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U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012

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Class I Veterinary Event

Event ID62597
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jul-12
Initial Firm Notification of Consignee or Public Other
Recalling FirmLand O Lakes Purina LLC
CityShoreview
StateMN
CountryUS
Distribution PatternWI 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 DescriptionLand O Lakes, Pheasant Starter A Medicated, Type C Medicated Feed. Item # 1125000-301
Code InfoL633
ClassificationClass I
Reason for RecallLand 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 Quantity23,824 lbs
Recall NumberV-092-2013
Product DescriptionEXPANDED 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 InfoLot Codes: , 2MAY23MFI1, 2JUN11MFI3, 2JUN12MFI1, 2JUN14MFI3, 2JUN20MFI3, 2JUN28MFI3, 2JUL06MFI1, 2JUL16MFI3
ClassificationClass I
Reason for RecallLand 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 Quantity2882 bags
Recall NumberV-093-2013
Product DescriptionEXPANDED 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 InfoLot Codes: 2MAY23MFI1, 2MAY31MFI1, 2JUN12MFI3, 2JUN20MFI3, 2JUN27MFI1, 2JUL06MFI1, 2JUL11MF13, 2JUL18MFI1
ClassificationClass I
Reason for RecallLand 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 Quantity353 bags
Recall NumberV-094-2013
Product DescriptionEXPANDED 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 InfoLot Codes: 2MAY31MFI1, 2JUN06MFI3, 2JUN11MF13, 2JUN19MFI3, 2JUN22MFI3, 2JUL03MFI1, 2JUL11MF13, 2JUL13MFI1
ClassificationClass I
Reason for RecallLand 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 Quantity936 bags
Recall NumberV-095-2013
Product DescriptionEXPANDED 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 InfoLot Codes: 2JUN11MFI3, 2JUL11MFI3, 2JUL18MFI1
ClassificationClass I
Reason for RecallLand 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 Quantity20 bags
Recall NumberV-096-2013
Product DescriptionEXPANDED 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 InfoLot Codes: 2MAY30MFI1, 2JUN13NST1A1, 2MAY31STJ1, 2JUN13MFI1, 2JUN14NST1A1, 2MAY31STJ3, 2JUN22MFI1, 2JUN19NST2A1, 2JUN05STJ2, 2JUL11MFI3, 2JUN20NST2A1, 2JUN20STJ1, 2JUL02NST2A1, 2JUN26STJ2, 2JUL16NST2A1, 2JUL03STJ2, 2JUL16STJ2
ClassificationClass I
Reason for RecallLand 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 Quantity4,491 bags
Recall NumberV-097-2013
Product DescriptionEXPANDED 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 InfoLot 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
ClassificationClass I
Reason for RecallLand 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 Quantity18,588 bags
Recall NumberV-098-2013
Product DescriptionEXPANDED 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 Info60BQ
ClassificationClass I
Reason for RecallLand 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 Quantity11,820 lb
Recall NumberV-099-2013
Product DescriptionEXPANDED 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 Info60KK, 60KL
ClassificationClass I
Reason for RecallLand 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 Quantity147,760 lb + 97,700 lb
Recall NumberV-100-2013
Product DescriptionEXPANDED 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 Info806G
ClassificationClass I
Reason for RecallLand 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 Quantity48,000 lb
Recall NumberV-101-2013
Product DescriptionEXPANDED 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 Info804A
ClassificationClass I
Reason for RecallLand 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 Quantity254,040 lb
Recall NumberV-102-2013
Product DescriptionEXPANDED 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 Info61XU
ClassificationClass I
Reason for RecallLand 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 Quantity19,882 lb
Recall NumberV-103-2013
Product DescriptionEXPANDED RECALL: PURINA LATHROP BROILER FINISHER, 783Z, 3000846-201, BULK NET WEIGHT, PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812
Code Info783Z
ClassificationClass I
Reason for RecallLand 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 Quantity85,518 lb
Recall NumberV-104-2013

Class I Food Event

Event ID63082
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmGiant Eagle
CityPittsburgh
StatePA
CountryUS
Distribution PatternProduct was distributed within the US to select supermarkets (not under the Giant Eagle banner) in OH AND PA.
 

Associated Products

Product DescriptionMango 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 InfoUPC 3003430338, all product with expiration dates of 8/11/2012 through 8/31/2012
ClassificationClass I
Reason for RecallRecalling firm was notified the Mangoes used in production of product were recalled by supplier (Splendid Foods) for possible Salmonella contamination.
Product Quantity28 cases of 4-16 oz containers
Recall NumberF-0635-2013

Class I Food Event

Event ID63291
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmFresh Express Incorporated
CitySalinas
StateCA
CountryUS
Distribution PatternAZ, CA, CO, ID, MD, MN, MT, OR, TX, WA and Canada.
 

Associated Products

Product DescriptionFresh Express, Hearts of Romaine, 18 oz, Fresh Express Incorporated, packed in clear flexible plastic package.
Code InfoProduct Code: S270A24, UPC 71279-26201, Best Use By Date: Oct 11.
ClassificationClass I
Reason for RecallSample of Fresh Express Hearts of Romaine tested positive for Salmonella.
Product Quantity1176 cases
Recall NumberF-0599-2013

Class I Food Event

Event ID63292
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Sep-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmFreshPoint Central Florida
CityOrlando
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionFruit Mango Peeled & Halved, Ready-To-Eat Product, 2, 2.5-lb trays per case
Code InfoItem Number 881262
ClassificationClass I
Reason for RecallCoast 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 Quantity123 trays / 2/2.5#
Recall NumberF-0604-2013
Product DescriptionMixes, Salsa Mango Papaya, Ready-To-Eat Product, 2, 5-lb trays per case
Code InfoItem Number 480124
ClassificationClass I
Reason for RecallCoast 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 Quantity3 trays / 2/5#
Recall NumberF-0605-2013
Product DescriptionFruit Mango Peeled & Diced 1/4, Ready-To-Eat Product, 2, 5-LB Trays per case
Code InfoItem Number 512544 & 812544
ClassificationClass I
Reason for RecallCoast 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 Quantity174 trays / 2/5LB
Recall NumberF-0606-2013
Product DescriptionFruit Mango Peeled & Diced 1/2, Ready To Eat Product, 2, 5-LB Trays per case
Code InfoItem Number 480095, 481351, and 880095
ClassificationClass I
Reason for RecallCoast 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 Quantity40.5 trays / 2/5LB
Recall NumberF-0607-2013
Product DescriptionFruit Mango Whole Peeled, Ready-To-Eat Product, 2, 5-LB Trays per case
Code InfoItem Number 481286
ClassificationClass I
Reason for RecallCoast 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 Quantity4 trays / 2/5LB
Recall NumberF-0608-2013
Product DescriptionMixes, Salsa Mango Bucket, Ready To Eat Product, 1 Gal; & Salsa Mango packaged in 5-lb Trays with 2 trays per case.
Code InfoItem Number 513400, 880126 & 480126
ClassificationClass I
Reason for RecallCoast 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 Quantity1 gallon bucket & 35.5 Trays
Recall NumberF-0609-2013
Product DescriptionFruit Mango Peeled and Sliced, Ready To Eat Product, 2, 5-lb Trays per case
Code InfoItem Number 482100 & 481274
ClassificationClass I
Reason for RecallCoast 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 Quantity2 trays / 5#
Recall NumberF-0610-2013
Product DescriptionMixes Salsa/Mango Pineapple, Ready To Eat Product, 2, 5-lb Trays per case
Code InfoItem Number 481870
ClassificationClass I
Reason for RecallCoast 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 Quantity4 trays / 2/5#
Recall NumberF-0611-2013

Class I Food Event

Event ID63346
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmJamba Juice
CityEmeryville
StateCA
CountryUS
Distribution PatternProducts were released for distribution in US.
 

Associated Products

Product DescriptionJamba 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 InfoNo codes (Stop sale date: September 24, 2012)
ClassificationClass I
Reason for RecallThe products were manufactured using peanut butter recalled by Sunland Inc. because it may be contaminated with Salmonella.
Product QuantityUnknown
Recall NumberF-0636-2013
Product DescriptionJamba 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 InfoNo codes (Stop sale date: September 24, 2012)
ClassificationClass I
Reason for RecallThe products were manufactured using peanut butter recalled by Sunland Inc. because it may be contaminated with Salmonella.
Product QuantityUnknown
Recall NumberF-0637-2013

Class I Food Event

Event ID63408
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmClemmy's LLC
CityRancho Mirage
StateCA
CountryUS
Distribution PatternUS States: CA, WA, NC, DE, HI, MN, OH, NH, NY, and IL. No international distribution.
 

Associated Products

Product DescriptionClemmy'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 InfoUPC 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
ClassificationClass I
Reason for RecallClemmy'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 Quantity12,000 cases
Recall NumberF-0596-2013

Class I Food Event

Event ID63411
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmBelfonte Ice Cream & Dairy Foods Co
CityKansas City
StateMO
CountryUS
Distribution PatternThe products were distributed in MO, KS, OK, AR
 

Associated Products

Product DescriptionBelfonte 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 InfoUPC 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
ClassificationClass I
Reason for RecallProducts may contain peanut butter base with potentially contaminated with Salmonella.
Product Quantity20,304/56oz-paper carton
Recall NumberF-0651-2013
Product DescriptionBelfonte 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 InfoUPC 83057-17033 Best Used By Date: 07/15/2011; 10/02/2011; 12/02/2011; 02/09/2012; 04/06/2012; 06/02/2012
ClassificationClass I
Reason for RecallProducts may contain peanut butter base with potentially contaminated with Salmonella.
Product Quantity15,252/56-oz paper cartons
Recall NumberF-0652-2013

Class I Food Event

Event ID63413
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Oct-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmBliss Unlimited
CityEugene
StateOR
CountryUS
Distribution PatternProduct was distributed to California, Illinois, New Hampshire, New York, Washington, and Wisconsin.
 

Associated Products

Product DescriptionChocolate 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 DESSERT***Luna & Larry's ORGANIC COCONUT BLISS***1 PINT 473mL***".
Code InfoThe 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
ClassificationClass I
Reason for RecallLuna & 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 Quantity8,628 cases/8 units/1 pint
Recall NumberF-0598-2013

Class I Food Event

Event ID63437
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Oct-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmDanielle Livolsi Jagrma
CitySan Diego
StateCA
CountryUS
Distribution PatternCA & NH
 

Associated Products

Product DescriptionOrganic NuttZo Omega-3 SEVEN Nut & Seed Butter, Net Wt. 16 oz (1lb) 454 g, UPC 894697002030.
Code InfoBest By Dates 10/7/12-12/31/12
ClassificationClass I
Reason for RecallJagRma 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 Quantity1510 cases
Recall NumberF-0638-2013

Class I Food Event

Event ID63438
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Oct-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmPureFit Inc
CityIrvine
StateCA
CountryUS
Distribution PatternNationwide in the US and worldwide: Australia, Canada, Norway, New Zealand, Ireland, Italy, and United Kingdom.
 

Associated Products

Product DescriptionPureFit Peanut Butter Bars, size 2 oz (56.7g) and box of 15 bars in 1 box/carton. UPC 812787001008, 812787002005
Code Info01MAR13 and 12JUL13
ClassificationClass I
Reason for RecallPureFit 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 Quantity128,160 units
Recall NumberF-0597-2013

Class I Food Event

Event ID63440
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Oct-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmFlying Food Group, Inc.
CityNewark
StateNJ
CountryUS
Distribution PatternCT, MA, NY, NJ, PA, DE, MD, DC, VA, GA, FL, IL, WI, MN, IN, TX, AZ, NV, and CA
 

Associated Products

Product DescriptionStarbucks 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 InfoEnjoy 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
ClassificationClass I
Reason for RecallStarbucks Protein Bistro Boxes contain Honey Peanut Butter Squeeze Packs which are involved in Justin's Nut Butter expanded recall.
Product Quantity955,541 units
Recall NumberF-0632-2013

Class I Food Event

Event ID63441
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Oct-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmHannaford Bros.
CityScarborough
StateME
CountryUS
Distribution PatternNew York, Maine, New Hampshire, Massachusetts and Vermont
 

Associated Products

Product DescriptionHannaford Red Velvet Cake Truffle, 6 count UPC #20335800000
Code InfoAll sell by dates
ClassificationClass I
Reason for RecallProduct labels fails to declare allergens: egg, milk, peanuts, wheat, soy and tree nuts
Product Quantity
Recall NumberF-0621-2013
Product DescriptionHannaford Triple Chocolate Cake Truffle, 6 count UPC # 20335700000
Code InfoAll sell by dates
ClassificationClass I
Reason for RecallProduct labels fails to declare allergens: egg, milk, peanuts, wheat, soy and tree nuts
Product Quantity
Recall NumberF-0622-2013

Class I Food Event

Event ID63444
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Oct-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmS & P Company Limited
CityParamount
StateCA
CountryUS
Distribution PatternUS states: AZ, CA, IL, NE, and TX. No international distribution.
 

Associated Products

Product DescriptionSu-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***BRAND***HOT***CRUSHED 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 InfoNo lot codes. Only UPC code: 659613000770. Distribution dates July 2012 to October 2012. No expiration date listed.
ClassificationClass I
Reason for RecallThe recall was initiated in response to positive Salmonella resuts during FDA routine import sampling of the product.
Product Quantity150 cases/1800 jars
Recall NumberF-0618-2013

Class I Food Event

Event ID63450
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMondelez Global Llc
CityEast Hanover
StateNJ
CountryUS
Distribution PatternNationwide.
 

Associated Products

Product DescriptionGreen & Black's Organic Peanut & Sea Salt Milk Chocolate Bar NET WT. 3.5 oz (100g). UPC 708656 100562.
Code InfoUPC - 708656 100562; Code Dates: Oct 26, 2012; Oct 27, 2012; Oct 30, 2012; Nov 1, 2012.
ClassificationClass I
Reason for RecallMondelez 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 Quantity558 cases (120 bars in each case)
Recall NumberF-0653-2013

Class I Food Event

Event ID63453
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCreative Energy Foods, Inc. LLC
CityOakland
StateCA
CountryUS
Distribution PatternProduct was only sold on the internet.
 

Associated Products

Product DescriptionRidgebar Peanut Butter Crunch, 40 grams
Code InfoUPC : 855468003052, Best by dates: 022413, 042813
ClassificationClass I
Reason for RecallCreative Energy Foods manufactured nutrition bars with peanuts from Sunland, Inc which are under recall for the potential to be contaminated with salmonella.
Product Quantity1269
Recall NumberF-0613-2013

Class I Food Event

Event ID63469
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmVelvet Ice Cream Company
CityUtica
StateOH
CountryUS
Distribution PatternIN, KY, OH, and WV
 

Associated Products

Product DescriptionPeanut 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 Info1 and 2 - Code Number #10181, MFD Date: 6/30/2010
ClassificationClass I
Reason for RecallThe product was manufactured using peanut butter ingredient recalled by Sunland Inc. due to potential Salmonella contamination.
Product Quantity1) 494 units; 2) 30 units
Recall NumberF-0619-2013
Product DescriptionVelvet 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 InfoUPC #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
ClassificationClass I
Reason for RecallThe product was manufactured using peanut butter ingredient recalled by Sunland Inc. due to potential Salmonella contamination.
Product Quantity56oz- 801 units; 3 gal 585 units; Pints- 548 units
Recall NumberF-0620-2013

Class I Food Event

Event ID63473
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Oct-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmThink Thin, LLC
CityVentura
StateCA
CountryUS
Distribution PatternUS states nationwide. No international distribution.
 

Associated Products

Product DescriptionNutrition 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 InfoUPC 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
ClassificationClass I
Reason for RecallThe 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 Quantity7,683 cases
Recall NumberF-0623-2013
Product DescriptionNutrition 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 InfoUPC Code: 7 53656 70861 4 Best by Dates: 030113 ,032513, 042013, 052213, 060113, 061513, 062213 AND expired lots prior to Best By 101012
ClassificationClass I
Reason for RecallThe 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 Quantity14,435 cases
Recall NumberF-0624-2013
Product DescriptionNutrition 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 InfoUPC 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
ClassificationClass I
Reason for RecallThe 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 Quantity3,112 cases
Recall NumberF-0625-2013
Product DescriptionNutrition 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 InfoUPC Code: 7 53656 70879 9 Best by Dates: 112812, 030813, 040513, 042113, 051013, 060113, 061513, 071313 AND expired lots prior to Best By 101012
ClassificationClass I
Reason for RecallThe 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 Quantity2,408 cases
Recall NumberF-0626-2013
Product DescriptionNutrition 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 InfoUPC Code: 7 53656 70915 4 Best by Dates: 022313, 032513, 041913, 042513, 061113 AND expired lots prior to Best By 101012
ClassificationClass I
Reason for RecallThe 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 Quantity1,099 cases
Recall NumberF-0627-2013
Product DescriptionNutrition 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 InfoUPC 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
ClassificationClass I
Reason for RecallThe 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 Quantity1,775 cases
Recall NumberF-0628-2013
Product DescriptionNutrition 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 InfoUPC Code: 7 53656 70909 3 Best by Dates: 030813, 041113, 052913, 062213 AND expired lots prior to Best By 101012
ClassificationClass I
Reason for RecallThe 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 Quantity1221 cases
Recall NumberF-0629-2013

Class I Food Event

Event ID63483
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Oct-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmDole Fresh Vegetables Inc
CityMonterey
StateCA
CountryUS
Distribution PatternIL, IN, ME,. MO, NJ, NY, OH, PA, TN and WI
 

Associated Products

Product DescriptionDole 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 InfoCode: A275208A or B275208B; Enjoy by Date: 10-17-12.
ClassificationClass I
Reason for RecallTennessee Department of Agriculture collected a random sample of Dole American Blen and had a positive result for Listeria Monocytogenes.
Product Quantity922 cases
Recall NumberF-0615-2013

Class I Food Event

Event ID63484
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Oct-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmNatural Selection Foods LLC dba Earthbound Farm
CitySan Juan Bautista
StateCA
CountryUS
Distribution PatternCA, FL, HI, LA, MA, MT, NE, NJ, NY, OH, OR, PA, TX and Canada
 

Associated Products

Product DescriptionEarthbound 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 InfoBest if Used by Dates: 10/17-12 through 10/28/12.
ClassificationClass I
Reason for RecallPeanuts 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 Quantity362 cases
Recall NumberF-0614-2013

Class I Food Event

Event ID63487
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Oct-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmEnergy Club Inc
CityPacoima
StateCA
CountryUS
Distribution Patternnationwide in the US
 

Associated Products

Product DescriptionPeanuts 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 InfoBest By Date 11/23/2012 to 04/10/2013
ClassificationClass I
Reason for RecallTrifecta 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 Quantity22,271 units total
Recall NumberF-0616-2013
Product DescriptionPeanuts 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 InfoBest by Date 11/23/12 to 4/10/13.
ClassificationClass I
Reason for RecallTrifecta 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 Quantity22,271 units total
Recall NumberF-0617-2013

Class I Food Event

Event ID63501
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Oct-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmThe Nut Factory Inc.
CitySpokane Valley
StateWA
CountryUS
Distribution PatternProduct was distributed in Washington state. There are no Canadian consignees.
 

Associated Products

Product DescriptionFiesta 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 InfoDates 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).
ClassificationClass I
Reason for RecallFiesta Mix product is recalled due to undeclared soy, milk, wheat, and FD& C Yellow #6 on finished product label.
Product Quantity13-25 pound bags (325 lbs of product total).
Recall NumberF-0634-2013

Class I Food Event

Event ID63519
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Oct-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmHonolulu Baking Company, Ltd.
CityHonolulu
StateHI
CountryUS
Distribution PatternHI distribution only on island of Oahu.
 

Associated Products

Product DescriptionStarbucks 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 InfoEnjoy 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.
ClassificationClass I
Reason for RecallFirm 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 Quantity146,311 boxes since 9/1/2010
Recall NumberF-0633-2013

Class I Food Event

Event ID63534
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSouthern Belle, Inc.
CityMurfreesboro
StateTN
CountryUS
Distribution PatternTN
 

Associated Products

Product DescriptionPeanut brittle, 2 lbs packaged in plastic bags (bulk product)
Code Infoall date codes between 09/30/2012 - 10/04/2012
ClassificationClass I
Reason for RecallProducts were manufactured using peanuts recalled by Sunland
Product Quantity41 units
Recall NumberF-0630-2013
Product DescriptionBacon Brittle, 2 lbs packaged in plastic bags (bulk product)
Code Infoall date codes between 09/30/2012 - 10/04/2012
ClassificationClass I
Reason for RecallProducts were manufactured using peanuts recalled by Sunland
Product Quantity27 units
Recall NumberF-0631-2013

Class I Food Event

Event ID63587
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmWilliams and Company Inc dba The Nut Shop
CityTuscaloosa
StateAL
CountryUS
Distribution PatternAL and MS
 

Associated Products

Product DescriptionThe Nut Shop (brand) Roasted Peanuts, 3.0 oz MIN Wt.
Code InfoThe product is not coded. All product on the shelf as of October 18, 2012
ClassificationClass I
Reason for RecallProduct manufactured using peanuts which were recalled by Sunland.
Product Quantity3000 units
Recall NumberF-0612-2013

Class II Devices Event

Event ID52796
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Aug-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSechrist Industries Inc
CityAnaheim
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada
 

Associated Products

Product DescriptionSechrist 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 InfoSerial Numbers: 330001-330069, 330071, 330072, 330074, 330075.
ClassificationClass II
Reason for RecallSechrist 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 Quantity73 units
Recall NumberZ-0208-2013
Product DescriptionSechrist 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 InfoSerial Numbers: 360001-360049, 360051-360064, 360068.
ClassificationClass II
Reason for RecallSechrist 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 Quantity65 units total (61 units in the US)
Recall NumberZ-0209-2013

Class II Devices Event

Event ID53337
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Oct-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMedacta Usa Inc
CityCamarillo
StateCA
CountryUS
Distribution PatternWorldwide Distribution -- US including the states of Texas, Nevada and Colorado., and the country of Belgium.
 

Associated Products

Product DescriptionQuadra 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 InfoRef: 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)
ClassificationClass II
Reason for RecallMedacta 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 Quantity12 units
Recall NumberZ-0267-2013

Class II Drugs Event

Event ID62113
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Mar-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAurobindo Pharma LTD
CityMehbubnagar
State
CountryIN
Distribution PatternNationwide
 

Associated Products

Product DescriptionNorthstar 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 InfoBatch Number ZPSB11054-A Exp. 05/13
ClassificationClass II
Reason for RecallAdulterated 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 Quantity23,616 bottles
Recall NumberD-041-2013

Class II Devices Event

Event ID62271
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Oct-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmShimadzu Medical Systems
CityTorrance
StateCA
CountryUS
Distribution PatternUS Nationwide Distribution
 

Associated Products

Product DescriptionR-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 InfoDevice Model #R-30H
ClassificationClass II
Reason for RecallShimadzu 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 Quantity665 units
Recall NumberZ-0260-2013
Product DescriptionR-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 InfoDevice Model #R-20J
ClassificationClass II
Reason for RecallShimadzu 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 Quantity308 units
Recall NumberZ-0261-2013
Product Description0.7U163CS-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 InfoS/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
ClassificationClass II
Reason for RecallShimadzu 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 Quantity288 units
Recall NumberZ-0262-2013
Product Description0.7/1.3U163CS-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 InfoS/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
ClassificationClass II
Reason for RecallShimadzu 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 Quantity133 units
Recall NumberZ-0263-2013
Product Description0.7/1.2JG326D-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 InfoMobileArt 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
ClassificationClass II
Reason for RecallShimadzu 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 Quantity5 units
Recall NumberZ-0264-2013
Product Description0.4/0.7JG326D-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 InfoS/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
ClassificationClass II
Reason for RecallShimadzu 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 Quantity3 units
Recall NumberZ-0265-2013

Class II Devices Event

Event ID62580
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSysmex America, Inc.
CityMundelein
StateIL
CountryUS
Distribution PatternNationwide distribution: USA including Puerto Rico.
 

Associated Products

Product DescriptionSysmex 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 Infocatalog #983-1341-1, all serial numbers
ClassificationClass II
Reason for RecallThere 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 Quantity1,099 units
Recall NumberZ-0254-2013
Product DescriptionSysmex 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 Infocatalog #063-7591-7, all serial numbers
ClassificationClass II
Reason for RecallThere 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 Quantity763 units
Recall NumberZ-0255-2013
Product DescriptionSysmex 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 Infocatalog ##053-2311-4, all serial numbers
ClassificationClass II
Reason for RecallThere 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 Quantity69 units
Recall NumberZ-0256-2013

Class II Biologics Event

Event ID62820
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW036811144281;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2487-12
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036811807521;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2488-12
Product DescriptionFresh Frozen Plasma
Code InfoW036811144281;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2489-12

Class II Biologics Event

Event ID62821
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCentral Jersey Blood Center, Inc.
CityEatontown
StateNJ
CountryUS
Distribution PatternNew Jersey
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW053512009319; W053512000355; W053512002729; W053511145005;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity4 units
Recall NumberB-2490-12

Class II Biologics Event

Event ID62822
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Mar-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW036811002671;
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-2491-12

Class II Biologics Event

Event ID62823
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Jun-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmHoxworth Blood Center UC Medical Center
CityCincinnati
StateOH
CountryUS
Distribution PatternOhio
 

Associated Products

Product DescriptionCryoprecipitated AHF, Pooled
Code InfoW037711502217;
ClassificationClass II
Reason for RecallBlood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Product Quantity1 unit
Recall NumberB-2492-12

Class II Biologics Event

Event ID62825
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jun-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMississippi Blood Services Inc.
CityFlowood
StateMS
CountryUS
Distribution PatternMississippi
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW069112124734(Part A); W069112124734(Part B)
ClassificationClass II
Reason for RecallBlood product, which did not meet the acceptable product specifications, were distributed.
Product Quantity2 units
Recall NumberB-2501-12

Class II Biologics Event

Event ID62837
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Aug-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers Inc - Birmingham Region
CityBirmingham
StateAL
CountryUS
Distribution PatternAlabama
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW1151121920405;
ClassificationClass II
Reason for RecallBlood product, which did not meet acceptable product specifications, was distributed.
Product Quantity1 unit
Recall NumberB-2499-12

Class II Biologics Event

Event ID62838
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers, Inc.
CityGainesville
StateFL
CountryUS
Distribution PatternAlabama
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW115112242560G;
ClassificationClass II
Reason for RecallBlood product, which did not meet the acceptable product specifications, was distributed.
Product Quantity1 unit
Recall NumberB-2500-12

Class II Biologics Event

Event ID62839
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Apr-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers Inc - Birmingham Region
CityBirmingham
StateAL
CountryUS
Distribution PatternAlabama
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW1151121581200;
ClassificationClass II
Reason for RecallBlood product, which did not meet acceptable product specifications, was distributed.
Product Quantity1 unit
Recall NumberB-2502-12

Class II Biologics Event

Event ID62840
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmWalter L. Shepeard Community Blood Center, Inc.
CityAugusta
StateGA
CountryUS
Distribution PatternGeorgia
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW038509323445;
ClassificationClass II
Reason for RecallBlood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed
Product Quantity1 unit
Recall NumberB-2503-12
Product DescriptionCryoprecipitated AHF
Code InfoW038509323445;
ClassificationClass II
Reason for RecallBlood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed
Product Quantity1 unit
Recall NumberB-2504-12

Class II Biologics Event

Event ID62861
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jun-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmFlorida's Blood Centers, Inc.
CityOrlando
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis)
Code InfoW038112098387;
ClassificationClass II
Reason for RecallBlood product, labeled 'leukoreduced', but which had not undergone leukoreduction, was distributed.
Product Quantity1 unit
Recall NumberB-2543-12

Class II Biologics Event

Event ID62862
StatusCompleted
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida; New York
 

Associated Products

Product DescriptionRed Blood Cells
Code Info2621030;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2611-12
Product DescriptionPlatelets Pooled Leukocytes Reduced Irradiated
Code Info2926630;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2612-12
Product DescriptionFresh Frozen Plasma
Code Info2621030;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2613-12

Class II Biologics Event

Event ID62863
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternIowa; New Jersey
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW333612044123; W333612010664; W333611093208;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to malarial endemic areas, were distributed.
Product Quantity3 units
Recall NumberB-2562-12

Class II Biologics Event

Event ID62876
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Aug-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBlood Systems Inc
CityScottsdale
StateAZ
CountryUS
Distribution PatternArizona
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW041010152697I;
ClassificationClass II
Reason for RecallBlood product, positive for the S-antigen but labeled as S-antigen negative, was distributed.
Product Quantity1 unit
Recall NumberB-2544-12

Class II Biologics Event

Event ID62878
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSuncoast Communities Blood Bank, Inc.
CitySarasota
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW038612824624; W038612824624; W038612824624;
ClassificationClass II
Reason for RecallBlood products, which did not meet acceptable product specifications, were distributed.
Product Quantity3 units
Recall NumberB-2546-12

Class II Biologics Event

Event ID62903
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMemorial Blood Centers
CitySaint Paul
StateMN
CountryUS
Distribution PatternMinnesota
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code Info W051512070531
ClassificationClass II
Reason for RecallBlood products, with a low pH, was distributed.
Product Quantity1 unit
Recall NumberB-2564-12

Class II Biologics Event

Event ID62904
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Jun-12
Initial Firm Notification of Consignee or Public Other
Recalling FirmMemorial Blood Centers
CitySaint Paul
StateMN
CountryUS
Distribution PatternSwitzerland; Minnesota
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW051512022383;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity1 unit
Recall NumberB-2144-12
Product DescriptionRed Blood Cells
Code InfoW051512022383;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity1 unit
Recall NumberB-2145-12

Class II Biologics Event

Event ID62905
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMemorial Blood Centers
CitySaint Paul
StateMN
CountryUS
Distribution PatternMinnesota
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW051511105499;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity1 unit
Recall NumberB-2558-12
Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW051511105499;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity1 unit
Recall NumberB-2559-12

Class II Biologics Event

Event ID62906
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmInterstate Blood Bank, Inc. of Wisconsin
CityMilwaukee
StateWI
CountryUS
Distribution PatternCalifornia; Germany, Federal Republic of
 

Associated Products

Product DescriptionSource Plasma
Code Info12MKEB0609; 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;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was permanently deferred, were distributed.
Product Quantity33 units
Recall NumberB-2566-12

Class II Biologics Event

Event ID62907
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmInterstate Blood Bank, Inc. of Wisconsin
CityMilwaukee
StateWI
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info12MKEA6076; 12MKEA5884;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was permanently deferred, were distributed.
Product Quantity2 units
Recall NumberB-2567-12

Class II Devices Event

Event ID62945
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSurgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
CityAguadilla
StatePR
CountryUS
Distribution PatternWorldwide 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 Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***" Ophthalmic surgery
Code InfoMAFD350, M381400, M407870, M439070, M439090, M466140, M495140, M495190, M510800, M554700, M554740, M585650, M656720, M656730, MABL380, MABQ000, MADM740
ClassificationClass II
Reason for RecallPotential for bent tips.
Product Quantity117,948 units (total)
Recall NumberZ-0201-2013
Product Description"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***" Ophthalmic surgery
Code InfoM342500, M342510, M415840, M439130, M446040, M495130, M495160, M510810, M553460, M553470, M553480, M585640, M585740, M652760, M652770, M652780, MADP160, MADP170
ClassificationClass II
Reason for RecallPotential for bent tips.
Product Quantity117,948 units (total)
Recall NumberZ-0202-2013
Product Description"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***" Ophthalmic surgery
Code InfoMABQ150, MAGS310, MAJC690
ClassificationClass II
Reason for RecallPotential for bent tips.
Product Quantity117,948 units (total)
Recall NumberZ-0203-2013
Product Description"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3240***" Ophthalmic surgery
Code InfoMAKR840, MALZ570, MALZ580, MAMQ990, MAMR000, MANP250, MAPR320, MAQD910
ClassificationClass II
Reason for RecallPotential for bent tips.
Product Quantity117,948 units (total)
Recall NumberZ-0204-2013

Class II Biologics Event

Event ID62952
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Aug-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeShare Blood Centers
CityBeaumont
StateTX
CountryUS
Distribution PatternSwitzerland
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036510091494;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Product Quantity1 unit
Recall NumberB-2571-12

Class II Biologics Event

Event ID62956
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036812405799;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2575-12
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036812834939;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2576-12
Product DescriptionFresh Frozen Plasma
Code InfoW036812405799;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2577-12

Class II Biologics Event

Event ID62957
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW036811173182;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2578-12
Product DescriptionFresh Frozen Plasma
Code InfoW036811173182;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2579-12
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036811811523;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2580-12

Class II Devices Event

Event ID63083
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Feb-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPrimus Medical LLC
CityBoardman
StateOH
CountryUS
Distribution PatternNationwide distribution: USA including states of: AZ, IL, KY, MD, MI, OH, OR, PA, TX and VA.
 

Associated Products

Product DescriptionAC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512. Usage: Hospital Bed.
Code InfoModel #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.
ClassificationClass II
Reason for RecallThe "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 Quantity342 Beds
Recall NumberZ-0270-2013

Class II Devices Event

Event ID63103
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmZimmer, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionAlloclassic SL Shaft
Code InfoItem 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
ClassificationClass II
Reason for RecallZimmer 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 Quantity1355
Recall NumberZ-0210-2013
Product DescriptionBiolox® delta Ceramic Femoral Head Rx only, sterile
Code InfoREF 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.
ClassificationClass II
Reason for RecallZimmer 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 Quantity2544
Recall NumberZ-0211-2013
Product DescriptionBiolox® Option Ceramic Femoral Head System Rx, sterile
Code InfoREF Numbers: 00-8777-028-02, 00-8777-036-01, 00-8777-036-02, and 00-8777-040-01.
ClassificationClass II
Reason for RecallZimmer 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 Quantity88
Recall NumberZ-0212-2013
Product DescriptionWagner SL Revision Stem, uncemented Sterile
Code InfoREF 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.
ClassificationClass II
Reason for RecallZimmer 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 Quantity87
Recall NumberZ-0213-2013
Product DescriptionAlloclassic® SL-Offset Stem sterile, Rx
Code InfoREF Numbers: 01.00121.020, 01.00121.030, 01.00121.040, 01.00121.050, 01.00121.060, 01.00121.070, and 01.00121.090.
ClassificationClass II
Reason for RecallZimmer 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 Quantity126
Recall NumberZ-0214-2013
Product DescriptionMetasul® LDH® Head Rx Sterile
Code InfoREF 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
ClassificationClass II
Reason for RecallZimmer 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 Quantity1739
Recall NumberZ-0215-2013
Product DescriptionMetasul® Durom® Femoral component Sterile, Rx
Code InfoREF 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
ClassificationClass II
Reason for RecallZimmer 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 Quantity209
Recall NumberZ-0216-2013
Product DescriptionMS-30® Stem
Code InfoREF Numbers: 01.00351.005, 01.00351.006, lots 2330077, 2397912
ClassificationClass II
Reason for RecallZimmer 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 Quantity30
Recall NumberZ-0217-2013
Product DescriptionMS-30® Distal centralizer, cemented, sterile, Rx
Code InfoREF 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.
ClassificationClass II
Reason for RecallZimmer 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 Quantity58
Recall NumberZ-0218-2013
Product DescriptionMS-30® Proximal positioner
Code InfoREF Number: 01.00351.265, lot 237973
ClassificationClass II
Reason for RecallZimmer 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 Quantity5
Recall NumberZ-0219-2013
Product DescriptionFitmore" Hip Stem
Code InfoREF 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
ClassificationClass II
Reason for RecallZimmer 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 Quantity1190
Recall NumberZ-0220-2013
Product DescriptionWagner cone Prosthesis, uncemented, sterile, Rx
Code InfoREF 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
ClassificationClass II
Reason for RecallZimmer 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 Quantity56
Recall NumberZ-0221-2013
Product DescriptionCoCr Head, sterile, Rx
Code InfoREF 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
ClassificationClass II
Reason for RecallZimmer 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 Quantity1000
Recall NumberZ-0222-2013
Product DescriptionAnatomical Shoulder" Humeral stem
Code InfoREF 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, .
ClassificationClass II
Reason for RecallZimmer 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 Quantity260
Recall NumberZ-0223-2013
Product DescriptionAnatomical Shoulder" Fracture Humeral stem
Code InfoREF 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,
ClassificationClass II
Reason for RecallZimmer 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 Quantity139
Recall NumberZ-0224-2013
Product DescriptionAnatomical Shoulder" Humeral Head
Code InfoREF 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
ClassificationClass II
Reason for RecallZimmer 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 Quantity224
Recall NumberZ-0225-2013
Product Descriptionzimmer 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 InfoREF 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.
ClassificationClass II
Reason for RecallZimmer 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 Quantity164 in USA
Recall NumberZ-0226-2013
Product DescriptionAnatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem
Code InfoREF 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
ClassificationClass II
Reason for RecallZimmer 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 Quantity45 USA
Recall NumberZ-0227-2013
Product DescriptionZimmer Inverse/Reverse Screw system,
Code InfoREF 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 ,
ClassificationClass II
Reason for RecallZimmer 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 Quantity45 USA
Recall NumberZ-0228-2013
Product DescriptionAnatomical Shoulder" Inverse Humeral Cup
Code InfoREF 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
ClassificationClass II
Reason for RecallZimmer 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 Quantity66
Recall NumberZ-0229-2013
Product DescriptionAnatomical Shoulder" Inverse/Reverse Glenoid Sterile, Rx
Code InfoREF Numbers: 01.04223.200 and 01.04223.236 2313338, 2314443, 2318819, 2331464, 2342906, 2343151, 2346399, 2368714, 2387755, 2425692, 2468583, 2468587, 2471765, 2503386, 2516402
ClassificationClass II
Reason for RecallZimmer 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 Quantity228
Recall NumberZ-0230-2013
Product DescriptionAnatomical Shoulder" Inverse/Reverse Humeral PE-Insert Sterile, Rx
Code InfoREF 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,
ClassificationClass II
Reason for RecallZimmer 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 Quantity74
Recall NumberZ-0231-2013
Product DescriptionAnatomical Shoulder" Ball taper for humeral stem
Code InfoREF Numbers: 01.04227.102, Lot:2350372, 2381792, 2398201, 2452078, 2460783
ClassificationClass II
Reason for RecallZimmer 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 Quantity54
Recall NumberZ-0232-2013
Product DescriptionAnatomical Shoulder" Fracture Humeral Head
Code InfoREF Numbers: 01.04227.400, 01.04227.405, 01.04227.480, and 01.04227.485 Lot 2352153, 2358721, 2366101, 2525804, 2494527, 2523912, 2385885, 2441471
ClassificationClass II
Reason for RecallZimmer 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 Quantity26
Recall NumberZ-0233-2013
Product DescriptionCLS Stem
Code InfoREF Numbers: 29.00.09.137, 29.00.09.162, 29.00.39.070, and 29.00.39.125 Lot 2397894, 2393484, 2480480, 2439729,
ClassificationClass II
Reason for RecallZimmer 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 Quantity18
Recall NumberZ-0234-2013
Product DescriptionOriginal M.E. Mueller" Low Profile Cup Sterile, Rx
Code InfoREF Numbers: 63.32.46, 63.32.60 and 63.32.62.Lot 2378026, 2468907, 2370934
ClassificationClass II
Reason for RecallZimmer 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 Quantity6
Recall NumberZ-0235-2013
Product DescriptionDynesys® Set screw M6
Code InfoREF Numbers: 01.03710.006 and 01.03711.006 Lot 2381797, 2429082
ClassificationClass II
Reason for RecallZimmer 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 Quantity58
Recall NumberZ-0236-2013
Product DescriptionDynesys® Universal spacer 6-45
Code InfoREF 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,
ClassificationClass II
Reason for RecallZimmer 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 Quantity5069
Recall NumberZ-0237-2013
Product DescriptionDynesys® L.I.S. Stabilizing cord Rx, Sterile
Code InfoREF Numbers: 01.03711.100 and 01.03711.200 Lot2290106, 2322753, 2322757, 2325303, 2328500, 2350135, 2363929, 2363972, 2366663, 2377045, 2391793, 2409738, 2422397, 2444114, 2448948, 2453742
ClassificationClass II
Reason for RecallZimmer 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 Quantity973
Recall NumberZ-0238-2013
Product DescriptionDynesys® Revision + set screw
Code InfoREF 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
ClassificationClass II
Reason for RecallZimmer 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 Quantity1575
Recall NumberZ-0239-2013
Product DescriptionDynesys® HA Pedicle + set screw
Code InfoREF 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, .
ClassificationClass II
Reason for RecallZimmer 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 Quantity1247
Recall NumberZ-0240-2013
Product DescriptionDTO" Implant
Code InfoREF Numbers: 01.03791.050, 01.03791.060, and 01.03791.080 Lot: 2417930, 2417948, 2417950, 2417956, 2429074, 2432771, 2462074, 2512965,
ClassificationClass II
Reason for RecallZimmer 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 NumberZ-0241-2013
Product DescriptionDynesys® Top-Loading System Cannulated Pedicle + Set Screw
Code InfoREF 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,
ClassificationClass II
Reason for RecallZimmer 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 Quantity1406
Recall NumberZ-0242-2013
Product DescriptionNCB® cancellous screw
Code InfoREF Number: 02.02152. 085 Lot 2477869
ClassificationClass II
Reason for RecallZimmer 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 Quantity2
Recall NumberZ-0243-2013
Product DescriptionNCB® screw Ø 4.0 self-tapping
Code InfoREF Numbers: 02.02155.026 and 02.02155.030 Lots2450611, 2475382
ClassificationClass II
Reason for RecallZimmer 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 Quantity41
Recall NumberZ-0244-2013
Product DescriptionNCB®-PT lateral proximal 3 hole tibial plate
Code InfoREF 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,
ClassificationClass II
Reason for RecallZimmer 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 Quantity589
Recall NumberZ-0245-2013
Product DescriptionNCB®-PH Plate
Code InfoREF Numbers: 02.02262.105 and 02.02262.107. Lot 2450659, 2450644
ClassificationClass II
Reason for RecallZimmer 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 Quantity95
Recall NumberZ-0246-2013
Product DescriptionSirus® intramedullary nail for tibia, cannulated Ø
Code InfoREF 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,
ClassificationClass II
Reason for RecallZimmer 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 Quantity195
Recall NumberZ-0247-2013
Product DescriptionKopf Adapter S Sterile, Rx
Code InfoREF 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
ClassificationClass II
Reason for RecallZimmer 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 Quantity2011
Recall NumberZ-0248-2013
Product DescriptionMS-30 Shaft, Sterile, Rx
Code Info30.00.49-100, 140, 160; Lots 2396807, 2390863, 2321477
ClassificationClass II
Reason for RecallZimmer 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 Quantity13
Recall NumberZ-0249-2013

Class II Food Event

Event ID63207
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFabrica Confecciones Soto, Inc.
CityCanovanas
StatePR
CountryUS
Distribution PatternPR only. Product sold by the firm at retail.
 

Associated Products

Product Description"Tacos de Jueyes" (Crab Tacos) - Food Service
Code Infonone
ClassificationClass II
Reason for RecallUndeclared allergens: wheat, soy, crustacean shellfish (crab), and yellow #5
Product Quantity180
Recall NumberF-0654-2013
Product Description "Alcapurria Jueyes" (Crab-filled fritters) - Food Service
Code Infonone
ClassificationClass II
Reason for RecallUndeclared allergens: wheat, soy, crustacean shellfish (crab), and yellow #5
Product Quantity160
Recall NumberF-0655-2013

Class II Devices Event

Event ID63270
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Jun-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmDiagnostica Stago, Inc.
CityParsippany
StateNJ
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and Canada
 

Associated Products

Product DescriptionSTA 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 InfoK082248 D089976 Ref 58104 units
ClassificationClass II
Reason for RecallFollowing 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 Quantity232 units US; 5 units Canada
Recall NumberZ-0252-2013

Class II Devices Event

Event ID63273
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Howmedica Osteonics Corp.
CityMahwah
StateNJ
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionHoffman 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 InfoK113327 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
ClassificationClass II
Reason for RecallThree 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 Quantity165 units
Recall NumberZ-0266-2013

Class II Devices Event

Event ID63297
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Feb-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmKerr Corporation
CityRomulus
StateMI
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of Canada, Europe, and Australia.
 

Associated Products

Product DescriptionThe 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 InfoÿProduct Part Numbers Lot Number AlgiNot Intra Kit 34683 1-1017 AlgiNot Volume Refills 34682 1-1017
ClassificationClass II
Reason for RecallThe 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 Quantity45 kits and 87 refills
Recall NumberZ-0268-2013

Class II Food Event

Event ID63334
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmKellogg Company
CityBattle Creek
StateMI
CountryUS
Distribution PatternUS, nationwide and Canada
 

Associated Products

Product DescriptionKellogg'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 InfoUSA 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,
ClassificationClass II
Reason for RecallThis 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 Quantity2,853, 130 cases; 28,158,243 pkgs
Recall NumberF-0600-2013
Product DescriptionKellogg'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 InfoUSA 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
ClassificationClass II
Reason for RecallThis 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 Quantity2,853, 130 cases; 28,158,243 pkgs
Recall NumberF-0601-2013
Product DescriptionKellogg'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 InfoUSA 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
ClassificationClass II
Reason for RecallThis 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 Quantity2,853, 130 cases; 28,158,243 pkgs
Recall NumberF-0602-3013
Product DescriptionCanadian Product: Kellogg's Mini Wheats, Brown Sugar Flavour Cereal, 6 ct., 10 ct, 12 ct, 16ct; 400G, 510G, 850 G, 1300 G
Code InfoDate code 2013 AL 01-2013 Jl 29 Case UPC6410020738, 6410044892, 6410052652, 6410059008, 6410059011
ClassificationClass II
Reason for RecallThis 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 Quantitynone in USA
Recall NumberF-0603-2013

Class II Devices Event

Event ID63368
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Jan-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSendx Medical Inc
CityCarlsbad
StateCA
CountryUS
Distribution PatternWorldwide 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 DescriptionABL80 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 InfoSerial Numbers: all ABL80 FLEX CO-OX analyzers with sofware versions 1.30, 1.31, 1.32, 1.33, and 1.34.
ClassificationClass II
Reason for RecallThe 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 Quantity767 units
Recall NumberZ-0195-2013

Class II Devices Event

Event ID63369
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Nov-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSunquest Information Systems, Inc.
CityTucson
StateAZ
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and Internationally to Ireland
 

Associated Products

Product DescriptionSunquest Laboratory, version 7.0 not available
Code Infonot available
ClassificationClass II
Reason for RecallSunquest 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 Quantity14 sites
Recall NumberZ-0250-2013

Class II Devices Event

Event ID63380
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Nov-09
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSunquest Information Systems, Inc.
CityTucson
StateAZ
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionSunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
Code Infov3.0.0_07222004 and later
ClassificationClass II
Reason for RecallThe 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 Quantity9 units
Recall NumberZ-0251-2013

Class II Devices Event

Event ID63383
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSorin Group USA, Inc.
CityArvada
StateCO
CountryUS
Distribution PatternWorldwide 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 DescriptionS5 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 InfoSerial 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.
ClassificationClass II
Reason for RecallSorin 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 Quantity35 units
Recall NumberZ-0271-2013
Product DescriptionS5 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 InfoSerial Numbers: 10E51854,10E51856-10E51858, 10E51860, 10E51861, 10E51864, 10E51867, 10E51870, 10E51871, 10E51873, 10E51880-10E51897, 10E51899-10E51913.
ClassificationClass II
Reason for RecallSorin 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 Quantity5 units
Recall NumberZ-0272-2013
Product DescriptionS5 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 InfoSerial Numbers: 50E50766--50E50769, 50E50772-50E50774, 50E50783-50E50784.
ClassificationClass II
Reason for RecallSorin 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 Quantity3 units
Recall NumberZ-0273-2013
Product DescriptionS5 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 InfoSerial Numbers: 50E00680--50E00681, 50E00688, 50E00696-50E00706, 50E00708-50E00718.
ClassificationClass II
Reason for RecallSorin 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 Quantity2 units
Recall NumberZ-0274-2013
Product DescriptionSorin 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 InfoSerial Numbers: 58E00135; 58E00136
ClassificationClass II
Reason for RecallSorin 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 Quantity2 units (no product distributed within the US).
Recall NumberZ-0275-2013

Class II Devices Event

Event ID63396
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmOrthoPediatrics Corp
CityWarsaw
StateIN
CountryUS
Distribution PatternNationwide Distribution including AL, IL, NY, FL, TX, MI, KY, NC, CO, and GA.
 

Associated Products

Product DescriptionTrochar 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 InfoPart number: 01-1500-9014 and Lot #'s 1466707 and 1466710
ClassificationClass II
Reason for RecallA 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 Quantity27
Recall NumberZ-0207-2013

Class II Devices Event

Event ID63412
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Dec-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOrmco/Sybronendo
CityGlendora
StateCA
CountryUS
Distribution PatternWorldwide 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 DescriptionVector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Code InfoPart Numbers 601-0007 and 601-0010, all lots
ClassificationClass II
Reason for RecallThe 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 Quantity4,543
Recall NumberZ-0205-2013

Class II Devices Event

Event ID63430
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Medical Systems (Cleveland), Inc.
CityFitchburg
StateWI
CountryUS
Distribution PatternNationwide distribution: USA including states of: ME, MI, NY, and WI.
 

Associated Products

Product DescriptionPinnacle3 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 InfoSerial # 317, 318, 319, 320,321,342, 343, 344,345, 346, 347
ClassificationClass II
Reason for RecallPhilips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution.
Product Quantity11
Recall NumberZ-0206-2013

Class II Food Event

Event ID63447
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmPennsylvania State University Berkey Creamery
CityPenn St Univ
StatePA
CountryUS
Distribution PatternOn site retail salesroom and internet customers
 

Associated Products

Product DescriptionPenn State Creamery/Berkey Creamery Ice Cream -- Black Raspberry flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Code InfoBest by dates falling on or between February 10, 2013 and August 11, 2013.
ClassificationClass II
Reason for RecallErring 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 NumberF-0639-2013
Product DescriptionPenn State Creamery/Berkey Creamery Ice Cream -- Scholar's Chip flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Code InfoBest by dates falling on or between February 10, 2013 and August 11, 2013.
ClassificationClass II
Reason for RecallErring 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 NumberF-0640-2013
Product DescriptionPenn State Creamery/Berkey Creamery Ice Cream -- Strawberry-No Sugar Added flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Code InfoBest by dates falling on or between February 10, 2013 and August 11, 2013.
ClassificationClass II
Reason for RecallErring 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 NumberF-0641-2013
Product DescriptionPenn State Creamery/Berkey Creamery Ice Cream -- Keeny Beany Chocolate flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Code InfoBest by dates falling on or between February 10, 2013 and August 11, 2013.
ClassificationClass II
Reason for RecallErring 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 NumberF-0642-2013
Product DescriptionPenn State Creamery/Berkey Creamery Ice Cream -- German Chocolate Cake flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Code InfoBest by dates falling on or between February 10, 2013 and August 11, 2013.
ClassificationClass II
Reason for RecallErring 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 NumberF-0643-2013
Product DescriptionPenn State Creamery/Berkey Creamery Ice Cream -- Cookies-N-Cream flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Code InfoBest by dates falling on or between February 10, 2013 and August 11, 2013.
ClassificationClass II
Reason for RecallErring 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 NumberF-0644-2013
Product DescriptionPenn State Creamery/Berkey Creamery Ice Cream -- Chocolate Chip Cookie Dough flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Code InfoBest by dates falling on or between February 10, 2013 and August 11, 2013.
ClassificationClass II
Reason for RecallErring 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 NumberF-0645-2013
Product DescriptionPenn State Creamery/Berkey Creamery Ice Cream -- Chocolate Chocolate Nut flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Code InfoBest by dates falling on or between February 10, 2013 and August 11, 2013.
ClassificationClass II
Reason for RecallErring 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 NumberF-0646-2013
Product DescriptionPenn State Creamery/Berkey Creamery Ice Cream -- Strawberry flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Code InfoBest by dates falling on or between February 10, 2013 and August 11, 2013.
ClassificationClass II
Reason for RecallErring 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 NumberF-0647-2013
Product DescriptionPenn State Creamery/Berkey Creamery Ice Cream -- Strawberry Cheesecake flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Code InfoBest by dates falling on or between February 10, 2013 and August 11, 2013.
ClassificationClass II
Reason for RecallErring 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 NumberF-0648-2013
Product DescriptionPenn State Creamery/Berkey Creamery Frozen Yogurt - Vanilla flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Code InfoBest by dates falling on or between February 10, 2013 and August 11, 2013.
ClassificationClass II
Reason for RecallErring 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 NumberF-0649-2013
Product DescriptionPenn State Creamery/Berkey Creamery Frozen Yogurt - Strawberry flavor; 3 gallon (paper), 1/2 gallon (paper), and pints (plastic)
Code InfoBest by dates falling on or between February 10, 2013 and August 11, 2013.
ClassificationClass II
Reason for RecallErring 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 NumberF-0650-2013

Class II Food Event

Event ID63470
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmTurkey Hill Dairy, Inc.
CityConestoga
StatePA
CountryUS
Distribution PatternProduct was distributed to one retail chain and 3 independent grocers in the State of Pennsylvania.
 

Associated Products

Product DescriptionTurkey Hill Mint Chocolate Chip All Natural Ice Cream, 48 oz, UPC 0-20735-11203-8
Code InfoUPC 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
ClassificationClass II
Reason for RecallThe product contains undeclared coconut.
Product Quantity1200 Packages
Recall NumberF-0595-2013

Class II Devices Event

Event ID63506
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSpacelabs Healthcare, Llc
CityIssaquah
StateWA
CountryUS
Distribution PatternWorldwide 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 DescriptionThe 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 InfoSerial 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.
ClassificationClass II
Reason for RecallPotential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights failed to illuminate upon installation.
Product Quantity169 units distributed (98 in US and 71 Internationally)
Recall NumberZ-0196-2013

Class II Devices Event

Event ID63540
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Medical Systems, Inc.
CityMinnetonka
StateMN
CountryUS
Distribution PatternWorldwide 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 DescriptionAMS 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
ClassificationClass II
Reason for RecallAmerican 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 Quantity4872
Recall NumberZ-0259-2013

Class II Devices Event

Event ID63598
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmKimberly-Clark Corporation
CityRoswell
StateGA
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionULTRA 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 InfoProduct Code 95221 - All lot numbers beginning with: AH9284*** to AH9356***, AH0007*** to AH0356***, AH1008 *** to AH1364***, AH2006*** to AH2146***
ClassificationClass II
Reason for RecallPackage seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
Product Quantity89,856 (28 units per case)
Recall NumberZ-0257-2013
Product DescriptionMicroCool 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 InfoProduct Code 92042 - All lot numbers beginning with: AH9282*** to AH9309***, AH0013*** to AH0329***, AH1020 *** to AH1293***, AH2019*** to AH2175***
ClassificationClass II
Reason for RecallPackage seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
Product Quantity933 ((30 units per case)
Recall NumberZ-0258-2013

Class II Devices Event

Event ID63599
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Dec-10
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAlphatec Spine, Inc.
CityCarlsbad
StateCA
CountryUS
Distribution PatternNationwide Distribution including TN, WI, and FL.
 

Associated Products

Product DescriptionTI 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 InfoLot # 634745
ClassificationClass II
Reason for RecallThe 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 Quantity11 units
Recall NumberZ-0269-2013

Class III Biologics Event

Event ID62824
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jun-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmThe American National Red Cross - Southern Region
CityDouglasville
StateGA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionPlasma Frozen
Code Info03KH50314;
ClassificationClass III
Reason for RecallBlood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-2497-12

Class III Devices Event

Event ID62833
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics, Inc.
CityNewark
StateDE
CountryUS
Distribution PatternUSA (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 DescriptionSiemens 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 InfoLot numbers 12062MA, exp 12/01/2012; and 12066MA, exp 12/05/2012
ClassificationClass III
Reason for RecallCartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge.
Product Quantity583 cartons
Recall NumberZ-0253-2013

Class III Biologics Event

Event ID62902
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW333612081852;
ClassificationClass III
Reason for RecallBlood product, manufactured with an undetermined quantity of additive solution, was distributed.
Product Quantity1 unit
Recall NumberB-2553-12

Class III Biologics Event

Event ID62933
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Assurance Inc
CityChattanooga
StateTN
CountryUS
Distribution PatternTennessee
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW043212055994;
ClassificationClass III
Reason for RecallBlood product, collected using expired cryo blood collection bag was distributed.
Product Quantity1 unit
Recall NumberB-2570-12

Class III Biologics Event

Event ID62953
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmITXM Clinical Services
CityPittsburgh
StatePA
CountryUS
Distribution PatternPennsylvania
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis)
Code InfoW086212003130; W086212003124;
ClassificationClass III
Reason for RecallBlood products, leukoreduced greater than five days after collection, were distributed.
Product Quantity2 units
Recall NumberB-2572-12

Class III Devices Event

Event ID63094
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Aug-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmClinical Diagnostic Solutions
CityPlantation
StateFL
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionBoule 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 InfoProduct part 501-605, Lot #1005-549
ClassificationClass III
Reason for RecallClinical 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 Quantity532 packs
Recall NumberZ-0193-2013
Product DescriptionBoule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Code InfoProduct part 501-607, Lot #1005-549
ClassificationClass III
Reason for RecallClinical 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 Quantity690 packs
Recall NumberZ-0194-2013

Class III Devices Event

Event ID63096
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Mar-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmClinical Diagnostic Solutions
CityPlantation
StateFL
CountryUS
Distribution PatternWorldwide 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 DescriptionBoule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Code InfoProduct Part 501-605, Lot #1102-575 and Lot # 1102-576
ClassificationClass III
Reason for RecallClinical 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 Quantity623 vials
Recall NumberZ-0189-2013
Product DescriptionBoule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Code InfoProduct Part 501-607, Lot #1102-576
ClassificationClass III
Reason for RecallClinical 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 Quantity901 vials
Recall NumberZ-0190-2013
Product DescriptionBoule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Code InfoProduct Part 502-012, Lot #1102-574
ClassificationClass III
Reason for RecallClinical 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 Quantity197 vials
Recall NumberZ-0191-2013

Class III Devices Event

Event ID63309
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAbbott Point Of Care Inc.
CityPrinceton
StateNJ
CountryUS
Distribution PatternWorldwide 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 DescriptionCliniqa 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 InfoCliniqa 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)
ClassificationClass III
Reason for RecallAbbott 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 Quantity154 (06F12-09 (74) boxes; 06F12-10 (35) boxes and 06F12-11 (45) boxes.) 1 box contains six, 3ml plastic bottles.
Recall NumberZ-0192-2013

Class III Drugs Event

Event ID63488
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmValeant Pharmaceuticals
CityBridgewater
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionAcneFree 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 InfoAll lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12008 6
ClassificationClass III
Reason for RecallSubpotent (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 Quantity1,097,846 cartons
Recall NumberD-042-2013
Product DescriptionAcneFree 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 InfoAll lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12900 3
ClassificationClass III
Reason for RecallSubpotent (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 Quantity477,107 cartons
Recall NumberD-043-2013
Product DescriptionAcneFree 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 InfoAll lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12020 8
ClassificationClass III
Reason for RecallSubpotent (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 Quantity145,650 bottles
Recall NumberD-044-2013
Product DescriptionAcneFree 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 InfoAll lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12030 7
ClassificationClass III
Reason for RecallSubpotent (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 Quantity619,029 tubes
Recall NumberD-045-2013
Product DescriptionAcneFree 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 InfoAll lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13551 6
ClassificationClass III
Reason for RecallSubpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.
Product Quantity71,369 jars
Recall NumberD-046-2013
Product DescriptionAcneFree 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 InfoAll lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13548 6
ClassificationClass III
Reason for RecallSubpotent (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 Quantity81,319 canisters
Recall NumberD-047-2013
Product DescriptionAcneFree 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 InfoAll lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13550 9
ClassificationClass III
Reason for RecallSubpotent (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 Quantity10,434 canisters
Recall NumberD-048-2013
Product DescriptionAcneFree 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 InfoAll lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13546 2
ClassificationClass III
Reason for RecallSubpotent (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 Quantity115,785 canisters
Recall NumberD-049-2013

Mixed Classification Biologics Event

Event ID62819
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Mar-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternPennsylvania; Florida; New York
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW036811167601(Part A); W036811167601(Part B)
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-2472-12
Product DescriptionRed Blood Cells
Code InfoW036810147118;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2473-12
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036810810933;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2474-12
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036810147118;
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2475-12
Product DescriptionCryoprecipitated AHF
Code InfoW036810147118;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2476-12

Mixed Classification Biologics Event

Event ID62841
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida; New Zealand
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW036811000752;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2505-12
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036811000752;
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2506-12

Mixed Classification Biologics Event

Event ID62860
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternSwitzerland; Florida
 

Associated Products

Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036809807127;
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2540-12
Product DescriptionCryoprecipitated AHF
Code InfoW036809230283;
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2541-12
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036809230283;
ClassificationClass III
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2542-12

Mixed Classification Biologics Event

Event ID62931
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCarter BloodCare
CityBedford
StateTX
CountryUS
Distribution PatternAustria; Texas
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW035212163746N;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2568-12
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW035212163746N;
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2569-12

Mixed Classification Biologics Event

Event ID62955
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLake Worth
StateFL
CountryUS
Distribution PatternFlorida; New Zealand
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code InfoW036808102669;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2573-12
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036808102669;
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2574-12

Mixed Classification Biologics Event

Event ID62958
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLake Worth
StateFL
CountryUS
Distribution PatternFlorida; New Zealand
 

Associated Products

Product DescriptionRed Blood Cells
Code Info2737405;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2581-12
Product DescriptionCryoprecipitated AHF
Code Info2737405;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2582-12
Product DescriptionBlood and Blood Products for Reprocessing
Code Info2737405;
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2583-12
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