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Enforcement Report - Week of February 6, 2013

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Biologics Devices Drugs Food / Cosmetics Veterinary

Class I Drugs Event

Event ID	63818
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Dec-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
City	Huntsville
State	AL
Country	US
Distribution Pattern	Nationwide and Puerto Rico

Associated Products

Product Description	Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811.
Code Info	Lot #: All that begin with the letter "C" a) C1160712C, Exp 12/13; b) C0930812A, C1110412A, C1141012B, C1160712A, Exp 12/13; c) C0950812B, C1110412B, C1151012B, C1160712B, C1530512A, Exp 12/13; d) C0540212A, C0550212A, C0560212A, C0710312A, C0720312A, C0730112B, C0730312A, C0740112B, C0740312A, C0750112A, C0760112A, C0770112C, C0780112C, C0790112C, C0860812A, C0870812A, C0880812A, C0890812A, C0900812A, C0910812A, C0920812A, C0950412A, C0950812D, C0960412A, C0970412A, C0980412A, C1030412A, C1040412A, C1050412A, C1060412A, C1061012A, C1070412A, C1071012A, C1081012A, C1101012A, C1111012A, C1120412A, C1121012A, C1130412A, C1131012A, C1140412A, C1141012A, C1160712D, C1440512A, C1450512A, C1460512A, C1470512A, C1510512A, C1520512A, C1530512B, C1540512A, C1550512A, C1560512A, C1570512A, Exp 12/13; e) C0670312A, C0680312A, C0930812B, C0950812C, Exp 12/13; f) C1160712E, Exp 12/13; g) C0950812A, C1110412C, Exp 12/13; h) C0630212B, C0640212B, C0690312A, C0700312A, C0720112B,C0940812A, C0941112A, C0960812A, C1010412B, C1020412B, C1080412A, C1090412A, C1100412A, C1170712A, C1180712A, C1480512A, C1490512A, C1500512A, Exp 12/13; i) C0570212B, C0580212B, C0590212B, C0600212A, C0610212A, C0620212A, C0750312A, C0760312A, C0930812C, C0970812A, C0990412A, C1000412A, Exp 12/13
Classification	Class I
Reason for Recall	Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.
Product Quantity	897,379 bottles
Recall Number	D-138-2013

Class I Food/Cosmetics Event

Event ID	63996
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	31-Dec-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Jerusalem Manufacturing Natural Foods & Wholesalers, Inc.
City	Dearborn
State	MI
Country	US
Distribution Pattern	MI Only (Dexter and Clinton Twp)

Associated Products

Product Description	Kinnikinnick Foods Brand Frozen Pie Crusts, 290g/10 ounces. 2 crusts per box, 6 boxes per case
Code Info	Product code 620133006009 and lot BB2013DE13
Classification	Class I
Reason for Recall	Kinnikinnick Foods Inc., a Canadian manufacturer notifed Jerusalem Manufacturing Natural Food and Wholesalers, Inc. in Dearborn, MI to recall the Kinnikinnick Foods Brand Frozen Pies, 290g/10 ounces. 2 crusts per box, 6 boxes per case due to EGG not declared on the label.
Product Quantity	80 cs
Recall Number	F-0948-2013

Class I Food/Cosmetics Event

Event ID	64009
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	02-Jan-13
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Gilster-Mary Lee Corp.
City	Chester
State	IL
Country	US
Distribution Pattern	Distribution made to VA, KY and TN.

Associated Products

Product Description	Food Club Chocolate Chunk Brownie Mix, packaged in 21.5-oz. boxes, UPC# 36800-13486, distributed by TOPCO Associates LLC, Skokie, IL.
Code Info	NOV 28 13 DO2, use by 11/28/2013
Classification	Class I
Reason for Recall	The product contains walnuts and it was packaged in the wrong carton. Due to the mis-packaging the ingredient label does not have walnuts listed.
Product Quantity	25/12/21.5-oz carton cases
Recall Number	F-0942-2013

Class I Food/Cosmetics Event

Event ID	64058
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	31-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Unified Grocers Inc.
City	City Of Commerce
State	CA
Country	US
Distribution Pattern	WA, OR

Associated Products

Product Description	Kinnikinnick Foods Pie Crusts, 10.2 oz, Item code: 21-35265, UPC 6-20133-00600.
Code Info	Lot code: BB2013DE12
Classification	Class I
Reason for Recall	Unified Grocers is recalling Kinnikinnick Pie Crust because it contains undeclared egg allergen.
Product Quantity	5 cases (30 units)
Recall Number	F-0949-2013

Class I Food/Cosmetics Event

Event ID	64059
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Jan-13
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	KeHE/Tree of life Bloomington
City	Bloomington
State	IN
Country	US
Distribution Pattern	MN and PA

Associated Products

Product Description	Kinnikinnick Pie Crust (frozen) Weight: 290 g/10 oz Qty/Pkg: 2 UPC: 62013300600 9
Code Info	BB2013DE13
Classification	Class I
Reason for Recall	Kinnikinnick Foods, Inc in Edmonton, Alberta Canada indicated that KeHE Distributors in Bloomington, IN had received pie crusts in association with their recall/allergy alert issued 12/28-29/2012
Product Quantity	5 cases/6 packages per case
Recall Number	F-0943-2013

Class I Food/Cosmetics Event

Event ID	64080
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-Jan-13
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Jiffy Food Service, LLC
City	Chelsea
State	MI
Country	US
Distribution Pattern	Nationwide including Arizona, California, Colorado, Connecicut, Florida, Georgia, Idaho, Illinois, Kentucky, Louisiana, Michigan, Missouri, Montana, New England, New Jersey, New Mexico, Nevada, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virgina and Wisconsin.

Associated Products

Product Description	Spice Cake Mix , 25 lb. and 50 lb. kraft bags, labelled a) CMC Quality and Value, Spice Cake Mix, 46702-00985, NET Wt. 25 lbs. (11.34 kg) JIFFY Foodservice, LLC, Chelsea, Michigan 48188; b) CMC Quality and Value, Spice Cake Mix, 46702-00920, NET Wt. 50 lbs. (22.68 kg.), JIFFY Foodservice, LLC, Chelsea, Michigan 48188.
Code Info	UPC Code 84670200985 Manufacturing Date Codes (printed on the inside seam/gusset of the bag): 08/01/2012, 08/23/2012, 10/03/2012, 11/18/2012, 11/19/2012.
Classification	Class I
Reason for Recall	Undeclared Allergen (Milk). Firm initiated a voluntary recall of their 25 lb. and 50 lb. bags of Spice Cake Mix that had been distributed since August 2012 due to an undeclared allergen, milk. The Spice Cake Mix is manufactured for correctional facilities/institutions only.
Product Quantity	7,422 bags (total 25 lb. and 50 lb. combined)
Recall Number	F-0941-2013

Class I Food/Cosmetics Event

Event ID	64086
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Jan-13
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Island Delights, Inc.
City	Seville
State	OH
Country	US
Distribution Pattern	Product was shipped to the following states: AZ, CA, FL, MA, MN, MS, NC, NY, OH, SC, TX, VA, WA & WY.

Associated Products

Product Description	Island Delights Coconut Haystack Candy Maple Natural Flavor Coconut Haystacks, NET WEIGHT 2 OZ, 4 oz and 8 oz clear plastic bags. Bags labeled in part "INGREDIENTS: SUGAR, COCONUT*NATURAL MAPLE FLAVOR*Island Delights, Inc. Seville, OH 44273"
Code Info	2 oz, Lot #13410400.02, UPC Code 0 19694 19020 1 4 oz, Lot #13410400.04, UPC Code 0 19694 19040 9 8 oz, Lot #13410400.08, UPC Code 0 19694 19080 5 2 lb, Lot #13410402.00, no bar code
Classification	Class I
Reason for Recall	During a visual inspection from Ohio Dept of Agriculture the firm was notified that they did not list milk in their ingredient statement.
Product Quantity	45/2 oz bags, 207/4 oz bags, 50/8 oz bags & 13/2 lb bags = 315 BAGS
Recall Number	F-0944-2013

Product Description	Island Delights Almond Chocolate/Almond Mix Natural Flavor Coconut Haystacks, NET WEIGHT 2 oz, 4 oz, 8 oz and 2 lb clear plastic bags. Bags labeled in part "INGREDIENTS: SUGAR, COCONUT*COCOANATURAL ALMOND FLAVOR**Island Delights, Inc., Seville, OH 44273"
Code Info	2 oz, Lot #13413100.02, UPC Code 0 19694 71020 1 4 oz, Lot #13413100.04, UPC Code 0 19694 71040 9 8 oz, Lot #13413100.08, UPC Code 0 19694 71080 5 2 lb, Lot #13413100.00, no bar code
Classification	Class I
Reason for Recall	During a visual inspection from Ohio Dept of Agriculture the firm was notified that they did not list milk in their ingredient statement.
Product Quantity	12/2 oz bags, 26/4 oz bags, 13/8 oz bags & 2/2 lb bags
Recall Number	F-0945-2013

Product Description	Island Delights COFFEE NATURAL Natural Flavor Coconut Haystacks, NET WEIGHT 2 oz, 4 oz, 8 oz and 2 lb clear plastic bags. Bags labeled in part "INGREDIENTS: SUGAR, COCONUT*COCOANATURAL COFFEE FLAVOR**Island Delights, Inc. Seville, OH 44273"
Code Info	2 oz, Lot #13411300.02, UPC Code 0 19694 60020 5 4 oz, Lot #13411300.04, UPC Code 0 19694 60040 3 8 oz, Lot #13411300.08, UPC Code 0 19694 60080 9
Classification	Class I
Reason for Recall	During a visual inspection from Ohio Dept of Agriculture the firm was notified that they did not list milk in their ingredient statement.
Product Quantity	24/4 oz bags & 38/8 oz bags = 62 bags
Recall Number	F-0946-2013

Product Description	Island Delights ALMOND Natural Flavor Coconut Haystacks, NET WEIGHT 2 oz, 4 oz, 8 oz and 2 lb clear plastic bags. Bags labeled in part "INGREDIENTS: SUGAR, COCONUT*COCOANATURAL COFFEE FLAVOR**Island Delights, Inc., Seville, OH 44273"
Code Info	2 oz, Lot #13413000.02, UPC Code 0 19694 70020 2 4 oz, Lot #13413000.04, UPC Code 0 19694 70040 0 8 oz, Lot #13413000.08, UPC Code 0 19694 70080 6 2 lb, Lot #13413002.00, no bar code
Classification	Class I
Reason for Recall	During a visual inspection from Ohio Dept of Agriculture the firm was notified that they did not list milk in their ingredient statement.
Product Quantity	1/2 oz bag, 4/4oz bags, 5/8 oz bags = 10 bags
Recall Number	F-0947-2013

Class I Devices Event

Event ID	64117
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-Jan-13
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Hamilton Medical Inc
City	Reno
State	NV
Country	US
Distribution Pattern	US Nationwide Distribution including the country of Switzerland.

Associated Products

Product Description	HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics
Code Info	Software Versions 1.1.2 and below; Part numbers 161005, 161006.
Classification	Class I
Reason for Recall	Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a Hamilton T1 ventilator with software versions 1.1.2 and lower must be calculated using a larger margin than originally expected.
Product Quantity	97 total ventilators; 69 of part number 161005 and 28 of part number 161006
Recall Number	Z-0741-2013

Class I Food/Cosmetics Event

Event ID	64138
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Jan-13
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Knotts Wholesale Foods Inc
City	Paris
State	TN
Country	US
Distribution Pattern	TN, KY

Associated Products

Product Description	Knott's FINE FOODS, CHICKEN SALAD (sandwich), KNOTT's WHOLESALE FOODS, INC. 125 North Blakemore, Paris, TENNESSEE 38242, (731) 642-1961 www.knotsfoods.com, UPC 011984011326
Code Info	all date codes up to and including 01/29
Classification	Class I
Reason for Recall	Sample collected by State of Tennessee Department of Agriculture was found to contain Listeria Monocytogenes
Product Quantity	461 units
Recall Number	F-0961-2013

Class I Food/Cosmetics Event

Event ID	64153
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-Jan-13
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Belmont Confections Inc
City	Youngstown
State	OH
Country	US
Distribution Pattern	Product was shipped to the following state: Texas

Associated Products

Product Description	DYMATIZE NUTRITION ELITE Gourmet Cookies & Cream 6-LAYER HI-PROTEIN BAR Label reads in part "NET WT*INGREDIENTS: Elite Protein Blend*Distributed by: Dymatize Enterprises, Inc. 13737 N. Stemmons FWY, Dallas, TX 75234, (888) 334-LEAN or (972) 732-1990.
Code Info	Dymatize Nutrition Elite Gourmet Cookies & Cream 1.5oz (42.5g), UPC Code, 705016993147, Lot # 12200A, Best By Date SEP 2013, Lot # 12249A, Best By Date NOV 2013, Lot # 12310A, Best By Date JAN 2014 & Lot # 12353A, Best By Date FEB 2014. Dymatize Nutrition Elite Gourmet Cookies & Cream 3oz (85g), UPC Code, 705016993000, Lot #, 12072A, Best By Date MAY 2013, Lot # 12200A, Best By Date SEP 2013, Lot # 12310A, Best By Date JAN 2014 & Lot # 12353A, Best By Date FEB 2014.
Classification	Class I
Reason for Recall	Belmont was notified by their customer, Dymatize, that a consumer complained on an allergic reaction after eating the product. The consumer is allergic to peanuts & peanut protein.
Product Quantity	195,552/3 oz bars & 73,296/1.5 oz bars
Recall Number	F-0963-2013

Product Description	DYMATIZE NUTRITION ELITE Gourmet Fudge Brownie 6-LAYER HI-PROTEIN BAR Label reads in part "NET WT*INGREDIENTS: Elite Protein Blend*Distributed by: Dymatize Enterprises, Inc. 13737 N. Stemmons FWY, Dallas, TX 75234, (888) 334-LEAN or (972) 732-1990.
Code Info	Dymatize Nutrition Elite Gourmet Fudge Brownie 1.5oz (42.5g), UPC Code, 705016993130, Lot #, 12199A, Best By Date SEP 2013, Lot # 12244A, Best By Date OCT 2013, Lot # 12311B, Best By Date JAN 2014 & Lot # 12352B, Best By Date FEB 2014. Dymatize Nutrition Elite Gourmet Fudge Brownie 3oz (85g), UPC Code, 705016993079, Lot #, 12084A, Best By Date MAY 2013, Lot # 12199A, Best By Date SEP 2013, Lot # 12205A, Best By Date SEP 2013, Lot # 12311B, Best By Date JAN 2014 & Lot # 12352B, Best By Date FEB 2014.
Classification	Class I
Reason for Recall	Belmont was notified by their customer, Dymatize, that a consumer complained on an allergic reaction after eating the product. The consumer is allergic to peanuts & peanut protein.
Product Quantity	152,280/3 oz bars & 67,536/1,5 oz bars
Recall Number	F-0964-2013

Class I Food/Cosmetics Event

Event ID	64184
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Jan-13
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	United Natural Foods, Inc. - Greenwood
City	Greenwood
State	IN
Country	US
Distribution Pattern	Customers are retail locations in 6 states: Illinois, Indiana, Kentucky, Michigan, Missouri, and Ohio.

Associated Products

Product Description	Kinnikinnick Pie Crust (frozen), Weight: 290 g/10 oz, Qty/Pkg: 2, Product packaged in a cardboard box with printed label. UPC: 62013300600 9
Code Info	Expiration date 2013-12-11
Classification	Class I
Reason for Recall	Kinnikinnick Foods, Inc. in Edmonton, Alberta Canada indicated that United Natural Foods Inc. distributors received pie crusts in association with their expanded recall/allergy alert issued 01/17/13.
Product Quantity	28 cases/6 packages per case
Recall Number	F-0960-2013

Class II Biologics Event

Event ID	39108
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Jun-07
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced Irradiated
Code Info	KN07457
Classification	Class II
Reason for Recall	Blood product, collected from a donor who disclosed taking a daily dose of Aspirin , was distributed.
Product Quantity	1 Unit
Recall Number	B-0486-13

Class II Biologics Event

Event ID	39986
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Apr-05
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Red Blood Cells
Code Info	T23108
Classification	Class II
Reason for Recall	Blood product, manufactured from an overweight whole blood unit, was distributed.
Product Quantity	1 Unit
Recall Number	B-0495-13

Class II Biologics Event

Event ID	40385
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Jul-05
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Fresh Frozen Plasma
Code Info	Y42952
Classification	Class II
Reason for Recall	Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Product Quantity	1 Unit
Recall Number	B-0496-13

Class II Biologics Event

Event ID	41456
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Jan-06
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	C74031
Classification	Class II
Reason for Recall	Blood product, which tested as CMV positive but labeled as CMV negative, was distributed.
Product Quantity	1 Unit
Recall Number	B-0492-13

Class II Biologics Event

Event ID	41903
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Apr-06
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Puget Sound Blood Center and Program
City	Seattle
State	WA
Country	US
Distribution Pattern	Washington.

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	G177400
Classification	Class II
Reason for Recall	Blood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed.
Product Quantity	1 component
Recall Number	B-0441-13

Class II Biologics Event

Event ID	44134
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Dec-06
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	University of Texas Medical Branch at Galveston (The)
City	Galveston
State	TX
Country	US
Distribution Pattern	TX

Associated Products

Product Description	Red Blood Cells (Apheresis)
Code Info	4045540
Classification	Class II
Reason for Recall	Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed. .
Product Quantity	1 unit
Recall Number	B-0437-13

Class II Biologics Event

Event ID	45117
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Aug-07
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	American National Red Cross (The)
City	Saint Louis
State	MO
Country	US
Distribution Pattern	MO

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	011LT11137, 011LT11139 (2 units), 011LT11140, 011LT11141 (2 units), 011LT11142, 011LT11143 (2 units), 011LT11145, 011LT11146 (2 units), 011LT11148
Classification	Class II
Reason for Recall	Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
Product Quantity	13 units
Recall Number	B-0251-13

Class II Biologics Event

Event ID	47139
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Jan-08
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W045007912369A; W045007912369B
Classification	Class II
Reason for Recall	Blood products, with positive bacterial detection testing, were distributed.
Product Quantity	2 Units
Recall Number	B-0440-13

Class II Biologics Event

Event ID	47621
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Mar-08
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	American Red Cross Blood Services
City	Saint Louis
State	MO
Country	US
Distribution Pattern	MO

Associated Products

Product Description	Plasma Frozen
Code Info	011FL56125
Classification	Class II
Reason for Recall	Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity	1 unit
Recall Number	B-0250-13

Class II Biologics Event

Event ID	47985
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Mar-08
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Red Blood Cells (Apheresis) Leukocytes Reduced
Code Info	W045006108058;W045006108058
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity	2 Units
Recall Number	B-0430-13

Product Description	Red Blood Cells Leukocytes Reduced Irradiated
Code Info	W045007010581
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity	1 Unit
Recall Number	B-0431-13

Product Description	Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated
Code Info	W045007001094;W045007001094
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity	2 Units
Recall Number	B-0432-13

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W045007142019
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity	1 Unit
Recall Number	B-0433-13

Product Description	Fresh Frozen Plasma
Code Info	W045007010581
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity	1 Unit
Recall Number	B-0434-13

Class II Biologics Event

Event ID	48835
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Jun-08
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Blood Systems, Inc.
City	El Paso
State	TX
Country	US
Distribution Pattern	TX

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced Irradiated
Code Info	W04110800723900 (2 units)
Classification	Class II
Reason for Recall	Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
Product Quantity	2 units
Recall Number	B-0252-13

Class II Biologics Event

Event ID	49703
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	23-Jul-08
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Puget Sound Blood Center and Program
City	Seattle
State	WA
Country	US
Distribution Pattern	California.

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W141608213448
Classification	Class II
Reason for Recall	Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity	1 component
Recall Number	B-0487-13

Class II Biologics Event

Event ID	49719
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Aug-08
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Puget Sound Blood Center and Program
City	Seattle
State	WA
Country	US
Distribution Pattern	Washington.

Associated Products

Product Description	Red Blood Cells
Code Info	W141608630171.
Classification	Class II
Reason for Recall	Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity	1 component
Recall Number	B-0490-13

Class II Biologics Event

Event ID	49996
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Aug-08
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	DCI Biologicals Bryan LLC
City	Bryan
State	TX
Country	US
Distribution Pattern	UK

Associated Products

Product Description	Source Plasma
Code Info	BY0261044, BY0261311, BY0261769, BY0261701
Classification	Class II
Reason for Recall	Blood products, which were not quarantined after receiving post donation information regarding an undocumented piercing, were distributed.
Product Quantity	4 units
Recall Number	B-0327-13

Class II Biologics Event

Event ID	50295
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Sep-08
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W045008003256, W045008057390
Classification	Class II
Reason for Recall	Blood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed.
Product Quantity	2 units
Recall Number	B-0331-13

Product Description	Fresh Frozen Plasma
Code Info	W045008003256
Classification	Class II
Reason for Recall	Blood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed.
Product Quantity	1 unit
Recall Number	B-0332-13

Product Description	Recovered Plasma
Code Info	W045008057390
Classification	Class II
Reason for Recall	Blood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed.
Product Quantity	1 unit
Recall Number	B-0333-13

Class II Biologics Event

Event ID	52279
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Mar-09
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Talecris Plasma Resources, Inc.
City	Research Triangle Park
State	NC
Country	US
Distribution Pattern	NC

Associated Products

Product Description	Source Plasma
Code Info	3330029477, 3330027679, 3330027202, 3330025120, 3330024506, 3330024164, 3330023581, 3330023226, 3330022681, 3330022333, 3330021059, 3330020730, 3330020209, 3330019963, 3330019508, 3330019196, 3330018730, 3330018444, 3330018035, 3330017783, 3330030309, 3330018282, 3330018712, 3330019199, 3330025765, 3330026011, 3330024976, 3330024363, 3330024052, 3330023419, 3330023101, 3330022517, 3330022195, 3330021609, 3330021307, 3330020758, 3330020486, 3330019998, 3330019726, 3330019222, 3330018765, 3330018494, 3330018062, 3330017810, 3330026718, 3330026182, 3330024953, 3330023960, 3330023396, 3330022135, 3330021580, 3330021215, 3330020676, 3330020241, 3330019793, 3330018720, 3330018265, 3330018374, 3330018793, 3330019188, 3330017772, 3330018034, 3330019059, 3330019369, 3330019837, 3330020033, 3330020587, 3330020917, 3330021424, 3330021787, 3330022332, 3330022513, 3330023224, 3330024160, 3330024499, 3330025116, 3330025523, 3330026164, 3330026563, 3330028333, 3330028819, 3330029476, 3330029945, 3330030611, 3330031014, 3330027096, 3330027533, 3330028409, 3330029375, 3330026417, 3330026023, 3330025354, 3330023120, 3330022530, 3330022215, 3330021616, 3330020481, 3330020323, 3330019728, 3330019417, 3330018956, 3330018260, 3330017828, 3330027099, 3330027829, 3330029433, 3330018381, 3330021722, 3330023176, 3330018778, 3330019135, 3330022272, 3330022619, 3330023495, 3330024089, 3330025041, 3330025479, 3330028782, 3330018441, 3330018863, 3330019904, 3330020850, 3330021260, 3330023485, 3330023882, 3330027594, 3330028065, 3330028691, 3330017850, 3330021000, 3330022117, 3330022238, 3330023010, 3330023163, 3330029378, 3330017844, 3330018092, 3330019868, 3330020167, 3330023142, 3330023459, 3330027176, 3330030150, 3330017963, 3330018244, 3330018795, 3330018946, 3330018414, 3330018970, 3330019469, 3330019720, 3330020258, 3330020551, 3330021338, 3330021896, 3330022285, 3330027030, 3330027659, 3330030365, 3330030962, 3330027788, 3330029972, 3330027293, 3330029049, 3330018504, 3330018775, 3330022766, 3330029401, 3330018790, 3330018404, 3330017858, 3330018129, 3330026309, 3330028363, 3330028238, 3330026648, 3330027376
Classification	Class II
Reason for Recall	Blood products, collected from donors who did not have a complete physical examination, were distributed.
Product Quantity	177 units
Recall Number	B-0300-13

Class II Biologics Event

Event ID	53065
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Jul-09
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Biomat USA, Inc.
City	Logan
State	UT
Country	US
Distribution Pattern	Austria

Associated Products

Product Description	Source Plasma
Code Info	0660055061, 0660054502, 0660054240, 0660049416, 0660048942, 0660048564, 0660047987, 0660047710, 0660047085, 0660046742, 0660046235, 0660045960, 0660045588, 0660045338, 0660044759, 0660044393, 0660043882, 0660043549, 0660041282, 0660040566, 0660040325, 0660039692, 0660039074, 0660038222, 0660037800, 0660037736, 0660037193, 0660036536, 0660036319, 0660035739, 0660035564, 0660035055, 0660034745, 0660034036, 0660033826, 0660033293, 0660032698, 0660032218, 0660031927, 0660031452, 0660031150
Classification	Class II
Reason for Recall	Blood products, collected from a donor with a history of incarceration, were distributed.
Product Quantity	41 units
Recall Number	B-0339-13

Class II Biologics Event

Event ID	54960
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Feb-10
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	CSL Plasma, Inc.
City	Oklahoma City
State	OK
Country	US
Distribution Pattern	IL, Germany, Switzerland

Associated Products

Product Description	Source Plasma
Code Info	4220524051, 4220494958, 4220494293, 4220491853, 4220489422, 4220487129, 4220486475, 4220484309, 4220483659, 4220481231, 4220480399, 4220478728, 4220477840, 4220475733, 4220474704, 4220472654, 4220471314, 4220444494, 4220443659, 4220441380, 4220438250, 4220435898, 4220434960, 4220432970, 4220432061, 4220430182, 4220429369, 4220427170, 4220424871, 4220424060, 4220422093, 4220421302, 4220419533, 4220418804, 4220417064, 4220416438, 4220414286, 4220412438, 4220411684, 4220409165, 4220408380, 4220406850, 4220361334, 4220360279, 22BJSXJX, 22BJSWSB, 22BJSTQH, 22BJSTDM, 22BJPWZT, 22BJRVCR, 22GBTRMZ, 22GBTRDV, 22GBTQGW, 22GBTPXV, 22GBTHMR, 22GBQYBT, 22GBQXQJ, 22GBQWVZ, 22GBQWKK, 22GBQTHM, 22GBQSVT, 22GBRFGD, 22GBRDVY, 22GBRCTD, 22GBRBZX, 22GBKVGJ, 22GBKTPV, 22GBKRPK, 22GBKQJH, 22GBKPJB, 22GBKLYT, 22GBKKZZ, 22GBKKKT, 22GBKJNX, 22GBKGXH, 22GBKFTG, 22GBKFGB, 22GBKCSG, 22GBJYQW, 22GBJXZM, 22GBBNVK, 22GBBMZC, 22GBBFQK, 22GBBKLJ, 22GBBHNR, 22GBBDZC, 22GBBBKB, 22BJWWZT, 22BJVZWT, 22BJVWJY, 22BJVVVQ, 22BJVVFN, 22BJVTQK, 22BJTSKT, 22BJTRXW, 22BJTRJX, 22BJTPKW, 22BJTPCW, 22BJSPSF, 22BJSNRD, 22BJQLPC, 22BJQHZX, 22BJQHHQ, 22BJQFSR, 22BJQFBG, 22BJQDDC, 22BJQCNX, 22BJQBPG, 22HJQYDG, 22HJQWZH
Classification	Class II
Reason for Recall	Blood products, collected from donors who were previously deferred for high risk behavior, were distributed.
Product Quantity	110 units
Recall Number	B-0284-13

Class II Biologics Event

Event ID	57284
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Oct-10
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Source Plasma
Code Info	0750007513 ;0750007843 ;0750008087 ;0750008301 ; 0750008547 ;0750000881 ; 0750009025 ;0750009484 ; 0750009742 ;0750010030 ;0750010314 ;0750010775 ; 0750011032 ;0750011312 ;0750011547 ;0750011877 ; 0750012029 ;0750012316 ;0750012601 ;0750012935 ; 0750013195 ;0750013556 ;0750013768 ;0750014035 ; 0750014273 ;0750014558 ;0750014804 ;0750015046 ; 0750021576 ;0750021705 ;0750022226 ;0750022421 ; 0750022825 ;0750023063 ;0750023388 ;0750023759 ; 0750024210 ;0750024500 ;0750024981 ;0750025221 ; 0750025577 ;0750026013 ;0750026548 ; 0750027012 ;0750027282 ;0750028041 ;0750028455 ; 0750028661 ;0750029157 ;0750029509 ;0750029982 ; 0750030304 ;0750030650 ;0750031601 ;0750032227 0750000010; 0750000072 ; 0750000121 ; 0750000232 ; 0750000319 ;0750000474;0750000547 ;0750000727 ; 0750000887 ;0750001012 ;0750001234 ;0750001493 ; 0750001693 ;0750001795 ;0750002091 ;0750002225 ; 0750002468 ;07500024601 ;0750002906 ;0750003104 ; 0750003318 ;0750003540 ;0750003839 ;0750004019 ; 0750004298 ;0750004489 ;0750004788 ;0750005077 ; 0750005322 ;0750005627 ;0750005850 ;0750006181 ; 0750006407; 075 0006736 ;0750007002 ;0750007335
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was previously deferred, were distributed.
Product Quantity	91
Recall Number	B-0497-13

Class II Biologics Event

Event ID	58605
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Apr-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Coffee Memorial Blood Center, Inc.
City	Amarillo
State	TX
Country	US
Distribution Pattern	TX

Associated Products

Product Description	Platelets Leukocytes Reduced
Code Info	W067311002332A; W067311002638A; W067311002346A; W067311002603; W067311002663; W067311002665; W067311002723; W067311002327; W067311002326; W067311002329; W067311002722A; 067311002722B; W067311002545; W067311002332B;W067311002638A; W0673110026142A; W0673110026142B
Classification	Class II
Reason for Recall	Blood products, for which the sterility may have been compromised, were distributed.
Product Quantity	17 components
Recall Number	B-0415-13

Product Description	Platelets Pheresis Leukocytes Reduced Irradiated
Code Info	W067311002604; W067311002662; W067310026142A; W067310026142B; W067311002329; W067311002722; W067311002338
Classification	Class II
Reason for Recall	Blood products, for which the sterility may have been compromised, were distributed.
Product Quantity	7 components
Recall Number	B-0416-13

Class II Devices Event

Event ID	60906
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Nov-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Abbott Vascular
City	Temecula
State	CA
Country	US
Distribution Pattern	Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, China, Germany, Spain, France, United Kingdom, Italy, Pakistan, Poland, Russia, Slovakia, Taiwan, and South Africa.

Associated Products

Product Description	Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.
Code Info	Lot Number: 1081061, 1082561, 1091361, 1080561, 1081761, 1090261, 1091561, 1100461, 1080361, 1081661, 1090161, 1090861, 1092361, 1080861, 1082661, 1100761, 1081761, 1092861, 1082461, 1081161, 1082261, 1083061, 1081961, 1093061.
Classification	Class II
Reason for Recall	The recall was initiated because Abbot Vascular has discovered that the identified lots of the RX Accunet Embolic Protection System may exhibit difficult removal of the peel away sheath due to higher than normal wall thickness.
Product Quantity	1253 units (962 units in the US & Puerto Rico)
Recall Number	Z-0757-2013

Class II Devices Event

Event ID	61611
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	GE Healthcare, LLC
City	Waukesha
State	WI
Country	US
Distribution Pattern	Worldwide Distribution - USA including AL, CT, FL, IL, MA, MO, NJ, NY, PA, TX VA, WA, WI and Internationally to TURKEY, TAIWAN, SWITZERLAND, SWEDEN, SOUTH AFRICA, NIGERIA, MALAYSIA, KOREA, JAPAN, INDIA, GERMANY, FRANCE, EGYPT, DENMARK, CHINA, CHILE, CANDA, BRAZIL, AUSTRIA, and GREAT BRITAIN.

Associated Products

Product Description	AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.
Code Info	Mfg Lot or Serial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
Classification	Class II
Reason for Recall	It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated. A second issue was discovered internally in which the Interpolation in Advantage Sim MD 7.5 would not give a correct result when some part wee removed from an existing structure. If the contour truncation is not recognized, it may lead to inappropriate irradiation of the patient.
Product Quantity	65
Recall Number	Z-0754-2013

Class II Devices Event

Event ID	61870
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Apr-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Motorola Inc
City	Holtsville
State	NY
Country	US
Distribution Pattern	Nationwide distribution

Associated Products

Product Description	Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products
Code Info	Motorola Solutions PCS3000/CS3070 Laser
Classification	Class II
Reason for Recall	It was discovered the CS3000/CS3070 was manufactured using the laser power settings for a Class 2 laser device instead of the Class 1 power levels as specified on the product label.
Product Quantity	16,961 units domestically
Recall Number	Z-0516-2013

Class II Devices Event

Event ID	61879
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Apr-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Varian Medical Systems, Inc.
City	Charlottesville
State	VA
Country	US
Distribution Pattern	US Nationwide Distribution

Associated Products

Product Description	Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
Code Info	All lots
Classification	Class II
Reason for Recall	A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
Product Quantity	344 pieces
Recall Number	Z-0759-2013

Product Description	Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
Code Info	All lots
Classification	Class II
Reason for Recall	A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
Product Quantity	152 units
Recall Number	Z-0760-2013

Class II Devices Event

Event ID	63485
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	MOOG Medical Devices Group
City	Salt Lake City
State	UT
Country	US
Distribution Pattern	Worldwide Distribution and US Nationwide in the countries of (Germany, Sweeden, Croatia, Lithuania, and Dubai).

Associated Products

Product Description	Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications.
Code Info	003, 509350004, 509350005, 509350006, 509350007, 509350008, 509350009, 509350010, 509350011, 509350012, 509350013, 509350014, 509350015, 509350016, 509350017, 509350018, 509350019, 509350020, 509350021, 509350022, 509350023, 509350024, 509350025, 509350026, 509350027, 509350028, 509350029, 509350030, 509350031, 509350032, 509350033, 509350034, 509350035, 509350036, 509350037, 509350038, 509350039, 509350040, 509350041, 509350042, 509350043, 509350044, 509350045, 509350046, 509350047, 509350048, 509350049, 509350050, 509350051, 509350052, 509350053, 509350054, 509350055, 509350056, 509350057, 509350058, 509350059, 509350060, 509350061, 509350062, 509350063, 509350064, 509350065, 509350066, 509350067, 509350068, 509350069, 509350070, 509350071, 509350072, 509350073, 509350074, 509350075, 509350076, 509350077, 509350078, 509350079, 509350080, 509350081, 509350082, 509350083, 509350084, 509350085, 509350086, 509350087, 509350088, 509350089, 509350090, 509350091, 509350092, 509350093, 509350094, 509350095, 509350096, 509350097, 509350098, 509350099, 509350100, 509350101, 509350102, 509350103, 509350104, 509350105, 509345014, 509345015, 509345016, 509345017, 509345018, 509345019, 509345020, 509345021, 509345005, 509345006, 509345007, 509345008, 509345009, 509351011, 509351012, 509351013, 509351014, 509351015, 509351016, 509351017, 509351018, 509351019, 509351020, 509351021, 509351022, 509351023, 509351024, 509351025, 509351026, 509351027, 509351028, 509351029, 509351030, 509351031, 509351032, 509351033, 509351034, 509351035, 509351038, 509351037, 509351003, 509351004, 509351005, 509351006, 509351007, 509351008, 509351009, 509351010, 509351036, 509351039, 509351040, 509351041, 509351042, 509351043, 509351049, 509351050, 509351051, 509351052, 509351053, 509351054, 509351055, 509351056, 509351057, 509351058, 509351059, 509351060, 509351061, 509351062, 509351063, 509351064, 509351065, 509351066, 509351067, 509351068, 509351069, 509351070, 509351071, 509351072, 509351073, 509351048, 509351047, 509351046, 509351045, 509351044, 509351103, 509351102, 509351101, 509351100, 509351099, 509351098, 509351097, 509351096, 509351095, 509351094, 509351093, 509351092, 509351091, 509351090, 509351089, 509351088, 509351087, 509351086, 509351085, 509351084, 509351083, 509351082, 509351081, 509351080, 509351079, 509351078, 509351077, 509351076, 509351075, 509351074, 509351112, 509351127, 509351128, 509351129, 509351130, 509351131, 509351132, 509351113, 509351114, 509351115, 509351116, 509351117, 509351118, 509351119, 509351120, 509351121, 509351122, 509351123, 509351124, 509351125, 509351126, 509351133, 509351134, 509351135, 509351136, 509351137, 509351138, 509351106, 509351105, 509351107, 509351108, 509351109, 509351111, 509351110, 509351104, 509357071, 509357070, 509357069, 509357068, 509357067, 509357077, 509357076, 509357075, 509357074, 509357073, 509357072, 509357066, 509357065, 509357064, 509357063, 509357062, 509351154, 509357030, 509351156, 509351157, 509357031, 509351158, 509357055, 509351159, 509351160, 509351153, 509357034, 509357033, 509351152, 509351151, 509357056, 509351150, 509351149, 509351161, 509357035, 509357036, 509351148, 509357032, 509351146, 509351145, 509351144, 509351143, 509357037, 509357038, 509357039, 509351162, 509351163, 509351164, 509357040, 509351142, 509351141, 509351140, 509351139, 509351165, 509357041, 509351166, 509351167, 509357042, 509357043, 509357044, 509357045, 509357046, 509357047, 509351168, 509351155, 509357049, 509351170, 509357050, 509357051, 509357052, 509357053, 509351171, 509351172, 509357001, 509357002, 509357003, 509357004, 509357005, 509357006, 509357007, 509357008, 509357009, 509357010, 509357057, 509357011, 509357012, 509357013, 509357054, 509357014, 509357061, 509357015, 509357016, 509357017, 509357018, 509357019, 509357020, 509357021, 509357022, 509357058, 509357023, 509357024, 509357025, 509357026, 509357027, 509357028, 509357029, 509357059, 509357060, 509351169, 509357048, 509351147, 509357078, 50
Classification	Class II
Reason for Recall	The firm is adding an addendum to the operator's manual for Infinity Enteralite Ambulatory Feeding Pumps pertaining to the Infinite Dose mode and the inability of the Pump to detect air in line.
Product Quantity	92,488 units
Recall Number	Z-0764-2013

Class II Biologics Event

Event ID	63593
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Sep-12
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W036812426425;
Classification	Class II
Reason for Recall	Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-0413-13

Class II Biologics Event

Event ID	63595
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Puget Sound Blood Center and Program
City	Seattle
State	WA
Country	US
Distribution Pattern	Washington

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced Irradiated
Code Info	W141610155472;
Classification	Class II
Reason for Recall	Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	1
Recall Number	B-0427-13

Product Description	Fresh Frozen Plasma
Code Info	W141610154831;
Classification	Class II
Reason for Recall	Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	1
Recall Number	B-0428-13

Product Description	Red Blood Cells
Code Info	W141610157832; W141610157430;
Classification	Class II
Reason for Recall	Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-0429-13

Class II Biologics Event

Event ID	63625
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Sep-12
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Red Blood Cells (Apheresis) Leukocytes Reduced
Code Info	W038112114651A; W038112114651B;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Product Quantity	2
Recall Number	B-0414-13

Class II Biologics Event

Event ID	63627
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Puget Sound Blood Center and Program
City	Seattle
State	WA
Country	US
Distribution Pattern	California; Washington

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W141610018913; W141610048862;
Classification	Class II
Reason for Recall	Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-0420-13

Product Description	Red Blood Cells Leukocytes Reduced Irradiated
Code Info	W141611017625;
Classification	Class II
Reason for Recall	Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	1
Recall Number	B-0421-13

Class II Biologics Event

Event ID	63636
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Oct-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	LifeServe Blood Center
City	Des Moines
State	IA
Country	US
Distribution Pattern	Iowa

Associated Products

Product Description	Platelets Pooled Leukocytes Reduced
Code Info	W044112124744;
Classification	Class II
Reason for Recall	Blood product, which tested negative for viral markers, but was collected from a donor that subsequently reported a previous history of positive test hepatitis, was distributed.
Product Quantity	1
Recall Number	B-0422-13

Class II Biologics Event

Event ID	63637
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Sep-12
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W036812538893;
Classification	Class II
Reason for Recall	Blood product, which did not meet acceptable product specifications, was distributed.
Product Quantity	1
Recall Number	B-0423-13

Class II Biologics Event

Event ID	63638
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Oct-12
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W036212518486;
Classification	Class II
Reason for Recall	Blood product, which was collected from a donor who had lived in a malarial endemic area, was distributed.
Product Quantity	1
Recall Number	B-0424-13

Class II Biologics Event

Event ID	63639
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Sep-12
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Platelets
Code Info	W333612094877;
Classification	Class II
Reason for Recall	Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-0425-13

Class II Devices Event

Event ID	63800
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Mindray DS USA, Inc. d.b.a. Mindray North America
City	Mahwah
State	NJ
Country	US
Distribution Pattern	US Nationwide Distribution including the states of: VA, TN, FL, & TX

Associated Products

Product Description	Mindray, DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.
Code Info	p/n 9201F-PA000XX DS- 0C000565 02000335 12000603 12000599 12000597 0C000569 9A000247 9A000252 17000648 06000490 05000470 05000466 02000373
Classification	Class II
Reason for Recall	Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.
Product Quantity	13 units
Recall Number	Z-0742-2013

Class II Devices Event

Event ID	63805
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Mar-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Extremity Medical LLC
City	Parsippany
State	NJ
Country	US
Distribution Pattern	Worldwide Distribution -- Nationwide Distribution including the states of AR, AZ, CA, FL, GA, IL, IN, MD, MT, NC, NE, NH, NJ, NY, OH, PA, TN, TX, WI and WA.

Associated Products

Product Description	Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone. Orthopedic implant.
Code Info	Catalog Number 101-00010 Lot number AP3V12 AP4E01 AP4N04 AP5E25 AP6A44 AP6E42 AP6L14 AP6M17 AP6T08.
Classification	Class II
Reason for Recall	Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the IO FIX Surgical Technique Rev C. which can lead to possible inappropriate implant size selection (e.g. shorter screw size selected).
Product Quantity	93 units
Recall Number	Z-0752-2013

Class II Devices Event

Event ID	63827
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Cordis Corporation
City	Miami Lakes
State	FL
Country	US
Distribution Pattern	US (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Hawaii.

Associated Products

Product Description	Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device REF cat. No EX500, EX600, and EX700. Used for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional procedures.
Code Info	Model EX500: Lot #'s: 15410906, 15411659, 15424968, 15429098, 15429879, 15437509, 15437958, 15444208, 15449422, 15453540, 15456567, 15456568, 15462779, 15462780, 15469984, 15479199, 15481341, 15485491, 15489970, 15501955, 15505186, 15578709, 15589368, 15586530, 15602199, 15603369, 15608590, 15610801, 15617548, 15630141, 15630171, 15639388, 15642692, 15648662, 15650923, 15656441, 15664083, 15670351, 15670768. Model EX600: Lot #'s: 15408606, 15409332, 15410622, 15410623, 15426890, 15430798, 15433095, 15433098, 15441594, 15443327, 15446063, 15448005, 15451542, 15452987, 15455770, 15455771, 15459366, 15459367, 15461179, 15461781, 15463296, 15463297, 15464298, 15464299, 15466362, 15472044, 15475128, 15475795, 15479644, 15484135, 15487458, 15491737, 15496311, 15497038, 15500078, 15500709, 15503015, 15504223, 15504224, 15504748, 15506926, 15508012, 15508353, 15508856, 15510541, 15512713, 15518232, 15540529, 15545067, 15548555, 15549324, 15550196, 15550197, 15557284, 15561545, 15561546, 15566744, 15572185, 15573480, 15579468, 15585121, 15587184, 15596793, 15601234, 15601753, 15604477, 15605089, 15609335, 15613282, 15617549, 15625033, 15627316, 15635233, 15637262, 15643624, 15644116, 15644789, 15644790, 15649759, 15663330. Model EX700 Lot #'s: 15466361, 15471271, 15471272, 15476317, 15476743, 15482155, 15483371, 15486224, 15490397, 15535011, 15540530.
Classification	Class II
Reason for Recall	On 10/29/2012 Cordis Corporation, Miami Lakes, FL initiated a recall of their Cordis ExoSeal (TM) Vascular Closure Device. Affected lots of Cordis ExoSeal (TM) VCD have been sterilized using a process that did not achieve the sterility assurance level that is required by the standards of this class of product. Model Numbers EX500, EX600, and EX700.
Product Quantity	98,675 units distributed in US.
Recall Number	Z-0740-2013

Class II Food/Cosmetics Event

Event ID	63865
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	General Mills, Inc
City	Minneapolis
State	MN
Country	US
Distribution Pattern	AZ, CA, HI, ID, MT, OR, UT, WA GUAM, AMERICAN SAMOA, MEXICO, SINGAPORE, PAPUA NW GUINEA.

Associated Products

Product Description	Betty Croker, Super Moist Cake Mix, Golden Vanilla, NET WT 15.25 oz (432 g), UPC 0 16000 40993 4, Dist by General Mills Sales, Inc., Minneapolis, MN 55440. Case UPC code 1600040993000
Code Info	Consumer package code: Better Used By 14SEP2013 Case code: 14SEP3LD
Classification	Class II
Reason for Recall	General Mills is recalling a limited quantity of Betty Crocker SuperMoist Golden Vanilla cake because of a labeling issue. Some product was packaged incorrectly, and contains undeclared FDandC color ingredient not listed on the box's ingredient label. The undeclared colors are: Yellow 5, Yellow 6, Red 40 and Blue 1.
Product Quantity	6223 cases (12 consumer packages / case)
Recall Number	F-0936-2013

Class II Devices Event

Event ID	63866
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Alfa Wassermann, Inc.
City	W Caldwell
State	NJ
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and the countries of Canada and Cayman Islands

Associated Products

Product Description	Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute reagents and rinse the parts of a clinical chemistry instrument.
Code Info	Lot Number 155599
Classification	Class II
Reason for Recall	Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.
Product Quantity	4,104 kits
Recall Number	Z-0743-2013

Class II Devices Event

Event ID	63868
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Philips Healthcare Inc.
City	Andover
State	MA
Country	US
Distribution Pattern	US Nationwide Distribution including the states of AL, CA, CO, CT, IL, MD, MI, MO, NY, OH, PA

Associated Products

Product Description	Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use
Code Info	Serial Numbers: 10110770 11030805 11070848 11070845 11070849 11030806 11090864 11110900 12020982 114087 12030999 12061020 12041003 12061014 12061018 12081040 :
Classification	Class II
Reason for Recall	Values of fluoroscopy time, Air Kerma Rate and Cumulated Air Kerma may not be displayed "at the fluoroscopist's working position" as per 21 CFR 1003.21
Product Quantity	16 units
Recall Number	Z-0702-2013

Class II Devices Event

Event ID	63875
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Jan-13
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Envoy Medical Corporation
City	Saint Paul
State	MN
Country	US
Distribution Pattern	Worldwide Distribution-USA including the states of AL, AZ, CA, CT, FL, GA, IL, MA, MI, MN, NC, OK, RI, and TX, and the country of GERMANY.

Associated Products

Product Description	Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX. Part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on a laptop personal computer.
Code Info	Lot# EMC0004011 EMC0004665 EMC0004114 EMC0004356 EMC0004639 EMC0004399 EMC0004922 EMC0004923 EMC0004989 EMC0004126 EMC0004310 EMC0004724 EMC0004967 EMC0004759 EMC0004235 EMC0004929 EMC0004234 EMC0004965 EMC0004932 EMC0004928 EMC0004969 EMC0004930 EMC0004844 EMC0004053 Lot# EMC0003968 EMC0003985 EMC0003935 EMC0004028 EMC0004027 EMC0004376 EMC0004125 EMC0004303 EMC0004196 EMC0003852 EMC0004191 EMC0004286 EMC0004491 EMC0004594 EMC0004757 EMC0004510 Lot# EMC0004304 EMC0004797 Lot# EMC0003827 EMC0004233
Classification	Class II
Reason for Recall	Envoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers, part of the Esteem Totally Implantable Hearing System, to reduce their susceptibility to noise interference.
Product Quantity	44
Recall Number	Z-0750-2013

Class II Drugs Event

Event ID	63879
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Schering-Plough Products, LLC
City	Las Piedras
State	PR
Country	US
Distribution Pattern	Nationwide and Puerto Rico

Associated Products

Product Description	Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033
Code Info	Lot: 0NCW005, Exp 02/2013
Classification	Class II
Reason for Recall	Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.
Product Quantity	17,169 Packages
Recall Number	D-139-2013

Class II Devices Event

Event ID	63934
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Ortho-Clinical Diagnostics
City	Rochester
State	NY
Country	US
Distribution Pattern	Worldwide Distribution, including Nationwide (USA) and the countries of AU, GM, FR, IT, SP, BR, BM, AR, CA, JA, MX, UK, CH, CL, CO, IN, EC, PE, PY, PA, PT, NZ, SG, VE and UY.

Associated Products

Product Description	Ortho Clinical Diagnostics VITROS® Chemistry Products Vapor Adsorption Cartridge REF/CAT No. 680 0100. VITROS® Vapor Adsorption Cartridges are used to remove vapor contaminants that may potentially interfere with Signal Reagent used with MicroWell Assays on the VITROS® 3600, VITROS® 5600, and VITROS® ECi/ECiQ Systems.
Code Info	CAT No. 680 0100; the cartridges do not have lot numbers.
Classification	Class II
Reason for Recall	Some VITROS® Chemistry Products Vapor Adsorption Cartridge CAT No. 6800100 cartons incorrectly contain a Particulate Cartridge Part No. J19612. In some instances, the Particulate Cartridge has been inadvertently installed on the VITROS® System instead of the intended VITROS® Vapor Adsorption Cartridge which may bias results.
Product Quantity	Domestic: 15,891; Foreign: 5237
Recall Number	Z-0755-2013

Class II Food/Cosmetics Event

Event ID	63982
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Dec-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Chocolate Decadence
City	Eugene
State	OR
Country	US
Distribution Pattern	Product was distributed in Arkansas California, Florida, Georgia, Indiana, Michigan, Minnesota, New Hampshire, New Jersey, New Mexico, New York, Oregon, Virginia, Washington, West Virginia, Wisconsin,

Associated Products

Product Description	Chocolate Covered Coconut Balls is packaged in either 2-ounce packages (2 pieces per package) or in 0.5 lb and 1 lb. boxes. The 2-ounce package has a UPC 19815 90007 8. There is no UPC for 0.5 lb. and 1 lb. packages. The product is labeled in parts: "*Chocolate Covered Coconut BallsCHOCOLATE DECADENCENet Wt. 2oz (56.7g)*INGREDIENTS: Semi-sweet chocolate (sugar,
Code Info	None
Classification	Class II
Reason for Recall	There is a potential of cross contamination with peanuts. The Chocolate Covered Coconut Balls were dipped in the same pot of melting chocolate that was used to make product containing peanut butter.
Product Quantity	46/2 oz. packages; 5/1 lb. boxes; and 2/0.5 lbs boxes
Recall Number	F-0940-2013

Class II Devices Event

Event ID	63997
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Nov-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Roche Molecular Systems, Inc.
City	Branchburg
State	NJ
Country	US
Distribution Pattern	Worldwide Distribution - Foreign (22 EU countries - Austria, Belgium, Bulgaria, Croatia, Cypress, Czech Republic, Denmark, Germany, Finland, France, Greenland, Hungary, Iceland, Italy, Luxembourg, Netherland, Norway, Sweden, Switzerland, Spain, Turkey, UK); (41 Rest of World countries - See Attachment for full country distribution + Japan, Portugal and Mexico)

Associated Products

Product Description	COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
Code Info	Material Number: CE-IVD: 04803531190 Kit, 05574455190 TDF; JPN-IVD: 04653360190 Kit, 05574447190 TDF. Lot/Serial Number: CE-IVD: All Kits, JPN-IVD: All Kits.
Classification	Class II
Reason for Recall	The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being used with AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test Kits, both CE-IVD and JPN-IVD, have an incorrect Target Elbow Max cutoff value of 48 creating the potential for false negative results to be generated for patient samples with Target Elbows in the range of 48 to 50.
Product Quantity	335 CE-IVD TDFs; 48 JPN-IVD TDFs
Recall Number	Z-0762-2013

Class II Devices Event

Event ID	64004
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Jan-13
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Biomet, Inc.
City	Warsaw
State	IN
Country	US
Distribution Pattern	Worldwide Distribution - USA including CA, FL, IL, AL, OH, KY, TX , and Internationally to Australia, Columbia, Mexico, Netherlands, and Chile.

Associated Products

Product Description	TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease. Implants used for this application include: screws, washers, anchors, pins, and suture. Interference Screws and Set Screws are intended for use in fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
Code Info	Catalog Number: 909668 Lot Number Identification: 716710
Classification	Class II
Reason for Recall	Thru hole at the tip of the screw is undersized.
Product Quantity	44 units distributed
Recall Number	Z-0753-2013

Class II Devices Event

Event ID	64008
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Becton Dickinson & Co.
City	Sparks
State	MD
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and internationally to Australia, Belgium, Canada, South Korea, Taiwan, Hong Kong, Japan, Mexico, and Singapore.

Associated Products

Product Description	BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part *Becton Dickinson and Company, Sparks, MD 21152 USA* Intended Use: Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms. Fildes Enrichment is a peptic digest of sheep blood used to enhance the growth of fastidious organisms. It may be added to Tryptic/Trypticase Soy Broth or Agar in final concentration of 5% for cultivation of Haemophilus influenzae. Fildes Enrichment is intended to be a rich source of growth factors stimulatory to various microorganisms, including the X (hemin) and V (nicotinamide adenine dinucleotide, NAD) factors necessary for the growth of Haemophilus influenzae. Labeling: For Laboratory Use.
Code Info	Lot/Exp 2079066/ EXP March 6, 2013 2096375/ EXP March 22, 2013 2216092/ EXP July 20, 2013 2227271/ EXP Auqust 2, 2013
Classification	Class II
Reason for Recall	Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species.
Product Quantity	11,710 tubes
Recall Number	Z-0739-2013

Class II Devices Event

Event ID	64010
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Becton Dickinson & Company
City	Franklin Lakes
State	NJ
Country	US
Distribution Pattern	Worldwide Distribution-USA (nationwide) and the countries of Canada, India, Japan, Nepal, Malaysia, Singapore, Brazil, Costa Rica, and Virgin Islands.

Associated Products

Product Description	BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL
Code Info	Lot No. 2180434; Expiration Date: April 2013
Classification	Class II
Reason for Recall	BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to extended Partial Thromboplastin Time (aPTT) test results reported in two customer complaints.
Product Quantity	2,944,700 units
Recall Number	Z-0756-2013

Class II Food/Cosmetics Event

Event ID	64011
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	02-Jan-13
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	EonNutra, LLC
City	Colorado Springs
State	CO
Country	US
Distribution Pattern	Nationwide, AR, CA, CO, FL, GA, IO, MI, MO, NC, ND, NE, NJ, SC, TN, TX, UT, WI

Associated Products

Product Description	Growth Factor Complex 200 GFC 200, Dietary Supplement 2 Fl Oz, Manufactured for: Soto Supplements P.O. Box 75774 Colorado Springs, CO 80237, Instructions: Place drops under your tongue for 2 min then swallow. Do not eat or drink for 15 min. Only approved for distribution from Authorized Distributors/Retailers, pharmaceutical laboratories and governmental research facilities.
Code Info	SRK91512; SRK92112; SRK92512; SRK102312; SRK11412; SRK111912.
Classification	Class II
Reason for Recall	Eon Nutra, LLC is recalling certain SOTO Supplements GFC 200 because the liquid dietary supplement products may be contaminated with various types of bacteria.
Product Quantity	199 x 2 oz bottles
Recall Number	F-0937-2013

Class II Drugs Event

Event ID	64020
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Dec-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Hillyard GMP
City	Saint Joseph
State	MO
Country	US
Distribution Pattern	Distribution nationwide

Associated Products

Product Description	HILLYARD, Alcohol Free Foaming Instant Hand Sanitizer, Benzalkonium Chloride 0.10%, 1.25 L plastic bottle, OTC, HILLYARD IDUSTRIES, St. Joseph, MO. 64502 NDC 76402-403-03
Code Info	Lot 1025554, Exp: 03/14 and Lot 1030652, Exp: 09/14
Classification	Class II
Reason for Recall	Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria.
Product Quantity	2,139 bottles
Recall Number	D-140-2013

Class II Food/Cosmetics Event

Event ID	64021
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Jan-13
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	C H S Inc
City	Hutchinson
State	KS
Country	US
Distribution Pattern	Distribution was made to MI, KY, WI, OH,

Associated Products

Product Description	Kitchen Essentials Imitation Bacon Flavored Bits, contains soy and wheat, packaged in 10 lb bulk cartons. Distributed by Gordon Food Service, Grand Rapids, MI. UPC 0 00 93901 6, Supplier item 293628
Code Info	Lot 12257 and Lot 12258
Classification	Class II
Reason for Recall	The product contains Soy and Wheat and is packaged in cartons in which the ingredient statement is missing.
Product Quantity	2,474 containers
Recall Number	F-0962-2013

Class II Devices Event

Event ID	64054
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Dec-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	bioMerieux, Inc.
City	Durham
State	NC
Country	US
Distribution Pattern	Worldwide Distribution.USA including the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WI, and WV, and the countries of China, Curacao and Japan.

Associated Products

Product Description	BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
Code Info	Catalog Number: 259789, Lots/Batch: 1031866
Classification	Class II
Reason for Recall	BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.
Product Quantity	1690 cases
Recall Number	Z-0738-2013

Class II Devices Event

Event ID	64055
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Ethicon Endo-Surgery Inc
City	Cincinnati
State	OH
Country	US
Distribution Pattern	Worldwide Distribution - USA including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, & WV. and the countries Arab Emirates, Australia, Belgium, Canada, Chile, China, Colombia, Cyprus, Hong Kong, Indonesia, Israel, India, South Korea, Kuwait, Malaysia, Panama, Philippines, Puerto Rico, Russia, Saudi Arabia, Singapore, Slovenia, Thailand, Turkey & Vietnam.

Associated Products

Product Description	Ethicon Endo-Surgery Inc. The ENSEAL® G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. Model Numbers: NSLG2C14 NSLG2C25 NSLG2C35 NSLG2C45 NSLG2514 NSLG2S25 NSLG2S35 NSLGS545
Code Info	Product Code NSLG2C14, Lot # H44Y2P, Exp. Date 11-2013, Lot # J4AR58, Exp. Date 4-2017, Lot # J4AT3V, Exp. Date 4-2017, Lot # J4AW5A, Exp. Date 5-2017, Lot # J4AX7D, Exp. Date 5-2017, Lot # J4C34A, Exp. Date 6-2017, Lot # J4C448, Exp. Date 7-2017, Lot # J4C449, Exp. Date 7-2017, Lot # J4C85G, Exp. Date 7-2017, Lot # J4CF5Z, Exp. Date 9-2017 and Lot # J4CG31, Exp. Date 9-2017. Product Code NSLG2C25, Lot # H44Z6V, Exp. Date 11-2013, Lot # J4A16C, Exp. Date 12-2013, Lot # J4AT1P, Exp. Date 4-2017, Lot # J4AR5L, Exp. Date 4-2017, Lot # J4AU2K, Exp. Date 5-2017, Lot # J4AV17, Exp. Date 5-2017, Lot # J4AW75, Exp. Date 5-2017, Lot # J4AW76, Exp. Date 5-2017, Lot # J4AY0T, Exp. Date 5-2017, Lot # J4C09P, Exp. Date 6-2017, Lot # J4C30A, Exp. Date 6-2017, Lot # J4C34L, Exp. Date 6-2017, Lot # J4C44N, Exp. Date 7-2017, Lot # J4C928, Exp. Date 7-2017, Lot # J4C92C, Exp. Date 7-2017, Lot # J4C968, Exp. Date 8-2017, Lot # J4CA4P, Exp. Date 8-2017, Lot # J4CF0D, Exp. Date 8-2017, Lot # J4CH3W, Exp. Date 9-2017, Lot # J4CJ5Y, Exp. Date 9-2017, Lot # J4CJ99, Exp. Date 9-2017 and Lot # J4CK1H, Exp. Date 9-2017. Product Code NSLG2C35, Lot # H44V7N, Exp. Date 10-2013, Lot # H44V7M, Exp. Date 10-2013, Lot # H44V7P, Exp. Date 10-2013, Lot # H44X9M, Exp. Date 11-2013, Lot # H44X9L, Exp. Date 11-2013, Lot # H44X9R, Exp. Date 11-2013, Lot # H44Z3R, Exp. Date 11-2013, Lot # H44Z4C, Exp. Date 11-2013, Lot # H44Z54, Exp. Date 11-2013, Lot # J4A085, Exp. Date 12-2013, Lot # J4A134, Exp. Date 12-2013, Lot # J4AN7K, Exp. Date 4-2017, Lot # J4AN8E, Exp. Date 4-2017, Lot # J4AN8D, Exp. Date 4-2017, Lot # J4AP7W, Exp. Date 4-2017, Lot # J4AR5P, Exp. Date 4-2017, Lot # J4AT05, Exp. Date 4-2017, Lot # J4AT9G, Exp. Date 4-2017, Lot # J4AT9V, Exp. Date 4-2017, Lot # J4AU2Z, Exp. Date 5-2017, Lot # J4AV2R, Exp. Date 5-2017, Lot # J4AV2V, Exp. Date 5-2017, Lot # J4AV4P, Exp. Date 5-2017, Lot # J4AV4Z, Exp. Date 5-2017, Lot # J4AW3F, Exp. Date 5-2017, Lot # J4AW3N, Exp. Date 5-2017, Lot # J4AW8P, Exp. Date 5-2017, Lot # J4AW8Y, Exp. Date 5-2017, Lot # J4AX37, Exp. Date 5-2017, Lot # J4AX5Z, Exp. Date 5-2017, Lot # J4AX6E, Exp. Date 5-2017, Lot # J4AX8T, Exp. Date 5-2017, Lot # J4AX8U, Exp. Date 5-2017, Lot # J4AZ3P, Exp. Date 6-2017, Lot # J4AZ3V, Exp. Date 6-2017, Lot # J4AZ4W, Exp. Date 6-2017, Lot # J4AZ51, Exp. Date 6-2017, Lot # J4C11M, Exp. Date 6-2017, Lot # J4C11H, Exp. Date 6-2017, Lot # J4C15E, Exp. Date 6-2017, Lot # J4C17G, Exp. Date 6-2017, Lot # J4C174, Exp. Date 6-2017, Lot #, J4C187, Exp. Date 6-2017, Lot # J4C197, Exp. Date 6-2017, Lot # J4C17Y, Exp. Date 6-2017, Lot # J4C19M, Exp. Date 6-2017, Lot #, J4C225, Exp. Date 6-2017, Lot # J4C22H, Exp. Date 6-2017, Lot # J4C358, Exp. Date 6-2017, Lot # J4C35C, Exp. Date 6-2017, Lot # J4C36T, Exp. Date 6-2017, Lot # J4C427, Exp. Date 7-2017, Lot # J4C42D, Exp. Date 7-2017, Lot # J4C44P, Exp. Date 7-2017, Lot # J4C51U, Exp. Date 7-2017, Lot # J4C51W, Exp. Date 7-2017, Lot # J4C56E, Exp. Date 7-2017, Lot # J4C56A, Exp. Date 7-2017, Lot # J4C56Z, Exp. Date 7-2017, Lot # J4C56P, Exp. Date 7-2017, Lot # J4C58J, Exp. Date 7-2017, Lot # J4C58V, Exp. Date 7-2017, Lot # J4C65M, Exp. Date 7-2017, Lot # J4C66A, Exp. Date 7-2017, Lot # J4C66L, Exp. Date 7-2017, Lot # J4C758, Exp. Date 7-2017, Lot # J4C768, Exp. Date 7-2017, Lot # J4C85H, Exp. Date 7-2017, Lot # J4C85W, Exp. Date 7-2017, Lot # J4C906, Exp. Date 7-2017, Lot # J4C96P, Exp. Date 8-2017, Lot # J4C96Z, Exp. Date 8-2017, Lot # J4C879, Exp. Date 7-2017, Lot # J4CA4X, Exp. Date 8-2017, Lot # J4CA4Y, Exp. Date 8-2017, Lot # J4CC01, Exp. Date 8-2017, Lot # J4CC2G, Exp. Date 8-2017, Lot # J4CC4J, Exp. Date 8-2017, Lot # J4CD0C, Exp. Date 8-2017, Lot # J4CE10, Exp. Date 8-2017, Lot # J4CE16, Exp. Date 8-2017, Lot # J4CF0J, Exp. Date 8-2017, Lot # J4CF66, Exp. Date 9-2017, Lot # J4CJ0L, Exp. Date 9-2017, Lot # J4CJ5Z, Exp. Date 9-2017, Lot # J4CJ6J, Exp. Date 9-2017 and Lot # J4CK1K, Exp. Date 9-2017. Product Code NSLG2C45, Lot # H44W26, Exp. Date 10-2013, Lot # H44W25, Exp. Date 10-2013, Lot # H44W27, Exp. Date 10-2013, Lot # J4A19D, Exp. Date 12-2013, Lot # J4AR6G, Exp. Date 4-2017, Lot # J4AU2R, Exp. Date 5-2017, Lot # J4AV5U, Exp. Date 5-2017, Lot # J4AZ53, Exp. Date 6-2017, Lot # J4C042, Exp. Date 6-2017, Lot # J4C122, Exp. Date 6-2017, Lot # J4C18F, Exp. Date 6-2017, Lot # J4C23J, Exp. Date 6-2017, Lot # J4C270, Exp. Date 6-2017, Lot # J4C32F, Exp. Date 6-2017, Lot # J4C62J, Exp. Date 7-2017, Lot # J4C62P, Exp. Date 7-2017, Lot # J4C816, Exp. Date 7-2017, Lot # J4C90E, Exp. Date 7-2017, Lot # J4C90F, Exp. Date 7-2017, Lot # J4C99K, Exp. Date 8-2017, Lot # J4CA8M, Exp. Date 8-2017, Lot # J4CD6Z, Exp. Date 8-2017, Lot # J4CJ73, Exp. Date 9-2017 and Lot # J4CK5E, Exp. Date 9-2017. Product Code NSLG2S14, Lot # H44Z5R, Exp. Date 11-2013, Lot # J4C312, Exp. Date 6-2017, Lot # J4C639, Exp. Date 7-2017 and Lot # J4CG7Z, Exp. Date 9-2017. Product Code NSLG2S25, Lot # H44Z57, Exp. Date 11-2013, Lot # J4AU2W, Exp. Date 5-2017, Lot # J4AW4P, Exp. Date 5-2017, Lot # J4AW4N, Exp. Date 5-2017, Lot # J4AX4W, Exp. Date 5-2017, Lot # J4AZ5M, Exp. Date 6-2017, Lot # J4C09V, Exp. Date 6-2017, Lot # J4C18R, Exp. Date 6-2017, Lot # J4C22J, Exp. Date 6-2017, Lot # J4C27C, Exp. Date 6-2017, Lot # J4C34E, Exp. Date 6-2017, Lot # J4C34F, Exp. Date 6-2017, Lot # J4C34K, Exp. Date 6-2017, Lot # J4C37R, Exp. Date 6-2017, Lot # J4C49E, Exp. Date 7-2017, Lot # J4C49G, Exp. Date 7-2017, Lot # J4C576, Exp. Date 7-2017, Lot # J4C577, Exp. Date 7-2017, Lot # J4C63W, Exp. Date 7-2017, Lot # J4C67U, Exp. Date 7-2017, Lot # J4C75N, Exp. Date 7-2017, Lot # J4C75X, Exp. Date 7-2017 and Lot # J4C92G, Exp. Date 7-2017. Product Code NSLG2S35, Lot # H44Y6N, Exp. Date 11-2013, Lot # H44Y8A, Exp. Date 11-2013, Lot # H44Y8K, Exp. Date 11-2013, Lot # H44Z65, Exp. Date 11-2013, Lot # H44Z6J, Exp. Date 11-2013, Lot # J4A164, Exp. Date 12-2013, Lot # J4AR9C, Exp. Date 4-2017, Lot # J4AT1U, Exp. Date 4-2017, Lot # J4AT22, Exp. Date 4-2017, Lot # J4AT4H, Exp. Date 4-2017, Lot # J4AU2X, Exp. Date 5-2017, Lot # J4AW31, Exp. Date 5-2017, Lot # J4AW36, Exp. Date 5-2017, Lot # J4AW9D, Exp. Date, 5-2017, Lot # J4AW9H, Exp. Date, 5-2017, Lot # J4AX62, Exp. Date, 5-2017, Lot # J4AX8Y, Exp. Date, 5-2017, Lot # J4AX9F, Exp. Date, 5-2017, Lot # J4C100, Exp. Date, 6-2017, Lot # J4C109, Exp. Date, 6-2017, Lot # J4C15H, Exp. Date, 6-2017, Lot # J4C18W, Exp. Date, 6-2017, Lot # J4C209, Exp. Date, 6-2017, Lot # J4C20A, Exp. Date, 6-2017, Lot # J4C23K, Exp. Date, 6-2017, Lot # J4C27E, Exp. Date, 6-2017, Lot # J4C27H, Exp. Date, 6-2017, Lot # J4C32G, Exp. Date, 6-2017, Lot # J4C34M, Exp. Date, 6-2017, Lot # J4C435, Exp. Date, 7-2017, Lot # J4C43J, Exp. Date, 7-2017, Lot # J4C537, Exp. Date, 7-2017, Lot # J4C53G Exp. Date, 7-2017, Lot # J4C53T, Exp. Date, 7-2017, Lot # J4C57N, Exp. Date, 7-2017, Lot # J4C57P, Exp. Date, 7-2017, Lot # J4C64N, Exp. Date, 7-2017, Lot # J4C64U, Exp. Date, 7-2017, Lot # J4C73T, Exp. Date, 7-2017, Lot # J4C73X, Exp. Date, 7-2017, Lot # J4C914, Exp. Date, 7-2017, Lot # J4C90W, Exp. Date, 7-2017, Lot # J4C92Z, Exp. Date, 7-2017, Lot # J4CE93, Exp. Date, 8-2017 and Lot # J4CC02, Exp. Date, 8-2017. Product Code NSLG2S45, Lot # J4A12R, Exp. Date 12-2013, Lot # J4AV6G, Exp. Date 5-2017, Lot # J4AV6T, Exp. Date 5-2017, Lot # J4AX9V, Exp. Date 5-2017, Lot # J4C15V, Exp. Date 6-2017, Lot # J4C30V, Exp. Date 6-2017, Lot # J4C37T, Exp. Date 6-2017, Lot # J4C67E, Exp. Date 7-2017, Lot # J4C67J, Exp. Date 7-2017, Lot # J4C67M, Exp. Date 7-2017, Lot # J4C74T, Exp. Date 7-2017 and Lot # J4CC9G, Exp. Date 8-2017.
Classification	Class II
Reason for Recall	Ethicon Endo-Surgery initiated a voluntary global recall for all production lots of ENSEAL G2 Curved and Straight Tissue Sealers due to a potential for self activation while the device is in use, which may result in unintended thermal damage.
Product Quantity	58,338 Instruments
Recall Number	Z-0758-2013

Class II Food/Cosmetics Event

Event ID	64082
Status	Completed
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Dec-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Gordon Food Service, Inc.
City	Plant City
State	FL
Country	US
Distribution Pattern	Florida only

Associated Products

Product Description	*GFSCLAW MEATWild-Caught and Hand-PickedPASTEURIZED CRABCarne de mano de jaiba* NET WT/PESO NETO*16 OZ (1 LB) 453gReorder #536030PRODUCT OF THAILAND*.
Code Info	Product ID# 536030, best by Feb 12 2013
Classification	Class II
Reason for Recall	Concern with Time/Temperature abused during transit.
Product Quantity	10 cases
Recall Number	F-0952-2013

Class II Food/Cosmetics Event

Event ID	64101
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-Jan-13
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Dawn's Foods, Inc.
City	Portage
State	WI
Country	US
Distribution Pattern	IL, IA, WI

Associated Products

Product Description	Ocean Harbor Smoked Salmon Spread Net Wt 5 lb.(2.27 kg). UPC: 0 32345-77707 1 Dist by Roundy's Inc.
Code Info	1/9/13 -3/05/13
Classification	Class II
Reason for Recall	Dawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth.
Product Quantity	6,940 lbs
Recall Number	F-0953-2013

Product Description	Ocean Harbor Cajun Krab Spread Net Wt 5 lb (2.27 kg) UPC: 0 32345-77711 8 Dist by Roundy's Inc.
Code Info	1/9/13 -3/05/13
Classification	Class II
Reason for Recall	Dawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth.
Product Quantity	3,130 lbs
Recall Number	F-0954-2013

Product Description	Ocean Harbor Jalapeno Krab Spread Net Wt 5 lbs (2.27kg) UPC: 0 32345-77715 6 Dist by Roundy's Inc.
Code Info	1/9/13 -3/05/13
Classification	Class II
Reason for Recall	Dawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth.
Product Quantity	1,250 lbs
Recall Number	F-0955-2013

Product Description	Five Star Dip Smoked Salmon Dip Net WT 10 oz (284g). UPC: 0 32345 61463 5 Mfg By Dawn Food, Portage, WI 53901. Dawns Smoked Salmon Dip NET WT 5 LBS (2.27 kg) UPC: 0 32345 61480 2 MFG BY DAWN'S FOODS, INC., PORTAGE, WI 53901
Code Info	1/9/13 -3/05/13
Classification	Class II
Reason for Recall	Dawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth.
Product Quantity	11,841 lbs
Recall Number	F-0956-2013

Product Description	Five Star Dip Cajun Krab Dip Net Wt 10 oz (284g). UPC: 0 32345 84063 8, Mfg By Dawns Foods, Inc., Portage, WI 53901. 84080 Dawns Cajun Krab Dip NET WT 5 LBS (2.27 kg), UPC: 0 32345 88888 3 MFG BY DAWN'S FOODS, INC., PORTAGE, WI 53901
Code Info	1/9/13 -3/05/13
Classification	Class II
Reason for Recall	Dawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth.
Product Quantity	4,176 lbs
Recall Number	F-0957-2013

Product Description	Dawns Alaskan Krab and Shrimp Salad NET WT 5 LBS (2.27 kg), UPC: 0 32345 70103 8 MFG BY DAWN'S FOODS, INC., PORTAGE, WI 53901 Ocean Harbor Krab and Shrimp Salad NET WT 5 LBS (2.27 kg), UPC: 0 32345 77701 9 Dist by Roundy's Inc.
Code Info	1/9/13 -2/19/13
Classification	Class II
Reason for Recall	Dawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth.
Product Quantity	7,470 lbs
Recall Number	F-0958-2013

Product Description	Dawns Alaskan Krab Salad NET WT 5 LBS (2.27 kg), UPC: 0 32345 85072 9 , MFG BY DAWN'S FOODS, IN., PORTAGE, WI 53901 Ocean Harbor Alaskan Krab Salad NET WT 5 LBS (2.27 kg), UPC: 0 32345 77705 7, Dist by Roundy's Inc.
Code Info	1/9/13 -2/19/13
Classification	Class II
Reason for Recall	Dawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth.
Product Quantity	10,635 lbs
Recall Number	F-0959-2013

Class II Devices Event

Event ID	64129
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Jan-13
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Greatbatch Medical
City	Minneapolis
State	MN
Country	US
Distribution Pattern	Worldwide Distribution-USA including the states of CA, IN, KS, MA, NJ, PA, TN, and TX, and the countries of AUSTRALIA, BRAZIL, CANADA, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, PORTUGAL, and SWITZERLAND.

Associated Products

Product Description	45° Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU260045AO01, MPU260045ZH01. The Driver is intended to act as an interface between the cutting tool and a motorized driving system (i.e. surgical drill).
Code Info	All lots
Classification	Class II
Reason for Recall	Greatbatch Medical has initiated a global voluntary recall and market withdrawal of its entire Small Angled Driver 45° product line. Greatbatch has received reports of noisy and / or rough operation when using these Small Angled Drivers.
Product Quantity	913
Recall Number	Z-0751-2013

Class II Drugs Event

Event ID	64154
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Jan-13
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Mylan Pharmaceuticals Inc.
City	Morgantown
State	WV
Country	US
Distribution Pattern	Nationwide.

Associated Products

Product Description	Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-3633-05, UPC 3 0378-3633-05 3.
Code Info	Lot #: ZCMH12031, ZCMH12032, ZCMH12033, ZCMH12034, Exp 02/14
Classification	Class II
Reason for Recall	Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
Product Quantity	11,580 bottles
Recall Number	D-137-2013

Class III Biologics Event

Event ID	40843
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Sep-05
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	C72367
Classification	Class III
Reason for Recall	Blood product, which did not have the correct amount red cell preservative solution added, was distributed.
Product Quantity	1 Unit
Recall Number	B-0494-13

Class III Biologics Event

Event ID	41266
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Nov-05
Initial Firm Notification of Consignee or Public	Other

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

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	GH01615; GH00089
Classification	Class III
Reason for Recall	Blood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity	2 Units
Recall Number	B-0471-13

Class III Biologics Event

Event ID	44158
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Jan-07
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	BioLife Plasma Services L.P.
City	Denton
State	TX
Country	US
Distribution Pattern	CA

Associated Products

Product Description	Source Plasma
Code Info	06DTXC0279
Classification	Class III
Reason for Recall	Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity	1 unit
Recall Number	B-0330-13

Class III Biologics Event

Event ID	48264
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Mar-08
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Blood Systems, Inc.
City	El Paso
State	TX
Country	US
Distribution Pattern	TX

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	115998840
Classification	Class III
Reason for Recall	Blood products, which were possibly contaminated, were distributed.
Product Quantity	1 unit
Recall Number	B-0260-13

Product Description	Platelets Pheresis Leukocytes Reduced Irradiated
Code Info	115998840
Classification	Class III
Reason for Recall	Blood products, which were possibly contaminated, were distributed.
Product Quantity	1 unit
Recall Number	B-0261-13

Class III Biologics Event

Event ID	49814
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Aug-08
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Puget Sound Blood Center and Program
City	Seattle
State	WA
Country	US
Distribution Pattern	Austria.

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	W141608007333
Classification	Class III
Reason for Recall	Blood product, which was collected from a donor who was taking the medication Finasteride, was distributed.
Product Quantity	1 component
Recall Number	B-0491-13

Class III Biologics Event

Event ID	51265
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Nov-08
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	American National Red Cross (The)
City	Dedham
State	MA
Country	US
Distribution Pattern	MA, ME, NH, NY, PA

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced Irradiated
Code Info	004E25878, 004E25879, 004F77446, 004FJ44307, 004FJ44310, 004J10528, 004J10531, 004N71839, 004N71842, 004N71862, 004N71866, 004N71867, 004N71875
Classification	Class III
Reason for Recall	Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed.
Product Quantity	13 units
Recall Number	B-0334-13

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	004E25855, 004E25857, 004E25868, 004F77410, 004F77419, 004F77468, 004FJ44301, 004FJ44308, 004J10538, 004J10546, 004M56906
Classification	Class III
Reason for Recall	Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed.
Product Quantity	11 units
Recall Number	B-0335-13

Product Description	Platelets Pheresis Leukocytes Reduced Irradiated
Code Info	004FG06539 (Parts 1 & 2), 004FH06057 (Parts 1 & 2), 004FP94622 (Parts 1 & 2), 004FP94628, 004FP94631
Classification	Class III
Reason for Recall	Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed.
Product Quantity	8 units
Recall Number	B-0336-13

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	004FG06532, 004FG06535, 004FP94622, 004FP94623, 004FP94626, 004FP94628, 004FP94630, 004GC27533, 004FG06537 (Parts 1 & 2), 004FH06061 (Parts 1, 2, & 3), 004FH06063 (Parts 1 & 2), 004FP94620 (Parts 1 & 2), 004FP94627 (Parts 1, 2, & 3), 004FP94629 (Parts 1 & 2), 004FP94631 (Parts 1 & 2)
Classification	Class III
Reason for Recall	Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed.
Product Quantity	24 units
Recall Number	B-0337-13

Class III Biologics Event

Event ID	63594
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Puget Sound Blood Center and Program
City	Seattle
State	WA
Country	US
Distribution Pattern	Washington

Associated Products

Product Description	Red Blood Cells
Code Info	W141610132562;
Classification	Class III
Reason for Recall	Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-0426-13

Class III Devices Event

Event ID	63918
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Alere San Diego, Inc.
City	San Diego
State	CA
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea.

Associated Products

Product Description	Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), glucose (GLU), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) test procedures on the Alere Cholestech LDX System. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Assayed quality control material for use with the Alere Cholestech LDX System.
Code Info	Lot#C2510 and C2510A
Classification	Class III
Reason for Recall	Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control (MAC) and the Alere Cholestech LDX Calibrator Verification, 4 vial set, because of issues with increased HDL Cholesterol results.
Product Quantity	2,471 kits
Recall Number	Z-0746-2013

Product Description	Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), and glucose (GLU) test procedures on the Alere Cholestech LDX System. Calibration verification is optional for CLIA waived systems, such as the Alere Cholestech LDX System, under CLIA regulations. However local or state regulations may require that calibration verification is run at regular intervals.
Code Info	Lot#271097
Classification	Class III
Reason for Recall	Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control (MAC) and the Alere Cholestech LDX Calibrator Verification, 4 vial set, because of issues with increased HDL Cholesterol results.
Product Quantity	320 kits
Recall Number	Z-0747-2013

Class III Food/Cosmetics Event

Event ID	63977
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Dec-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	The Father's Table, LLC
City	Sanford
State	FL
Country	US
Distribution Pattern	DOMESTIC: Arkansas, California, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Texas, Washington, and Wisconsin INTERNATIONAL: Trinidad and Tobago

Associated Products

Product Description	Individual packages labeled in part: *The Father's TableVanilla Roll8oz and Master carton labeled in part: "The Father's TableShelf Stable Mini Vanilla RollContains 12/8oz.**
Code Info	UPC' #s = L72483N, L49983N, and L49983N SKU # 49983, 72483, and 63583
Classification	Class III
Reason for Recall	Incorrectly labeled with a label that does not list strawberries and color additives (FC&C Red 40 and Blue 1).
Product Quantity	3,733 cartons / 12 rolls / 8 oz ea
Recall Number	F-0938-2013

Product Description	Individual packages labeled in part: *The Bakery baked with prideVanilla Mini Cake Roll8oz with strawberry filling* NETWT 8oz (226g)
Code Info	UPC' #s = L02367N SKU # 02367
Classification	Class III
Reason for Recall	Incorrectly labeled with a label that does not list strawberries and color additives (FC&C Red 40 and Blue 1).
Product Quantity	5,535 cases / 12 rolls / 8oz ea
Recall Number	F-0939-2013

Class III Food/Cosmetics Event

Event ID	63978
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	31-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	J F C International Inc
City	Los Angeles
State	CA
Country	US
Distribution Pattern	nationwide in the US

Associated Products

Product Description	WP Saki Ika Cuttlefish JFC# 15603, 4/24/0.75oz; JFC# 06315, 8/12/2oz; JFC# 07266, 5/12/4oz; JFC# 06375, 3/12/8oz.
Code Info	JFC# Lot# 15603 Q066A & Q109A; 06315 Q065A & Q108A; 07266 Q067A & Q110A; 06375 Q066A & Q109A.
Classification	Class III
Reason for Recall	JFC International is recalling WelPac Saki Ika Cuttlefish because of mold.
Product Quantity	500 cartons
Recall Number	F-0950-2013

Product Description	WP Saki Ika Cuttlefish Hot JFC# 15606, 4/24/0.75 oz; JFC# 06318, 8/12/2 oz; JFC# 07269, 5/12/4 oz; JFC# 06360, 3/12/8 oz.
Code Info	JFC# Lot# 15606 Q069A & Q110A; 06318 Q068A & Q111A; 07269 Q070A & Q112A; 06360 Q069A & Q112A.
Classification	Class III
Reason for Recall	JFC International is recalling WelPac Saki Ika Cuttlefish because of mold.
Product Quantity	500 cartons
Recall Number	F-0951-2013

Class III Drugs Event

Event ID	64014
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Warner Chilcott Company LLC
City	Fajardo
State	PR
Country	US
Distribution Pattern	US Nationwide

Associated Products

Product Description	Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738
Code Info	0.9 mg: 512348A
Classification	Class III
Reason for Recall	Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Product Quantity	5439 bottles
Recall Number	D-141-12013

Product Description	Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738
Code Info	0.45 mg: 505969A
Classification	Class III
Reason for Recall	Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Product Quantity	3155 bottles
Recall Number	D-142-2013

Class III Devices Event

Event ID	64081
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Siemens Healthcare Diagnostics, Inc.
City	Newark
State	DE
Country	US
Distribution Pattern	Nationwide Distribution.

Associated Products

Product Description	Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dimension(R) clinical chemistry system.
Code Info	Siemens material number 10445010 -- and lot numbers 2DN060, exp 2013-10-01; 2FN063, exp 2013-12-01; 2GN068, exp 2014-01-01; and 2JN073, exp 2014-03-01.
Classification	Class III
Reason for Recall	Siemens Healthcare Diagnostics has received complaints of IRON calibrations outside of acceptable calibration slope (m) values (0.97 - 1.03) when using IRON calibrator lots 2DN060 and 2FN063. Lots 2GN068 and 2JN074 may also be impacted but no complaints have been received.
Product Quantity	5999
Recall Number	Z-0745-2013

Mixed Classification Biologics Event

Event ID	43710
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Nov-06
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	02GG13901
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-0435-13

Product Description	Blood and Blood Products for Reprocessing
Code Info	02GG13901
Classification	Class III
Reason for Recall	Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-0436-13

Mixed Classification Biologics Event

Event ID	44463
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Jan-07
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	02LC78216
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-0438-13

Product Description	Blood and Blood Products for Reprocessing
Code Info	02LC78216
Classification	Class III
Reason for Recall	Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-0439-13

Mixed Classification Biologics Event

Event ID	63626
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Oct-12
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W0352120385900;
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	1
Recall Number	B-0417-13

Product Description	Platelets
Code Info	W0352120385900; W035212226967D;
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-0418-13

Product Description	Blood and Blood Products for Reprocessing
Code Info	W0352120385900;
Classification	Class III
Reason for Recall	Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	1
Recall Number	B-0419-13

Mixed Classification Devices Event

Event ID	64135
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Jan-13
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Carestream Health, Inc.
City	Rochester
State	NY
Country	US
Distribution Pattern	US Nationwide Distribution including the states of California, Florida, Texas, Illinois, Indiana, Maryland, Pennsylvania and Canada.

Associated Products

Product Description	KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 packets. Product Usage: Dental intraoral radiography
Code Info	Lot 2114596 (Exp. September 2014)
Classification	Class II
Reason for Recall	The company discovered that some cartons of KODAK INSIGHT with SureSoft Packets Dental Film Catalog Number 8118226 have missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The Lot symbol is missing but the lot number is not missing. The Manufacturer symbol, name and address including country of origin are missing. All of the remaining symbols and information are on the case label. Missing information is only associated with the clear carton label.
Product Quantity	101 cartons: Domestic - 95 cartons; Foreign - 6 cartons
Recall Number	Z-0744-2013

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