event ID	62876
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Aug-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Blood Systems Inc
City	Scottsdale
State	AZ
Country	US
Distribution Pattern	Arizona

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W041010152697I;
Classification	Class II
Reason for Recall	Blood product, positive for the S-antigen but labeled as S-antigen negative, was distributed.
Product Quantity	1 unit
Recall Number	B-2544-12

Class II Biologics Event

Event ID	62878
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Jul-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Suncoast Communities Blood Bank, Inc.
City	Sarasota
State	FL
Country	US
Distribution Pattern	Florida

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W038612824624; W038612824624; W038612824624;
Classification	Class II
Reason for Recall	Blood products, which did not meet acceptable product specifications, were distributed.
Product Quantity	3 units
Recall Number	B-2546-12

Class II Biologics Event

Event ID	62903
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Memorial Blood Centers
City	Saint Paul
State	MN
Country	US
Distribution Pattern	Minnesota

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced Irradiated
Code Info	W051512070531
Classification	Class II
Reason for Recall	Blood products, with a low pH, was distributed.
Product Quantity	1 unit
Recall Number	B-2564-12

Class II Biologics Event

Event ID	62904
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Jun-12
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	Memorial Blood Centers
City	Saint Paul
State	MN
Country	US
Distribution Pattern	Switzerland; Minnesota

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	W051512022383;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity	1 unit
Recall Number	B-2144-12

Product Description	Red Blood Cells
Code Info	W051512022383;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity	1 unit
Recall Number	B-2145-12

Class II Biologics Event

Event ID	62905
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Memorial Blood Centers
City	Saint Paul
State	MN
Country	US
Distribution Pattern	Minnesota

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W051511105499;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity	1 unit
Recall Number	B-2558-12

Product Description	Platelets Pheresis Leukocytes Reduced Irradiated
Code Info	W051511105499;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity	1 unit
Recall Number	B-2559-12

Class II Biologics Event

Event ID	62906
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Jul-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Interstate Blood Bank, Inc. of Wisconsin
City	Milwaukee
State	WI
Country	US
Distribution Pattern	California; Germany, Federal Republic of

Associated Products

Product Description	Source Plasma
Code Info	12MKEB0609; 12MKEB0320; 12MKEA9877; 12MKEA9596; 12MKEA9031; 12MKEA8768; 12MKEA8361; 12MKEA8054; 12MKEA7641; 12MKEA7343; 12MKEA5778; 12MKEA5299; 12MKEA5112; 12MKEA4574; 12MKEA3828; 12MKEA3383; 12MKEA3237; 12MKEA2878; 12MKEA2739; 12MKEA2429; 12MKEA2241; 12MKEA1812; 12MKEA1638; 12MKEA1270; YP028051; 12MKEA0759; 12MKEA0530; 12MKEA0047; 11MKED9274; 11MKED8647; 11MKED8357; 11MKED7556; 11MKED7270;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was permanently deferred, were distributed.
Product Quantity	33 units
Recall Number	B-2566-12

Class II Biologics Event

Event ID	62907
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Jul-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Interstate Blood Bank, Inc. of Wisconsin
City	Milwaukee
State	WI
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	12MKEA6076; 12MKEA5884;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was permanently deferred, were distributed.
Product Quantity	2 units
Recall Number	B-2567-12

Class II Devices Event

Event ID	62945
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
City	Aguadilla
State	PR
Country	US
Distribution Pattern	Worldwide Distribution - USA including DE,IL, NC, CA, CO, GA, KY, PA, MD, MN, NY, and MA and internationally to Austria, UAE, China, Argentina, Italy, Taiwan, Czech Republic, Australia, UK, India, Germany, Spain, France, South Africa, Malaysia, Japan, Lebanon, Korea, Greece, Saudi Arabia, Switzerland, Pakistan, Tunisia, Serbia, Morocco, Netherlands, Portugal, Truk, Belgium, and New Zealand

Associated Products

Product Description	"*Sharpoint IQ Geometry Slit Knife Angled, Bevel UpSurgical Specialties Corporation Reading, PAREF 72-2740*" Ophthalmic surgery
Code Info	MAFD350, M381400, M407870, M439070, M439090, M466140, M495140, M495190, M510800, M554700, M554740, M585650, M656720, M656730, MABL380, MABQ000, MADM740
Classification	Class II
Reason for Recall	Potential for bent tips.
Product Quantity	117,948 units (total)
Recall Number	Z-0201-2013

Product Description	"*Sharpoint IQ Geometry Slit Knife Angled, Bevel UpSurgical Specialties Corporation Reading, PAREF 72-2840*" Ophthalmic surgery
Code Info	M342500, M342510, M415840, M439130, M446040, M495130, M495160, M510810, M553460, M553470, M553480, M585640, M585740, M652760, M652770, M652780, MADP160, MADP170
Classification	Class II
Reason for Recall	Potential for bent tips.
Product Quantity	117,948 units (total)
Recall Number	Z-0202-2013

Product Description	"*Sharpoint IQ Geometry Slit Knife Angled, Bevel UpSurgical Specialties Corporation Reading, PAREF 72-3040*" Ophthalmic surgery
Code Info	MABQ150, MAGS310, MAJC690
Classification	Class II
Reason for Recall	Potential for bent tips.
Product Quantity	117,948 units (total)
Recall Number	Z-0203-2013

Product Description	"*Sharpoint IQ Geometry Slit Knife Angled, Bevel UpSurgical Specialties Corporation Reading, PAREF 72-3240*" Ophthalmic surgery
Code Info	MAKR840, MALZ570, MALZ580, MAMQ990, MAMR000, MANP250, MAPR320, MAQD910
Classification	Class II
Reason for Recall	Potential for bent tips.
Product Quantity	117,948 units (total)
Recall Number	Z-0204-2013

Class II Biologics Event

Event ID	62952
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Aug-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	LifeShare Blood Centers
City	Beaumont
State	TX
Country	US
Distribution Pattern	Switzerland

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	W036510091494;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Product Quantity	1 unit
Recall Number	B-2571-12

Class II Biologics Event

Event ID	62956
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Aug-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Community Blood Centers of South Florida, Inc.
City	Hialeah
State	FL
Country	US
Distribution Pattern	Florida

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W036812405799;
Classification	Class II
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-2575-12

Product Description	Platelets Pooled Leukocytes Reduced
Code Info	W036812834939;
Classification	Class II
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-2576-12

Product Description	Fresh Frozen Plasma
Code Info	W036812405799;
Classification	Class II
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-2577-12

Class II Biologics Event

Event ID	62957
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Jul-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Community Blood Centers of Florida, Inc.
City	Miami
State	FL
Country	US
Distribution Pattern	Florida

Associated Products

Product Description	Red Blood Cells
Code Info	W036811173182;
Classification	Class II
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-2578-12

Product Description	Fresh Frozen Plasma
Code Info	W036811173182;
Classification	Class II
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-2579-12

Product Description	Platelets Pooled Leukocytes Reduced
Code Info	W036811811523;
Classification	Class II
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-2580-12

Class II Devices Event

Event ID	63083
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	02-Feb-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Primus Medical LLC
City	Boardman
State	OH
Country	US
Distribution Pattern	Nationwide distribution: USA including states of: AZ, IL, KY, MD, MI, OH, OR, PA, TX and VA.

Associated Products

Product Description	AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512. Usage: Hospital Bed.
Code Info	Model #TL500; Serial Number: 001, 002, 003, 004, 005, 006, 007, 010, 013, 014, 015, 016, 017, 018, 021, 022, 023, 024, 025, 026, 027, 028, 029, 030, 031, 032, 033, 034, 035, 039, 040, 041, 042, 043, 044, 045, 046, 047, 048, 049, 050, 052, 053, 054, 055, 056, 057, 058, 059, 060, 061, 062, 063, 064, 065, 070, 075, 081, 09350014, 09350015, 09350016, 09350017, 09350018, 09350021, 09350023, 09350025, 09350026, 09350027, 09350028, 09350029, 09350030, 09350031, 09350032, 09350033, 09350035, 09350038, 09350040, 09350041, 09350042, 09350045, 09350048, 09350049, 09350054, 09350055, 09350056, 09350057, 09350058, 09350059, 09350060, 09350062, 09350063, 09350064, 09350065, 09350066, 09350067, 09350068, 09350069, 09350070, 09350072, 09350074, 09350082, 09350085, 09350087, 09350088, 09350089, 09350090, 09350091, 09350092, 09430001, 09430002, 09430003, 09430004, 09430005, 09430006, 09430007, 09430008, 09430010, 09430013, 09430014, 09430015, 09430017, 09430019, 09430020, 09430021, 09430022, 09430024, 09430026, 09430027, 09430028, 09430029, 09430030, 09430032, 09430033, 09430034, 09430036, 09430037, 09430038, 09430039, 09430040, 09430041, 09430042, 09430043, 09430044, 09430045, 09430046, 09430047, 09430049, 09430050, 09430051, 09430052, 09430053, 09430054, 09430056, 09430057, 09430058, 09430059, 09430060, 09430061, 09430062, 09430063, 09430065, 09430066, 09463067, 09430068, 09430069, 09430070, 09430071, 09430072, 09430074, 09430075, 09430076, 09430077, 09430078, 09430079, 09430080, 09430081, 09430083, 09430085, 09430086, 09430087, 09430088, 09430089, 09430091, 09430093, 09430094, 09430097, 09430099, 09430100, 09520001, 09520002, 09520003, 09520004, 09520005, 09520006, 09520007, 09520008, 09520009, 09520011, 09520012, 09520013, 09520015, 09520017, 09520018, 09520019, 09520020, 09520021, 09520022, 09520025, 09520026, 09520027, 09520028, 09520029, 09520030, 09520031, 09520032, 09520033, 09520034, 09520035, 09520036, 09520037, 09520038, 09520039, 09520040, 09520041, 09520042, 09520043, 09520044, 09520045, 09520046, 09520047, 09520048, 09520049, 09520050, 10040001, 10040003, 10040004, 10040005, 10040006, 10040007, 10040008, 10040009, 10040010, 10040011, 10040012, 10040013, 10040014, 10040015, 10040016, 10040017, 10040028, 10040029, 10040030, 10040032, 10040033, 10040034, 10040035, 10040036, 10040037, 10040038, 10040039, 10040040, 10040041, 10040042, 10040043, 10040044, 10040045, 10040046, 10040047, 10040048, 10040049, 10040050, 10040051, 10040052, 10040053, 10040054, 10040055, 10040056, 10040057, 10040058, 10040059, 10040062, 10040063, 10040064, 10040065, 10040066, 10040067, 10040068, 10040069, 10040070, 10040071, 10040073, 10040074, 10040075, 10040076, 10040077, 10040078, 10400029, 10400050, 10400056, 10400057, 10400058, 10400059, 10400065, 10370016, 10370017, 10370018, 10370019, 10370020, 10370032, 10370033, 10370034, 10370035, 10370038, 10370052, 10370053, 10370054, 10370056, 10370060, 10370063, 10370078, 10370079, 10370080 , 09380031, 09380029, 09380064, 09380070, 09380089, 09380040, 09380038, 09380085, 09380045, 09380054, 09380060, 09380059, 09380058, 09380048, 09380042, 09380038, 09380069, 09380063, 09380067 & 09380065.
Classification	Class II
Reason for Recall	The "Retaining washers & Clevis Pins" provided with the AC -powered adjustable hospital beds may fail under certain circumstances. The pins at the top of the leg were disengaging from the channel. This may cause the bed frame to come off tracks or collapse.
Product Quantity	342 Beds
Recall Number	Z-0270-2013

Class II Devices Event

Event ID	63103
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Zimmer, Inc.
City	Warsaw
State	IN
Country	US
Distribution Pattern	Nationwide Distribution.

Associated Products

Product Description	Alloclassic SL Shaft
Code Info	Item 2839, 2840, 2841, 2842, 2843, 2844, 2845, 2846, 2847, 2848, 2949, 2851, 2852, 2883, 2884, 2885, 2886, and 2887 Lots: 2359249, 2359251, 2359251, 2368739, 2413914, 2413914, 2426010, 2526138, 2335608, 2381324, 2387449, 2388541, 2401237, 2401237, 2492774, 2523553, 2355767, 2355767, 2361511, 2361511, 2371517, 2376476, 2440672, 2453100, 2479736, 2498363, 2529208, 2303302, 2347856, 2355765, 2355765, 2428247, 2428247, 2446699, 2456353, 2497037, 2506067, 2506067, 2509374, 2517494, 2316056, 2326792, 2335862, 2355428, 2370478, 2376478, 2382854, 2388539, 2391204, 2428742, 2431991, 2439733, 2453093, 2301633, 2343382, 2363829, 2363829, 2363829, 2370490, 2492887, 2513725, 2513725, 2513725, 2515404, 2515404, 2517796, 2529231, 2319316, 2340681, 2345324, 2359179, 2359179, 2413790, 2432646, 2479750, 2501280, 2509376, 2509376, 2509378, 2510392, 2510392, 2303201, 2333704, 2340906, 2368928, 2375002, 2388530, 2403651, 2445551, 2471087, 2507375, 2511623, 2523569, 2345382, 2396573, 2428657, 2432681, 2464083, 2469537, 2475899, 2529943, 2421855, 2421855, 2437494, 2437494, 2475746, 2475746, 2526284, 2391015, 2391015, 2391015, 2390171, 2418766, 2397095, 2399625, 2352268, 2406373, 2406373, 2437316, and 2518394
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	1355
Recall Number	Z-0210-2013

Product Description	Biolox® delta Ceramic Femoral Head Rx only, sterile
Code Info	REF Numbers: 00-8775-028-01, 00-8775-028-02, 00-8775-028-03, 00-8775-032-01, 00-8775-032-02, 00-8775-032-03, 00-8775-032-04, 00-8775-036-01, 00-8775-036-02, 00-8775-036-03, 00-8775-036-04, 00-8775-040-01, 00-8775-040-02, 00-8775-040-03, and 00-8775-040-04.
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	2544
Recall Number	Z-0211-2013

Product Description	Biolox® Option Ceramic Femoral Head System Rx, sterile
Code Info	REF Numbers: 00-8777-028-02, 00-8777-036-01, 00-8777-036-02, and 00-8777-040-01.
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	88
Recall Number	Z-0212-2013

Product Description	Wagner SL Revision Stem, uncemented Sterile
Code Info	REF Numbers: 01.00101.914, 01.00101.915, 01.00101.916, 01.00101.917, 01.00101.918, 01.00102.217, 01.00102.219, 01.00102.221, 01.00102.619, 01.00102.620, 01.00102.621, 01.00102.622, 01.00103.015, 01.00103.017, 01.00103.021, 01.00103.025, 30.00.89.160, and 30.00.89.190.
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	87
Recall Number	Z-0213-2013

Product Description	Alloclassic® SL-Offset Stem sterile, Rx
Code Info	REF Numbers: 01.00121.020, 01.00121.030, 01.00121.040, 01.00121.050, 01.00121.060, 01.00121.070, and 01.00121.090.
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	126
Recall Number	Z-0214-2013

Product Description	Metasul® LDH® Head Rx Sterile
Code Info	REF Numbers: 01.00181.380, 01.00181.400, 01.00181.420, 01.00181.440, 01.00181.460, 01.00181.480, 01.00181.500, 01.00181.520, 01.00181.540, 01.00181.560, 01.00181.580, 01.00181.600, Lots:2336407, 2384226, 2417501, 2379463, 2414200, 2435636, 2437758, 2437758, 2439049, 2318066, 2318066, 2318066, 2337823, 2341591, 2341591, 2350267, 2350642, 2356116, 2379464, 2393154, 2393154, 2407029, 2417505, 2417505, 2334410, 2337816, 2337817, 2342259, 2350644, 2356119, 2356129, 2357620, 2357620, 2367367, 2414126, 2417566, 2431247, 2458307, 2470473, 2314684, 2330846, 2330846, 2331024, 2331024, 2331024, 2336380, 2337812, 2341474, 2341474, 2341474, 2342282, 2343844, 2344862, 2345939, 2374886, 2384620, 2398703, 2414135, 2419493, 2421904, 2431254, 2452258, 2470507, 2320781, 2320781, 2320781, 2337810, 2345946, 2356142, 2356142, 2356155, 2374303, 2378382, 2381628, 2388393, 2395787, 2403721, 2406900, 2431262, 2439060, 2442487, 2332977, 2341611, 2341613, 2343332, 2343332, 2344271, 2346316, 2350291, 2350291, 2357379, 2361010, 2367418, 2367418, 2367426, 2370634, 2374371, 2404509, 2423600, 2424387, 2426405, 2491198, 2504866, 2320794, 2320794, 2320794, 2332984, 2349179, 2352519, 2352530, 2374377, 2377619, 2377620, 2380655, 2380656, 2380656, 2380656, 2383410, 2383410, 2390934, 2417553, 2433540, 2437127, 2453492, 2341639, 2344273, 2344274, 2344274, 2345961, 2355663, 2357626, 2367445, 2369446, 2378396, 2342292, 2342292, 2345963, 2350422, 2357629, 2330839, 2345965, 2353077, 2353077, 2353078, 2353078, 2353078, 2361032, 2361032, and 2481362
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	1739
Recall Number	Z-0215-2013

Product Description	Metasul® Durom® Femoral component Sterile, Rx
Code Info	REF Numbers: 01.00211.140, 01.00211.144, 01.00211.152, 01.00211.154. 01.00211.156, 01.00211.158, and 01.00211.160. Lot: 2367454, 2367454, 2367454, 2367454, 2367455, 2367455, 2374382, 2374382, 2374382, 2374382, 2381632, 2381632, 2381634, 2381634, 2409055, 2414048, 2397713, 2397713, 2417888, 2380622, 2380622, 2388389, 2388389, 2388389, 2453506, 2422704, 2375235, 2375235, 2375235, 2394700, and 2508571
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	209
Recall Number	Z-0216-2013

Product Description	MS-30® Stem
Code Info	REF Numbers: 01.00351.005, 01.00351.006, lots 2330077, 2397912
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	30
Recall Number	Z-0217-2013

Product Description	MS-30® Distal centralizer, cemented, sterile, Rx
Code Info	REF Numbers: 01.00351.005, 01.00351.006, 01.00351.014, 01.00351.214, 01.00351.216, 01.00351.416, 01.00351.620, 01.00356.008, 01.00356.010.Lot 2330077, 2397912, 2319413, 2280640, 2386348, 2399448, 2389980, 2389980, 2389980, 2389980, 2426020, and 2430035.
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	58
Recall Number	Z-0218-2013

Product Description	MS-30® Proximal positioner
Code Info	REF Number: 01.00351.265, lot 237973
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	5
Recall Number	Z-0219-2013

Product Description	Fitmore" Hip Stem
Code Info	REF Numbers: 01.00551.102, 01.00551.103, 01.00551.104, 01.00551.106, 01.00551.108, 01.00551.109, 01.00551.110, 01.00551.111, 01.00551.112, 01.00551.201, 01.00551.202, 01.00551.203, 01.00551.204, 01.00551.205, 01.00551.206, 01.00551.207, 01.00551.208, 01.00551.209, 01.00551.210, 01.00551.211, 01.00551.301, 01.00551.302, 01.00551.303, 01.00551.307, 01.00551.308, 01.00551.309, 01.00551.312, 01.00551.313, 00551.402, 00551.405, 00551.407, 00551.408, 00551.409, and 00551.411. Lot: 2492112, 2405383, 2461916, 2486221, 2486734, 2414003, 2379860, 2384352, 2382041, 2406708, 2486291, 2458770, 2479902, 2508062, 2381041, 2486227, 2384141, 2463958, 2476244, 2375830, 2455461, 2470164, 2493934, 2496756, 2376419, 2494086, 2496005, 2528591, 2376542, 2478039, 2500720, 2507124, 2376544, 2461922, 2495240, 2376606, 2384344, 2478043, 2476248, 2478878, 2479894, 2490109, 2489434, 2493749, 2389960, 2478868, 2476256, 2478035, 2397744, 2493741, 2516631, 2398158, 2478724, 2411541, 2407956, 2401609, 2401590, 2402542, 2402544, 2401623, and 2405399
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	1190
Recall Number	Z-0220-2013

Product Description	Wagner cone Prosthesis, uncemented, sterile, Rx
Code Info	REF Numbers: 01.00561.214, 01.00561.215, 01.00561.222, 01.00561.313, 01.00561.314, 01.00561.316, 01.00561.317, 01.00561.318, 01.00561.319, and 01.00561.321 Lot:2323157, 2411401, 2505266, 2352457, 2352457, 2323311, 2381296, 2446509, 2336139, 2451855, 2397244, 2451874, 2459988, 2517770, 2528611, 2455390, 2336084, 2413210
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	56
Recall Number	Z-0221-2013

Product Description	CoCr Head, sterile, Rx
Code Info	REF Numbers: 01.01012.384, 01.01012.385, 01.01012.386, 01.01012.387, and 01.01012.388 Lot2369409, 2435773, 2448280, 2480485, 2480485, 2397348, , 2402739, 2412633, , 2420719, 2481695, 2520521, 2333576, 2354292, 2369416, 2398778, 2412631, 2447614, 2462604, 2484118, 2498778, 2501857, 2524940, 2524941, 2527698, 2531506, 2531507, 2330195, 2341655, 2448278, 2482086, 2512070, 2518101, 2490816, and 2498784
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	1000
Recall Number	Z-0222-2013

Product Description	Anatomical Shoulder" Humeral stem
Code Info	REF Numbers: 01.04201.072, 01.04201.092, 01.04201.102, 01.04201.122, 01.04201.142, 01.04211.072, 01.04211.092, 01.04211.122, and 01.04211.142 Lot 2333904, 2403849, 2416919, 2443150, 2327341, 2452413, 2320506, 2323574, 2364979, 2373235, 2406171, 2416913, 2438286, 2485091, 2331445, 2357957, 2436420, 2440113, 2470299, 2492996, 2320516, 2334543, 2387483, 2411827, 2421859, 2441600, 2511328, .
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	260
Recall Number	Z-0223-2013

Product Description	Anatomical Shoulder" Fracture Humeral stem
Code Info	REF Numbers: 01.04207.072, 01.04207.082, 01.04207.092, 01.04207.112, 01.04207.132, 01.04207.142, 01.04217.072, and 01.04217.132. Lot 2360479, 2373842, 2331163, 2401526, 2458833, 2360473, 2451660, 2387138, 2521377, 2342166, 2455419, 2342646, 2436406, 2362563, 2413744, 2423092, 2423094, 2472576, 2433869,
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	139
Recall Number	Z-0224-2013

Product Description	Anatomical Shoulder" Humeral Head
Code Info	REF Numbers: 01.04212.400, 01.04212.420, 01.04212.440, 01.04212.460, 01.04212.480, 01.04212.500, 01.04213.480, and 01.04213.520. LotsLots: 2335921, 2388114, 2475819, 2475819, , 2444895, 2485536, 2397602, 2437195, 2485540, 2397014, 2408970, 2483098, 2370444, 2437201, 2458785, 2458785, 2323268, 2434637, 2334433, 2473843, 2530732, 2336444
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	224
Recall Number	Z-0225-2013

Product Description	zimmer Anatomical Shoulder Glenoid S, cemented, sterile; REF 01.04214.340 PE Keeled Glenoid S, cemented, sterile; REF 01.04214.345, Glenoid M, cemented, sterile; REF 01.04214.370, Glenoid L, cemented, sterile; REF 01.04214.400 PE Keeled Glenoid L, cemented, sterile; REF 01.04214.405
Code Info	REF Numbers: 01.04214.340, 01.04214.345, 01.04214.370, 01.04214.400, and 01.04214.405. Lot 2416527, 2430357, 2447460, 2450204, 2348311, 2348311, 2364768, 2364768, 2364768, 2403597, 2418592, 2418592, 2452946, 2453947, 2503319, 2503319, 2517200, 2329832, 2349655, 2388161, 2453280, 2453280, and 2533474.
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	164 in USA
Recall Number	Z-0226-2013

Product Description	Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem
Code Info	REF Numbers: 01.04215.072, 01.04215.092, 01.04215.122, 01.04215.142. , 01.04217.072, 01.04217.132 Lot 2398402, 2485014, 2347028, 2347028, 2380422, 2348099, 2341901, 2435527, 2398475
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	45 USA
Recall Number	Z-0227-2013

Product Description	Zimmer Inverse/Reverse Screw system,
Code Info	REF Numbers: . 01.04223.018, 01.04223.024, 027, 030, 033, 036, 042 Lot 2398030, 2430525, 2384923, 2390913, 2396961, 2399397, 2416652, 2424581, 2430509, 2449770, 2497224, 2383780, 2430522, 2430523, 2430523, 2477654, 2484611, 2383751, 2396967, 2399398, 2416653, 2416653, 2422337, 2429084, 2447019, 2463617, 2521820, 2349258, 2383781, 2388857, 2420337, 2428101, 2447022, 2521822, 2383794, 2385133, 2387452, 2390941 ,
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	45 USA
Recall Number	Z-0228-2013

Product Description	Anatomical Shoulder" Inverse Humeral Cup
Code Info	REF Numbers: 01.04223.100, 01.04223.106, 01.04223.111, 01.04223.121, 01.04223.190, and 01.04223.196.Lot 2310656, 2429295, 2468509, 2310648, 2410046, 2486362, 2474203, 2317777
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	66
Recall Number	Z-0229-2013

Product Description	Anatomical Shoulder" Inverse/Reverse Glenoid Sterile, Rx
Code Info	REF Numbers: 01.04223.200 and 01.04223.236 2313338, 2314443, 2318819, 2331464, 2342906, 2343151, 2346399, 2368714, 2387755, 2425692, 2468583, 2468587, 2471765, 2503386, 2516402
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	228
Recall Number	Z-0230-2013

Product Description	Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert Sterile, Rx
Code Info	REF Numbers: 01.04223.360, 01.04223.366, 01.04223.400, 01.04223.403, and 01.04223.406 Lot:2330423, 2337486, 2503675, 2335914, 2324383, 2395586, 2405596, 2465511, 2309008, 2309008, 2309008, 2446964,
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	74
Recall Number	Z-0231-2013

Product Description	Anatomical Shoulder" Ball taper for humeral stem
Code Info	REF Numbers: 01.04227.102, Lot:2350372, 2381792, 2398201, 2452078, 2460783
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	54
Recall Number	Z-0232-2013

Product Description	Anatomical Shoulder" Fracture Humeral Head
Code Info	REF Numbers: 01.04227.400, 01.04227.405, 01.04227.480, and 01.04227.485 Lot 2352153, 2358721, 2366101, 2525804, 2494527, 2523912, 2385885, 2441471
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	26
Recall Number	Z-0233-2013

Product Description	CLS Stem
Code Info	REF Numbers: 29.00.09.137, 29.00.09.162, 29.00.39.070, and 29.00.39.125 Lot 2397894, 2393484, 2480480, 2439729,
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	18
Recall Number	Z-0234-2013

Product Description	Original M.E. Mueller" Low Profile Cup Sterile, Rx
Code Info	REF Numbers: 63.32.46, 63.32.60 and 63.32.62.Lot 2378026, 2468907, 2370934
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	6
Recall Number	Z-0235-2013

Product Description	Dynesys® Set screw M6
Code Info	REF Numbers: 01.03710.006 and 01.03711.006 Lot 2381797, 2429082
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	58
Recall Number	Z-0236-2013

Product Description	Dynesys® Universal spacer 6-45
Code Info	REF Number: 01.03710.645, Lot 2323776, 2340853, 2347195, 2347196, 2349405, 2352968, 2361598, 2363757, 2368549, 2371803, 2374584, 2374695, 2390243, 2390244, 2392322, 2394946, 2395677, 2410170, 2410171, 2413068, 2414198, 2417869, 2419315, 2419317, 2424170, 2430156, 2439598, 2449297, 2452033, 2454477, 2455648, 2455649, 2469131, 2469132,
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	5069
Recall Number	Z-0237-2013

Product Description	Dynesys® L.I.S. Stabilizing cord Rx, Sterile
Code Info	REF Numbers: 01.03711.100 and 01.03711.200 Lot2290106, 2322753, 2322757, 2325303, 2328500, 2350135, 2363929, 2363972, 2366663, 2377045, 2391793, 2409738, 2422397, 2444114, 2448948, 2453742
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	973
Recall Number	Z-0238-2013

Product Description	Dynesys® Revision + set screw
Code Info	REF Numbers: 01.03716.035, 01.03716.040, 01.03716.045, 01.03716.050, 01.03716.435, 01.03716.440, 01.03716.445, 01.03716.450, 01.03716.455 and 01.03717.250 Lot: 2368864, 2344115, 2367073, 2396142, 2334238, 2444021, 2377110, 2305486, 2377111, 2323497, 2389720, 2403550, 2433036, 2444022, 2298967, 2305536, 2348795, 2358159, 2368866, 2368867, 2389721, 2394352, 2449099, 2368870, 2441343, 2367060, 2367062, 2373095, 2373097
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	1575
Recall Number	Z-0239-2013

Product Description	Dynesys® HA Pedicle + set screw
Code Info	REF Numbers: 01.03756.040, 01.03756.050, 01.03756.440, 01.03756.445, 01.03756.450, 01.03756.455, 01.03757.235, 01.03757.240, 01.03757.245, 01.03757.250, 01.03757.255, 01.03758.040, 01.03758.050 and 01.03758.055 Lot: 2399360, 2502246, 2519160, 2323382, 2399361, 2459377, 2500751, 2383797, 2425044, 2449147, 2373116, 2411907, 2323399, 2344133, 2344133, 2426558, 2359295, 2426560, 2456268, 2502250, 2323446, 2488882, 2444047, 2323449, 2433071, 2323450, .
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthru, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	1247
Recall Number	Z-0240-2013

Product Description	DTO" Implant
Code Info	REF Numbers: 01.03791.050, 01.03791.060, and 01.03791.080 Lot: 2417930, 2417948, 2417950, 2417956, 2429074, 2432771, 2462074, 2512965,
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity
Recall Number	Z-0241-2013

Product Description	Dynesys® Top-Loading System Cannulated Pedicle + Set Screw
Code Info	REF Numbers: 01.03915.245, 01.03916.055, 01.03916.435, 01.03916.440, 01.03916.445, 01.03916.450, 01.03916.455, 01.03917.235, 01.03917.245, 01.03917.250, 01.03917.255, 01.03918.040, 01.03918.045, 01.03918.055, 01.03955.235, 01.03955.245, 01.03955.255, 01.03956.035, 01.03956.435, 01.03956.440, 01.03956.450, 01.03957.240, 01.03957.250, 01.03957.255, 01.03958.045 and 01.03958.050. Lot:2443724, 2443727, 2443738, 2443740, 2443750, 2443751, 2443770, 2449369, 2449373, 2449374, 2449375, 2449416, 2459041, 2459046, 2459051, 2459087, 2459106, 2471700, 2475668, 2475670, 2475672, 2475681, 2475690, 2475694, 2475695, 2475702, 2475704, 2528982, 2528984, 2528987, 2528988, 2529021,
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	1406
Recall Number	Z-0242-2013

Product Description	NCB® cancellous screw
Code Info	REF Number: 02.02152. 085 Lot 2477869
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	2
Recall Number	Z-0243-2013

Product Description	NCB® screw Ø 4.0 self-tapping
Code Info	REF Numbers: 02.02155.026 and 02.02155.030 Lots2450611, 2475382
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	41
Recall Number	Z-0244-2013

Product Description	NCB®-PT lateral proximal 3 hole tibial plate
Code Info	REF Numbers: 02.02261.305, 02.02261.307, 02.02261.309, and 02.02261.313. Lot:2442904, 2341498, , 2402100, 2407066, 2414036, 2422428, 2426611, 2434987, 2442908, 2387467, 2387467, 2402996, 2407064, 2422433, 2450659, 2450659, 2450644,
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	589
Recall Number	Z-0245-2013

Product Description	NCB®-PH Plate
Code Info	REF Numbers: 02.02262.105 and 02.02262.107. Lot 2450659, 2450644
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	95
Recall Number	Z-0246-2013

Product Description	Sirus® intramedullary nail for tibia, cannulated Ø
Code Info	REF Numbers: 02.02631.030, 02.02631.031, 02.02631.033, 02.02631.034, 02.02631.036, 02.02631.038, 02.02631.130, 02.02631.131, 02.02631.133, 02.02631.134, 02.02631.142, 02.02631.233, 02.02631.925, 02.02631.928, 02.02631.930, 02.02631.931, 02.02631.933, 02.02631.934, 02.02631.936, and 02.02631.940. Lot: 2394172, 2400103, 2400105, 2403109, 2403116, 2403125, 2403127, 2403136, 2403138, 2406268, 2406270, 2406272, 2406276, 2406278, 2406280, 2408059, 2408125, 2408131, 2408135, 2409963, 2409973, 2412348, 2414763, 2414765, 2414767, 2414773, 2414775, 2428019, 2429497, 2449749, 2449758, 2455924, 2477033, 2477059, 2490726, 2498026,
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	195
Recall Number	Z-0247-2013

Product Description	Kopf Adapter S Sterile, Rx
Code Info	REF Numbers: 01.00185.145, 146, 147, 148 2329720, 2345868, 2351558, 2351558, 2357964, 2357985, 2363710, 2365318, 2390727, 2401986, 2404475, 2420196, 2424824, 2424824, 2428509, 2449961, 2469199, 2476706, 2476706, 2476708, 2476708, 2486173, 2324764, 2335268, 2339607, 2342207, 2342207, 2342209, 2342211, 2354632, 2357988, 2365331, 2368841, 2385720, 2388044, 2396086, 2399440, 2404481, 2408183, 2414476, 2414480, 2420203, 2420203, 2424841, 2428528, 2430914, 2433313, 2455294, 2462031, 2462048, 2469203, 2469203, 2476713, 2476718, 2486178, 2486178, 2486180, 2499005, 2499005, 2509186, 2516387, 2516387, 2516389, 2314373, 2322686, 2329747, 2339609, 2339611, 2342218, 2350072, 2351571, 2351573, 2354637, 2356264, 2360204, 2430920, 2443367, 2455300, 2476723, 2482727, 2322688, 2322689, 2322689, 2335264, 2335264, 2336972, 2336972, 2399446, 2428549, 2428549, 2428549
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	2011
Recall Number	Z-0248-2013

Product Description	MS-30 Shaft, Sterile, Rx
Code Info	30.00.49-100, 140, 160; Lots 2396807, 2390863, 2321477
Classification	Class II
Reason for Recall	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Product Quantity	13
Recall Number	Z-0249-2013

Class II Food/Cosmetics Event

Event ID	63207
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Fabrica Confecciones Soto, Inc.
City	Canovanas
State	PR
Country	US
Distribution Pattern	PR only. Product sold by the firm at retail.

Associated Products

Product Description	"Tacos de Jueyes" (Crab Tacos) - Food Service
Code Info	none
Classification	Class II
Reason for Recall	Undeclared allergens: wheat, soy, crustacean shellfish (crab), and yellow #5
Product Quantity	180
Recall Number	F-0654-2013

Product Description	"Alcapurria Jueyes" (Crab-filled fritters) - Food Service
Code Info	none
Classification	Class II
Reason for Recall	Undeclared allergens: wheat, soy, crustacean shellfish (crab), and yellow #5
Product Quantity	160
Recall Number	F-0655-2013

Class II Devices Event

Event ID	63270
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-Jun-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Diagnostica Stago, Inc.
City	Parsippany
State	NJ
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and Canada

Associated Products

Product Description	STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
Code Info	K082248 D089976 Ref 58104 units
Classification	Class II
Reason for Recall	Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for printing incorrect secondary units when using an external printer and the customer printout mode on the STA Satellite®.
Product Quantity	232 units US; 5 units Canada
Recall Number	Z-0252-2013

Class II Devices Event

Event ID	63273
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Stryker Howmedica Osteonics Corp.
City	Mahwah
State	NJ
Country	US
Distribution Pattern	Nationwide Distribution.

Associated Products

Product Description	Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone structures. External fixation devices are intended to hold fractured bone surfaces in apposition to facilitate normal healing. While proven successful, the devices are manufactured from metal, plastic, and composite materials. No such fracture fixation device, subject to fatigue, can be expected to withstand activity levels in the same way as would a normal health bone. The external fixation system, therefore, will not be as strong, reliable or durable as a normal human bone.
Code Info	K113327 Catalog No: Telescopic Strut Extra Short Hoffman LRF Length: 4933-0-100 :100-125mm (Black) 4933-0-120 Telescopic Strut Short Hoffman LRF Length: 119-161 mm (Yellow) 4933-0-140 Telescopic Strut Medium Hoffman LRF Length 138-201 mm (Blue) 4933-0-180 Telescopic Strut Long Hoffman LRF Length: 177-277 mm (Red); Lot Code: 4933-0-100 Telescopic Strut Extra Short Hoffman LRF Length 100-125mm (Black) X28937; Z04197; Z09163; Z09597; Z12135; 4933-0-120 Telescopic Strut Short Hoffman LRF Length: 119-161 mm (Yellow) X28961; Z04199; Z09161; Z09769; Z12012; 4933-0-140 Telescopic Strut Medium Hoffman LRF Length 138-201 mm (Blue) X34352; Z04200; Z05068; Z09011; Z09598; Z10872; 4933-0-180 Telescopic Strut Long Hoffman LRF Length: 177-277 mm (Red); X28963 ;Z04429; Z09471; Z11686
Classification	Class II
Reason for Recall	Three complaints have been filed where the Hoffman LRF Telescopic Struts have broken during load bearing application by patients having a body weight greater than 250 LBS.
Product Quantity	165 units
Recall Number	Z-0266-2013

Class II Devices Event

Event ID	63297
Status	Completed
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Feb-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Kerr Corporation
City	Romulus
State	MI
Country	US
Distribution Pattern	Worldwide Distribution-USA (nationwide) and the countries of Canada, Europe, and Australia.

Associated Products

Product Description	The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for Kerr Corporation is 1815757. Intended as an alternative to traditional alginate materials.
Code Info	ÿProduct Part Numbers Lot Number AlgiNot Intra Kit 34683 1-1017 AlgiNot Volume Refills 34682 1-1017
Classification	Class II
Reason for Recall	The firm recalled the product because it may cure harder than expected within the shelf life, which could result in a material that may be more difficult to remove. Use of this product on patients with loose teeth may result in possible tooth fracture or tooth extraction.
Product Quantity	45 kits and 87 refills
Recall Number	Z-0268-2013

Class II Food/Cosmetics Event

Event ID	63334
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	02-Oct-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Kellogg Company
City	Battle Creek
State	MI
Country	US
Distribution Pattern	US, nationwide and Canada

Associated Products

Product Description	Kellogg's Frosted Mini Wheats , Bite Size, Lightly Sweetened Whole Grain Wheat Cereal, 96 ct case single serve,each Nt. Wt. 1 oz (28g); 18 oz carton; 24 oz carton; 30 oz., 70 ct case single serve, 70 oz carton Canadian product: Kellogg's Mini-Wheats Original Frosted Cereal 440 G, 510 G,850 G, 1300 G, 1600 G carton
Code Info	USA ONLY products with the letters KB, AP, preceding or following the Better If Used Before Date Apr 01 2013 - Sep 21 2013. Frosted Case UPC: 3800004996, 3800031828, 3800031833, 3800059646, 3800073443, 3800077602, 3800021992, 3800051692 Package Frosted UPC: 3800004996, 3800031829, 3800031834, 3800031829, 3800073444, 3800046954, 3800021992, 3800031921 Canadian Case Codes: 6410020534, 6410052655, 6410056918, 6410058997, 6410058999, Canadian carton: 648041, 6410044897, 6410056919, 6410058998, 6410059000,
Classification	Class II
Reason for Recall	This voluntary recall is initiated due to the possible presence of fragments of flexible metal mesh from a faulty manufacturing part that were found in certain Mini-Wheats® cereal produced in a single Kellogg plant between April 1 and September 21, 2012.
Product Quantity	2,853, 130 cases; 28,158,243 pkgs
Recall Number	F-0600-2013

Product Description	Kellogg's Mini Wheats, Unfrosted, Bite Size, Lightly Sweetened Whole Grain Wheat Cereal, 18 oz carton; 70 ct case single serve; Canadian: Kellogg's Mini-Wheats Original cereal 12 ct, 850 G
Code Info	USA ONLY products with the letters KB, FK, preceding or following the Better If Used Before Date Apr 01 2013 - Sep 21 2013. FrostedCase UPC:3800004996, 3800031828, 3800031833, 3800021992, 3800005337, 3800070418, 3800022055, , 3800038118, , 3800007337, 3800007338. Unfrosted Case UPC 3800058689, 3800021982. Package Frosted UPC: 3800004996, 3800031829, 3800031834, 3800021992, 3800005332, 3800070973, 3800022056, 3800038118, 3800007337, 3800007338, 3800035982, 3800021982 . Package UPC unfrosted: 3800035982, 3800021982 Canadian Case Codes:6410020534, 6410020738, 6410044892, 6410044896 6410052652, 6410052655, 6410056918, 6410058997, 6410058999, 6410059008, 6410059011 Canadian carton: 648041, 648061, 6410044893 6410044897, 6410044893, 6410044897, 6410056919, 6410058998, 6410059000, 6410059010, 6410059013
Classification	Class II
Reason for Recall	This voluntary recall is initiated due to the possible presence of fragments of flexible metal mesh from a faulty manufacturing part that were found in certain Mini-Wheats® cereal produced in a single Kellogg plant between April 1 and September 21, 2012.
Product Quantity	2,853, 130 cases; 28,158,243 pkgs
Recall Number	F-0601-2013

Product Description	Kellogg's Variety and Assortment Packs containing Frosted/ Unfrosted Mini Wheats, Bite Size, Lightly Sweetened Whole Grain Wheat Cereal, 10 ct; 30 ct, 72 ct , 96 ct.
Code Info	USA ONLY products with the letters FK, HG preceding or following the Better If Used Before Date Apr 01 2013 - Sep 21 2013. Case UPC: 3800005337, 3800070418, 3800022055, 3800038118, 3800007337, 3800007338. Carton UPC3800005332, 3800070973, 3800022056, 3800038118, 3800007337, 3800007338
Classification	Class II
Reason for Recall	This voluntary recall is initiated due to the possible presence of fragments of flexible metal mesh from a faulty manufacturing part that were found in certain Mini-Wheats® cereal produced in a single Kellogg plant between April 1 and September 21, 2012.
Product Quantity	2,853, 130 cases; 28,158,243 pkgs
Recall Number	F-0602-3013

Product Description	Canadian Product: Kellogg's Mini Wheats, Brown Sugar Flavour Cereal, 6 ct., 10 ct, 12 ct, 16ct; 400G, 510G, 850 G, 1300 G
Code Info	Date code 2013 AL 01-2013 Jl 29 Case UPC6410020738, 6410044892, 6410052652, 6410059008, 6410059011
Classification	Class II
Reason for Recall	This voluntary recall is initiated due to the possible presence of fragments of flexible metal mesh from a faulty manufacturing part that were found in certain Mini-Wheats® cereal produced in a single Kellogg plant between April 1 and September 21, 2012.
Product Quantity	none in USA
Recall Number	F-0603-2013

Class II Devices Event

Event ID	63368
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Jan-10
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Sendx Medical Inc
City	Carlsbad
State	CA
Country	US
Distribution Pattern	Worldwide Distribution-- US Distribution including the state of Ohio and the countries of Switzerland, Germany, France, Poland, Austria, Italy, Japan, Australia, Denmark, China, Sweden, Norway, Spain, United Kingdom, Netherlands, and Czech Republic.

Associated Products

Product Description	ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point of care setting
Code Info	Serial Numbers: all ABL80 FLEX CO-OX analyzers with sofware versions 1.30, 1.31, 1.32, 1.33, and 1.34.
Classification	Class II
Reason for Recall	The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX analyzer related to the reporting of the hemoglobin fractional parameters.
Product Quantity	767 units
Recall Number	Z-0195-2013

Class II Devices Event

Event ID	63369
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Nov-11
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 Internationally to Ireland

Associated Products

Product Description	Sunquest Laboratory, version 7.0 not available
Code Info	not available
Classification	Class II
Reason for Recall	Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data.
Product Quantity	14 sites
Recall Number	Z-0250-2013

Class II Devices Event

Event ID	63380
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Nov-09
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
Code Info	v3.0.0_07222004 and later
Classification	Class II
Reason for Recall	The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately.
Product Quantity	9 units
Recall Number	Z-0251-2013

Class II Devices Event

Event ID	63383
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Sorin Group USA, Inc.
City	Arvada
State	CO
Country	US
Distribution Pattern	Worldwide distribution: USA (nationwide) including states of: AZ, GA, MI, MS, NC, NY, PA, SC, and TX; and countries of: Austria, Australia, Belgium, Canada, People's Republic of China, Columbia, Denmark, Finland, Germany, India, Iran-Islamic Republic of, Ireland, Japan, Lebanon, Morocco, Pakistan, Poland, Russian Federation, Saudia Arabia, Spain, South Africa, Thailand, Turkey and United Kingdom.

Associated Products

Product Description	S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Code Info	Serial Numbers: 10E06219,10E06220, 10E06231-10E06234, 10E06239-10E06241, 10E06255-10E06273, 10E06286-10E06289, 10E06291-10E06355, 10E06359-10E06364, 10E06366, 10E06368-10E06383, 10E06385, 10E06387-10E06391,10E06395-10E06401, 10E06403-10E06447, 10E6502.
Classification	Class II
Reason for Recall	Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determined to be the cause of some of these events.
Product Quantity	35 units
Recall Number	Z-0271-2013

Product Description	S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Code Info	Serial Numbers: 10E51854,10E51856-10E51858, 10E51860, 10E51861, 10E51864, 10E51867, 10E51870, 10E51871, 10E51873, 10E51880-10E51897, 10E51899-10E51913.
Classification	Class II
Reason for Recall	Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determined to be the cause of some of these events.
Product Quantity	5 units
Recall Number	Z-0272-2013

Product Description	S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Code Info	Serial Numbers: 50E50766--50E50769, 50E50772-50E50774, 50E50783-50E50784.
Classification	Class II
Reason for Recall	Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determined to be the cause of some of these events.
Product Quantity	3 units
Recall Number	Z-0273-2013

Product Description	S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Code Info	Serial Numbers: 50E00680--50E00681, 50E00688, 50E00696-50E00706, 50E00708-50E00718.
Classification	Class II
Reason for Recall	Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determined to be the cause of some of these events.
Product Quantity	2 units
Recall Number	Z-0274-2013

Product Description	Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Code Info	Serial Numbers: 58E00135; 58E00136
Classification	Class II
Reason for Recall	Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determined to be the cause of some of these events.
Product Quantity	2 units (no product distributed within the US).
Recall Number	Z-0275-2013

Class II Devices Event

Event ID	63396
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Sep-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	OrthoPediatrics Corp
City	Warsaw
State	IN
Country	US
Distribution Pattern	Nationwide Distribution including AL, IL, NY, FL, TX, MI, KY, NC, CO, and GA.

Associated Products

Product Description	Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel. The OrthoPediatrics PediNail" system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
Code Info	Part number: 01-1500-9014 and Lot #'s 1466707 and 1466710
Classification	Class II
Reason for Recall	A complaint received from sales representative that a replenishment instrument was too short. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.
Product Quantity	27
Recall Number	Z-0207-2013

Class II Devices Event

Event ID	63412
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Dec-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Ormco/Sybronendo
City	Glendora
State	CA
Country	US
Distribution Pattern	Worldwide distribution, including Nationwide (USA) and the countries of Canada, Austria, Belgium, Bulgaria, Switzerland, Germany, Denmark, France, Estonia, Spain, Finland, Iceland, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Luxembourg, Netherlands, Monaco, Poland, Romania, Serbia, Slovenia, Turkey, Jersey, and Martinique.

Associated Products

Product Description	Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Code Info	Part Numbers 601-0007 and 601-0010, all lots
Classification	Class II
Reason for Recall	The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections incorrectly lists the sterilization temperature as 130°C. The correct sterilization temperature should be listed as 132°C and/or 270°F.
Product Quantity	4,543
Recall Number	Z-0205-2013

Class II Devices Event

Event ID	63430
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Philips Medical Systems (Cleveland), Inc.
City	Fitchburg
State	WI
Country	US
Distribution Pattern	Nationwide distribution: USA including states of: ME, MI, NY, and WI.

Associated Products

Product Description	Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.
Code Info	Serial # 317, 318, 319, 320,321,342, 343, 344,345, 346, 347
Classification	Class II
Reason for Recall	Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution.
Product Quantity	11
Recall Number	Z-0206-2013

Class II Food/Cosmetics Event

Event ID	63447
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Sep-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Pennsylvania State University Berkey Creamery
City	Penn St Univ
State	PA
Country	US
Distribution Pattern	On site retail salesroom and internet customers

Associated Products

Product Description	Penn State Creamery/Berkey Creamery Ice Cream -- Black Raspberry flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Code Info	Best by dates falling on or between February 10, 2013 and August 11, 2013.
Classification	Class II
Reason for Recall	Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product.
Product Quantity
Recall Number	F-0639-2013

Product Description	Penn State Creamery/Berkey Creamery Ice Cream -- Scholar's Chip flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Code Info	Best by dates falling on or between February 10, 2013 and August 11, 2013.
Classification	Class II
Reason for Recall	Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product.
Product Quantity
Recall Number	F-0640-2013

Product Description	Penn State Creamery/Berkey Creamery Ice Cream -- Strawberry-No Sugar Added flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Code Info	Best by dates falling on or between February 10, 2013 and August 11, 2013.
Classification	Class II
Reason for Recall	Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product.
Product Quantity
Recall Number	F-0641-2013

Product Description	Penn State Creamery/Berkey Creamery Ice Cream -- Keeny Beany Chocolate flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Code Info	Best by dates falling on or between February 10, 2013 and August 11, 2013.
Classification	Class II
Reason for Recall	Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product.
Product Quantity
Recall Number	F-0642-2013

Product Description	Penn State Creamery/Berkey Creamery Ice Cream -- German Chocolate Cake flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Code Info	Best by dates falling on or between February 10, 2013 and August 11, 2013.
Classification	Class II
Reason for Recall	Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product.
Product Quantity
Recall Number	F-0643-2013

Product Description	Penn State Creamery/Berkey Creamery Ice Cream -- Cookies-N-Cream flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Code Info	Best by dates falling on or between February 10, 2013 and August 11, 2013.
Classification	Class II
Reason for Recall	Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product.
Product Quantity
Recall Number	F-0644-2013

Product Description	Penn State Creamery/Berkey Creamery Ice Cream -- Chocolate Chip Cookie Dough flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Code Info	Best by dates falling on or between February 10, 2013 and August 11, 2013.
Classification	Class II
Reason for Recall	Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product.
Product Quantity
Recall Number	F-0645-2013

Product Description	Penn State Creamery/Berkey Creamery Ice Cream -- Chocolate Chocolate Nut flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Code Info	Best by dates falling on or between February 10, 2013 and August 11, 2013.
Classification	Class II
Reason for Recall	Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product.
Product Quantity
Recall Number	F-0646-2013

Product Description	Penn State Creamery/Berkey Creamery Ice Cream -- Strawberry flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Code Info	Best by dates falling on or between February 10, 2013 and August 11, 2013.
Classification	Class II
Reason for Recall	Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product.
Product Quantity
Recall Number	F-0647-2013

Product Description	Penn State Creamery/Berkey Creamery Ice Cream -- Strawberry Cheesecake flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Code Info	Best by dates falling on or between February 10, 2013 and August 11, 2013.
Classification	Class II
Reason for Recall	Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product.
Product Quantity
Recall Number	F-0648-2013

Product Description	Penn State Creamery/Berkey Creamery Frozen Yogurt - Vanilla flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Code Info	Best by dates falling on or between February 10, 2013 and August 11, 2013.
Classification	Class II
Reason for Recall	Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product.
Product Quantity
Recall Number	F-0649-2013

Product Description	Penn State Creamery/Berkey Creamery Frozen Yogurt - Strawberry flavor; 3 gallon (paper), 1/2 gallon (paper), and pints (plastic)
Code Info	Best by dates falling on or between February 10, 2013 and August 11, 2013.
Classification	Class II
Reason for Recall	Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product.
Product Quantity
Recall Number	F-0650-2013

Class II Food/Cosmetics Event

Event ID	63470
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-Oct-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Turkey Hill Dairy, Inc.
City	Conestoga
State	PA
Country	US
Distribution Pattern	Product was distributed to one retail chain and 3 independent grocers in the State of Pennsylvania.

Associated Products

Product Description	Turkey Hill Mint Chocolate Chip All Natural Ice Cream, 48 oz, UPC 0-20735-11203-8
Code Info	UPC 0-20735-11203-8 with Sell By Code: 09/28/2013 42-092 L3/56 Affected Production Time: 05:58 AM to 06:30 AM
Classification	Class II
Reason for Recall	The product contains undeclared coconut.
Product Quantity	1200 Packages
Recall Number	F-0595-2013

Class II Devices Event

Event ID	63506
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Spacelabs Healthcare, Llc
City	Issaquah
State	WA
Country	US
Distribution Pattern	Worldwide Distribution--US (nationwide) including states of Alaska, California, Florida, Illinois, Michigan, South Carolina, and Texas., and the countries of Canada, Chile, France, Libya, Panama, Qatar, Saudi Arabia, Switzerland and United Kingdom

Associated Products

Product Description	The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal --- 67.7 mm (2.67 inches). The display is an integrated LCD 19-Inch. The Spacelabs Healthcare Xprezzon Bedside Monitor passively displays data generated by Spacelabs parameter modules.
Code Info	Serial Number for U.S. Cosignees: PRO-12240004, PRO-12240015, PRO-12240017, PRO-12240018, PRO-12240022, PRO-12240026, PRO-12240028, PRO-12240030, PRO-12240031, PRO-12240032, PRO-12240033, PRO-12240034, PRO-12240036, PRO-12240037, PRO-12240038, PRO-12240040, PRO-12240041, PRO-12240058, PRO-12240059, PRO-12240062, PRO-12240063, PRO-12240077, PRO-12240084, PRO-12240090, pro-12260008, PRO-12260016, pro-12260018, PRO-12260023, pro-12260024, PRO-12260032, pro-12260033, pro-12260035, PRO-12260036, PRO-12260037, pro-12260038, pro-12260041, pro-12260044, pro-12260055, pro-12260059, PRO-12260060, PRO-12260062, pro-12260064, pro-12260065, pro-12260068, pro-12260070, pro-12260071, pro-12260073, PRO-12260076, PRO-12260077, PRO-12260080, PRO-12260081, PRO-12260082, PRO-12260083, PRO-12260085, PRO-12260086, PRO-12260087, PRO-12260088, PRO-12260092, PRO-12260094, PRO-12260096, PRO-12260097, pro-12260121, pro-12260125, pro-12260131, pro-12260164, pro-12260167, pro-12260172, PRO-12260175, PRO-12260183, pro-12260185, pro-12280036, pro-12280049, pro-12280062, pro-12280119, pro-12280121, pro-12280126, pro-12280127, pro-12280131, pro-12280133, pro-12280134, pro-12280136, pro-12280137, pro-12280152, pro-12280155, pro-12280156, pro-12280160, pro-12280161, pro-12280162, pro-12280163, pro-12280173, pro-12280174, pro-12280175, pro-12280177, pro-12280182, pro-12280205, pro-12280232, pro-12280272, pro-12280273. Serial number for International Consignees: PRO-12240056, PRO-12260005, pro-12260006, PRO-12260012, PRO-12260013, pro-12260019, PRO-12260020, PRO-12260021, pro-12260022, pro-12260025, pro-12260026, pro-12260027, pro-12260028, PRO-12260029, PRO-12260030, pro-12260031, PRO-12260040, PRO-12260043, PRO-12260045, PRO-12260046, pro-12260047, PRO-12260051, PRO-12260053, PRO-12260057, PRO-12260075, pro-12260079, PRO-12260111, PRO-12260118, PRO-12260122, pro-12260124, pro-12260128, pro-12260140, pro-12260143, PRO-12260146, PRO-12260147, PRO-12260149, PRO-12260151, PRO-12260152, PRO-12260153, PRO-12260155, PRO-12260156, PRO-12260157, pro-12260158, PRO-12260159, PRO-12260160, PRO-12260161, PRO-12260162, PRO-12260163, PRO-12260169, PRO-12260170, pro-12260171, pro-12260174, PRO-12260176, PRO-12260178, pro-12260179, pro-12260180, pro-12260182, pro-12260189, pro-12260190, pro-12260191, PRO-12260192, pro-12260193, pro-12260195, pro-12260199, pro-12280006, pro-12280023, pro-12280132, pro-12280135, pro-12280141, pro-12280206, pro-12280225.
Classification	Class II
Reason for Recall	Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights failed to illuminate upon installation.
Product Quantity	169 units distributed (98 in US and 71 Internationally)
Recall Number	Z-0196-2013

Class II Devices Event

Event ID	63540
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	American Medical Systems, Inc.
City	Minnetonka
State	MN
Country	US
Distribution Pattern	Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of Austria, Australia, Brazil, Canada, Germany, Estonia, Spain, Finland, France, Great Britain, Hong Kong, Croatia, India, Morocco, Mexico, Malaysia, Netherlands, New Zealand, Panama, Poland, Russian Federation, Solomon Islands, Singapore, Thailand, Turkey, Venezuela, South Africa, Chile, Colombia, Costa Rica, Slovenia, Argentina, China, and Taiwan.

Associated Products

Product Description	AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (Intl) 72404224 AMS Male TO Sling System (Intl). The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence (SUI).
Code Info	Part # Lot/Serial Range 720088-01 722022001 to 796127002 720088-02 722024001 to 790266012 72404224 742528001 to 795689010
Classification	Class II
Reason for Recall	American Medical Systems® (AMS) is issuing a voluntary recall on a number of lots of the AdVance® Male Sling System (AdVance). AMS has recently received a small number of complaints regarding the resorbable suture in the AdVance sling not lasting for the entire 15 month shelf life of the product. An internal investigation has been conducted and confirmed that some sutures degraded prior to the expiration of the labeled shelf life. At this time AMS cannot confirm that there is no potential for premature degradation of the bioabsorbable tensioning sutures on the product included in this recall.
Product Quantity	4872
Recall Number	Z-0259-2013

Class II Devices Event

Event ID	63598
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Kimberly-Clark Corporation
City	Roswell
State	GA
Country	US
Distribution Pattern	Nationwide Distribution

Associated Products

Product Description	ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Code Info	Product Code 95221 - All lot numbers beginning with: AH9284* to AH9356, AH0007 to AH0356, AH1008 to AH1364, AH2006 to AH2146*
Classification	Class II
Reason for Recall	Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
Product Quantity	89,856 (28 units per case)
Recall Number	Z-0257-2013

Product Description	MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Code Info	Product Code 92042 - All lot numbers beginning with: AH9282* to AH9309, AH0013 to AH0329, AH1020 to AH1293, AH2019 to AH2175*
Classification	Class II
Reason for Recall	Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
Product Quantity	933 ((30 units per case)
Recall Number	Z-0258-2013

Class II Devices Event

Event ID	63599
Status	Completed
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Dec-10
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Alphatec Spine, Inc.
City	Carlsbad
State	CA
Country	US
Distribution Pattern	Nationwide Distribution including TN, WI, and FL.

Associated Products

Product Description	TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine. It intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac Polyaxial Pedicle Screw System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
Code Info	Lot # 634745
Classification	Class II
Reason for Recall	The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of 45 MM.
Product Quantity	11 units
Recall Number	Z-0269-2013

Class III Biologics Event

Event ID	62824
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Jun-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	The American National Red Cross - Southern Region
City	Douglasville
State	GA
Country	US
Distribution Pattern	California

Associated Products

Product Description	Plasma Frozen
Code Info	03KH50314;
Classification	Class III
Reason for Recall	Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
Product Quantity	1 unit
Recall Number	B-2497-12

Class III Devices Event

Event ID	62833
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	Siemens Healthcare Diagnostics, Inc.
City	Newark
State	DE
Country	US
Distribution Pattern	USA (nationwide) including the states of AL, CA, CO, CT, DC, DE, FL, IA, IL, IN, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA and WI.

Associated Products

Product Description	Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of total homocysteine (HCYS) in human serum, heparinized plasma, and EDTA plasma on the Dimension Vista(R) System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Code Info	Lot numbers 12062MA, exp 12/01/2012; and 12066MA, exp 12/05/2012
Classification	Class III
Reason for Recall	Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge.
Product Quantity	583 cartons
Recall Number	Z-0253-2013

Class III Biologics Event

Event ID	62902
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Jul-12
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W333612081852;
Classification	Class III
Reason for Recall	Blood product, manufactured with an undetermined quantity of additive solution, was distributed.
Product Quantity	1 unit
Recall Number	B-2553-12

Class III Biologics Event

Event ID	62933
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Aug-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Blood Assurance Inc
City	Chattanooga
State	TN
Country	US
Distribution Pattern	Tennessee

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W043212055994;
Classification	Class III
Reason for Recall	Blood product, collected using expired cryo blood collection bag was distributed.
Product Quantity	1 unit
Recall Number	B-2570-12

Class III Biologics Event

Event ID	62953
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Jul-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	ITXM Clinical Services
City	Pittsburgh
State	PA
Country	US
Distribution Pattern	Pennsylvania

Associated Products

Product Description	Red Blood Cells (Apheresis)
Code Info	W086212003130; W086212003124;
Classification	Class III
Reason for Recall	Blood products, leukoreduced greater than five days after collection, were distributed.
Product Quantity	2 units
Recall Number	B-2572-12

Class III Devices Event

Event ID	63094
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Aug-10
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Clinical Diagnostic Solutions
City	Plantation
State	FL
Country	US
Distribution Pattern	Nationwide Distribution.

Associated Products

Product Description	Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Code Info	Product part 501-605, Lot #1005-549
Classification	Class III
Reason for Recall	Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 501-605, Lot #1005-549 and Product part 501-607, Lot #1005-549) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was imitated due to receipt of customers stating the MCV values and RDW% recovered for Boule Con-Diff Tri pack Lot 1005-549 were low and out of the assay range.
Product Quantity	532 packs
Recall Number	Z-0193-2013

Product Description	Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Code Info	Product part 501-607, Lot #1005-549
Classification	Class III
Reason for Recall	Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 501-605, Lot #1005-549 and Product part 501-607, Lot #1005-549) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was imitated due to receipt of customers stating the MCV values and RDW% recovered for Boule Con-Diff Tri pack Lot 1005-549 were low and out of the assay range.
Product Quantity	690 packs
Recall Number	Z-0194-2013

Class III Devices Event

Event ID	63096
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Mar-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Clinical Diagnostic Solutions
City	Plantation
State	FL
Country	US
Distribution Pattern	Worldwide Distribution - USA including AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, ND, ND, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI, WV,and WY. Foreign: Brazil and Colombia

Associated Products

Product Description	Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Code Info	Product Part 501-605, Lot #1102-575 and Lot # 1102-576
Classification	Class III
Reason for Recall	Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complaint stating the MCHC parameter of the Low Control of Boule Con-Diff US Tri Pack lot number 1102-575 recovered low and out of range.
Product Quantity	623 vials
Recall Number	Z-0189-2013

Product Description	Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Code Info	Product Part 501-607, Lot #1102-576
Classification	Class III
Reason for Recall	Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complaint stating the MCHC parameter of the Low Control of Boule Con-Diff US Tri Pack lot number 1102-575 recovered low and out of range.
Product Quantity	901 vials
Recall Number	Z-0190-2013

Product Description	Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Code Info	Product Part 502-012, Lot #1102-574
Classification	Class III
Reason for Recall	Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complaint stating the MCHC parameter of the Low Control of Boule Con-Diff US Tri Pack lot number 1102-575 recovered low and out of range.
Product Quantity	197 vials
Recall Number	Z-0191-2013

Class III Devices Event

Event ID	63309
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Abbott Point Of Care Inc.
City	Princeton
State	NJ
Country	US
Distribution Pattern	Worldwide distribution: USA (nationwide) including states of: AZ, GA, ID, IL, LA, MD, MO, MN, NC, NV, OK, PA, TN, TX, VA and WI; and country of: Italy.

Associated Products

Product Description	Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 2 (List Number 06F12-10; Lot Number 081039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 3 (List Number 06F12-11; Lot Number 091039) Usage: Assayed human plasma which may be used to verify the integrity of newly received i-STAT CK-MB cartridges.
Code Info	Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039) Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 2 (List #06F12-10; Lot Number 081039) Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 3 (List #06F12-11; Lot Number 091039)
Classification	Class III
Reason for Recall	Abbott Point of Care (APOC) has determined that for the Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039); i-STAT Level 2 (List #06F12-10; Lot Number 081039); and i-STAT Level 3 (List #06F12-11; Lot Number 091039) results may be generated below the lower value assignment range for some vials.
Product Quantity	154 (06F12-09 (74) boxes; 06F12-10 (35) boxes and 06F12-11 (45) boxes.) 1 box contains six, 3ml plastic bottles.
Recall Number	Z-0192-2013

Class III Drugs Event

Event ID	63488
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Valeant Pharmaceuticals
City	Bridgewater
State	NJ
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free Purifying Cleanser (benzoyl peroxide 2.5% w/v) AFCS-0101-00, 1-count 4 fl oz (118 mL) Renewing Toner AFCS-0201-01, and 1-count 2 fl oz (59 mL) Repair Lotion (benzoyl peroxide 3.7% w/v) AFCS-0301-00 per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12008 6.
Code Info	All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12008 6
Classification	Class III
Reason for Recall	Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Product Quantity	1,097,846 cartons
Recall Number	D-042-2013

Product Description	AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 mL) bottle Antibacterial Cleansing Wash (benzoyl peroxide 2.5% w/v) AFSV-0101-00, 1-count 4 fl oz (118 mL) bottle Corrective Toner AFSV-0201-01, 1-count 2 fl oz (59 mL) bottle Maximum Strength Repair Lotion (benzoyl peroxide 10% w/v) AFCS-0303-00, and 1-count 1 oz (28 g) bottle AFSV-0305-03, Retinol Renewal Complex per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12900 3.
Code Info	All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12900 3
Classification	Class III
Reason for Recall	Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Product Quantity	477,107 cartons
Recall Number	D-043-2013

Product Description	AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottle, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0101-00, UPC 7 88521 12020 8.
Code Info	All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12020 8
Classification	Class III
Reason for Recall	Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Product Quantity	145,650 bottles
Recall Number	D-044-2013

Product Description	AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g) tube, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0402, UPC 7 88521 12030 7.
Code Info	All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12030 7
Classification	Class III
Reason for Recall	Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Product Quantity	619,029 tubes
Recall Number	D-045-2013

Product Description	AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads per jar, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13551 6.
Code Info	All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13551 6
Classification	Class III
Reason for Recall	Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.
Product Quantity	71,369 jars
Recall Number	D-046-2013

Product Description	AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13548 6.
Code Info	All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13548 6
Classification	Class III
Reason for Recall	Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Product Quantity	81,319 canisters
Recall Number	D-047-2013

Product Description	AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13350 9.
Code Info	All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13550 9
Classification	Class III
Reason for Recall	Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Product Quantity	10,434 canisters
Recall Number	D-048-2013

Product Description	AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13546 2.
Code Info	All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13546 2
Classification	Class III
Reason for Recall	Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Product Quantity	115,785 canisters
Recall Number	D-049-2013

Mixed Classification Biologics Event

Event ID	62819
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Mar-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Community Blood Centers of Florida, Inc.
City	Lauderhill
State	FL
Country	US
Distribution Pattern	Pennsylvania; Florida; New York

Associated Products

Product Description	Red Blood Cells (Apheresis) Leukocytes Reduced
Code Info	W036811167601(Part A); W036811167601(Part B)
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	2 units
Recall Number	B-2472-12

Product Description	Red Blood Cells
Code Info	W036810147118;
Classification	Class II
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-2473-12

Product Description	Platelets Pooled Leukocytes Reduced
Code Info	W036810810933;
Classification	Class II
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-2474-12

Product Description	Blood and Blood Products for Reprocessing
Code Info	W036810147118;
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-2475-12

Product Description	Cryoprecipitated AHF
Code Info	W036810147118;
Classification	Class II
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-2476-12

Mixed Classification Biologics Event

Event ID	62841
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	02-Jul-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Community Blood Centers of Florida, Inc.
City	Lauderhill
State	FL
Country	US
Distribution Pattern	Florida; New Zealand

Associated Products

Product Description	Red Blood Cells
Code Info	W036811000752;
Classification	Class II
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-2505-12

Product Description	Blood and Blood Products for Reprocessing
Code Info	W036811000752;
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-2506-12

Mixed Classification Biologics Event

Event ID	62860
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Community Blood Centers of South Florida, Inc.
City	Hialeah
State	FL
Country	US
Distribution Pattern	Switzerland; Florida

Associated Products

Product Description	Platelets Pooled Leukocytes Reduced
Code Info	W036809807127;
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-2540-12

Product Description	Cryoprecipitated AHF
Code Info	W036809230283;
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-2541-12

Product Description	Blood and Blood Products for Reprocessing
Code Info	W036809230283;
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-2542-12

Mixed Classification Biologics Event

Event ID	62931
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Carter BloodCare
City	Bedford
State	TX
Country	US
Distribution Pattern	Austria; Texas

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W035212163746N;
Classification	Class II
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-2568-12

Product Description	Blood and Blood Products for Reprocessing
Code Info	W035212163746N;
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-2569-12

Mixed Classification Biologics Event

Event ID	62955
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Aug-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Community Blood Centers of South Florida, Inc.
City	Lake Worth
State	FL
Country	US
Distribution Pattern	Florida; New Zealand

Associated Products

Product Description	Fresh Frozen Plasma
Code Info	W036808102669;
Classification	Class II
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-2573-12

Product Description	Blood and Blood Products for Reprocessing
Code Info	W036808102669;
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-2574-12

Mixed Classification Biologics Event

Event ID	62958
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Jul-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Community Blood Centers of South Florida, Inc.
City	Lake Worth
State	FL
Country	US
Distribution Pattern	Florida; New Zealand

Associated Products

Product Description	Red Blood Cells
Code Info	2737405;
Classification	Class II
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-2581-12

Product Description	Cryoprecipitated AHF
Code Info	2737405;
Classification	Class II
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-2582-12

Product Description	Blood and Blood Products for Reprocessing
Code Info	2737405;
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-2583-12

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