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Enforcement Report - Week of March 13, 2013

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Biologics Devices Drugs Food / Cosmetics Veterinary

Class I Food/Cosmetics Event

Event ID	50900
Status	Completed
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Jan-09
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Tropical Nut & Fruit Inc
City	Columbus
State	OH
Country	US
Distribution Pattern	The recalled product was sold in Tropical's Outlet Store in Columbus, OH.

Associated Products

Product Description	Granulated Peanuts in 1 lb plastic bags.
Code Info	Lot #'s 8148B, 8168B, 8288B & 8289B
Classification	Class I
Reason for Recall	The product is being recalled because it was manufactured using peanut products recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
Product Quantity	390/1 lb bags and 416/30 lb cases
Recall Number	F-1037-2013

Class I Food/Cosmetics Event

Event ID	51892
Status	Completed
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Feb-09
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	BA Sweetie Candy Co
City	Brooklyn
State	OH
Country	US
Distribution Pattern	The product was distributed to one customer in Ohio.

Associated Products

Product Description	B. A. Sweetie Double Dip Peanuts in plastic bags 2 lb, UPC 0 17598 90687 4, 5 lb, UPC 0 17598 00687 1; & Dave's Market Chocolate Double Dip Peanuts in plastic bags, 4 oz, UPC 017598 70687 0
Code Info	No code.
Classification	Class I
Reason for Recall	Product is being recalled because it was manufactured using peanut products recalled by Peanut Corporation of America. The peanut products has the potential to be contaminated with Salmonella
Product Quantity	168/4 oz plastic bags
Recall Number	F-1038-2013

Product Description	B. A. Sweetie Chocolate Bridge Mix in plastic bags 2 lb, UPC 0 17598 90609 6, 5 lb, UPC 0 17598 00609 3; & Dave's Markets Chocolate Bridge Mix in plastic bags, 4 oz, UPC 017598 70609 2.
Code Info	No code.
Classification	Class I
Reason for Recall	Product is being recalled because it was manufactured using peanut products recalled by Peanut Corporation of America. The peanut products has the potential to be contaminated with Salmonella
Product Quantity	72 bags
Recall Number	F-1039-2013

Product Description	Sugar Free/ NSA Chocolate Bridge Mix in plastic bags 2 lb, UPC 0 17598 94258 2, 5 lb, UPC 017598 04258 9
Code Info	All codes.
Classification	Class I
Reason for Recall	Product is being recalled because it was manufactured using peanut products recalled by Peanut Corporation of America. The peanut products has the potential to be contaminated with Salmonella
Product Quantity
Recall Number	F-1040-2013

Product Description	Sweetie Sugar Free/ NSA Chocolate Peanuts in plastic bag 2 lb, UPC 0 17598 94259 9, 5 lb, UPC 0 17598 04259 6
Code Info	No code.
Classification	Class I
Reason for Recall	Product is being recalled because it was manufactured using peanut products recalled by Peanut Corporation of America. The peanut products has the potential to be contaminated with Salmonella
Product Quantity
Recall Number	F-1041-2013

Class I Food/Cosmetics Event

Event ID	51893
Status	Terminated
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Feb-09
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Giannios Candy Co Inc
City	Struthers
State	OH
Country	US
Distribution Pattern	The product was distributed in the states of OH, PA, MI, NY.

Associated Products

Product Description	Milk Chocolate Catalog # 111, Dark Chocolate Peanut Clusters Catalog # 112 & Peanut Butter Pieces Catalog # 107 individually wrapped. Date Codes 121401-130831
Code Info	Peanut Butter Pieces Catalog #107, Milk Chocolate Clusters Catalog #111 & Dark Chocolate Clusters Catalog #112 Date Codes 121401-130831
Classification	Class I
Reason for Recall	This product is being recalled because it was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella
Product Quantity	5,090 boxes/250 pieces
Recall Number	F-1031-2013

Class I Food/Cosmetics Event

Event ID	51895
Status	Completed
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Feb-09
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Gorant Candies Inc A Division of Carlton Cards Retail Inc
City	Youngstown
State	OH
Country	US
Distribution Pattern	Product was distributed to wholesalers and retailers throughout the continental US and to Canada. US states product was distributed to includes: AL, AR, AZ, CA, CT, DE, FL, GA, IA, IL, IN, KY, MA, MD, MI, MS, NC, NE, NH, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI.

Associated Products

Product Description	Chocolate bridge mix in 10 oz, 3 oz, and 3.5 oz bags
Code Info	Sweet Sentiments: UPC-765915043329, 765915043534; Code date-09 AL 19, 09 AL 21, Gorant: UPC-765915043299, 765915017832, 765915047433, 765915046788, 765915047693; Code date-08 NO 23, 09 DE 15, 09 DE 16, 07 OC 17, 09 MA 30
Classification	Class I
Reason for Recall	The product is being recalled because it was manufactured using peanuts that were recalled by Peanut Corporation of America because of their potential to be contaminated with Salmonella.
Product Quantity	14762 pounds
Recall Number	F-1042-2013

Product Description	Milk Chocolate Peanuts in 10 oz, 3 oz, and 5 oz bags
Code Info	Sweet Sentiments: UPC-765915043367, 765915043527; Code date: 09 AL 21, Gorant: UPC-765915043282, 765915043435, 765915047457, 765915047709, 765915045125, 765915046771; Code Date: 09 MA 30, 09 AL 15, 09 MA 25,
Classification	Class I
Reason for Recall	The product is being recalled because it was manufactured using peanuts that were recalled by Peanut Corporation of America because of their potential to be contaminated with Salmonella.
Product Quantity	17380 pounds
Recall Number	F-1043-2013

Product Description	No Sugar Added Milk Chocolate Peanuts in 10 oz and 3 oz bags
Code Info	765915026179, 765915043773, 765915047549, 765915047594. Date code: 09 AU 12, 09 DE 12, 11-15-08,
Classification	Class I
Reason for Recall	The product is being recalled because it was manufactured using peanuts that were recalled by Peanut Corporation of America because of their potential to be contaminated with Salmonella.
Product Quantity	1287 pounds
Recall Number	F-1044-2013

Product Description	No Sugar Added Bridge Mix in 12 oz bags
Code Info	UPC: 765915026209, 765915047624. Date code: 09 DE 01.
Classification	Class I
Reason for Recall	The product is being recalled because it was manufactured using peanuts that were recalled by Peanut Corporation of America because of their potential to be contaminated with Salmonella.
Product Quantity	1536 pounds
Recall Number	F-1045-2013

Class I Devices Event

Event ID	64136
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Ad-Tech Medical Instrument Corporation
City	Racine
State	WI
Country	US
Distribution Pattern	Worldwide Distribution - USA Nationwide including the states of CA, GA, LA, MA, MD, MI, MN, NH, PA, RI, TX, UT, WI and the countries of: Australia, CANADA, ENGLAND, JAPAN, KOREA, and SWITZERLAND.

Associated Products

Product Description	Macro Micro Subdural Electrode Product Usage: The AD-TECH Subdural Electrodes are intended for temporary (<30 days) use with recording, monitoring and stimulation equipment, for the recording, monitoring and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.
Code Info	REF numbers (catalog numbers): EG10A-SP10N-000, EG34B-SP10X-000, EGD7A-MP12N-000, EGE4A-SP10N-000, EGE4A-SP10X-000, QG10B-SP10X-000, QG10C-SP10N-000, QG10D-SP10N-000, QG11A-SP10X-000, QG16A-SP10X-000, QG17A-SP10X-000, QG18A-SP10N-000, QG18A-SP10X-000, QG20B-SP10N-000, QG20B-SP10X-000, QG20C-SP10N-000, QG20C-SP10X-000, QG20D-SP10X-200, QG20E-SP10X-000, QG20F-SP10X-000, QG24A-SP10N-000, QG26A-SP10N-000, QG32A-SP10X-000, QG32B-SP10X-000, QG36A-SP10N-000, QG36A-SP10X-000, QG36B-SP10N-000, QG44A-SP10X-000, QG53A-SP10X-000, QG66A-SP85N-000, QG69A-SP10N-000, QG88A-SP10X-000, QG96A-SP10N-000, QG96A-SP10X-000, QG96C-SP10X-000, QG96D-SP10X-000, QGC6A-SP07N-000, QGC8A-SP10N-000, QGC8A-SP10X-000, QGC8B-SP10X-000, QGC8C-SP10X-000, QGC8D-SP10N-000, QGC8E-SP10X-000, QGC8F-SP10X-000, QS20A-SP10N-000, QS40B-SP10X-000, Lot numbers: 208140314, 208140343, 208140344, 208140353, 208140354, 208140362, 208140369, 208140374, 208140381, 208140382, 208140387, 208140390, 208140395, 208140398, 208140399, 208140414, 208140417, 208140421, 208140431, 208140443, 208140445, 208140450, 208140452, 208140453, 208140458, 019020, 208140356R, 208140357R, 208140452R, C010180001, C702201001, C703160006, C704040001, C800250002, C800350004, C801240003, C802220003, C802220005, C802220006, C805210003, C805210004, C908221002, G012111001, G012140002, G015020002, G016240001, G017250004, G017250005, G017250006, G018011001, G018011002, G018011003, G019021002, G019021003, G019150003, G112270004, G114160001, G114160002, G115080002, G115170004, G115280005, G119020004, G211220001, G608060002, G704150001, G805270001, G900211002, G903011001, G903080003, S903080004, S905280003.
Classification	Class I
Reason for Recall	The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of abrading the cortical surface, and may have remaining pieces which may fracture and remain in the cortical tissue with the electrode is explanted.
Product Quantity	115
Recall Number	Z-0892-2013

Class I Food/Cosmetics Event

Event ID	64232
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-Jan-13
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Ocean Beauty Seafoods, LLC
City	Monroe
State	WA
Country	US
Distribution Pattern	Whole Market Foods in Seattle, WA

Associated Products

Product Description	Cold-smoked salmon in a vacuum packed, clear plastic bag. Product labeled: Csea brand Cold Smoked Smoked Sockeye Trim, 2 lb., Ingredients: Sockeye Salmon, Salt, and Natural Hardwood Smoked Produced by Ocean Beauty Seafoods, LLC KEEP REFRIGERATED AT 38 DEG OR BELOW"
Code Info	7425A2297A, 7425A2298A and 7425A2298B
Classification	Class I
Reason for Recall	A surveillance sample was found positive for Listeria monocytogenes.
Product Quantity	336 pounds (2 pound packages)
Recall Number	F-1036-2013

Class I Food/Cosmetics Event

Event ID	64282
Status	Terminated
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	Mkg Provisions Inc
City	Miami
State	FL
Country	US
Distribution Pattern	FL and IL

Associated Products

Product Description	UpRiver brand Cold Smoke Atlantic Salmon Pre-sliced Vacuum Packed, 4 oz..
Code Info	Batch #911
Classification	Class I
Reason for Recall	Results from the company lab samples revealed that some of the samples contained Listeria monocytogenes.
Product Quantity	1,020 lbs Total
Recall Number	F-1047-2013

Product Description	UpRiver brand Cold Smoke Atlantic Salmon Balik Cut Sides Vacuum Packed
Code Info	Batch #911
Classification	Class I
Reason for Recall	Results from the company lab samples revealed that some of the samples contained Listeria monocytogenes.
Product Quantity	1,020 lbs total
Recall Number	F-1048-2013

Product Description	Cold Smoke Atlantic Salmon Nordic Choice Pre-sliced Vacuum Packed
Code Info	Batch #1478-69441
Classification	Class I
Reason for Recall	Results from the company lab samples revealed that some of the samples contained Listeria monocytogenes.
Product Quantity	3,425 lbs total
Recall Number	F-1049-2013

Product Description	Cold Smoke Atlantic Salmon Trimmings Vacuum Packed
Code Info	Batch #1478-69441 and #911
Classification	Class I
Reason for Recall	Results from the company lab samples revealed that some of the samples contained Listeria monocytogenes.
Product Quantity	3,425 lbs total
Recall Number	F-1050-2013

Class I Food/Cosmetics Event

Event ID	64369
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-Feb-13
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Decoty Coffee Company, Inc
City	San Angelo
State	TX
Country	US
Distribution Pattern	Mainly in TX but internet sales were nationwide.

Associated Products

Product Description	Taco Seasoning, Net Wt. 1.25 lb and 5.75 lb. Distributed by Decoty Coffee Company, San Angelo, TX 76903, 800-588-8001. The products come in 1.25lb and 5.75lb sizes and are distributed in plastic spice containers with resealable lids.
Code Info	The item code numbers are 71400 and 71410 with lot numbers from 010111 through 021313.
Classification	Class I
Reason for Recall	DeCoty Coffee Company of San Angelo, Texas is recalling its 1.25lb and 5.75lb of DeCoty Taco Seasoning because it contains an undeclared ingredient, Soy. People who have an allergy or severe sensitivity to Soy run the risk of a life threatening or serious allergic reaction if they consume these items.
Product Quantity	205 of the 1.25 lb and 310 of the 5.75 lb
Recall Number	F-1058-2013

Class I Food/Cosmetics Event

Event ID	64419
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Feb-13
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Herbalife International Of America Inc
City	Torrance
State	CA
Country	US
Distribution Pattern	Worldwide distribution

Associated Products

Product Description	HERBALIFE Formula 1 Instant Healthy Meal, Nutritional Shake Mix ( Vanilla Dream) Packets; net WT 1.83 oz/52 g; packaged as 12 packets in a cardboard carton; just add water; single serve powder in a packet;
Code Info	Lot #'s 133405G10; 133407G10; 133407C10; 133408C10; 133408G10; 133409C10; 133409G10; 133411L10; 133410L10; 133410J10;133412L10; 133410M11; 133410K07; 133411M11; 133412M11; 133418R10; Catalogue #2797; NNPart #'s: 68-00033; 68-00037; 68-00032; 68-00031; 68-00092.
Classification	Class I
Reason for Recall	Herbalife of America Inc is initiating this recall due to trace amounts of an undeclared milk protein allergen.
Product Quantity	5,928 (2,732 cartons and3,196 IBP Kits)
Recall Number	F-1059-2013

Class I Food/Cosmetics Event

Event ID	64442
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Feb-13
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Bruce Foods Corp
City	New Iberia
State	LA
Country	US
Distribution Pattern	VA, MN, IN

Associated Products

Product Description	Food Club(R) MEXICAN STYLE ENCHILADA SAUCE, RED, NET WT 10 OZ (284g), DISTRIBUTED BY TOPCO ASSOCIATES LLC, 7711 GROSS POINT RD., SKOKIE, IL 60077 UPC: 036800292208
Code Info	GES 462449, Best Before Date: 12/03/2016
Classification	Class I
Reason for Recall	Undeclared soy and wheat: One can of product labeled as containing red enchilada sauce, was found to contain green enchilada sauce which contains wheat and soy.
Product Quantity	141 cases of 12 units
Recall Number	F-1055-2013

Class II Biologics Event

Event ID	40172
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-May-05
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	011GF47386
Classification	Class II
Reason for Recall	Blood product, manufactured from a unit of whole blood lacking hematocrit documentation, was distributed.
Product Quantity	1 unit
Recall Number	B-0221-13

Class II Biologics Event

Event ID	40232
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-May-05
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Red Blood Cells (Apheresis) Leukocytes Reduced
Code Info	6519597; 6519597
Classification	Class II
Reason for Recall	Blood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity	2 units
Recall Number	B-0273-13

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	6032691; 6032687; 6032679; 6032689; 6519587
Classification	Class II
Reason for Recall	Blood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity	5 units
Recall Number	B-0274-13

Class II Biologics Event

Event ID	40629
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	23-Aug-05
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	9917207
Classification	Class II
Reason for Recall	Blood product, which did not meet acceptable product specifications, was distributed.
Product Quantity	1 unit
Recall Number	B-0357-13

Class II Biologics Event

Event ID	42790
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Aug-06
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	American National Red Cross (The)
City	West Henrietta
State	NY
Country	US
Distribution Pattern	New York

Associated Products

Product Description	Red Blood Cells (Apheresis)
Code Info	01FH11831, 01FH13343, 01KK20799, 01KK22605, 01KK23536, 01KM37179, 01KX97207, 01Q92728
Classification	Class II
Reason for Recall	Blood products, which did not meet the minimum requirement for total hemoglobin, were distributed.
Product Quantity	8 units
Recall Number	B-0041-13

Class II Biologics Event

Event ID	43004
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Sep-06
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Red Blood Cells
Code Info	LX28135
Classification	Class II
Reason for Recall	Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity	1 Unit
Recall Number	B-0742-13

Class II Biologics Event

Event ID	43008
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Aug-06
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	American National Red Cross (The)
City	West Henrietta
State	NY
Country	US
Distribution Pattern	New York

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	01FP43191
Classification	Class II
Reason for Recall	Blood product, which did not meet acceptable product specifications, was distributed.
Product Quantity	1
Recall Number	B-0741-13

Class II Biologics Event

Event ID	43678
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Oct-06
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	American National Red Cross
City	Portland
State	OR
Country	US
Distribution Pattern	Oregon.

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	021LL14609.
Classification	Class II
Reason for Recall	Blood product, collected from a donor who lived in a country endemic for malaria, was distributed. .
Product Quantity	1 component
Recall Number	B-0732-13

Class II Biologics Event

Event ID	43835
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Dec-06
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Red Blood Cells
Code Info	LT37295
Classification	Class II
Reason for Recall	Blood product, positive for the JKb-antigen but labeled as JKb-antigen negative, was distributed.
Product Quantity	1 Unit
Recall Number	B-0711-13

Class II Biologics Event

Event ID	44371
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Feb-07
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Red Blood Cells
Code Info	LC83075
Classification	Class II
Reason for Recall	Blood product, positive for the E-antigen but labeled as E-antigen negative, was distributed.
Product Quantity	1 Unit
Recall Number	B-0743-13

Class II Biologics Event

Event ID	44496
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-Jan-07
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	American National Red Cross (The)
City	West Henrietta
State	NY
Country	US
Distribution Pattern	NY, MD, and PA

Associated Products

Product Description	Platelets
Code Info	01Q99477;01Q99514
Classification	Class II
Reason for Recall	Blood products, possibly contaminated with air during collection, were distributed.
Product Quantity	2
Recall Number	B-0737-13

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	01Q99451; 01Q99454; 01Q99477; 01Q99489; 01Q99497; 01Q99519; 01Q99522; 01Q99528; 01Q99531; 01Q99548; 01Q99552
Classification	Class II
Reason for Recall	Blood products, possibly contaminated with air during collection, were distributed.
Product Quantity	11
Recall Number	B-0738-13

Product Description	Plasma Frozen
Code Info	01Q99451;01Q99454;01Q99497
Classification	Class II
Reason for Recall	Blood products, possibly contaminated with air during collection, were distributed.
Product Quantity	3
Recall Number	B-0739-13

Product Description	Red Blood Cells Leukocytes Reduced Irradiated
Code Info	01Q99487;01Q99492
Classification	Class II
Reason for Recall	Blood products, possibly contaminated with air during collection, were distributed.
Product Quantity	2
Recall Number	B-0740-13

Class II Biologics Event

Event ID	45105
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Aug-07
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	P40172 Part A ; P40172 Part B
Classification	Class II
Reason for Recall	Blood products, for which the required quality control testing was not performed, were distributed.
Product Quantity	2 Units
Recall Number	B-0712-13

Class II Biologics Event

Event ID	45357
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Sep-07
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	LE99344
Classification	Class II
Reason for Recall	Blood product, positive for the c-antigen but labeled as c-antigen negative, was distributed.
Product Quantity	1 Unit
Recall Number	B-0744-13

Class II Biologics Event

Event ID	46133
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Oct-07
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Community Blood Center of the Ozarks
City	Springfield
State	MO
Country	US
Distribution Pattern	North Carolina; Missouri;

Associated Products

Product Description	Red Blood Cells
Code Info	6798040
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity	1 Unit
Recall Number	B-0745-13

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	6819346
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity	1 Unit
Recall Number	B-0746-13

Class II Biologics Event

Event ID	46636
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-Nov-07
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	American National Red Cross
City	Portland
State	OR
Country	US
Distribution Pattern	California.

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	21LY18474
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 component
Recall Number	B-0735-13

Class II Biologics Event

Event ID	49793
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Aug-08
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	American National Red Cross (The)
City	Cleveland
State	OH
Country	US
Distribution Pattern	OH, NJ, GA, MO, NC, MI, SC, IN, and CA

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	42FE10146; 42FG38598; 42L54257; 42GX05663; 42GS32747; 42FE10012; 42FE10015; 42FE10144; 42FE10145; 42FE10019; 42FE10140; 42FE10148; 42FG38588; 42FG38596; 42FY87647; 42GX05665; 42L54010; 42L54256; 006LV50469; 006LP45246; 006FY93535; 006GS40395; 006LH17884; 006GT77083; 006GE34211; 006LV50477; 006LP45421; 006LQ04192; 006LV50512; 006LV50488; 006LV50506; 006LH17880; 006LY83121; 006LY83089; 006LY83117; 42FE10019; 42FE10140; 42FE10148; 42FG38588; 42FG38596; 006FY92834; 006FC59395; 42FW52035; 42FG38596; 42FG38597;42M35638; 42GT24395; 42GS33656; 42GM06234; 42GM06237; 42GM06238; 42W53470; 42GM06233; 42M35638; 006FE32665; 006GV77287; 42FY81647; 42GX05665; 42L54010; 42L54256
Classification	Class II
Reason for Recall	Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity	51 units
Recall Number	B-0527-13

Product Description	Plasma Frozen
Code Info	42FE10144; 42FG38596; 42GX05663; 42CX05665; 42L54010
Classification	Class II
Reason for Recall	Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity	5 units
Recall Number	B-0528-13

Product Description	Red Blood Cells
Code Info	42FG38734
Classification	Class II
Reason for Recall	Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity	1 unit
Recall Number	B-0529-13

Product Description	Cryoprecipitate AHF, Pooled
Code Info	006L16589
Classification	Class II
Reason for Recall	Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity	1 unit
Recall Number	B-0530-13

Product Description	Red Blood Cells Leukocytes Reduced Irradiated
Code Info	006FE32995
Classification	Class II
Reason for Recall	Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity	1 unit
Recall Number	B-0531-13

Product Description	Plasma Frozen within 24 hours after Phlebotomy (FP24)
Code Info	42FZ62526; 42FG38596; 42FZ31978; 006LV50504; 006LV50477; 006LH16787; 006FY92533; 006LT83833; 006FY93230; 006GV77545; 006GE03248; 006FC59791; 006FC59790; 006GX88824; 006GX88853; 006FE31590; 006FE31591; 006GX88583; 006FR07331; 006FR07309; 006FY91374; 006GX88558; 006FY91468; 006LT84124; 006FY91564; 006FY83209; 006LS18607; 006GP95732; 006FE32997; 006FC60183; 006LH16761; 006LQ04205; 006LT84139; 006FY92525; 006FR07284; 006GT77323; 006GW55916; 006LP45234; 006GE34230; 006FY93228; 006GT77327; 006FC60177; 006LT84391; 006FY92828; 006LT84147; 006LP43762; 006FR07279; 006FY91552; 006FY91461; 006FY91322; 006FE30810; 006GT76431; 006GL03267; 006FY91566
Classification	Class II
Reason for Recall	Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity	54 units
Recall Number	B-0532-13

Class II Biologics Event

Event ID	56583
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Jul-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	373106290, 373104952, 373102292, 373102227, 373104387, 373104046, 373103311, 373102963, 373102890, 3730023031, 3730022006, 3730021677, 3730020460, 3730019561, 3730019017, 3730017436, 3730016875, 3730015939, 3730015373, 3730014412, 3730013862, 3730012982, 3730012426, 3730011573, 3730011013, 3730010120, 3730009612, 3730008740, 3730008225, 3730007384, 3730006905, 3730006156, 3730005611, 3730004822, 3730004371, 3730003622, 3730003176, 3730002480, 3730002082, 3730001426, 3730001049, 3730000460, 3730000141, 373124259, 373123856, 373123171, 373122728, 373122071, 373121753, 373120437, 373119725, 373119289, 373118528, 373118110, 373117237, 373116718, 373115942, 373114631, 373114205, 373113359, 373112908, 373107951, 373107505, 373106615, 373106174, 373105287, 373104880, 373104009, 737103627, 373103027, 373101694, 373102022, 373102993, 373102011, 373102061, 373102917, 373102881, 373104906, 373104461, 373102159, 373102134, 3730011098, 3730010695, 3730009625, 3730009229, 3730008316, 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Classification	Class II
Reason for Recall	Blood products, collected from donors who did not have a complete physical exam, were distributed.
Product Quantity	3124 units
Recall Number	B-0751-13

Class II Food/Cosmetics Event

Event ID	60188
Status	Completed
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Oct-11
Initial Firm Notification of Consignee or Public	Visit

Recalling Firm	Tortilleria Provincia
City	Bowling Green
State	KY
Country	US
Distribution Pattern	The product was only distributed in the state of Kentucky.

Associated Products

Product Description	Yellow Corn Tortillas in 5 lb clear flexible plastic bags with green and yellow printing. Tortilleria Provincia 1200 B Clay Street Bowling Green, KY 42101
Code Info	Manufacture dates from 09/19/2011 through 10/19/2011 and all expiration dates between 10/19/2011 and 11/19/2011.
Classification	Class II
Reason for Recall	During an FDA inspection at the firm, it was discovered that the firm uses, FD&C Yellow #5, in the manufacture of their tortillas. However, FD&C Yellow #5 is not listed in the ingredient statement.
Product Quantity	60-70 cases ( 6 pkgs/case)
Recall Number	F-1046-2013

Class II Drugs Event

Event ID	63522
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Hospira Inc.
City	Lake Forest
State	IL
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045, NDC 0409-1555-54
Code Info	Lot # 10-199-JT Exp. 10/13
Classification	Class II
Reason for Recall	Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.
Product Quantity	11,412 bags
Recall Number	D-184-2013

Class II Biologics Event

Event ID	63571
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Sep-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Community Blood Center
City	Dayton
State	OH
Country	US
Distribution Pattern	OH

Associated Products

Product Description	Red Blood Cells
Code Info	W035412060950
Classification	Class II
Reason for Recall	Blood product, collected from a donor who had a previous history of travel to a malarial endemic area, was distributed.
Product Quantity	1 unit
Recall Number	B-0359-13

Class II Biologics Event

Event ID	63572
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Sep-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	LifeSouth Community Blood Centers Inc
City	Huntsville
State	AL
Country	US
Distribution Pattern	AL

Associated Products

Product Description	Red Blood Cells (Apheresis) Leukocytes Reduced
Code Info	W1151122758236- part 1; W1151122758236- part 2
Classification	Class II
Reason for Recall	Blood products, which were not quarantined subsequent to receiving post donation illness information, were distributed.
Product Quantity	2 units
Recall Number	B-0448-13

Class II Biologics Event

Event ID	63573
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Sep-12
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W115112327021R
Classification	Class II
Reason for Recall	Blood product, labeled leukoreduced but was not tested to verify the White Blood Cell count, was distributed.
Product Quantity	1 unit
Recall Number	B-0447-13

Class II Biologics Event

Event ID	63575
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	LifeSouth Community Blood Centers Inc - Birmingham Region
City	Birmingham
State	AL
Country	US
Distribution Pattern	AL

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W115112282932C
Classification	Class II
Reason for Recall	Blood product, which did not meet acceptable product specifications, was distributed.
Product Quantity	1 unit
Recall Number	B-0446-13

Class II Biologics Event

Event ID	63576
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Sep-12
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W115112277608P- part 1; W115112277608P-part 2
Classification	Class II
Reason for Recall	Blood products, which did not meet the acceptable product specifications for release, were distributed.
Product Quantity	2 units
Recall Number	B-0480-13

Class II Biologics Event

Event ID	63578
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Sep-12
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W115112277116S
Classification	Class II
Reason for Recall	Platelet, with a low platelet count, was distributed.
Product Quantity	1 unit
Recall Number	B-0481-13

Class II Biologics Event

Event ID	63579
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Lane Memorial Blood Bank
City	Eugene
State	OR
Country	US
Distribution Pattern	Tennessee; Oregon

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W137512105036; W137512107334
Classification	Class II
Reason for Recall	Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed.
Product Quantity	2 units
Recall Number	B-0477-13

Class II Biologics Event

Event ID	63591
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	D. D. Eisenhower Army Med. Ctr. - Blood Bank
City	Fort Gordon
State	GA
Country	US
Distribution Pattern	NJ, FL

Associated Products

Product Description	Red Blood Cells
Code Info	W010712004910;
Classification	Class II
Reason for Recall
Product Quantity
Recall Number	B-0478-13

Product Description	Blood and Blood Products for Reprocessing
Code Info	W010712004910
Classification	Class II
Reason for Recall	Blood products, collected from a donor considered to be at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity	1 unit
Recall Number	B-0479-13

Class II Devices Event

Event ID	63671
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Philips Healthcare Inc.
City	Andover
State	MA
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Canada, Chile, Czech republic, Estonia,France, Germany, Hungary, Inida, Ireland, Italy, Japan, Libyan Arab Jamahari, Mexico, Netherlands, New Zealand, Norway , Oman, Panama, Peru, Poland, Qatar, Reunion, Russia, Saudi Arabia, South Africa, South Korea,Spain, Sweden, Swizerland, Thailand, UAE, and the UK.

Associated Products

Product Description	Philips Digital Diagnost Stationary radiographic system
Code Info	All Digital Diagnost systems with Eleva software version 3.0.x
Classification	Class II
Reason for Recall	When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.
Product Quantity	360
Recall Number	Z-0900-2013

Class II Drugs Event

Event ID	63706
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	02-Nov-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Bristol Myers Squibb Manufacturing Company
City	Humacao
State	PR
Country	US
Distribution Pattern	LA, TN, CA

Associated Products

Product Description	ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35
Code Info	2E69023A, Exp. FEB 28 2015
Classification	Class II
Reason for Recall	CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed.
Product Quantity	21 blister packs
Recall Number	D-181-2013

Class II Devices Event

Event ID	64000
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Beckman Coulter Inc.
City	Brea
State	CA
Country	US
Distribution Pattern	Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Austria, Brazil, China, Czech Republic, France, Germany, Hungary, India, Ireland, Israel, Italy, Korea Republic, Malaysia, Netherlands, Russian Federation, Spain, Switzerland, Taiwan, Turkey, United Kingdom, and Viet Nam.

Associated Products

Product Description	Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
Code Info	All serial numbers / Multiple manufacture dates. Part# Item# ================ A94907 AU5811-02 A94912 AU5821-02 A94917 AU5831-02 A94922 AU5841-02 A94908 AU5811-03 A94913 AU5821-03 A94918 AU5831-03 A94923 AU5841-03 A94909 AU5811-04 A94914 AU5821-04 A94919 AU5831-04 A94924 AU5841-04 A94910 AU5811-06 A94915 AU5821-06 A94920 AU5831-06 A94925 AU5841-06
Classification	Class II
Reason for Recall	Due to a software data storage limitation which only occurs under certain conditions, measurements of the Reagent Blank (RB) or Calibration (CAL) sample results are not saved and the software reverts to a previously stored, acceptable RB/CAL result.
Product Quantity	28 in U.S.; 4 Canada; 318 to other foreign countries.
Recall Number	Z-0913-2013

Class II Drugs Event

Event ID	64001
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Jan-13
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Hospira Inc.
City	Lake Forest
State	IL
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7984-23,
Code Info	Lot Number 02-117-JT Exp. 02/13
Classification	Class II
Reason for Recall	Lack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill tube seal.
Product Quantity	325,056 bags
Recall Number	D-183-2013

Class II Devices Event

Event ID	64071
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-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 the states of AR, CA, CO, FL, GA, IL IN, IA, LA, MD, MA, MI, MN, MO, NJ, NM, NY, NC, OH, OK, PA, PR, SC, SD, TN, TX and VA. and the countries of ALGERIA, AUSTRALIA, AUSTRIA, ARGENTINA, BELARUS, CANADA, CHINA, CHILE, EGYPT CZECH REPUBLIC, FRANCE, FINLAND, GERMANY, GABON, HONG KONG, INDIA, IRELAND, ITALY KENYA, KOREA, JAPAN, MEXICO, NIGERIA, PHILIPPINES, PORTUGAL REPUBLIC OF MALTA, RUSSIAN FEDERATION SAUDI ARABIA, SPAIN SWITZERLAND, TURKEY, TAIWAN, TUNISIA, UNTIED KINGDOM and VENEZUELA.

Associated Products

Product Description	GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast, easy, volume visualization of three dimensional structures imaged with a computed tomography (CT) or magnetic resonance (MR) system. It is dedicated to clinical and diagnostic applications in radiology, surgery, and treatment planning.
Code Info	000000010009GS 000000010017GS 000000010049GS 000000010045GS 000000010001GS 000000010030GS 000000010004GS 000000010062GS 000000010054GS 000000010028GS 000000010005GS 000000010086GS 000000010002GS 00000L026FFE60 00000L0271A594 000000010081GS 000000010041GS 000000010024GS 000000010026GS 000000010043GS 000000010072GS 000000010079GS 000000010082GS 000000010057GS 000000010051GS 000000010071GS 000000010064GS 000000010073GS 000000010077GS 000000010038GS 000000010053GS 000000010047GS 000000010033GS 000000010094GS 000000010050GS 000000010021GS 000000010015GS 00000L0219C835 000000010059GS 000000010012GS 000000010018GS 000000010060GS 000000010003GS 000000010008GS 000000010014GS 000000010020GS 000000010075GS 000000010074GS 00000L0274A04C 000000010022GS 000000010048GS 000000010067GS 000000010063GS 000000010087GS 000000010034GS 000000010083GS 000000010036GS 000000010080GS 000000010044GS 000000010006GS 000000010068GS 000000010027GS 000000010091GS 000000010032GS 000000010029GS 000000010078GS 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082421210168AW 082421110051AW 082416210002AW 082445060002AW 082421120200AW 082427120044AW 082427020022AW 082445040002AW 082427100064AW 082445130005AW 082427130022AW 082416130019AW 082427130030AW 082427080016AW 082421270070AW 082427140024AW 082427140037AW 082421140158AW 082421140155 Not Available EG1103AW01 FI1003AW09 X90281602 M4216023 HC1711AW01 470240AW01 UHAN01AW11 HPAD01AW01 467946AW01 CC0618AW10 0828210061AW02 0828210061AW01 0828210046AW03 083049006211046 083028552566875 083055062100555 083049862100445 083049802100636 083049822280910 083049822101866 083055602200145 083049242101006 083049802100535 083049842100015 IE1028AW04 IE1053AW02 A5375120 A5236222 A5719817 A126322004 D5249933 A5401537 A5696307 PY0132 0850210582AW1 5272AW42 8346ADW41 311AW2601238 NG1024AW01 0843490011 PL1493AW01 PL1124AW01 PL1622AW02 PL1584AW01 PPR83708 PPR62202 PPR83607 SA1006AW04 SA1007AW02 SA1283AW01 SA2079AW01 ZA1006AW01 CE557022 DED64778 EE214310 ME504368 FPG72503 CPM80622 DPM19608 FP180608 CEE15656 NE651510 NP384112 41018DCS01 53004DCS01 05004DCS01 00192ADW12 70772ADW01 38824624IISOCC
Classification	Class II
Reason for Recall	Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation, Volume Viewer Plus and Volume Analysis.
Product Quantity	363
Recall Number	Z-0901-2013

Class II Drugs Event

Event ID	64105
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	West-ward Pharmaceutical Corp.
City	Eatontown
State	NJ
Country	US
Distribution Pattern	GA

Associated Products

Product Description	a)60 tablets NDC 61748-014-06, b)90 tablets, NDC 61748-014-09, c)100 tablets, NDC 61748-014-01, d)1000 tablets, NDC 61748-014-10, e) blister pack (10s) 61748-014-11
Code Info	69877A; 68977B; 68978B; 6978C; 68979A - exp JUL 2015 68977C; 68978A exp JUL 2013
Classification	Class II
Reason for Recall	Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.
Product Quantity	18,825 bottles
Recall Number	D-189-2013

Class II Devices Event

Event ID	64195
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	Synthes USA HQ, Inc.
City	West Chester
State	PA
Country	US
Distribution Pattern	Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT.

Associated Products

Product Description	Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
Code Info	Part number 487.831 - Lot numbers 7826459,7750064, 7667285, and 7806090.
Classification	Class II
Reason for Recall	It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
Product Quantity	2
Recall Number	Z-0903-2013

Product Description	Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening.
Code Info	Part number 487.966 - Lot numbers 7823465, 3817114, 7806086, 3824427, 3808871, 3794465, and 7793336.
Classification	Class II
Reason for Recall	It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
Product Quantity	24
Recall Number	Z-0904-2013

Product Description	Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.
Code Info	Part number 487.967 - Lot numbers 7883454, 3808876, 7824423, 3800758, 3817116, 3794466
Classification	Class II
Reason for Recall	It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
Product Quantity	18
Recall Number	Z-0905-2013

Class II Devices Event

Event ID	64214
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Jan-13
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Siemens Medical Solutions USA, Inc
City	Concord
State	CA
Country	US
Distribution Pattern	5 devices, all located outside of the United States in Germany.

Associated Products

Product Description	SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY.
Code Info	All codes/units of ARTISTE model.
Classification	Class II
Reason for Recall	Siemens became aware of a potential safety issue when using the "In-session resumption" feature of the syngo RT Therapist (RTT) 4.3 software. The RTT will send again the previously completed beam or segment for delivery to the control console, thus repeating the already delivered Monitor Units of the same beam or segment.
Product Quantity	5 units
Recall Number	Z-0907-2013

Class II Food/Cosmetics Event

Event ID	64257
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Jan-13
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	R-Kane Products Inc.
City	Pennsauken
State	NJ
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Z Pro 25 High Protein Supplement Net. Wt. 1.3 oz. - Vanilla Flavor Formulated and Distributed by: R-Kane Products, Inc. 8351 National Highway, Pennsauken, NJ 08110
Code Info	All codes distributed between 1/1/2011 and 1/24/2013
Classification	Class II
Reason for Recall	Z Pro High Protein Vanilla Flavor Supplement is under recall because it contains the allergens milk and coconut, a tree nut, which are not declared on the label of the individual packets of the product.
Product Quantity	unavailable
Recall Number	F-1056-2013

Product Description	Z Pro 25 High Protein Supplement Net. Wt. 1.5 oz. - Chocolate Flavor Formulated and Distributed by: R-Kane Products, Inc. 8351 National Highway, Pennsauken, NJ 08110
Code Info	All codes distributed between 1/1/2011 and 1/24/2013
Classification	Class II
Reason for Recall	Z Pro High Protein Chocolate Flavor Supplement is under recall since it contains milk and soy, allergens, which are not declared on the label of the individual packets of the product.
Product Quantity
Recall Number	F-1057-2013

Class II Devices Event

Event ID	64259
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Philips Medical Systems (Cleveland) Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	Worldwide Distribution - USA including the states of AL, AT, AZ, BAH, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NJ, NV, NY, OH, OR, PA, PR, PR, SC, TN, TX, VA, VT, WA, WI & WV. and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican, Republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Gabon, Georgia, Germany, Greece, Guadeloupe, Guinea, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, LAO People's Dem, Rep., Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Malta, Martinique, Mexico, Netherlands, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela & Viet Nam.

Associated Products

Product Description	Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Code Info	Model 728260, Serial #, 3467,5610,6151,6204,6209,6221,6437,6483,6543,6636,6658,6717,6788,6865,7154,7186,7253,7470, 7507,7576,7579,7639,7690,7692,7708,7835,7977,8099,8255,8332,8443,8756,8757,8890,8922,9079, 9201,9395,9422,10085,10086,10090,10102,10138,10155,10180,10197,10216,10240,10261,10264,10271, 10312, 10324,10328,10346,10355,10359,10378,10383,10389,10422,10427,10431,10435,10437,10442, 10455,10456,10470,10476,10492,10537,10547,10561,10584,10598,10604,10606,10622,10630,10646, 10672,10686,10699,10722,10727,10738,10745,10747,10770,10776,10778,10796,10798,10817,10821, 10822,10823,10838,10841,10874,10889,10890,10897,10952,10953,10965,10980,10985,10988,10998, 11007,11010,11025,11036,11037,11043,11051,11054,11058,11062,11065,11080,11083,11085,11086, 11088,11089,11105,11107,11113,11121,11127,11128,11140,11141,11147,11148,11149,11151,11152, 11153,11166,11169,11173,11174,11208,11221,11230,11232,11241,11243,11260,11262,11267,11274, 11278,11280,11282,11291,11314,11317,11324,11334,11339,11341,11557,11561,11564,11567,11572, 11577,11581,11585,11603,11610,11612,11620,11622,11630,11631,11633,11644,11649,11650,11656, 11657,11659,11660,11662,11663,11667,11668,11670,11673,11674,11684,11685,11692,11694,11696, 11699,11700,11703,11706,11708,11711,11714,11717,11718,11720,11729,11739,11740,11742,11743, 11744,11745,11747,11748,11749,11750,11751,11753,11754,11755,11756,11758,11760,11762,11765, 11766,11768,11769,11770,11772,11773,11774,11776,11779,11780,11781,11782,11784,11785,11788, 11790,11791,11793,11794,11795,11796,11797,11798,11800,11801,11802,11803,11804,11805,11806, 11807,11808,11809,11810,11812,11813,11814,11816,11817,11818,11819,11822,11823,11830,11831, 11832,11833,11834,11838,11839,11840,11841,11842,11843,11844,11845,11846,11847,11848,11850, 11851,11852,11854,11856,11858,11859,11862,11863,11864,11865,11866,11868,11869,11870,11873, 11874,11877,11878,11879,11880,11881,11882,11883,11884,11885,11886,11888,11889,11890,11891, 11892,11893,11896,11897,11898,11899,11900,11901,11902,11903,11904,11905,11906,11907,11911, 11912,11913,11916,11917,11918,11920,11923,11925,11927,11928,11929,11930,11932,11933,11934, 11935,11936,11937,11938,11939,11942,11943,11944,11947,11976,11977,11978,11979,11980,12049, 12051,12100,12100,12102,12103,12104,12105,12106,12107,12108,12109,12110,12111,12112,12115, 12117,12118,12119,12120,12121,12122,12123,12124,12125,12126,12128,12129,12130,12132,12133, 12136,12138,12139,12140,12141,12142,12144,12145,12146,12147,12152,12154,12155,12157,12158, 12159,12160,12162,12163,12164,12167,12170,12171,12172,12173,12174,12175,12176,12178,12179, 12180,12181,12182,12183,12200,12201,12202,12203,12204,12205,12206,12207,12208,12209,12210, 12211,12215,12216,12217,12218,12219,12220,12222,12223,12224,12225,12226,12227,12228,12229, 12230,12231,12236,12237,12239,12240,12241,12242,12243,12244,12248,12249,12250,12271,12273, 12274,12302,12303,12304,12305,12306,12309,12310,12311,12312,12314,12315,12316,12317,12318, 12321,12322,12323,12324,12325,12326,12327,12328,12329,12330,12331,12332,12333,12336,12337, 12338,12339,12341,12342,12343,12345,12346,12347,12348,12349,12350,12351,12352,12353,12354, 12355,12356,12357,12359,12360,12362,12363,12364,12366,12369,12370,12373,12376,12377,12379, 12380,12382,12383,12386,12388,12389,12391,12392,12394,12396,12397,12398,12399,12400,12403, 12405,12406,12407,12408,12409,12410,12411,12412,12413,12414,12415,12416,12417,12418,12419, 12420,12421,12422,12423,12424,12425,12428,12429,12430,12431,12432,12434,12435,12436,12438, 12439,12440,12441,12443,12444,12445,12446,12447,12471,12472,12473,12474,12475,12476,12477, 12492,12493,12494,12495,12496,12497,12498,12500,12501,12503,12504,12505,12508,12510,12513, 12514,12516,12517,12521,12522,12526,12527,12528,12530,12531,12538,12539,12541,12542,12543, 12544,12545,12546,12547,12548,12549,12550,12551,12552,12553,12554,12555,12556,12557,12558, 12559,12561,12562,12563,12565,12567,12568,12569,12570,12573,12574,12575,12577,12579,12580, 12581,12583,12584,12586,12587,12588,12589,12591,12592,12594,12595,12596,12597,12598,12601, 12602,12603,12604,12605,12606,12611,12612,12614,12617,12618,12619,12620,12621,12622,12623, 12625,12626,12627,12628,12629,12631,12632,12633,12634,12636,12638,12640,12641,12643,12645, 12646,12647,12648,12649,12650,12651,12652,12653,12654,12656,12657,12658,12662,12663,12664, 12665,12669,12670,12671,12672,12673,12674,12675,12676,12677,12678,12679,12680,12681,12700, 12701,12702,12703,12704,12705,12706,12707,12708,12709,12710,12711,12712,12713,12716,12719, 12720,12722,12723,12724,12725,12726,12727,12730,12731,12732,12733,12734,12735,12740,12741, 12742,12743,12744,12745,12747,12748,12752,12753,12756,12757,12761,12763,12765,12767,12768, 12769,12770,12771,12772,12773,12774,12776,12777,12778,12780,12783,12784,12786,12791,12792, 12797,12800,12801,12802,12803,12805,12806,12807,12808,12809,12814,12817,12818,12819,12820, 12821,12822,12823,12826,12827,12828,12829,12830,12831,12832,12833,12834,12835,12836,12837, 12838,12839,12840,12844,12845,12846,12847,12848,12849,12850,12851,12861,12865,12874,12875, 12877,12878,12879,12900,12901,12902,12904,12905,12907,12908,12909,12911,12913,12917,12919, 12920,12922,12923,12925,12926,12927,12928,12929,12930,12931,12932,12935,12937,12938,12939, 12940,12941,12942,12944,12947,12949,12953,12956,12957,12958,12960,12961,12962,12963,12964, 12965,12966,12967,12968,12969,12970,12971,12972,12973,12974,12976,12978,12979,12980,12983, 12985,12986,12987,12988,12992,12994,12996,12997,12999,13000,13002,13003,13004,13005,13007, 13008,13009,13010,13013,13014,13015,13016,13017,13018,13019,13020,13022,13023,13024,13025, 13026,13027,13028,13029,13031,13034,13035,13036,13039,13041,13042,13043,13044,13046,13047, 13060,13061,13062,13063,13064,13065,13066,13067,13068,13069,13070,13071,13072,13073,13074, 13075,13076,13077,13078,13079,13080,13081,13082,13083,13084,13086,13088,13089,13101,13102, 13103,13104,13105,13109,13110,13113,13114,13115,13116,13117,13118,13119,13120,13121,13122, 13123,13125,13128,13129,13131,13132,13133,13134,13135,13136,13137,13138,13139,13142,13148, 13149,13150,13151,13152,13153,13154,13155,13156,13157,13158,13159,13160,13163,13164,13165, 13166,13167,13168,13169,13170,13171,13173,13177,13178,13179,13180,13181,13182,13183,13184, 13185,13186,13188,13189,13190,13191,13192,13194,13195,13196,13197,13198,13199,13201,13202, 13203,13204,13206,13207,13208,13213,13214,13215,13217,13218,13219,13220,13221,13223,13224, 13225,13226,13227,13228,13229,13230,13231,13232,13233,13234,13238,13239,13240,13241,13242, 13244,13245,13246,13249,13263,13264,13265,13266,13272,13273,13274,13277,13278,13279,13298, 13299,13301,13302,13303,13304,13305,13306,13307,13308,13309,13310,13312,13313,13314,13315, 13316,13317,13318,13320,13321,13322,13323,13324,13325,13326,13327,13328,13329,13330,13331, 13332,13333,13334,13336,13337,13341,13342,13343,13344,13348,13351,13353,13355,13359,13362, 13363,13365,13366,13367,13368,13370,13371,13373,13374,13375,13376,13377,13378,13379,13381, 13382,13385,13386,13389,13391,13393,13397,13399,13400,13401,13402,13403,13404,13406,13407, 13408,13410,13411,13412,13415,13416,13417,13420,13421,13423,13425,13427,13428,13429,13430, 13431,13438,13439,13440,13443,13444,13445,13447,13448,13450,13451,13453,13454,13455,13456, 13458,13459,13463,13465,13466,13467,13471,13472,13473,13474,13475,13476,13477,13478,13500, 13501,13502,13508,13509,13510,13511,13512,13513,13514,13515,13516,13517,13518,13519,13520, 13521,13522,13523,13524,13525,13526,13527,13528,13529,13530,13531,13532,13533,13534,13535, 13536,13537,13538,13539,13540,13541,13542,13543,13544,13545,13546,13547,13548,13549,13550, 13552,13553,13556,13557,13558,13560,13561,13562,13563,13564,13566,13567,13568,13569,13570, 13571,13572,13574,13575,13578,13579,13580,13581,13582,13584,13585,13586,13587,13588,13589, 13590,13591,13592,13593,13594,13595,13596,13598,13599,13600,13602,13603,13604,13605,13606, 13607,13608,13609,13610,13611,13612,13613,13614,13616,13617,13619,13622,13624,13625,13626, 13627,13628,13629,13634,13637,13638,13639,13640,13641,13642,13643,13644,13645,13648,13649, 13651,13652,13653,13654,13655,13656,13657,13658,13659,13661,13664,13666,13667,13672,13675, 13679,13680,13681,13684,13686,13690,13693,13694,13696,13697,13698,13715,13716,13718,13727, 13739,13750,13751,13752,13753,13754,13755,13756,13757,13758,13759,13760,13761,13762,13763, 13764,13765,13766,13767,13768,13769,13770,13771,13772,13773,13774,13775,13776,13777,13779, 13784,13785,13786,13787,13788,13789,13790,13791,13792,13793,13794,13796,13797,13798,13799, 13803,13804,13805,13806,13808,13809,13810,13811,13814,13816,13817,13823,13824,13825,13846, 13847,13848,13849,13850,13851,13852,13853,13856,13857,13859,13862,13863,13864,13867,13868, 13869,13870,13871,13872,13875,13876,13877,13878,13880,13883,13884,13886,13887,13892,13893, 13894,13895,13896,13897,13899,13900,13901,13902,13903,13904,13905,13906,13907,13908,13909, 13910,13911,13912,13913,13914,13915,13916,13917,13918,13919,13920,13921,13923,13925,13926,13927,13928, 13930,13931,13950,13951,13952,13953,13954,13955,13957,13959,13962,13963,13966,13967,13968,13969,13970, 13971,13972,13974,13976,13977,13978,13980,13982,13983,13984,13986,13987,13988,13989,13990,13992,13993,13995,13997,13998,13998,13999,14000,14005,14006,14007,14008,14009,14010,14011,14012,14013,14014,14015,14016,14017,14018,14019,14020,14021,14022,14023,14024,14025,14026,14027,14028,14029,14030,14031,14032,14033,14034,14035,14036,14037,14038,14039,14040,14050,14054,14055,14058,14059,14061,14062,14063,14064,14065,14068,14069,14070,14071,14072,14073,14074,14075,14076,14077,14078,14079,14080,14081,14082,14083,14084,14085,14086,14087,14088,14089,14090,14091,14095,14096,14097,14098,14100,14101,14102,14103,14105,14106,14107,14108,14109,14110,14111,14113,14114,14115,14117,14118,14119,14120,14121,14122,14123,14125,14126,14129,14130,14131,14132,14133,14135,14136,14137,14138,14139,14140,14141,14142,14147,14148,14149,14152,14157,14158,14159,14162,14163,14164,14165,14167,14170,14174,14219,14221,14223,14224,14248,14250,14254,14255,14256,14257,14258,14259,14260,14261,14262,14263,14264,14265,14266,14267,14268,14269,14269,14270,14271,14274,14275,14276,14277,14278,14279,14282,14284,14285,14286,14287,14288,14289,14290,14291,14293,14295,14296,14297,14298,14299,14300,14301,14302,14303,14304,14305,14306,14307,14309,14311,14313,14314,14315,14316,14317,14318,14319,14320,14321,14322,14323,14324,14325,14327,14328,14329,14330,14331,14332,14333,14334,14335,14336,14337,14338,14339,14340,14341,14342,14343,14344,14345,14346,14347,14348,14349,14350,14351,14352,14353,14354,14355,14356,14357,14358,14359,14360,14361,14362,14363,14365,14366,14367,14368,14369,14370,14373,14374,14375,14376,14377,14378,14379,14380,14381,14382,14383,14384,14385,14386,14388,14389,14390,14391,14393,14394,14395,14396,14398,14399,14400,14402,14403,14450,14451,14452,14453,14454,14455,14456,14457,14458,14459,14460,14461,14462,14463,14464,14465,14466,14467,14468,14469,14470,14471,14472,14473,14474,14475,14476,14477,14478,14479,14481,14482,14483,14486,14489,14490,14491,14492,14493,14494,14495,14496,14497,14498,14499,14500,14504,14534,14535,14536,14537,14538,14539,14540,14541,14558,14559,14560,14561,14562,14563,14564,14566,14567,14568,14569,14570,14571,14572,14586,14587,14588,14595,14596,14597,14598,14599,14600,14603,14604,14605,14606,14607,14609,14610,14611,14613,14614,14617,14619,14620,14621,14622,14625,14627,14628,14629,14630,14631,14632,14633,14634,14635,14637,14638,14639,14640,14642,14644,14645,14647,14648,14649,14650,14651,14652,14653,14654,14655,14656,14657,14658,14659,14661,14662,14663,14664,14665,14667,14668,14669,14670,14671,14673,14674,14675,14676,14678,14679,14680,14683,14685,14686,14687,14688,14690,14691,14693,14696,14697,14698,14699,14701,14704,14706,14708,14709,14711,14712,14714,14715,14717,14719,14720,14721,14722,14723,14724,14725,14729,14731,14732,14733,14736,14737,14739,14740,14742,14743,14744,14745,14746,14747,14748,14749,14750,14753,14754,14756,14757,14759,14760,14761,14762,14763,14764,14765,14766,14767,14768,14770,14771,14773,14774,14775,14776,14777,14778,14779,14780,14782,14783,14785,14786,14787,14788,14789,14790,14791,14792,14793,14794,14795,14796,14797,14798,14799,14800,14801,14802,14803,14804,14806,14807,14808,14809,14810,14811,14812,14813,14815,14816,14819,14820,14821,14823,14826,14828,14829,14831,14832,14833,14834,14835,14837,14838,14839,14842,14843,14844,14845,14846,14847,14848,14849,14850,14851,14852,14853,14854,14855,14856,14857,14859,14860,14863,14864,14865,14867,14868,14869,14870,14871,14872,14873,14874,14875,14876,14878,14880,14881,14882,14883,14884,14885,14886,14888,14889,14890,14891,14892,14893,14894,14895,14896,14897,14898,14899,14900,14901,14902,14903,14904,14905,14906,14907,14908,14909,14910,14911,14912,14913,14914,14915,14916,14918,14919,14920,14922,14923,14924,14925,14927,14928,14931,14933,14934,14935,14937,14938,14941,14943,14944,14945,14946,14948,14949,14950,14951,14952,14953,14954,14955,14956,14957,14958,14959,14960,14961,14965,14966,14971,14972,14973,14974,14975,14976,14977,14979,14981,14982,14983,14984,14985,14986,14987,14988,14989,14990,14991,14992,14993,14994,14995,14996,14997,14999,15000,15001,15003,15004,15005,15007,15009,15010,15011,15013,15016,15018,15019,15023,15025,15026,15027,15028,15029,15030,15031,15032,15033,15035,15036,15040,15043,15044,15153,15154,15155,15156,15157,15158,15159,15160,15161,15162,15163,15164,15165,15166,15167,15168,15169,15170,15171,15172,15173,15174,15175,15176,15177,15178,15179,15180,15181,15182,15183,15185,15186,15188,15189,15196,15198,15199,15201,15203,15204,15207,15208,15209,15210,15211,15212,15213,15214,15215,15216,15222,15223,15224,15226,15228,15229,15230,15231,15254,15255,15256,15259,15260,15261,15263,15273,15274,15275,15276,15278,15279,15280,15283,15284,15288,15289,15290,15291,15292,15293,15294,15315,15316,15317,15320,15321,15322,15325,15326,15328,15330,15331,15332,15333,15334,15335, 15336,15338,15339,15340,15341,15343,15344,15347,15348,15349,15350,55525,55529,55533,10032,10175, 10192,10361,10372,10449, 10192, 10266,10356, 10372, 10449, 10690, 11016, 11167, 11229, 11320, 11611, 11618,11682,11683,11688,11698,11712,11763,11783,11792,11811,11815,11820,11825,11849,11853,11855,11860,11871,11872,11894,11895,11908,11909,11910,11914,11915,11921,11922,12062,12063,12064,12065,12113,12116,12134,12143,12148,12149,12150,12151,12161,12165,12166,12168,12214,12221,12238,12245,12246,12247,12267,12300,12301,12307,12308,12319,12320,12358,12365,12367,12374,12381,12385,12390,12427,12448,12449,12506,12507,12509,12515,12519,12525,12529,12560,12564,12566,12571,12572,12576,12585,12590,12593,12608,12609,12616,12637,12659,12660,12661,12666,12714,12739,12749,12750,12751,12754,12755,12758,12759,12760,12764,12787,12799,12804,12811,12812,12824,12841,12842,12876,12912,12914,12915,12921,12924,12933,12934,12936,12946,12951,12952,12954,12955,12959,12981,12989,12990,12991,12995,12998,13001,13006,13012,13021,13030,13032,13033,13038,13048,13049,13100,13106,13108,13111,13112,13124,13140,13141,13143,13145,13146,13147,13161,13162,13172,13187,13222,13235,13236,13237,13243,13247,13248,13276,13300,13311,13335,13352,13357,13358,13361,13372,13380,13383,13384,13388,13390,13398,13414,13419,13422,13424,13432,13433,13434,13446,13457,13468,13503,13504,13505,13506,13551,13559,13565,13583,13615,13620,13623,13630,13631,13632,13635,13646,13647,13650,13660,13662,13663,13665,13683,13699,13719,13720,13738,13740,13795,13807,13813,13815,13839,13854,13855,13860,13861,13865,13866,13873,13882,13885,13889,13890,13891,13898,13922,13924,13956,13960,13961,13973,13975,13979,13981,13985,13994,13996,14001,14002,14003,14051,14052,14053,14057,14060,14066,14067,140802,14092,14093,14094,14099,14104,14112,14116,14124,14143,14145,14155,14156,14160, 14161,14169,14171,14172,14173,14199,14200,14220,14222,14251,14252,14253,14273,14280,14281,14283, 14292,14294,14308,14310,14371,14372,14387,14397,14480,14624,14666,14677,14682,14694,14695,14702,14707,14710,14726,14727,14728,14730,14741,14769,14781,14784,14805,14814,14817,14818,14824,14827,14840,14926,14930,14932,14940,14967,14970,15002,15008,15015,15017,15020,15038,15039,15184,15187,15193,15194,15195,15197,15205,15206,15218,15219,15220,15221,15227,15281,15287,15295,15296,15297,15298,15299,15345,41968,41980,55553 & 72762.
Classification	Class II
Reason for Recall	Incorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the Extended Brilliance Workspace (EBW) systems currently running software version(s) 4.0.2, V4.5.2 or V4.5.3, addressing a number of non-conformances.
Product Quantity	2,580 units
Recall Number	Z-0906-2013

Class II Food/Cosmetics Event

Event ID	64284
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Dec-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Deep Foods Inc
City	Union
State	NJ
Country	US
Distribution Pattern	27 states (Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Louisiana, Massachusetts, Maryland, Maine, Mississippi, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia and West Virginia.

Associated Products

Product Description	Deep Best Quality Dry Garlic Chutney (Thechaa); Net Wt. 4 OZ.; UPC 011433111201; Deep Foods, Inc. Union, NJ 07083
Code Info	UPC 011433111201
Classification	Class II
Reason for Recall	Unapproved dye in product (Rhodamine B - Basic Violet 10).
Product Quantity	7000 units per month
Recall Number	F-1051-2013

Class II Devices Event

Event ID	64343
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Oct-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, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY; and, the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, GERMANY, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KUWAIT, LIBYAN ARAB JAMAHIRIYA, MALAYSIA, MEXICO, NETHERLANDS ANTILLES, NICARAGUA, NICOSIA, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PROVINCE OF CHINA, PUERTO RICO, REPUBLIC OF KOREA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA &, YEMEN.

Associated Products

Product Description	PROXIMATE® Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC Guaynabo, Puerto Rico 00969 USA Assembled in Mexico. For routine skin closure in a wide variety of surgical procedures.
Code Info	Expiration dates: September 2012 - August 2017
Classification	Class II
Reason for Recall	Ethicon Endo-Surgery initiated a voluntary recall for all PSX Proximate® Skin Staple Extractors because the possibility exists that damage to the packaging may have compromised the sterility of the device.
Product Quantity	5,894,975 pieces
Recall Number	Z-0918-2013

Class II Devices Event

Event ID	64383
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	31-Jan-13
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Salyer Prn Biomedical
City	Mesa
State	AZ
Country	US
Distribution Pattern	Distributed in the states of MA,CA, and WI.

Associated Products

Product Description	Century Console Base, Model #043625051b Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
Code Info	Serial Numbers: CCB40120, CCB40121, CCB40122, CCB40123, CCB40124, CCB40139, CCB40140, CCB40143, and CCB40144.
Classification	Class II
Reason for Recall	Concerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not comply with the FDA premarket notification regulations.
Product Quantity	9 units
Recall Number	Z-0902-2013

Class II Food/Cosmetics Event

Event ID	64396
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Feb-13
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Rich Products Corp
City	Buffalo
State	NY
Country	US
Distribution Pattern	NY, PA, VA, TN, IN, MI, WI, MN, SD, ND, IL, MO, NE, KS, OK, TX, CA, WA

Associated Products

Product Description	ALL NATURAL ANCIENT GRAIN BREAD, NET WT. 13.8 OZ. (393 g), PRODUCT OF CANADA, UPC 0 49800 08712 5 (appears on bag), Product Code 08712 --- RICH PRODUCTS CORP., BUFFALO, NY 14213 --- The product is a frozen bread dough packaged in a plastic bag with 24 plastic bags per case. The frozen dough is sold to in-store bakeries and food service customers.
Code Info	Product produced from July 27, 2012 through February 1, 2013 (Julian Dates 77002209 - 77003302)
Classification	Class II
Reason for Recall	Product was manufactured with bulk flour supplied by Dakota Specialty Milling which is being recalled due to reports of metal fragments..
Product Quantity	Approximately 6,000 cases
Recall Number	F-1052-2013

Class II Food/Cosmetics Event

Event ID	64397
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Feb-13
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Rich Products Corp
City	Buffalo
State	NY
Country	US
Distribution Pattern	CA, CO, TX, UT, SC, NC, WA, NM

Associated Products

Product Description	Sara Lee Thin Style Buns, 100% Multi-Grain, 1.5 oz., Goglanian Bakeries Product Code 77474, UPC 072945611788 --- The product is packaged in a plastic bag with a green bag clip. There are 8 buns per retail package (plastic bag) and there are 18 bags per tray.
Code Info	Production Date Green Bag Clip Code 7/24/12 G01206Gxx* 8/1/12 G01214Gxx* 8/6/12 G01219Gxx* 8/30/12 G01243Gxx* 9/26/12 G01270Gxx* 10/17/12 G01291Gxx* 11/28/12 G01333Gxx* 12/16/12 G01351Gxx* 12/31/12 G01366Gxx* 1/18/13 G01018Gxx* (*xx denotes the hour of production and will be represented by two numeric digits (e.g. 09 would mean 9:00 a.m. production hour).
Classification	Class II
Reason for Recall	The product was manufactured with bulk flour supplied by Dakota Specialty Milling. Dakota Specialty Milling is recalling the bulk flour because of reports of metal fragments (stainless steel) caused by a faulty mesh screen.
Product Quantity	Sara Lee Buns: 17,238 cases
Recall Number	F-1053-2013

Product Description	Daphne's California 6 inch Multigrain Flatbread, 2.1 oz., Product Code 77468, Net Wt. 13.50 lbs. (case) --- There are 12 - 10 count bags per case
Code Info	Production Date Bag Clip Code Case Jet Code 09/06/2012 09/06/12 09/06/12 L1 HH:MM 11/13/2012 11/13/12 11/13/12 L1 HH:MM 01/20/2013 01/20/13 01/20/13 L1 HH:MM *HH:MM denotes the hour and minute of production and will be represented by four numeric digits (e.g. 09:20 would mean 9:20 a.m. time of production)
Classification	Class II
Reason for Recall	The product was manufactured with bulk flour supplied by Dakota Specialty Milling. Dakota Specialty Milling is recalling the bulk flour because of reports of metal fragments (stainless steel) caused by a faulty mesh screen.
Product Quantity	Daphne's Flatbread: 1,254 cases
Recall Number	F-1054-2013

Class II Devices Event

Event ID	64404
Status	Ongoing
Product Type	Devices
Voluntary/Mandated
Recall Initiation Date	14-Jan-13
Initial Firm Notification of Consignee or Public

Recalling Firm	Atricure Inc
City	West Chester
State	OH
Country	US
Distribution Pattern	Nationwide Distribution including the states of MD, PA and TX.

Associated Products

Product Description	Atricure Inc. The Isolator Transpolar Pen is intended to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.
Code Info	Model Number(s): MAX1 A000163, Lot Number 41865
Classification	Class II
Reason for Recall	AtriCure has identified that products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
Product Quantity	5 devices
Recall Number	Z-0912-2013

Class II Devices Event

Event ID	64417
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Feb-13
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Medtronic Inc. Cardiac Rhythm Disease Management
City	Saint Paul
State	MN
Country	US
Distribution Pattern	Worldwide distribution, including USA nationwide, Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Viet Nam.

Associated Products

Product Description	Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318; 69320; 69322; 69324; 69328; 69331.
Code Info	Model Catalog# Lot 67312 6731210NO 2012090293 67312 6731210NO 2012090294 67312 6731210NO 2012090337 67312 6731210NO 2012100039 67312 6731210NO 2012100086 67312 6731210NO 2012100087 67312 6731210NO 2012100161 67312 6731210NO 2012110326 67312 6731210NO 2012110767 67312 6731210NO 2012110899 67312 6731210NO 2012111721 67314 6731410NO 2012090416 67314 6731410NO 2012090435 67314 6731410NO 2012090571 67314 6731410NO 2012090572 67314 6731410NO 2012100040 67314 6731410NO 2012100041 67314 6731410NO 2012100107 67314 6731410NO 2012101346 67314 6731410NO 2012110007 67314 6731410NO 2012110008 67314 6731410NO 2012110327 67314 6731410NO 2012111419 67314 6731410NO 2012111420 67314 6731410NO 2012120019 67316 6731610NO 2012090239 67316 6731610NO 2012090389 67316 6731610NO 2012090854 67316 6731610NO 2012091024 67316 6731610NO 2012110030 67316 6731610NO 2012110144 67316 6731610NO 2012110394 67316 6731610NO 2012110395 67316 6731610NO 2012110396 67318 67318 2012110850 67318 67318 2012110851 67318 67318 2012111013 67318 67318 2012111789 67318 67318 2012120328 67318 67318 2012120330 67318 67318 2013010932 67318 67318 2013010933 67318 67318 2013011226 67320 67320 2012121379 67320 67320 2012121629 67320 67320 2013010002 67320 67320 2013010105 69312 6931210NO 2012090236 69312 6931210NO 2012110010 69312 69312INK 2012090296 69312 69312INK 2012100905 69312 69312INK 2012110251 69312 69312INK 2012110252 69314 6931410NO 2012090855 69314 6931410NO 2012091222 69316 6931610NO 2012090240 69318 69318 2012111225 69318 69318 2013010966 69320 69320 2012121408 69320 69320 2013010003 69322 69322 2012111723 69322 69322 2012120118 69322 69322 2012120513 69322 69322 2013010812 69322 69322 2013010935 69324 69324 2012121060 69324 69324 2012121061 69324 69324 2012121062 69324 69324 2012121148 69324 69324 2012121149 69324 69324 2012121362 69328 69328 2012110184 69328 69328 2012120660 69328 69328 2012120661 69328 69328 2012120992 69328 69328 2012121004 69328 69328 2012121005 69328 69328 2012121006 69328 69328 2012121150 69328 69328 2012121192 69328 69328 2012121193 69328 69328 2012121364 69328 69328 201301C189 69331 69331 2012121063 69331 69331 2012121064 69331 69331 2012121151 69331 69331 2012121382 69331 69331 2013010224 69331 69331 2013010437 69331 69331 2013010438 69331 69331 2013010510 69331 69331 2013010511 CB67314 CB67314 206409412 CB67318 CB67318 206513557 CB67318 CB67318 206642303
Classification	Class II
Reason for Recall	Potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula.
Product Quantity	13,691 (6711 USA; 6980 OUS)
Recall Number	Z-0908-2013

Class II Devices Event

Event ID	64425
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Feb-13
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Bard Access Systems
City	Salt Lake City
State	UT
Country	US
Distribution Pattern	USA Nationwide Distribution and the countries Europe, Belgium, Australia, and Latin America.

Associated Products

Product Description	Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (pediatric product code 0600580; adult product code 0600600). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequate peripheral venous access.
Code Info	Lot numbers: HUWI1379 and HUWI1380.
Classification	Class II
Reason for Recall	Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer being included with the kit.
Product Quantity	195 units.
Recall Number	Z-0909-2013

Product Description	Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0600630). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequate peripheral venous access.
Code Info	Lot numbers: HUWI1379 and HUWI1380.
Classification	Class II
Reason for Recall	Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer being included with the kit.
Product Quantity	73 units
Recall Number	Z-0910-2013

Class II Devices Event

Event ID	64440
Status	Ongoing
Product Type	Devices
Voluntary/Mandated
Recall Initiation Date	12-Feb-13
Initial Firm Notification of Consignee or Public	Visit

Recalling Firm	Steris Corporation
City	Mentor
State	OH
Country	US
Distribution Pattern	Worldwide Distribution - USA including Canada and the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, SK, TN, TX, UT, VA, VT, WA, WI, and WV.

Associated Products

Product Description	AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
Code Info	AMSCO C: Serial Numbers: 021911201 023461202 AMSCO 400: Serial Numbers: 030181215-030291310
Classification	Class II
Reason for Recall	The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated during operation. When this alarm occurs, the sterilizer locks up and cannot be used until serviced, causing Customer nuisance.
Product Quantity	395 Units
Recall Number	Z-0915-2013

Class II Devices Event

Event ID	64464
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Jan-13
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Churchill Medical Systems, Inc.
City	Dover
State	NH
Country	US
Distribution Pattern	Nationwide Distribution including MO, IL, FL, PA, VA, MO, NY, NE, NH, and OH.

Associated Products

Product Description	Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
Code Info	Lot #1210099
Classification	Class II
Reason for Recall	The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a 22Ga set.
Product Quantity	2340
Recall Number	Z-0914-2013

Class II Drugs Event

Event ID	64541
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Jan-13
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	RX South LLC DBA RX3 Pharmacy
City	Chester
State	VA
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Medi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg/mL, inositol 16.6 mg/mL, cyanocobalamin USP [Vit B12] 0.33 mg/mL, chromium chloride 2.6 mg/mL), 30 mL multi-dose vials, Rx3 Compounding Pharmacy, 12230 Ironbridge Rd., Suite C, Chester, VA 23831.
Code Info	Lot #: 10292012:56, Exp 01/27/13 and 10302012:77, Exp 01/28/13
Classification	Class II
Reason for Recall	CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.
Product Quantity	126 vials
Recall Number	D-191-2013

Class III Biologics Event

Event ID	47152
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Jan-08
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	New York Blood Center, Inc.
City	New York
State	NY
Country	US
Distribution Pattern	New York

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	7764846;7764844
Classification	Class III
Reason for Recall	Blood products, which were exposed to unacceptable temperature during storage, were distributed.
Product Quantity	2 units
Recall Number	B-0724-13

Class III Biologics Event

Event ID	48953
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Mar-08
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Biomat USA, Inc.
City	Portland
State	OR
Country	US
Distribution Pattern	Spain and California

Associated Products

Product Description	Source Plasma
Code Info	0530052514, 0530052215, 0530050895, 0530050580, 0530047198, 0530046819, 0530046556, 0530046177, 0530045908, 0530045575, 0530045209, 0530044864, 0530044645, 0530044165, 0530043843, 0530043544, 0530043221, 0530042952, 0530042614, 0530042283, 0530041970, 0530041692, 0530041301, 0530040953, 0530040591, 0530040201, 0530040019, 0530039491, 0530039298, 0530038835, 0530038580, 0530038196, 0530037947, 0530037640, 0530037395, 0530037079, 0530036854, 0530036272, 0530035763, 0530035112, 0530034619, 0530034010, 0530033447, 0530031462, 0530031138, 0530030785, 0530030640, 0530030316, 0530029897, 0530029726, 0530029139, 0530028900, 0530028569, 0530028132, 0530024940, 0530024718, 0530024335, 0530024098, 0530023670, 0530023432, 0530023031.
Classification	Class III
Reason for Recall	Blood products, collected from a donor who was previously deferred, were distributed.
Product Quantity	61 units
Recall Number	B-0220-13

Class III Biologics Event

Event ID	57168
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Jul-10
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	CSL Plasma, Inc.
City	Portland
State	OR
Country	US
Distribution Pattern	Illinois, Germany, and Switzerland.

Associated Products

Product Description	Source Plasma
Code Info	05500078721, 0550884624, 0550880694, 0550878282, 0550877802, 0550876130, 0550874472, 0550872589, 0550869379, 0550866855, 0550866106, 0550865200, 0550864090, 0550862725, 0550862005, 0550860313, 0550859462, 0550857143, 0550856245, 0550855001, 0550854403, 0550852476, 0550850598, 0550850013, 0550848572, 0550848061, 0550846449, 0550844814, 0550843807, 0550842770, 0550840117, 0550838522, 0550837750, 0550836435, 0550834107, 0550832459, 0550829940, 0550828624, 0550827749, 0550826098, 0550825574, 0550823940, 0550823081, 0550821608, 0550819697, 0550819061.
Classification	Class III
Reason for Recall	Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
Product Quantity	46 components
Recall Number	B-0747-13

Class III Biologics Event

Event ID	63282
Status	Ongoing
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Ethicon, Inc.
City	Somerville
State	NJ
Country	US
Distribution Pattern	Nationwide and Foreign (Canada, Israel, Singapore, and Switzerland)

Associated Products

Product Description	Fibrin Sealant (Human) Evicel Rx Only Sterile Disposable Single Use Distributed by: Johnson and Johnson Wound Management A division of Ethicon Inc. Johnson & Johnson Wound Management A division of ETHICON, INC. P.O. Box 151, Somerville, NJ 08876-0151 USA Manufacturer: omrix Omrix biopharmaceuticals, Ltd. MDA blood bank, Sheba Hospital Ramat-Gan POB 888, Kiryat Ono 55000 ISRAEL NDC 63713-390-55 for EVICEL Fibrin Sealant (Human) 5 mL NDC 63713-390-11 for EVICEL Fibrin Sealant (Human) 1 mL NDC 63713-390-22 for EVICEL Fibrin Sealant (Human) 2 mL
Code Info	5 mL sample PRODUCT CODE S3905 LOT NUMBERS Q02F010, Q05F120, Q19F420, Q35F780, Q33F700 1 mL PRODUCT CODE 3901 LOT NUMBERS Q44F97K, Q53F350 2 mL PRODUCT CODE 3902 LOT NUMBERS Q03F030, Q09F310, Q29F610, Q44F980, Q31F640, Q35F750, Q36F820, Q46F040, Q47F050 5 mL PRODUCT CODE 3905 LOT NUMBERS P44F050 P45F100 P45F090 P46F120 P48F180 R06F130 R07F180 R07F190 R07F250 R07F260 R10F310 P50F330 R10F320 R10F330 R12F380 P48F190 P53F390 Q03F040 P50F310 Q02F010 P52F370 Q11F320 P52F360 Q02F020 Q04F090 Q04F100 Q04F110 Q05F120 Q32F660 Q05F130 Q05F140 Q06F160 Q06F170 Q07F210 Q08F280 Q08F290 Q16F400 Q08F300 Q13F340 Q33F710 Q13F350 Q14F360 Q14F370 Q15F380 Q15F390 Q19F410 Q28F560 Q19F420 Q21F470 Q21F480 Q32F670 Q31F620 Q31F630 Q22F490 R03F090 Q28F570 Q35F760 Q29F580 Q29F590 Q33F720 Q34F730 Q34F740 Q32F680 Q33F690 Q50F210 Q33F700 Q35F770 Q35F790 Q36F810 Q41F900 R01F010 R010F020 R01F030 Q41F920 Q40F880 Q41F910 Q48F090 R06F140 Q42F940 Q43F950 Q48F100 Q43F960 Q45F990 Q47F070 Q49F140 Q49F150 Q50F220 Q52F300 R03F080 Q51F280 Q52F290 R07F200 Q50F230 Q50F240 Q51F260 Q51F270 Q52F310 Q53F330 R02F060 R09F270 R10F300 R10F340 R11F350 R12F370
Classification	Class III
Reason for Recall	Evicel and Evithrom, manufactured with a processing deviation that potentially led to decreased potency, were distributed.
Product Quantity	120
Recall Number	B-1048-13

Product Description	Thrombin, Topical (Human) Evithrom Rx only Distributor: Johnson & Johnson Wound Management A division of Ethicon, Inc. Manufacturer: Omrix Biopharmaceuticals Ltd. 2 mL - NDC 63713-460-02 5 mL- NDC 63713-460-05
Code Info	Evithrom 2mL Product Code S4602, Lot Number Q36T62K; Product Code 4602, Lot Numbers P49T05K, Q11T44J, Q2T46K, Q45T77J; Evithrom 5 mL Product Code 4605 Lot Numbers P46T84J, P50T150, Q07T23J, Q08T28K, Q23T88K, Q25T93J, Q25T94J, Q27T08J, Q30T31J, Q31T34J, Q31T360, Q32T41K, Q33T48J
Classification	Class III
Reason for Recall	Evicel and Evithrom, manufactured with a processing deviation that potentially led to decreased potency, were distributed.
Product Quantity	18
Recall Number	B-1049-13

Class III Devices Event

Event ID	64013
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Mar-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Becton Dickinson & Company
City	Franklin Lakes
State	NJ
Country	US
Distribution Pattern	Nationwide Distribution

Associated Products

Product Description	BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA. Used in hospitals, outpatient clinics and physicians' offices to collect blood from patients for specialized chemistry testing.
Code Info	Reference No.: 367960; Tube Size: 13 X 75. Reference Nos. 367961-367963, and 368035; Tube Size: 13 X 100; all lots
Classification	Class III
Reason for Recall	BD is conducting a recall of the BD Vacutainer Plus Plastic Plasma Separator Tube (PST) with Light Green/BD Homogard Closure due to a deformed top of the tube reservoir reported in two customer complaints.
Product Quantity	225 million units
Recall Number	Z-0911-2013

Class III Biologics Event

Event ID	64206
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Florida Lions Eye Bank, Inc.
City	Miami
State	FL
Country	US
Distribution Pattern	Nationwide; Jamica; Costa Rica; Egypt, El Salvador, St. Thomas, Venezuela, Ecuador, China and Guatemala

Associated Products

Product Description	Cornea
Code Info	0801006COS, 0801006COD, 0801016COD, 0801016COS, 0801020COD, 0801022COS, 0801022COD, 0802009COSG2, 0802009COD, 0802009COSG1, 0802015COD, 0802015COSGPC, 0802015COS, 0802023COD, 0802023COS, 0802060COS, 0802060COD, 0802076COD, 0802076COS, 0802080CODG2, 0802080CODG1, 0802080COSG1, 0802080COSG2, 0802084COSG1, 0802084COSG2, 0802084CODG1, 0802084CODG2, 0803007COS, 0803007COD, 0803011COD, 0803011COS, 0803025COS, 0803025COD, 0803025COSGPC, 0803058COD, 0803076CODG1, 0803076CODG2, 0803076COSG2, 0803076COSG1, 0804015COD, 0804015COS, 0804042COD, 0805019COSG2, 0805019COSG1, 0805019COD, 0805056COS, 0805056COD, 0805056COSGPC, 0805064COD, 0805064COS, 0806007COD, 0806007COS, 0806014CODG2, 0806014COS, 0806014CODG1, 0806018COD, 0806018COS, 0806022COS, 0806022COD, 0806024COD, 0806024COSG2, 0806024COSG1, 0806032CODGPC, 0806032COSG1, 0806032COD, 0806032COSG2, 0806040CODG1, 0806040CODG2, 0806040COSG2, 0806040COSG1, 0806046COSG2, 0806046COSG1, 0806046CODG2, 0806046CODG1, 0806058COS, 0806058COD, 0807006COS, 0807006COD, 0807037COS, 0807037COD, 0807041COS, 0807041COD, 0807049COD, 0807049COS, 0808009COD, 0808009COS, 0808009COSGPC, 0808009CODGPC, 0808012COD, 0808041COD, 0808041COS, 0808046COS, 0808046COD, 0808046COSGPC, 0808046CODGPC, 0809002COD, 0809002COS, 0809028COD, 0809028COS, 0809075COSGPC, 0809075COS, 0809075COD, 0810002COD, 0810002COS, 0810012CODG2, 0810012COS, 0810012CODG1, 0810041COS, 0810041COD, 0811008CODG1, 0811008CODG2, 0811008COSG2, 0811008COSG1, 0811057COS, 0811057CODGPC, 0811057COD, 0811069COD, 0811069COS, 0811080CODG1, 0811080COSG1, 0811080CODG2, 0811080COSG2, 0811084COSG1, 0811084CODG2, 0811084CODG1, 0811084COSG2, 0812015COD, 0812015COS, 0812045CODG2, 0812045CODG1, 0812045COSG2, 0812045COSG1, 0812045COD, 0812059COSG2, 0812059COSG1, 0812059CODG2, 0812059CODG1, 0812060COD, 0812060COS, 0901001COS, 0901001COD, 0901016COD, 0901016COS, 0901021COS, 0901021COD, 0901055COS, 0901055COD, 0901059COS, 0901059COD, 0901066CODGPC, 0901066COS, 0901066COD, 0902020COS, 0902020COD, 0902028COD, 0902028COS, 0902032COS, 0902032COD, 0902043CODG1, 0902043CODG2, 0902043COSG1, 0902043COSG2, 0902061COSG1, 0902061COSG2, 0902061COD, 0903004WEOS, 0903004CODG1, 0903004SOD2, 0903004SOD3, 0903004SOD5, 0903004CODG2, 0903004SOD1, 0903004SOD4, 0903004SOD6, 0903004SOD7, 0903004SOD8, 0903027COD, 0903050COSG1, 0903050COD, 0903050COSG2, 0904012COS, 0904012COD, 0904039COSG1, 0904039COD, 0904039COSG2, 0904041COD, 0904041COS, 0904047COS, 0904047COD, 0904065COD, 0904065COS, 0904095COSG2, 0905006COSG1, 0905006COD, 0905006COSG2, 0905012COS, 0905012COD, 0905067COSG2, 0905067CODG1, 0905067CODG2, 0905067SOSW, 0905067SODW, 0905067COSG1, 0906011COS, 0906011COD, 0907015CODG1, 0907015COS, 0907015CODG2, 0907016SOD1, 0907016SOD2, 0907016SOD3, 0907016SOD4, 0907016CODG1, 0907016SOD7, 0907016SOD8, 0907016SOS1, 0907016SOS3, 0907016SOS4, 0907016COSG2, 0907016SOS7, 0907016COSG1, 0907016SOD5, 0907016SOD6, 0907016SOS2, 0907016SOS5, 0907016SOS6, 0907016CODG2, 0907025COSG1, 0907025COSG2, 0907025SOSW, 0907025SODW, 0907025CODG1, 0907025CODG2, 0907045COS, 0907045COD, 0908048COS, 0908048CODG2, 0908048CODG1, 0909009COD, 0909009COS, 0909022WEOD, 0909059CODG1, 0909059CODG2, 0909059COSG1, 0909059COSG2, 0909059SOSW, 0909059SODW, 0909073COS, 0909073COD, 0909078COSG2PC, 0909078COSG1PC, 0909078CODG1PC, 0909078CODG2PC, 0909089COD, 0909089COS, 0910002COS, 0910003COSG1, 0910003SOSW, 0910003SODW, 0910003COSG2, 0910003CODG1, 0910003CODG2, 0911007COS, 0911007COSGPC, 0911007COD, 0911008COD, 0911008CODGPC, 0911008COS, 0911021COS, 0911021COD, 0911033COSGPC, 0911033COD, 0911033COS, 0911040CODG2, 0911040COSG2, 0911040COSG1, 0911040CODG1, 0911065COD, 0911065COS, 0912002CODG2, 0912002SOS2, 0912002SOS7, 0912002SODW, 0912002SOS1, 0912002SOS3, 0912002SOS4, 0912002SOS5, 0912002SOS6, 0912002SOS8, 0912002COSG1, 0912002COSG2, 0912002CODG1, 0912013COS, 0912013COD, 0912022COS, 0912022COD, 0912052CODG1, 0912052CODG2, 0912062COS, 0912062COD, 1001004COD, 1001004COS, 1001008SOSW, 1001008CODG1, 1001008SODW, 1001008CODG2, 1001008COSG1, 1001008COSG2, 1001009COD, 1001009COS, 1001010COD, 1001010COS, 1001011CODG2, 1001011CODG1, 1001011COSG1, 1001011COSG2, 1001016COSG1, 1001016COSG2, 1001016WEOD, 1001016SOSW, 1001017COD, 1001017CODGPC, 1001017COSGPC, 1001017COS, 1001052COD, 1001052COS, 1001090COD, 1001096COS, 1001096COD, 1002008SOD2, 1002008SOS4, 1002008SOD1, 1002008SOD8, 1002008SOD7, 1002008SOS6, 1002008CODG2, 1002008COSG2, 1002008SOD3, 1002008SOD4, 1002008SOD5, 1002008SOD6, 1002008SOS1, 1002008SOS2, 1002008SOS7, 1002008SOS8, 1002008CODG1, 1002008COSG1, 1002008SOS3, 1002008SOS5, 1002009COD, 1002009COS, 1002009CODGPC, 1002009COSGPC, 1002035COS, 1002035COD, 1002066COD, 1002066COS, 1003002COD, 1003002COS, 1003010COD, 1003010COS, 1003016COS, 1003016COD, 1004031COD, 1004031COS, 1004037COS, 1004037COD, 1004045CODG2, 1004045COSG1, 1004045CODG1, 1004045COSG2, 1004049COS, 1004049CODG1, 1004049CODG2, 1004050COD, 1004050COS, 1004051CODG2, 1004051CODG1, 1004051COSG1, 1004051SODW, 1004051SOSW, 1004051COSG2, 1004054COD, 1004054COS, 1004054COD, 1004054COS, 1004077COS, 1004077CODG2, 1004077CODG1, 1004079COD, 1004079COS, 1005004COSG1, 1005004COD, 1005004COSG2, 1005009COD, 1005009COSG1, 1005009COSG2, 1005011COD, 1005011COS, 1005013CODG2, 1005013CODG1, 1005013COSG2, 1005019COS, 1005019COD, 1005021COD, 1005021COS, 1005023CODG2, 1005023COS, 1005023CODG1, 1005024COD, 1005024COS, 1005037COD, 1005037COSG1PC, 1005037COSG2PC, 1005037COSGPC, 1005060CODG1, 1005060CODG2, 1005060COS, 1005063COSGW, 1005067COD, 1005067COS, 1005077COD, 1005077COS, 1005078COD, 1005078COS, 1005079COS, 1005079COD, 1006002COD, 1006002COS, 1006005COS, 1006005COD, 1006013COD, 1006013COS, 1006014COSG1, 1006014CODG1, 1006014CODG2, 1006014COSG2, 1006021COD, 1006021COS, 1006027COD, 1006027COS, 1006033COD, 1006033COS, 1006049COD, 1006049COS, 1006053COS, 1006053COD, 1006055COD, 1006055COS, 1006059COD, 1006059COS, 1006067CODG1, 1006067COS, 1006067CODG2, 1007001CODG2, 1007001CODG1, 1007001COS, 1007007COD, 1007007COS, 1007008COS, 1007008COD, 1007010COD, 1007010COS, 1007014COD, 1007014COS, 1007019COS, 1007019COD, 1007024COD, 1007024COS, 1007041COS, 1007041COD, 1007043COD, 1007043COS, 1007052COSG1, 1007052COSG2, 1007052CODG1, 1007052SODW, 1007052SOSW, 1007052CODG2, 1007055COD, 1007055COS, 1007062COS, 1007062CODG1, 1007062CODG2, 1007064CODG1, 1007064COSG1, 1007064SODW, 1007064SOSW, 1007064CODG2, 1007064COSG2, 1007072COD, 1007072COS, 1008004CODG1PC, 1008004CODG2PC, 1008004CODGPC, 1008004COS, 1008005COD, 1008005COS, 1008008COS, 1008008COD, 1008009COD, 1008009COS, 1008019COS, 1008019COD, 1008022COD, 1008022COS, 1008036COD, 1008036COS, 1008042CODG1, 1008042COSG1, 1008042COSG2, 1008042CODG2, 1008077COD, 1008077COSG1PC, 1008077COSG2PC, 1008079COD, 1008079COS, 1009001CODG1, 1009001CODG2, 1009001COSG1, 1009001COSG2, 1009046COS, 1009046COD, 1009057SODW, 1009057COSG2, 1009057SOSW, 1009057CODG1, 1009057CODG2, 1009057COSG1, 1009061COS, 1009061COD, 1010006CODG1, 1010006CODG2, 1010006COSG1, 1010006COSG2, 1010012COS, 1010012COD, 1010035SOS1, 1010035SOS2, 1010035SOS3, 1010035COSG2, 1010035COD, 1010035SOD1, 1010035SOD2, 1010035SOD4, 1010035SOS4, 1010035SOD3, 1010037COS, 1010037SODW, 1010037SOSW, 1010037COD, 1010044CODG1, 1010044CODG2, 1010044COS, 1010044SOD1, 1010044SOD2, 1010044SOD3, 1010044SOD4, 1010044SOS1, 1010044SOS2, 1010044SOS3, 1010044SOS4, 1010051COD, 1010051COS, 1010066COD, 1010066COS, 1011006SOS6, 1011006COS, 1011006SOS5, 1011006SOD5, 1011006SOD6, 1011006SOD8, 1011006SOS3, 1011006SOS4, 1011006SOS7, 1011006SOS8, 1011006SOD3, 1011006SOD1, 1011006SOD2, 1011006SOD4, 1011006SOS1, 1011006SOS2, 1011006COD, 1011028CODG2, 1011028COSG1, 1011028COSG2, 1011028SOS2, 1011028SOS3, 1011028SOS1, 1011028CODG1, 1011028SODW, 1011034COSG1, 1011034CODG2, 1011034CODG1, 1011034COSG2, 1011040COD, 1011040SOD1, 1011040SOD2, 1011040COS, 1011045COD, 1011045COS, 1012021CODG2, 1012021CODG1, 1012044COD, 1012044COS, 1101042CODG1, 1101042CODG2, 1101042COSG1, 1101042COSG2, 1101061COD, 1101061COS, 1101064COS, 1101064COD, 1101070CODG1PCBED, 1101070CODG2PCBED, 1101070COS, 1101074CODG1, 1101074CODG2, 1101074COS, 1101084CODG1, 1101084CODG2, 1101084COSG1, 1101084COSG2, 1102007COD, 1102007COS, 1102030COD, 1102030COS, 110232CODG1PCBED, 110232CODG2PCBED, 102032COSG1PCBED, 1102032COSG2PCBED, 1102033COD, 1102033COSG1, 1102033COSG2, 1102044COD, 1102044COSG1, 1102044COSG2, 1103024COD, 1103024COS, 1103028COD, 1103028COSG1, 1103028COSG2, 1103057COD, 1103057COS, 1103063COD, 1103063COS, 1105017COD, 1105017COSG1, 1105017COSG2, 1105026COD, 1105026COS, 1105039COD, 1105039COS, 1105053COD, 1105053COS, 1106002CODG1, 1106002CODG2, 1106002COSG1, 1106002COSG2, 1106056COSGW, 1107036COD, 1107036COS, 1107045CODG1, 1107045CODG2, 1107045COS, 1107047COS, 1108027CODG2PCBED, 1108027CODG1PCBED, 1108027CODG2PCBED, 1108027COS, 1108027CODG1PCBED, 1108027CODGPCCAP, 1108031COD, 1108031COS, 1108045CODG1, 1108045CODG2, 1108045COSG1, 1108045COSG2, 1108050COD, 1108050COSG1, 1108050COSG2, 1108075COD, 1108075COS, 1108076CODG2, 1108076CODG1, 1108076COSG1, 1108076COSG2, 1108079COD, 1108079COS, 1202048SOSW, 1202048COS, 1202048SODW, 1202048COD
Classification	Class III
Reason for Recall	Human Corneas, recovered from donors whose donor eligibility was not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed.
Product Quantity	693
Recall Number	B-0971-13

Class III Drugs Event

Event ID	64298
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Jan-13
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Aaron Industries Inc
City	Lynwood
State	CA
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Well at Walgreens Wal-Tussin CF Max, MAXIMUM STRENGTH ADULT NON-DROWSY, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (237 mL) bottles, Distributed by: Walgreen Co, Deerfield, IL 60015 ---- NDC 0363-0229-08
Code Info	Lot# 80798; FP-49-081-14870
Classification	Class III
Reason for Recall	Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Product Quantity	6,108 bottles (509 cases)
Recall Number	D-185-2013

Product Description	Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg, 4 FL. OZ./12 PK (UPC Code: 0-11822-57307-8) and 8 FL.OZ./12 PK (UPC Code: 0-11822-57313-9), Distributed by: Rite Aid, Camp Hill, PA, 17011
Code Info	Lot# 68089, 68415, 70046, 700516, 70665, 71157, 71704, 80795; FP-38-081-57313; FP-38-041-57307
Classification	Class III
Reason for Recall	Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Product Quantity	35,652 bottles (2,971 cases)
Recall Number	D-186-2013

Product Description	Select Brand Cough Control CF Max, Maximum Strength for MUCUS RELIEF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 4 fl.oz 12pk (NDC 15127-025-04; UPC Code: 0-15127-02535-5), Distributed by: Select Brand Distributors, Pine Bluff, AR 71603 USA.
Code Info	Lot# 71648, 68088; FP-47-041-02535
Classification	Class III
Reason for Recall	Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Product Quantity	5,676 bottles (473 cases)
Recall Number	D-187-2013

Product Description	Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (235 mL) (NDC 49035-229-08; UPC Code: 6-81131-03884-30), Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72712.
Code Info	Lot# 81198, 82183, 80797; FP-44-081-03884
Classification	Class III
Reason for Recall	Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Product Quantity	43,464 bottles (3,622 cases)
Recall Number	D-188-2013

Class III Drugs Event

Event ID	64338
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Feb-13
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Glenmark Generics Inc., USA
City	Mahwah
State	NJ
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per bottle (NDC 68462-392-30) and b) 90-count tablets per bottle (NDC 68462-392-90), Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430.
Code Info	02122956, 02123226, 02123269, 02123480, 02123481, 02122933, 02122955, 02123062, 02123075, 02123085, 02123114, 02123115, 02123124, 02123125, 02123189, 02123199, 02123205, 02123219, 02123253, 02123270, 02123289, 02123295, 02123320, 02123333, 02123343, 02123349, 02123411, 02123421, 02123431, Exp 09/14 and 10/14
Classification	Class III
Reason for Recall	Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moldy, musty or fishy in nature which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA).
Product Quantity	591,972 bottles
Recall Number	D-182-2013

Class III Devices Event

Event ID	64367
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Jan-13
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Linvatec Corp. dba ConMed Linvatec
City	Largo
State	FL
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) including the states of: CA, FL, GA, IL, KS, MA, MD, MO, NE, NY, and TX and the countries of: Canada, Germany, Romania, Spain, Palestine, South Africa, France, Sweden and Singapore

Associated Products

Product Description	D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone
Code Info	Model #D3000
Classification	Class III
Reason for Recall	The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207 is used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third edition IEC60606-01 Medical Electrical Equipment: General requirements for basic safety and essential performance.
Product Quantity	31 units
Recall Number	Z-0916-2013

Product Description	D3000I Advantage Drive System, 230v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone
Code Info	Model #D3000I
Classification	Class III
Reason for Recall	The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207 is used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third edition IEC60606-01 Medical Electrical Equipment: General requirements for basic safety and essential performance.
Product Quantity	23 units
Recall Number	Z-0917-2013

Class III Drugs Event

Event ID	64506
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Feb-13
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Actavis Elizabeth LLC
City	Elizabeth
State	NJ
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx Only, C II, 100 capsules per bottle, MFG. By Actavis Elizabeth LLC. 200 Elmora Ave, Elizabeth, NJ, 07207, USA, NDC 0228-3063-11.
Code Info	Lot #: 50077231
Classification	Class III
Reason for Recall	Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
Product Quantity	9,264 Bottles
Recall Number	D-190-2013

Mixed Classification Biologics Event

Event ID	63590
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	02-Oct-12
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Red Blood Cells
Code Info	2533388
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-0269-13

Product Description	Blood and Blood Products for Reprocessing
Code Info	2533388
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-0270-13

Mixed Classification Biologics Event

Event ID	63592
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Sep-12
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W036811258578
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-0474-13

Product Description	Blood and Blood Products for Reprocessing
Code Info	W036811258578; W036810173369
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	2 units
Recall Number	B-0475-13

Product Description	Red Blood Cells
Code Info	W036810173369
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-0476-13

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