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Enforcement Report - Week of January 16, 2013

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Biologics Devices Drugs Food / Cosmetics Veterinary

Class I Biologics Event

Event ID	63120
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	31-Jul-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Tissue Banks International
City	San Rafael
State	CA
Country	US
Distribution Pattern	Allograft products were released for distribution to 6 consignees in US. located in CA, MD and PA.

Associated Products

Product Description	Bone, Human Tissue allograft; CeSpace (Brand for Aesculap, Inc.); Prepared by Aesculap, Inc., Center Valley, PA and distributed by TBI National Processing Center, San Rafael, CA
Code Info	CL1202013057; CL1202013061; CL1202013064; CL1202013068; CL1202013071; CL1202013075; CL1202013079; CL1202013084; CL1202013077; CL1202013083; CL1202013056; CL1202013058; CL1202013059; CL1202013060; CL1202013062; CL1202013063; CL1202013065; CL1202013066; CL1202013067; CL1202013069; CL1202013070; CL1202013072; CL1202013073; CL1202013074; CL1202013076; CL1202013078; CL1202013080; CL1202013081; CL1202013082; CL1202013085; CL1202013086; CL1202013006; CL1202013004
Classification	Class I
Reason for Recall	Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.
Product Quantity	33
Recall Number	B-0162-13

Product Description	Tendon, Human Tissue allograft; TranZgraft (brand for TBI); Product is prepared and distributed by TBI/Tissue Banks International, San Rafael, CA
Code Info	CL1202013007; CL1202013008; CL1202013009; CL1202013010; CL1202013003
Classification	Class I
Reason for Recall	Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.
Product Quantity	5
Recall Number	B-0163-13

Class I Biologics Event

Event ID	63229
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Jul-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Musculoskeletal Transplant Foundation
City	Edison
State	NJ
Country	US
Distribution Pattern	AK, AZ, CA, MI, PA. TX

Associated Products

Product Description	Tendon
Code Info	06711073061037; 06711073061038; 06711073061043; 06711073061027; 06711073061031; 06711073061041; 06711073061040; 06711073061028; 06711073061039; 06711073061029; 00311087151038; 00311087151045;0311087151039; 00311087151046; 00311087151047; 00311087151040; 00311087151042; 00311087151049
Classification	Class I
Reason for Recall	.Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.
Product Quantity	18 units
Recall Number	B-0164-13

Product Description	Bone
Code Info	06711073061066; 06711073061059; 06711073061067; 06711073061073; 06711073061065; 06711073061060; 06711073061061; 06711073061062; 06711073061072; 06711073061069; 06711073061070; 06711073061071; 06711073061051; 06711073061052; 06711073061053; 06711073061054; 06711073061068; 06711073061056; 06711073061057; 06711073061058; 06711073061055; 06711073061064; 06711073061063; 00311087151030; 00311087151031; 00311087151032; 00311087151033; 00311087151034
Classification	Class I
Reason for Recall	Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.
Product Quantity	28 units
Recall Number	B-0165-13

Class I Food/Cosmetics Event

Event ID	63425
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Oct-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Whole Foods Market Brand 365, Llc
City	Austin
State	TX
Country	US
Distribution Pattern	KY

Associated Products

Product Description	Kentucky Bleu cheese was sold in the Louisville, KY, Whole Foods Market store, and was cut and packaged in clear plastic wrap. It was sold with a Whole Foods Market scale label reading 'Kenny's Farmhouse Cheese KY BL.
Code Info	The Kenny's Farmhouse Cheese KY BL has a PLU of 209578 and includes all 'sell by' dates, which are noted on the scale label.
Classification	Class I
Reason for Recall	Whole Foods Market announces that it is recalling Kenny's Farmhouse Cheese KY BL sold in its Louisville, KY store and Blue Kentucky Rose Kenny's cheese sold in its Nashville, TN store. These cheeses are being recalled because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. To date, no illnesses have been reported. This recall is in response to a recall by Kenny's Farmhouse Cheese of Austin, Kentucky.
Product Quantity	1.21 lbs
Recall Number	F-0868-2013

Product Description	The Blue Kentucky Rose cheese sold in the Nashville, TN, Whole Foods Market store was cut and packaged in clear plastic wrap. It was sold with a Whole Foods Market scale label reading 'Blue Kentucky Rose Kenny's.
Code Info	The Blue Kentucky Rose Kenny's had a PLU of 71113 and includes all sell by dates, which are noted on the scale label.
Classification	Class I
Reason for Recall	Whole Foods Market announces that it is recalling Kenny's Farmhouse Cheese KY BL sold in its Louisville, KY store and Blue Kentucky Rose Kenny's cheese sold in its Nashville, TN store. These cheeses are being recalled because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. To date, no illnesses have been reported. This recall is in response to a recall by Kenny's Farmhouse Cheese of Austin, Kentucky.
Product Quantity	0 lbs - it was found that the TN store never received the recalled lots
Recall Number	F-0869-2013

Class I Food/Cosmetics Event

Event ID	63735
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Nov-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Maplehurst Deli-Bake South Inc
City	Carrollton
State	GA
Country	US
Distribution Pattern	FL & GA

Associated Products

Product Description	Publix 7 Yellow Special Blend Layers, Net Wt. 14.25 lbs. (24 count), frozen in bulk paper cartons to be frosted and sold individually at the retail stores.
Code Info	Lot numbers: 2311B00610, 2311B00611, 23110C00611, Lot 231C00610 and 2311A00611.
Classification	Class I
Reason for Recall	Product sample was found to be positive for Listeria monocytogenes.
Product Quantity	859 cases (24 units per case)
Recall Number	F-0871-2013

Product Description	Publix 7 Chocolate Split Layers, Net Wt. 12.75 lbs. (24 count), frozen in bulk paper cartons to be frosted and sold individually at the retail stores.
Code Info	Lot numbers: 2311B00610, 2311B00611, 23110C00611, Lot 231C00610 and 2311A00611.
Classification	Class I
Reason for Recall	Product sample was found to be positive for Listeria monocytogenes.
Product Quantity
Recall Number	F-0872-2013

Class I Food/Cosmetics Event

Event ID	63747
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Oct-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Michael's Seafood Inc. DBA Michael's Gourmet & Delicacies
City	Miami
State	FL
Country	US
Distribution Pattern	Products was distributed in Florida.

Associated Products

Product Description	Alaskan Wild Smoked Sockeye Salmon in vacuum packed plastic package, labeled in part: MICHAEL'S WILD SOCKEYE SMOKED SALMON*INGREDIENTS: WILD ALASKAN SOCKEYE SALMON, SALT, SUGAR, NATURAL HARDWOOD SMOKE.KEEP FROZEN UNTIL USE/THAWED UNDER REFRIGERATION IMMEDIATELY BEFORE USE.DISTRIBUTED BY: MICHAEL'S SEAFOOD INC. 500 NE 185TH STREET, MIAMI FL 33179.READY TO EAT WITHIN 3 DAYS AFTER OPENING OR BEFORE SELL BY DATE.**
Code Info	Batch #1443
Classification	Class I
Reason for Recall	Michael's Gourmet Delicacies, Miami, FL is recalling their Alaskan Wild Smoked Sockeye Salmon, Batch #1443 (4oz., 8 oz., 16 oz. and Trimmings) after a sample of 4 oz. Smoked Sockeye Salmon tested positive for Listeria Monocytogenes.
Product Quantity	2,440 pieces and 250 lbs. of Trimmings
Recall Number	F-0866-2013

Class I Food/Cosmetics Event

Event ID	63750
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Nov-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Capital City Fruit Co.
City	Norwalk
State	IA
Country	US
Distribution Pattern	The product was distributed to IA, MO, NE, MN and WI.

Associated Products

Product Description	Cherry tomatoes packaged in 1 pint clear, plastic clamshells. The clamshells are packaged either 9/1-pint clamshells or 12/1-pint clamshells per case.
Code Info	P96290001 date code: 4604 P96330002 date code: 4605 P96477001 date code: 4606 P96368001 date code: 4605 P96500001 date code: 4701 P96313001 date code: 4604 P96330007 date code: 4605 P96290006 date code: 4604 P96500006 date code: 4701
Classification	Class I
Reason for Recall	The recalled cherry tomatoes are associated with the Rio Queen Citrus, Inc. recall received on November 12, 2012 and used in the packaging of certain lots of Capital Brand Clamshell Cherry tomatoes have the potential to be contaminated with Salmonella.
Product Quantity	283/9/1-pint clamshell cases and 190/12/1-pint clamshell cases
Recall Number	F-0867-2013

Class I Food/Cosmetics Event

Event ID	63928
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Dec-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Udi's Healthy Foods,Granola & Gluten Free
City	Denver
State	CO
Country	US
Distribution Pattern	US Distribution: 5 direct accounts in WA, CA, CO with subaccount distribution to WA, CA, CO, NV, UT, MT, ID, and OR.

Associated Products

Product Description	Udi's gluten free au naturel granola in 12 ounce clear plastic bag, UPC 6-98997-80615-8, best by 041913 12265 1.
Code Info	UPC 6-98997-80615-8 Best by 041913 122565 1
Classification	Class I
Reason for Recall	Product may contain undeclared almonds.
Product Quantity	3510 - 12 ounce bags shipped (585 cases)
Recall Number	F-0864-2013

Class I Food/Cosmetics Event

Event ID	63980
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Dec-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Multiexport Foods, Inc.
City	Miami
State	FL
Country	US
Distribution Pattern	Alabama, Arkansas, Alaska, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Montana, Missouri, Mississippi, Nebraska, North Carolina, New Hampshire, New Jersey, New York, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Washington, Virginia, Wisconsin and West Virginia

Associated Products

Product Description	Product labeled in part: *PARAMOUNT RESERVEPRODUCT OF CHILE FARM RAISED ATLANTIC SALMON PACKED BY: ALIMENTOS MULTIEXPORT S.A. DISTRIBUTED BY MULTIEXPORT FOODS INC. 703 WATERFORD WAY (NW 62ND AVE) SUITE 510, MIAMI, FL 33126*
Code Info	Twin Pack 12 oz = 931-59733-2, 933-59753-1, 933-59754-2, 875-701413-1, and 890-701413-1 // 12oz UPC 6 88264 86705 0 ===================================== 1.25 lb Pack = 870-701342-1, 873-701342-1, 870-701344-1, 873-701360-1, 870-701364-1, 873-701364-1, 900-701344-1, 873-701344-1, 873-701360-1, 886-701413-1, 900-701413-1, 873-701344-1, and 870-701360-1 // 1.25 lb UPC 6 88264 86664 0
Classification	Class I
Reason for Recall	The firm initiated the recall based on positive results for Listeria monocytogenes obtained from a composite sample tested by a private laboratory.
Product Quantity
Recall Number	F-0875-2013

Class I Food/Cosmetics Event

Event ID	63998
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	United National Foods (Unfi)
City	Aurora
State	CO
Country	US
Distribution Pattern	Distributed to UNFI distribution centers located in WA, CA, CO, and TX.

Associated Products

Product Description	Kinnikinnick Pie Crust Glutent Free (frozen) weight 290 g/ 10 oz Qty/Pkg: 2, UPC 620133006229, Kinnikinnick Foods 10940 120 Street, Edmonton, AB Canada.
Code Info	US distribution: BB2013NO30; BB2013DE12; BB2013DE13; BB2013DE14; BB2013DE17.
Classification	Class I
Reason for Recall	UNFI Aurora, Colorado is recalling certain Kinnikinnick Pie Crusts (frozen) because they were notified by the manufacturer, Kinnikinnick Foods (Alberta, Canada) that the products contain eggs and are not identified in the finished product labeling.
Product Quantity	56 x 10 oz packages
Recall Number	F-0865-2013

Class II Biologics Event

Event ID	42599
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Jun-06
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Biomat USA, Inc.
City	Salt Lake City
State	UT
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	0630000144, 0630000390
Classification	Class II
Reason for Recall	Blood products, collected from a donor who received a piercing within one year of donation, were distributed.
Product Quantity	2 units
Recall Number	B-0322-13

Class II Biologics Event

Event ID	42601
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Jun-06
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Biomat USA, Inc.
City	Salt Lake City
State	UT
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	0630000313
Classification	Class II
Reason for Recall	Blood product, collected from a donor who received a piercing within one year of donation, was distributed.
Product Quantity	1 unit
Recall Number	B-0323-13

Class II Biologics Event

Event ID	42750
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Jun-06
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Biomat USA, Inc.
City	Salt Lake City
State	UT
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	0630001318
Classification	Class II
Reason for Recall	Blood product, collected from a donor who received a piercing within one year of donation, was distributed.
Product Quantity	1 unit
Recall Number	B-0324-13

Class II Biologics Event

Event ID	42877
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Jul-06
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Community Blood Center of the Ozarks
City	Springfield
State	MO
Country	US
Distribution Pattern	Austria

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	6702463
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-0204-13

Class II Biologics Event

Event ID	49158
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-May-08
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	8160052763, 8160051047, 8160050780, 8160050356, 8160048823, 8160048574, 8160046973, 8160044948, 8160044626, 8160044266, 8160044047, 8160043643, 8160043634, 8160042902, 8160042819, 8160039198, 8160039056, 8160037466, 8160036624, 8160036207, 8160034821, 8160034135, 8160033992, 8160033693, 8160033432, 8160032439
Classification	Class II
Reason for Recall	Blood products, collected from a donor who received a tattoo within one year of donation, were distributed.
Product Quantity	26 units
Recall Number	B-0325-13

Class II Biologics Event

Event ID	49910
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
City	Seattle
State	WA
Country	US
Distribution Pattern	Washington

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced Irradiated
Code Info	W141608084774
Classification	Class II
Reason for Recall	Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Product Quantity	1 unit
Recall Number	B-0218-13

Class II Biologics Event

Event ID	50250
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-May-08
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Source Plasma
Code Info	0420047676, 0420047864, 0420049894, 0420058168
Classification	Class II
Reason for Recall	Blood products, collected from a donor who received a tattoo within one year of donation, were distributed.
Product Quantity	4 units
Recall Number	B-0326-13

Class II Biologics Event

Event ID	50662
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Nov-08
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Source Plasma
Code Info	I52016184, I52016394, I52018262, I52018570, I52018970, I52019242, I52019495, I52019724, I52022606, I52020929, I52021091, I52021531, I52021688
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity	13 units
Recall Number	B-0044-13

Class II Biologics Event

Event ID	50671
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Nov-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	W141608653413
Classification	Class II
Reason for Recall	Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Product Quantity	1 unit
Recall Number	B-0219-13

Class II Biologics Event

Event ID	50672
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Nov-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	Platelets Pooled
Code Info	W141608253881
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	1 unit
Recall Number	B-0216-13

Product Description	Red Blood Cells Leukocytes Reduced Irradiated
Code Info	W141608253881
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	1 unit
Recall Number	B-0217-13

Class II Biologics Event

Event ID	50954
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Jun-08
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Source Plasma
Code Info	366114186, 366112717, 366111503, 366113827, 366110539, 366110229, 366109212, 366102779, 366101468, 366100729, 366099619, 366098290, 366096881, 366096418, 366094371, 366093295, 366091439, 366091305, 366087915, 366087494, 366086570, 366084819, 366084594, 366083584, 366083319, 366081603, 366081414, 366080176, 366079795, 366077808, 366077428, 366076904, 366075364, 366074966, 366074174, 366073803, 366073008, 366072170, 366071460, 366071145, 366070369, 366068705, 366068050, 366067625, 366065135, 366065088, 366049285, 366048534, 366048220, 366047767, 366046406, 366045572, 366044844, 366044738, 366043964, 366043723, 366043313, 366042910, 366042564, 366041779, 366041598, 366040691, 366040325, 366039315, 366038536, 366037633, 366037133, 366036815, 366036174, 366036017, 366034409, 366034140, 366032820, 366032471, 366031837, 366031504, 366030946, 366030561, 366030071, 366029625, 366029090, 366028713, 366028238, 366027747, 366027321, 366026861, 366025865, 366025246, 366024526, 366024038, 366023589, 366023138, 366022682, 366022179, 366021714, 366021250, 366020842, 366020279, 366019308, 366018970, 366018247, 366017925, 366016988, 366016619, 366015248, 366014789, 366014164, 366013846, 366013044, 366010830, 366010513, 366009717, 366009311, 366008834, 366008231, 366007661, 366007316, 366006344, 366005384, I52062487, I52062224, I52061675, I52061454, I52060803, I52060608, I52059995, I52059786, I52058636, I52058376, I52057692, I52057317, I52048664, I52048466, I52047404, I52047110, I52046647, I52046418, I52043742, I52043708,366111027
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	139 units
Recall Number	B-0205-13

Class II Biologics Event

Event ID	52276
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Mar-09
Initial Firm Notification of Consignee or Public	FAX

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	3750018826; 3750018468; 3750018140; 3750017888; 3750017558; 3750017267; 3750016872; 3750016618; 3750016294; 3750016103; 3750015912; 3750015355; 3750015165; 3750014628; 3750014478; 3750013901; 3750019392; 3750019209; 3750013791; 3750013274; 3750012705; 3750012296; 3750011663; 3750011357; 3750010704; 3750010364; 3750009783; 3750009359;3750008672; 3750008402
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was permanently deferred, were distributed.
Product Quantity	30
Recall Number	B-0207-13

Class II Biologics Event

Event ID	53059
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Jan-09
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Biomat USA, Inc.
City	Amarillo
State	TX
Country	US
Distribution Pattern	Spain

Associated Products

Product Description	Source Plasma
Code Info	0020185088, 0020184599, 0020184373, 0020184089, 0020183872
Classification	Class II
Reason for Recall	Blood products, which were not quarantined subsequent to receiving information regarding high risk behavior, were distributed.
Product Quantity	5 units
Recall Number	B-0146-13

Class II Biologics Event

Event ID	61707
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Mar-12
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W128711240444
Classification	Class II
Reason for Recall	Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Product Quantity	1 unit
Recall Number	B-0199-13

Class II Devices Event

Event ID	61718
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	23-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Stryker Howmedica Osteonics Corp.
City	Mahwah
State	NJ
Country	US
Distribution Pattern	Nationwide distribution, including the states of NY, NJ, CA and FL.

Associated Products

Product Description	Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.
Code Info	Catalog Number: 6021-2530 Lot #40264005 Catalog Number: 6021-3535 Lot #40163005. This lot was not received in the US.
Classification	Class II
Reason for Recall	Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix.
Product Quantity	6021-2530- four units; 6021-3535-
Recall Number	Z-0656-2013

Class II Devices Event

Event ID	62121
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Mar-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Maquet Cardiovascular, LLC
City	Wayne
State	NJ
Country	US
Distribution Pattern	Worldwide Distribution - USA including ID and Fl and Internationally to United Arab Emirates, France, Luxembourg, Poland, Spain, Sweden, Germany, Italy, Netherlands, Republic of China, Spain, Sweden, and Thailand

Associated Products

Product Description	CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.
Code Info	510K K112372 Device Listing Number D132687 US Customer IABPs CA202159K1 CA202167K1 CA203492L1 CA203494L1 International Customer IABPs CA203486L1 CA202155K1 CA202161K1 CA203487L1 CA203490L1 CA203507L1 CA204330L1 CA204328L1 CA203505L1 International Company Owned IABPs CA204327L1 CA202150K1 CA203506L1 CA204324L1 CA204326L1 CA202163K1 CA202169K! CA203497L1 CA203498L1 CA203496L1 CA203503L1 CA203488L1 CA203493L1 CA203508L1 CA204337L1 CA203502L1
Classification	Class II
Reason for Recall	In the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly, a prominent connector cord between the Cardiosave IABP housing and the dual display head which secured atop the IABP may fail as a result of mishandling.
Product Quantity	29 units (total)
Recall Number	Z-0662-2013

Class II Devices Event

Event ID	62950
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Zoll Circulation, Inc.
City	Sunnyvale
State	CA
Country	US
Distribution Pattern	Worldwide distribution.

Associated Products

Product Description	AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.
Code Info	all
Classification	Class II
Reason for Recall	Complaints associated with an unexpected stop in AutoPulse compressions.
Product Quantity	3881 in US, 1846 ROW.
Recall Number	Z-0658-2013

Class II Devices Event

Event ID	63030
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Philips Medical Systems North America Co. Phillips
City	Bothell
State	WA
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and the countries of Japan and Malaysia.

Associated Products

Product Description	Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
Code Info	1)Philips brand FRx Model Number 861304 under 510(k) K050004, sold nationally and Internationally, Serial numbers range from BO4L-00001 through B12F-00286 and represents 181,226 devices; 2) Laerdal brand FRx Model Number 861305 unfrt 510(k) K050004, sold nationally and Internationally, serial numbers range from B04L-00013 through B12E-04135 and represents 20,372 devices. Please note the serial number range represents first and last serial number for each model. Serial numbers are not continguous.
Classification	Class II
Reason for Recall	Philips determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305), OnSite (models M5066A and M5067A), or HeartStart Home (model M5068A) automated external defibrillators (AEDs) shipped between December 2005 and July 2012. Philips had determined there is a need to emphasize the importance of all owners contacting their local Philips representative if an affected FRx or HS1 AED has emitted a pattern of triple chirps. If the device is emitting a pattern of triple chirps, it is a signal that the defibrillator's behavior needs to be investigated by Philips.
Product Quantity	201,598
Recall Number	Z-0642-2013

Product Description	Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
Code Info	HS1 product family all start with A in the serial number and break down into 3 catalog numbers - M5066A, M5067A and M5068A: 1) M5066A (referred to as Onsite or HS1), Philips brand, 510 (k) = K020715, sold nationally and internationally, serial numbers range from A021-00038 through A12E-03490, with 306,108 total devices. 2) M5067A, Philips brand 510(k) = K040904, sold nationally and internationally, serial numbers range from A05C-00727 through A12D-01406, with 978 total devices. 3) M5068A, Philips brand 510(k) = K020715, sold nationally and internationally, serial numbers range from A021J-00207 through A12E-01900, with 22,760 total devices 4) M5066A, Laerdal brand, 510 (k) = K020715, sold internationally, serial numbers range from A021-00036 through A12D-02148, with 60,433 total devices. 5) M5067A, Laerdal brand, sold as Home device- cleared for OTC on initial 510(k) = K040904, serial numbers range from A021-00133 through A11B-00970, with 8659 total devices. 6) M5068A, Laerdal brand, 510(k) = K020715, sold internationally, serial numbers range from A02K-00172 through A11H-00868, with 5217 total devices. Please note the serial number range represents first and last serial number for each model. Serial numbers are not continguous. Laerdal is a distribution partner in EU and Canada, sold internationally
Classification	Class II
Reason for Recall	Philips determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305), OnSite (models M5066A and M5067A), or HeartStart Home (model M5068A) automated external defibrillators (AEDs) shipped between December 2005 and July 2012. Philips had determined there is a need to emphasize the importance of all owners contacting their local Philips representative if an affected FRx or HS1 AED has emitted a pattern of triple chirps. If the device is emitting a pattern of triple chirps, it is a signal that the defibrillator's behavior needs to be investigated by Philips.
Product Quantity	Estimate 613,000 devices shipped
Recall Number	Z-0643-2013

Class II Devices Event

Event ID	63226
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Mar-12
Initial Firm Notification of Consignee or Public

Recalling Firm	Surgical Tissue Network, Inc.
City	Orlando
State	FL
Country	US
Distribution Pattern	Worldwide Distribution including Turkey, Greece, & Mexico.

Associated Products

Product Description	Ultrafill DBM labeled in part: *TISSUENETSterilized by T10^6 (r)Description: UltraFill DBMSize: 1ccProduct Code: RT53001Donated Human Tissue AllograftSINGLE PATIENT USE ONLYFOR INTERNATIONAL USE ONLYSee Package Insert for Additional Information* TissueNet's Porcine DBM product line is used as a bone void filler
Code Info	Product Code: RT53001 Tissue ID: TN29041-11-0072 Through TN29041-11-0081; and TN29041-11-0083 through TN29041-11-0119
Classification	Class II
Reason for Recall	Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates.
Product Quantity	25 units
Recall Number	Z-0651-2013

Product Description	UltraFill DBM labeled in part: *TISSUENETSterilized by T10^6 (r)Description: UltraFill DBMSize: 5ccProduct Code: RT53005Donated Human Tissue AllograftSINGLE PATIENT USE ONLYFOR INTERNATIONAL USE ONLYSee Package Insert for Additional Information* TissueNet's Porcine DBM product line is used as a bone void filler.
Code Info	Product Code: RT53005 Tissue ID: TN48005-11-0021 through TN48055-11-0059; TN48055-11-0070 through TN48055-11-0075; TN58063-11-0101 through TN58063-11-0142; TN61039-11-0031 through TN61039-11-0097; TN70037-11-0017 through TN70037-11-0018; TN70037-11-0020 through TN70037-11-0037; TN74060-11-0021 through TN74060-11-0047; TN74060-11-0050 through TN74060-11-0056
Classification	Class II
Reason for Recall	Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates.
Product Quantity	208 units
Recall Number	Z-0652-2013

Product Description	UltraFill DBM labeled in part: *TISSUENETSterilized by T10^6 (r)Description: UltraFill DBMSize: 10ccProduct Code: RT53010Donated Human Tissue AllograftSINGLE PATIENT USE ONLYFOR INTERNATIONAL USE ONLYSee Package Insert for Additional Information* TissueNet's Porcine DBM product line is used as a bone void filler.
Code Info	Product Code: RT53010 Tissue ID: 07-175-330 through 07-175-359; TN61032-11-0017 through TN61032-11-0041; TN62034-11-0001 through TN62034-11-0024; TN62053-11-0155 through TN62053-11-0209; TN67049-11-0291 through TN67049-11-0316; TN70037-11-0020 through TN70037-11-0037; TN74060-11-0021 through TN74060-11-0047; TN74060-11-0050 through TN74060-11-0056
Classification	Class II
Reason for Recall	Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates.
Product Quantity	160 units
Recall Number	Z-0653-2013

Class II Devices Event

Event ID	63231
Status	Completed
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Merit Medical Systems, Inc.
City	Chester
State	VA
Country	US
Distribution Pattern	Distributed in Mississippi and New Jersey.

Associated Products

Product Description	Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F. Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
Code Info	Tray and Kit - K12T-03162B &amp;amp;amp;amp; K12T-02641F/ Lots #T243169, Exp. 2012-12, T276753, Exp. 2013-04, T282465, Exp. 2013-02, T259844, Exp. 2013-02, T265274, Exp. 2013-02, Chloride Injection Lot 05-201-JT
Classification	Class II
Reason for Recall	Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one confirmed customer report where four separate particulate issues were identified in four individual flexible containers. The particular matter may result acutely in local inflammation, phlebitis and/or generalized low-level allergic response to the particulate and/or embolize to other organs in the body.
Product Quantity	422 total kits/trays
Recall Number	Z-0663-2013

Class II Biologics Event

Event ID	63326
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Aug-12
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Red Blood Cells
Code Info	2723207;
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-0281-13

Product Description	Fresh Frozen Plasma
Code Info	2723207;
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-0282-13

Product Description	Platelets Pooled Leukocytes Reduced Irradiated
Code Info	2930687;
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-0283-13

Class II Devices Event

Event ID	63355
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Stryker Communications, Inc.
City	Flower Mound
State	TX
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and Internationally to Australia, Japan, Taiwan, Canada, United Kingdom, France, Netherlands, Spain, Mexico, India, Korea, Singapore, New Zealand, Hong Kong, Philippines and Brazil.

Associated Products

Product Description	(l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker Flat Panel & Navigation Arm The Spring Arm Circlip is part of the Stryker Spring Arm used in multiple configurations as a component of the (1)Visum Halogen Surgical Light, (2)Visum LED Surgical Light, and (3)Stryker Flat Panel & Navigation Arm. The Spring Arm that is subject to this field action suspends loads, is a conduit for power/data, and facilitates multi-directional movement. The Spring Arms that have been identified within scope are replacement parts that have potentially been serviced incorrectly.
Code Info	Code Number and Product Name: 0682000112-SPRING ARM, LIGHT 12-18KG, 0682000211 - FLAT PANEL SPRING ARM, ONDAL SUSPENSION, 15-21KG, 0682000212 - FLAT PANEL SPRING ARM, ONDAL SUSP., 12-18KG, 0682000226 - SPRING ARM,3.5-7KG,NAVIGATION, 0682000228 - SPRING ARM, LIGHT 9-15KG, 0682001062 - PKG EDS LIGHT SUSPENSION CENTRAL AXIS 5P/FP, 0682001270 - 9-POLE SPRING ARM, AC 2000,15-21 KG, 0682001274 - 5-POLE SPRING ARM AC 2000 15-21 KG, 0682400034 - FLAT PANEL SPRING ARM, EDS SUSPENSION, 15-21KG, 0682400059 - UNIVERSAL YOKE SPRING ARM RETROFIT KIT, 06824000591 - UNIVERSAL YOKE &amp;amp;amp; SPRING ARM RETROFIT KIT, INT, 0682400151 - LOW CEILING SPRING ARM, 5P SIDE MOUNT, 0682400152 - LOW CEILING SPRING ARM, 9P SIDE MOUNT, 0682400169 - 5-POLE SPRING ARM AC 2000 9-15KG, CARDINAL, 0682400207 - STANDARD SPRING ARM WITH BEARING, 5P, 0682400208 - STANDARD SPRING ARM WITH BEARING, 9P, and 0682400365 - FLAT PANEL SPRING ARM WITH ERA ADAPTER BEARING.
Classification	Class II
Reason for Recall	Stryker has become aware that there is a low likelihood of incomplete engagement of the Spring Arm Circlip during service or replacement of the Spring Arm. If the Spring Arm Circlip is not fully seated, the Spring Arm could separate and fall along with the surgical lights or monitors mounted to the end of the Spring Arm. To date, there have been no serious injuries reported from the incomplete engagement of the Spring Arm Circlip.
Product Quantity	United States: 1,082 units and Outside United States: 199 units
Recall Number	Z-0657-2013

Class II Biologics Event

Event ID	63398
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-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; California

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced Irradiated
Code Info	W141610180553;
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-0262-13

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W141610178698;
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-0263-13

Product Description	Red Blood Cells
Code Info	W141610173064;
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-0264-13

Class II Biologics Event

Event ID	63414
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-Sep-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	LifeShare Blood Centers
City	Shreveport
State	LA
Country	US
Distribution Pattern	Arkansas

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W036512094817
Classification	Class II
Reason for Recall	Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Product Quantity	1 unit
Recall Number	B-0197-13

Class II Biologics Event

Event ID	63416
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Sep-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	LifeShare Blood Centers
City	Lake Charles
State	LA
Country	US
Distribution Pattern	Louisiana, Texas

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W036512045868
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity	1 unit
Recall Number	B-0313-13

Product Description	Fresh Frozen Plasma
Code Info	W036512045868
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity	1 unit
Recall Number	B-0314-13

Class II Devices Event

Event ID	63559
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Sep-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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

Associated Products

Product Description	The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the inserter shaft allowing the lateral grasping arms to secure the implant. Once the implant is inserted and its position confirmed radiographically, the inserter is removed from the implant by turning the shaft knob counterclockwise to loosen the lateral grasping arms from the implant.
Code Info	Part number: 96-701-10001; Lot numbers: &amp;amp;amp;quot; 61946711, 61946712, 61991588, 62000412,
Classification	Class II
Reason for Recall	Zimmer Spine, Inc. is initiating a voluntary medical device correction to the Surgical Technique (L1607) for the TM Ardis Inserter because Zimmer has received complaints reporting difficulty in turning the implant release knob after final positioning of the TM Ardis interbody spacer implant. There has been two reports where the inserter instrument was inadvertently removed from the patient with the implant still engaged. The correction includes revised directions explaining the technique to remove the implant from the inserter.
Product Quantity	170
Recall Number	Z-0659-2013

Class II Food/Cosmetics Event

Event ID	63826
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Dec-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Lifevantage Corp
City	Sandy
State	UT
Country	US
Distribution Pattern	Sale of products through a network of independent distributors, preferred customers and end consumers in the United States, Japan, Australia and Mexico. Sales also directly to end consumers for personal consumption in Canada. Independent distributors consume the product themselves and in some cases sell the product or provide the product gratis to those potentially interested in LifeVantage. Preferred customers purchase the products on a monthly, auto-ship basis directly from Life Vantage. Other end consumers purchase directly from LifeVantage via the website and are assigned to a distributor.

Associated Products

Product Description	Protandim is packaged in a 90cc cylindrical blue bottle with a silver cap and contains thirty caplets per bottle. Label has a blue background with multi-colored print and pictorial stating in part:Lifevantage PROTANDIM *the Nrf2 Synergizer Dietary Supplement I 30 Caplets.
Code Info	Lot # / Expiration Date: 12-0258 / 7/2/2015;12-0259 / 7/3/2015; 12-0292 / 7/9/2015; 12-0294 / 7/11/2015; 12-0295 / 7/12/2015; 12-0304 / 7/18/2015; 12-0306 / 8/16/2015; 12-0307 / 8/17/2015; 12-0373 / 8/21/2015; 12-0382 / 9/21/2015.
Classification	Class II
Reason for Recall	Possible inclusion of small metal fragments embedded within the tablets of Protandim Dietary Supplement.
Product Quantity	247,896 bottles
Recall Number	F-0876-2013

Class II Devices Event

Event ID	63829
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Horiba Instruments, Inc dba Horiba Medical
City	Irvine
State	CA
Country	US
Distribution Pattern	Nationwide in the US, including the states of CA, MI, IN, FL, and GA.

Associated Products

Product Description	ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Code Info	Lot/Serial# PML0937
Classification	Class II
Reason for Recall	Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software versions are Versions 9.0.1, 9.0.2, 8.0x and below.
Product Quantity	10 units
Recall Number	Z-0645-2013

Class II Devices Event

Event ID	63842
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Nov-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Applied Medical Resources Corp
City	Rancho Santa Margarita
State	CA
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and France.

Associated Products

Product Description	Laparoscope, general&plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
Code Info	Lot Number: 1179107
Classification	Class II
Reason for Recall	Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain exposed after shield deployment. Further use of any affected product should cease immediately. The affected model number is CTB71, and the affected lot is 1179107.
Product Quantity	72 units
Recall Number	Z-0644-2013

Class II Devices Event

Event ID	63850
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Biomet, Inc.
City	Warsaw
State	IN
Country	US
Distribution Pattern	Worldwide Distribution -- US (nationwide) including the countries of , Canada, Japan, Argentina, Australia ,Netherlands, Europe and Chile.

Associated Products

Product Description	PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Code Info	Part 113950 Lot 093540, 093550,093570,093580,093590,093600,093610,093620,093720, 093730,093740,093760,093770,093780,282590,282600,282620,282630, 282680,282700,282710,489160,489180,489200,489210,489770,489780, 489790,714480,714550,714570,714700,714730,722210,722250,722280, 984770,984780,984790,984800,984810,984820,984830,984840, and 984850
Classification	Class II
Reason for Recall	Biomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post, following an investigation which identified that the male thread of the post may be oversized. This oversized condition can vary in degree and may lead to the following three events: 1) If the PT Hybrid Glenoid Post is not fully seated into the Hybrid Base and the implant construct is implanted, then a gap of 1-3 mm will be present. 2) If excessive torque is applied to assemble the post into the base, the PT Hybrid Glenoid Post drive tip could break off. 3) The PT Hybrid Glenoid Post may not thread at all into the Hybrid Glenoid Base, which would prevent assembly of the two implant components.
Product Quantity	1050
Recall Number	Z-0660-2013

Class II Devices Event

Event ID	63877
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Advanced Sterilization Products
City	Irvine
State	CA
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and internationally to the following countries: AR, CO, TW, SI, AU, MX, MY, HU, PH, BE, FR, DE, IE, IT, ES, NO, CH, and GB.

Associated Products

Product Description	STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD NX Cassettes are only used in conjunction with the STERRAD NX Sterilization system.
Code Info	Lot # 11J037, 11L038, 11J033
Classification	Class II
Reason for Recall	Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it does not have adequate data to support the entire duration of the product's labeled shelf-life.
Product Quantity	12,280 units
Recall Number	Z-0661-2013

Class II Devices Event

Event ID	63892
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	Siemens Healthcare Diagnostics, Inc.
City	Newark
State	DE
Country	US
Distribution Pattern	Distributed in the states of CA, FL, IL, KS, MA, MI, MN, MS, NM, NY, NC, OH, OR, PA, TN, TX, UT, and WA.

Associated Products

Product Description	Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended for use in the quantitative analysis of Phenobarbital in human serum or plasma.
Code Info	Emit(R) 2000 Phenobarbital Assay (OSR4D229) lots 1237 and 1264 and/or Syva(R) Emit(R) Phenobarbital Assay (4D019UL), lots E1, E2, and E3.
Classification	Class II
Reason for Recall	Firm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and the Syva(R) Emit(R) 2000 Phenobarbital (4D019UL) lots E1, E2, and E3 as an application if the AU(R) System is used, the issue may be experienced. Firm has found that within-run imprecision of the recalled lots frequency of outliers that differ from the expected value by 20%. This is an expansion of the recall initiated in July, 2012 to include additional lots.
Product Quantity	1979 cartons
Recall Number	Z-0664-2013

Class II Devices Event

Event ID	63896
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	02-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	California Medical Laboratories Inc
City	Costa Mesa
State	CA
Country	US
Distribution Pattern	Worldwide Distribution - USA including AZ, FL, CA, LA, CO, and MS. Internationally to Canada, Israel, Greece, Hong Kong, India, Ireland, Jordan, Lebanon, Malaysia, Netherlands, Russia, Saudi Arabia, South Africa and Spain.

Associated Products

Product Description	Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.
Code Info	Catalog No: SU-12202 Lot No: S112462, S111480
Classification	Class II
Reason for Recall	California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.
Product Quantity	S112462=995 units & S111480 1430 units
Recall Number	Z-0649-2013

Product Description	Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated for use to remove excess fluid from the surgical field.
Code Info	Catalog No: SU-12202NS Lot No: S112468N, S120196N, S120197N
Classification	Class II
Reason for Recall	California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.
Product Quantity	S112468N=1000 units, S120196N=1400 units, & S120197N=1200 units
Recall Number	Z-0650-2013

Class II Food/Cosmetics Event

Event ID	63932
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Dec-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Dawn Food Products, Inc.
City	Jackson
State	MI
Country	US
Distribution Pattern	Distribution Centers in GA, IL, Ca, TX,

Associated Products

Product Description	Sam's Club Artisan Fresh Miniature Candy Cookie Carton 504 Count , 28.35 lb (12.89 kg)
Code Info	2 348 18 2 349 18
Classification	Class II
Reason for Recall	Outer case of Sam's Artisan Fresh Miniature Candy Cookie contained White Chocolate Macadamia Nut Cookie and separate labels matching the White Chocolate Macadamia Nut Cookies.
Product Quantity	1650 cases
Recall Number	F-0862-2013

Class II Devices Event

Event ID	63938
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	Concentric Medical Inc
City	Mountain View
State	CA
Country	US
Distribution Pattern	US (nationwide) including the states of CA, FL, GA, OR and TN.

Associated Products

Product Description	FlowGate Balloon Guide Catheter, Manufactured by Concentric Medical, Mountain View, CA. FlowGate Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A balloon is flush mounted on the distal end. FlowGate Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.
Code Info	Catalog number 90253, lot # 36140; Catalog number 90254, lot numbers 36009, 36135.
Classification	Class II
Reason for Recall	Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration.
Product Quantity	13 units
Recall Number	Z-0655-2013

Class II Food/Cosmetics Event

Event ID	63944
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-Dec-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	S & M International Inc
City	Bayonne
State	NJ
Country	US
Distribution Pattern	Northeast

Associated Products

Product Description	Yangsheng Duck Eggs Cooked Salted Duck Eggs Content:6 pieces Net Wt. 12.69 oz (360g) S & M (USA0 ENTERPRISE CORP. RED. B/T YUOXIU Bldg. 160-174 Lockhart Road, Man Chai, HK Distributed by: S & M INT'L. INC 100 Pulaski Street, Bayonne NJ 07002 UPC 6949682803568
Code Info	Lot #YS12-02C
Classification	Class II
Reason for Recall	Cooked Salted Duck Eggs have the potential to be contaminated with C. botulinum.
Product Quantity	200 CASES (24 individual packages of 6 eggs each)
Recall Number	F-0863-2013

Class III Biologics Event

Event ID	41848
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Mar-06
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Biomat USA, Inc.
City	Salt Lake City
State	UT
Country	US
Distribution Pattern	Spain

Associated Products

Product Description	Source Plasma
Code Info	0440061470
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-0318-13

Class III Biologics Event

Event ID	41850
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Mar-06
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Biomat USA, Inc.
City	Taylorsville
State	UT
Country	US
Distribution Pattern	Spain

Associated Products

Product Description	Source Plasma
Code Info	0440060645
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-0319-13

Class III Biologics Event

Event ID	41852
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Mar-06
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Biomat USA, Inc.
City	Taylorsville
State	UT
Country	US
Distribution Pattern	Spain

Associated Products

Product Description	Source Plasma
Code Info	0440062579
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-0320-13

Class III Biologics Event

Event ID	41854
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Mar-06
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Biomat USA, Inc.
City	Taylorsville
State	UT
Country	US
Distribution Pattern	Spain

Associated Products

Product Description	Source Plasma
Code Info	0440062480
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-0321-13

Class III Biologics Event

Event ID	42448
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Jun-06
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	LifeServe Blood Center
City	Des Moines
State	IA
Country	US
Distribution Pattern	Iowa; Pennsylvania; CSL fractionator.

Associated Products

Product Description	Red Blood Cells
Code Info	LX51298
Classification	Class III
Reason for Recall	Blood products, collected from a donor who disclosed taking Dapsone, were distributed.
Product Quantity	1 Unit
Recall Number	B-0201-13

Product Description	Platelets Pooled Leukocytes Reduced
Code Info	LP46813
Classification	Class III
Reason for Recall	Blood products, collected from a donor who disclosed taking Dapsone, were distributed.
Product Quantity	1 Unit
Recall Number	B-0202-13

Product Description	Blood and Blood Products for Reprocessing
Code Info	LX51298
Classification	Class III
Reason for Recall	Blood products, collected from a donor who disclosed taking Dapsone, were distributed.
Product Quantity	1 Unit
Recall Number	B-0203-13

Class III Biologics Event

Event ID	56479
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Mar-10
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	3960036260, 3960040395, 3960045419, 3960044791, 3960049126, 3960038309, 3960041518, 3960042604, 3960044381, 3960045946, 3960049362, 3960041668, 3960036528, 3960037383, 3960039345, 3960040984, 3960046561, 3960047630, 3960038635, 3960039269, 3960037127, 3960038858, 3960042900, 3960048564, 3960037839, 3960040945, 3960043000, 3960036786, 3960037820, 3960043349, 3960043948, 3960044834, 3960036398, 3960038024, 3960038438, 3960049641, 3960046652, 3960036766, 3960037199, 3960036246, 3960038727, 3960039751, 3960046557, 3960047168, 3960048574, 3960041287, 3960035846, 3960037530, 3960041029, 3960041529, 3960042520, 3960048748, 3960040882, 3960048088, 3960038704, 3960039209, 3960039132, 3960043247, 3960046343, 3960040957, 3960036795, 3960046690, 3960047822, 3960048229, 3960048016, 3960043208, 3960038207, 3960038817, 3960039478, 3960039839, 3960044368, 3960045996, 3960039230, 3960042516, 3960043563, 3960048652, 3960049172, 3960048237, 3960038729, 3960039044, 3960041088, 3960042104, 3960043206, 3960040371, 3960047916, 3960049402, 3960040124, 3960041779, 3960043161, 3960046220, 3960036695, 3960048310, 3960036017, 3960037050, 3960039042, 3960040085, 3960040718, 3960043135, 3960049163, 3960038158, 3960041166, 3960043249, 3960038300, 3960039363, 3960039358, 3960043694, 3960046521, 3960037131, 3960037657, 3960039186, 3960036240, 3960042874, 3960037096, 3960043815, 3960044337, 3960045634, 3960035655, 3960038822, 3960038549, 3960039822, 3960040428, 3960040548, 3960041023, 3960041688, 3960042726, 3960037849, 3960047692, 3960044851, 3960040355, 3960039942, 3960040810, 3960037790, 3960036830, 3960037494, 3960040527, 3960040631, 3960045772, 3960046192, 3960047675, 3960047339, 3960040297, 3960045482, 3960036191, 3960036780, 3960038795, 3960040431, 3960045591, 3960046667, 3960049120, 3960049455, 3960045541, 3960039029, 3960038867, 3960048833, 3960049470, 3960040956, 3960041983, 3960042480, 3960036045, 3960042149, 3960044233, 3960038012, 3960042637, 3960046030, 3960042652, 3960041375, 3960036848, 3960043788, 3960048104, 3960048401, 3960039737, 3960040131, 3960040738, 3960043455, 3960040497, 3960037877, 3960038276, 3960040235, 3960042244, 3960043998, 3960037067, 3960039071, 3960041330, 3960044783, 3960048955, 3960039192, 3960040484, 3960046664, 3960039630, 3960045926, 3960047655, 3960048082, 3960049595, 3960041751, 3960042316, 3960042771, 3960048807, 3960036910, 3960039341, 3960039853, 3960040854, 3960038085, 3960040676, 3960044210, 3960044843, 3960049007, 3960049339, 3960047965, 3960037172, 3960040614, 3960038116, 3960038504, 3960039464, 3960036568, 3960039075, 3960037662, 3960038044, 3960037202, 3960038776, 3960041161, 3960042321, 3960046384, 3960039759, 3960040352, 3960043534, 3960042855, 3960040452, 3960037534, 3960036301, 3960039302, 3960041776, 3960046549, 3960038714, 3960042327, 3960041548, 3960039002, 3960037848, 3960040657, 3960036179, 3960037717, 3960047360, 3960044622, 3960048305, 3960047331, 3960037241, 3960049465, 3960049791, 3960048597, 3960037370, 3960040682, 3960048222, 3960048558, 3960042222, 3960042860, 3960043277, 3960036382, 3960040003, 3960040999, 3960037149, 3960037431, 3960040055, 3960040730, 3960043774, 3960044274, 3960045914, 3960036742, 3960037144, 3960039295, 3960048466, 3960041513, 3960041840, 3960043942, 3960047520, 3960048138, 3960042885, 3960045786, 3960035973, 3960036633, 3960037018, 3960039652, 3960049604, 3960041596, 3960043597, 3960044840, 3960047359, 3960048241, 3960042177, 3960048027, 3960038110, 3960040809, 3960044150, 3960048967, 3960038741, 3960036030, 3960037057, 3960041862, 3960041532, 3960044618, 3960043126, 3960043777, 3960036814, 3960039981, 3960041961, 3960040668, 3960041704, 3960038958, 3960039988, 3960039679, 3960047802, 3960035821, 3960037509, 3960039276, 3960039684, 3960049496, 3960041851, 3960042492, 3960046095, 3960045638, 3960048300, 3960048886, 3960049359, 3960037012, 3960044400, 3960040377, 3960040913, 3960037448, 3960038442, 3960045781, 3960041870, 3960038783, 3960042832, 3960047388, 3960038813, 3960037899, 3960039051, 3960039757, 3960040099, 3960042938, 3960044634, 3960047064, 3960037434, 3960041857, 3960044571, 3960049806, 3960038580, 3960039977, 3960044075, 3960047197, 3960047890, 3960048460, 3960048884, 3960038805, 3960039457, 3960040792, 3960042513, 3960047394, 3960040481, 3960043571, 3960040285, 3960047494, 3960049376, 3960038669, 3960041173, 3960039076, 3960044652, 3960048212, 3960038638, 3960039701, 3960043853, 3960039562, 3960042188, 3960042654, 3960043846, 3960046060, 3960046539, 3960048643, 3960039880, 3960040177, 3960045757, 3960036279, 3960040232, 3960039468, 3960040059, 3960041464, 3960049041, 3960039032, 3960040655, 3960042284, 3960035840, 3960036525, 3960041885, 3960043005, 3960044063, 3960044568, 3960047814, 3960047971, 3960048265, 3960040600, 3960043399, 3960040964, 3960040538, 3960046659, 3960042645, 3960040351, 3960046530, 3960047557, 3960037006, 3960048394, 3960040135, 3960042457, 3960042881, 3960037721, 3960039313, 3960038374, 3960039233, 3960047765, 3960040684, 3960047658, 3960048270, 3960044241, 3960036548, 3960038566, 3960039556, 3960039939, 3960041586, 3960041965, 3960043016, 3960047185, 3960045394, 3960037846, 3960038816, 3960045022, 3960046055, 3960043626, 3960045478, 3960046929, 3960047626, 3960037635, 3960045574, 3960038615, 3960039151, 3960040769, 3960042236, 3960046401, 3960037189, 3960048148, 3960049392, 3960037709, 3960040047, 3960045877, 3960046920, 3960048350, 3960035984, 3960037105, 3960036792, 3960045547, 3960045938, 3960047888, 3960040822, 3960041887, 3960037783, 3960045918, 3960039455, 3960038499, 3960038881, 3960039353, 3960038659, 3960038290, 3960043447, 3960038216, 3960038914, 3960039498, 3960039906, 3960040742, 3960041762, 3960042184, 3960043123, 3960037644, 3960038187, 3960040562, 3960046936, 3960048819, 3960042170, 3960044129, 3960044360, 3960049065, 3960047568, 3960035850, 3960039654, 3960043157, 3960045569, 3960037351, 3960038701, 3960039911, 3960046082, 3960035445, 3960036062, 3960042426, 3960044872, 3960047774, 3960038429, 3960039493, 3960040075, 3960039725, 3960040071, 3960040876, 3960041893, 3960043582, 3960039099, 3960040092, 3960046701, 3960048783, 3960041013, 3960037648, 3960038261, 3960039647, 3960040224, 3960038340, 3960038046, 3960038524, 3960039027, 3960041506, 3960037528, 3960040550, 3960036983, 3960039598, 3960040194, 3960041621, 3960041579, 3960045431, 3960038963, 3960040593, 3960040976, 3960042267, 3960038593, 3960046481, 3960048363, 3960047089, 3960047544, 3960045909, 3960048260, 3960048805, 3960039289, 3960040168, 3960043798, 3960044239, 3960045227, 3960037714, 3960040479, 3960041758, 3960045040, 3960047797, 3960042196, 3960037194, 3960038182, 3960038788, 3960041213, 3960043540, 3960044324, 3960045375, 3960037081, 3960038305, 3960039877, 3960043603, 3960046216, 3960048194, 3960046052, 3960041436, 3960039887, 3960037500, 3960036483, 3960037138, 3960039272, 3960041695, 3960043164, 3960043008, 3960048462, 3960038051, 3960037088, 3960048775, 3960045511, 3960048093, 3960048746, 3960038745, 3960043806, 3960035828, 3960038630, 3960044838, 3960048209, 3960047552, 3960046550, 3960046987, 3960036097, 3960037626, 3960037989, 3960040763, 3960041181, 3960044116, 3960039224, 3960043870, 3960049675, 3960038650, 3960047515, 3960048874, 3960035709, 3960041573, 3960042174, 3960038088, 3960036854, 3960038344, 3960038930, 3960040334, 3960043945, 3960045474, 3960046032, 3960041897, 3960042939, 3960036113, 3960043758, 3960043243, 3960040430, 3960037995, 3960035436, 3960040660, 3960037703, 3960041217, 3960036425, 3960035708
Classification	Class III
Reason for Recall	Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity	628 units
Recall Number	B-0301-13

Class III Biologics Event

Event ID	59696
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Jun-11
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W117011433853, W117011433861, W117011433878, W117011433887
Classification	Class III
Reason for Recall	Blood products, collected using scales that did not meet the acceptable quality control specifications, were distributed.
Product Quantity	4 units
Recall Number	B-0214-13

Product Description	Red Blood Cells Leukocytes Reduced Irradiated
Code Info	W117011433855
Classification	Class III
Reason for Recall	Blood products, collected using scales that did not meet the acceptable quality control specifications, were distributed.
Product Quantity	1 unit
Recall Number	B-0215-13

Class III Biologics Event

Event ID	63415
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Aug-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	LifeShare Blood Centers
City	Shreveport
State	LA
Country	US
Distribution Pattern	Louisiana

Associated Products

Product Description	Cryoprecipitated AHF, Pooled
Code Info	W036512061595
Classification	Class III
Reason for Recall	Blood product, which reached an unacceptable temperature during storage, was distributed.
Product Quantity	1 unit
Recall Number	B-0198-13

Class III Devices Event

Event ID	63852
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	Siemens Healthcare Diagnostics
City	Tarrytown
State	NY
Country	US
Distribution Pattern	Worldwide Distribution - USA including CA, GA, IL, IN, MI, MN, NY, and Puerto Rico. Internationally to Agentina, Bolivia, Brazil, Canada, Chile, Guatemala, South Korea, Philippines, Paraguay, Taiwan, and Uraguay,

Associated Products

Product Description	Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.
Code Info	Lots 969 and 970
Classification	Class III
Reason for Recall	The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H) lot 035 calibrator vials are not affected. The darker yellow calibrator vials yield a 15-20% lower dose values compared to the target values. This may result in out of range (+2 SD) controls.
Product Quantity	Lot 969=33 units (29 units foreign) Lot 970=7 units (42 units foreign)
Recall Number	Z-0646-2013

Product Description	Immunoradiometric assay.
Code Info	Lots 831 and 832
Classification	Class III
Reason for Recall	The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H) lot 035 calibrator vials are not affected. The darker yellow calibrator vials yield a 15-20% lower dose values compared to the target values. This may result in out of range (+2 SD) controls.
Product Quantity	Lot 831=19 units (all foreign consignees) and Lot 832=2 units (all foreign consignees)
Recall Number	Z-0647-2013

Product Description	Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.
Code Info	Lots 742 and 743
Classification	Class III
Reason for Recall	The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H) lot 035 calibrator vials are not affected. The darker yellow calibrator vials yield a 15-20% lower dose values compared to the target values. This may result in out of range (+2 SD) controls.
Product Quantity	Lot 742= 8 units all foreign consignees) Lot 743=7 units (all foreign consignees)
Recall Number	Z-0648-2013

Class III Food/Cosmetics Event

Event ID	63883
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-Dec-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Meijer Distribution, Inc
City	Grand Rapids
State	MI
Country	US
Distribution Pattern	199 Meijer stores located in Illinois, Indiana, Kentucky, Michigan, and Ohio may have received product from Meijer distribution centers.

Associated Products

Product Description	Markets of Meijer 16oz Redskin Peanuts
Code Info	Lot 07 2234; Sell by date 12/20/2012 Lot 08 2279; Sell by date 1/1712013 Lot 07 2318; Sell by date 5/3/2013 lot 07 2340; Sell by date 5/3/2013 UPC 8-8692619797-6
Classification	Class III
Reason for Recall	Sodium was not correctly stated on the label.
Product Quantity	15336 units
Recall Number	F-0861-2013

Class III Devices Event

Event ID	63941
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-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 to the following states: AL, AR, CA, CO, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NY, OH, PA, TN, TX and WI.

Associated Products

Product Description	Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(R) tox(TM) Serum Barbiturate and Benzodiazepine Assays as a reference for the semi-quantitative analis of barbiturates and benzodiazepines in human serum.
Code Info	Lot D1
Classification	Class III
Reason for Recall	Incorrect expiration date was assigned to the D1 lot of Emit(R) tox(TM) Serum Calibrators. The correct expiration date is 2013-12-31. The incorrect assigned expiration date is 2014-12-31.
Product Quantity	1,998 cartons
Recall Number	Z-0665-2013

Class III Food/Cosmetics Event

Event ID	63965
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	23-Oct-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	New B.C.N. Trading Inc
City	South Plainfield
State	NJ
Country	US
Distribution Pattern	CT, FL, NJ, NY, PA, & VA

Associated Products

Product Description	Asian Boy (EBQ) Tapioca Stick 3.5 oz (100g) New B.C.N. Trading Inc. 701 Hadky South Plainfield, NJ 07080 MINH NGUYET TRADING CO., LTD. BIN CHANH -HOCHIMINH CITY VIETNAM UPC 627404021822
Code Info	UPC 627404021822
Classification	Class III
Reason for Recall	Tapoica stick contains undeclared sulfites.
Product Quantity	71 cases (50 retail units per carton)
Recall Number	F-0870-2013

Mixed Classification Food/Cosmetics Event

Event ID	63792
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Aug-12
Initial Firm Notification of Consignee or Public	Visit

Recalling Firm	Pastry Food Products Inc.
City	San Juan
State	PR
Country	US
Distribution Pattern	Puerto Rico only

Associated Products

Product Description	TRIGAL*Empanadillas de Pizza (Pizza turnovers)12 ct**Pastry Foods Inc., Rio Piedras, PR
Code Info	none
Classification	Class II
Reason for Recall	Undeclared milk as the source of cheese.
Product Quantity	120 packages of 12 units each
Recall Number	F-0873-2013

Product Description	TRIGAL*Pastelillos Coctel de Pizza (Pizza Mini turnovers)12 ct**Pastry Foods Inc., Rio Piedras, PR
Code Info	none
Classification	Class I
Reason for Recall	Undeclared milk
Product Quantity	12 packages of 12 units each
Recall Number	F-0874-2013

Mixed Classification Biologics Event

Event ID	63327
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Aug-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	Tennessee; Switzerland; Florida

Associated Products

Product Description	Cryoprecipitated AHF, Pooled
Code Info	W036811822350;
Classification	Class II
Reason for Recall	Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity	1
Recall Number	B-0275-13

Product Description	Fresh Frozen Plasma
Code Info	2243062;
Classification	Class II
Reason for Recall	Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity	1
Recall Number	B-0276-13

Product Description	Cryoprecipitated AHF
Code Info	W036809216741; 2479070;
Classification	Class II
Reason for Recall	Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-0277-13

Product Description	Platelets Pooled Leukocytes Reduced
Code Info	W036810821967; W036809821585; W036809813222; 2911209;
Classification	Class II
Reason for Recall	Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity	4
Recall Number	B-0278-13

Product Description	Blood and Blood Products for Reprocessing
Code Info	W036811262717; W036810243696; W036810039414; W036809359200; W036809216741; 2479070;
Classification	Class III
Reason for Recall	Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity	6
Recall Number	B-0279-13

Product Description	Red Blood Cells
Code Info	W036811262717; W036810039414; W036809359200; W036809216741; 2243062; 2479070; W036810243696;
Classification	Class II
Reason for Recall	Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity	7
Recall Number	B-0280-13

Mixed Classification Devices Event

Event ID	63809
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Siemens Healthcare Diagnostics Inc
City	Norwood
State	MA
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,

Associated Products

Product Description	Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek-Stix® Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX® positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
Code Info	Carton/Bottle Lot Number: C9093061B P9093061B C9094081B P9094081B C0097091B P0097091B C0100101C P0100101C C0103042F P0103042F C0106062B P0106062B C91 01022D P91 01022D CP9105052B P9105052B C9108092A P9108092A
Classification	Class III
Reason for Recall	When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25°C (77°F).
Product Quantity	7865
Recall Number	Z-0635-2013

Product Description	Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS® Automated urine Chemistry Analyzer and CLINITEK ATLAS® 10 reagent Pak, CLINITEK ATLAS® Positive and Negative Control Strips provide defined results for color, clarity, glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes. Each CLINITEK ATLAS Positive Control Strip is a firm plastic strip to which are affixed seven separate analyte areas.
Code Info	Carton/Bottle Lot Number: S9093061A P9093061A S9094081A P9094081A S0097091C P0097091C S9093061A P9093061A S9094081A P9094081A S0097091C P0097091C S0100101B P0100101B S0103042A P0103042A S0103042H P0103042H S0106062A P0106062A S9101022A P9101022A S9101022B P9101022B S9105052A P9105052A
Classification	Class III
Reason for Recall	When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25°C (77°F).
Product Quantity	6466
Recall Number	Z-0636-2013

Product Description	Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix® Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX® positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
Code Info	Carton/Bottle Lot Number: C9093061C P9093061C C9094081J P9094081J C0100101D P0100101D C0097091E P0097091E C9101022E P9101022E C0099091D P0099091D C0100101E P0100101E C9101022H P9101022H C9101022J P9101022J C0103042B P0103042B C0103042G P0103042G C0106062D P0106062D C9105052C P9105052C
Classification	Class III
Reason for Recall	When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25°C (77°F).
Product Quantity	16711
Recall Number	Z-0637-2013

Product Description	Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) Catalog Number: 1360L Chek-Stix® Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX® positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
Code Info	Carton/Bottle Lot Number: C9094081C P9094081C C0100101A P0100101A C9101022C P9101022C
Classification	Class III
Reason for Recall	When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25°C (77°F).
Product Quantity	700
Recall Number	Z-0638-2013

Product Description	Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix® Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX® positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
Code Info	Carton/Bottle Lot Number: CP0099091B P0099091B C0100101G P0100101G C0103042E P0103042E
Classification	Class III
Reason for Recall	When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25°C (77°F).
Product Quantity	325
Recall Number	Z-0639-2013

Product Description	Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix® Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX® positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
Code Info	Carton/BottleLot Number: C0099091A P0099091A C0100101 H P0100101 H C0103042C P0103042C
Classification	Class II
Reason for Recall	When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25°C (77°F).
Product Quantity	1130
Recall Number	Z-0640-2013

Product Description	Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix® Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX® positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
Code Info	Carton/Bottle Lot Number: C0099091C P0099091C C0100101F P0100101F C9101022I P9101022I C0103042D P0103042D C0106062E P0106062E
Classification	Class III
Reason for Recall	When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25°C (77°F).
Product Quantity	4642
Recall Number	Z-0641-2013

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