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Enforcement Report - Week of January 23, 2013

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Biologics Devices Drugs Food / Cosmetics Veterinary

Class I Veterinary Event

Event ID	63137
Status	Ongoing
Product Type	Veterinary
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Breeders Choice Pet Foods Inc
City	Irwindale
State	CA
Country	US
Distribution Pattern	U.S. states to include California, Georgia, Illinois, Nevada, Ohio, Virginia, and Washington.

Associated Products

Product Description	AvoDerm Natural Lamb Meal Brown Rice Adult Dog Formula, 26 lb. Packaged in plastic bag with plastic liner.
Code Info	Product Code/SKU/Material # 1000065074, UPC Code 0 5290702043 8, Best before dates of 28 Aug 2013, 29 Aug 2013, 30 Aug 2013.
Classification	Class I
Reason for Recall	The firm recalled because the product has the potential to be contaminated with Salmonella.
Product Quantity	7,392 bags
Recall Number	V-126-2013

Class I Devices Event

Event ID	63319
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Aug-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Vycor Medical, Inc.
City	Boca Raton
State	FL
Country	US
Distribution Pattern	Worldwide Distribution - USA (Nationwide) in the states of TX, IL, NJ, FL, OH, PA and (International) in the country of Japan.

Associated Products

Product Description	Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device*STERILE* Product Usage: The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.
Code Info	Model # TC171105 Lot # VM83450
Classification	Class I
Reason for Recall	Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.
Product Quantity	3000 devices
Recall Number	Z-0673-2013

Class I Veterinary Event

Event ID	63454
Status	Ongoing
Product Type	Veterinary
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Del Monte Corp
City	San Francisco
State	CA
Country	US
Distribution Pattern	Products were distributed nationwide.

Associated Products

Product Description	Nature's Recipe, Oven Baked Biscuits with Real Chicken, Made with sweet potatoes, oats, flaxseed., 19 ounces; UPC: 30521 51549
Code Info	UPC: 30521 51549 Lot code: 2199TP; Best by: 10/11/13 Lot code: 2200TP; Best by: 10/12/13
Classification	Class I
Reason for Recall	Product may be contaminated with Salmonella.
Product Quantity	4282 cases ( 6 unit/ case)
Recall Number	V-120-2013

Class I Veterinary Event

Event ID	63513
Status	Ongoing
Product Type	Veterinary
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Oct-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Wildwood Seeds
City	Monroe
State	OR
Country	US
Distribution Pattern	Products are distributed in Oregon and Washington

Associated Products

Product Description	Pet Bird Feed- Sleek and Sassy are sold under multiple names. Products with UPCs are listed below. Garden Conure has the following UPCs: 0-1253111602-0; 0-1253111604-4; 0-1253111620-4; 0-1253111640-2; Garden Large Hookbill has the following UPCs: 0-1253113102-3; 0-1253113104-7; 0-1253113120-7; 0-1253113140-5; Garden Large Hookbill No Sunflower has the following UPCs: 0-1253113202-0; 0-1253113204-4; 0-1253113220-4; 0-1253113240-2; Garden Parrot has the UPCs: 0-1253112103-1; 0-1253112125-3; Nutty Garden Grain has the UPCS: 0-1253115502-9; 0-1253115504-3; 0-1253115520-3; 0-1253115540-1; Garden Macaw has the UPCs: 0-1253115602-6; 0-1253115604-0; 0-1253115620-0; 0-1253115640-8; Garden Complete Pellet has the UPCs: 0-1253115702-3; 0-1253115704-7; 0-1253115720-7; 0-1253115740-5; Fruit Veggie Nut Treat has the UPCs: 0-1253114302-6; 0-1253114304-0; 0-1253114320-0; 0-1253114316-3; 0-1253114332-3;
Code Info	No expiration dates on packages. Product has lot code 01148 through 01241 (it is interpreted as: 11 is for manufacturing year 2011, and 48 is week 48 of 2011).
Classification	Class I
Reason for Recall	Pet bird food and small animal pet foods are recalled due to a potential to be contaminated with Salmonella.
Product Quantity	approximately 4904 lbs.
Recall Number	V-121-2013

Product Description	Small Pet Animal Food is sold under Sleek and Sassy brand. Product are packaged from 2 lb., 4 lb., 20 lb., to 40 lb in polysynth bag. Garden Small Animal has the following UPCs: 0-1253113902-9; 0-1253113904-3; 0-1253113920-3; 0-1253113940-1;
Code Info	No expiration dates on packages. Product has lot code 01148 through 01241 (it is interpreted as: 11 is for manufacturing year 2011, and 48 is week 48 of 2011).
Classification	Class I
Reason for Recall	Pet bird food and small animal pet foods are recalled due to a potential to be contaminated with Salmonella.
Product Quantity	approximately 566 lbs.
Recall Number	V-122-2013

Product Description	Garden Guinea Pig/Rabbit diet is sold under Sleek and Sassy brand. Product is packaged from 2 lb., 4 lb., 20 lb., to 40 lb in polysynth bag. Garden Guinea Pig/Rabbit has UPC is 0-1253113502-1.
Code Info	No expiration dates on packages. Product has lot code 01148 through 01241 (it is interpreted as: 11 is for manufacturing year 2011, and 48 is week 48 of 2011).
Classification	Class I
Reason for Recall	Pet bird food and small animal pet foods are recalled due to a potential to be contaminated with Salmonella.
Product Quantity	approximately 984 lbs.
Recall Number	V-123-2013

Product Description	Fortified feeds are sold under Sleek and Sassy brand. Different products with UPCs are listed below. Fortified Large Hookbill with the UPCs: 0-1253111402-6; 0-1253111404-0; 0-1253111420-0; 0-1253111440-8; Fortified Large Hookbill No Sunflower with the UPCs: 0-1253111502-3; 0-1253111504-7; 0-1253111520-7; 0-1253111540-5; Fortified Parrot with the UPCs: 0-1253113003-3; 0-1253113025-5; Fortifed Small Animal with the UPCs: 0-1253112902-0; 0-1253112904-4; 0-1253112920-4; 0-1253112940-2;
Code Info	No expiration dates on packages. Product has lot code 01148 through 01241 (it is interpreted as: 11 is for manufacturing year 2011, and 48 is week 48 of 2011).
Classification	Class I
Reason for Recall	Pet bird food and small animal pet foods are recalled due to a potential to be contaminated with Salmonella.
Product Quantity	approximately 1560 lbs.
Recall Number	V-124-2013

Class I Veterinary Event

Event ID	63537
Status	Terminated
Product Type	Veterinary
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Oct-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	HBD International
City	Brentwood
State	TN
Country	US
Distribution Pattern	OR

Associated Products

Product Description	WILD WINGS, CERTIFIED ORGANIC, PREMIUM ORGANIC BLEND, PREMIUM SEED FOR BIRDS, Net wt. 80 oz (5 lbs) (2.27 kg), HBD INTERNATIONAL, 7108 CROSSROADS BLVD., SUITE 325 BRENTWOOD, TN 37027, 615.221.9890 800.346.0269
Code Info	POM9512WL2201A4
Classification	Class I
Reason for Recall	Product was manufactured with peanuts recalled by Sunland due to the potential for salmonella contamination.
Product Quantity	36 units
Recall Number	V-125-2013

Class I Veterinary Event

Event ID	63606
Status	Ongoing
Product Type	Veterinary
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	31-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Wixon, Inc.
City	Saint Francis
State	WI
Country	US
Distribution Pattern	CA, IL, GA, NJ, CT, KS, MN, MA, WA, ME, NY.

Associated Products

Product Description	Charlee Bear Protein Crunch Bars, 84% Chicken Recipe with Sweet Potatoes, 5.5 oz, UPC Code 8710890001.
Code Info	Lot # 20112
Classification	Class I
Reason for Recall	Charlee Bear Products, a division of Wixon, Inc., is voluntarily recalling certain lots of its Charlee Bear Protein Crunch Treats because they have the potential to be contaminated with Salmonella.
Product Quantity	444 cases (12 pouches/case)
Recall Number	V-127-2013

Product Description	Charlee Bear Protein Crunch Bars, 84% Chicken Recipe with Carrots, 5.5 oz, UPC Code 8710890000.
Code Info	Lot # 19812, 19912, 20012, 20212.
Classification	Class I
Reason for Recall	Charlee Bear Products, a division of Wixon, Inc., is voluntarily recalling certain lots of its Charlee Bear Protein Crunch Treats because they have the potential to be contaminated with Salmonella.
Product Quantity	448 cases (12 pouches/case)
Recall Number	V-128-2013

Class I Food/Cosmetics Event

Event ID	63677
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Nov-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Frito Lay, Inc
City	Plano
State	TX
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Grandma's Peanut Butter Sandwich Creme Cookies, Net WT. 3.025 oz, Frito-Lay, Inc. Plano, TX 75024
Code Info	GRANDMA'S Peanut Butter Sandwich Creme cookies have a sell-by date of March 12, 2013 or earlier and UPC code of 28400-00153.
Classification	Class I
Reason for Recall	The firm is recalling GRANDMA'S Peanut Butter Sandwich Creme cookies and GRANDMA'S Peanut Butter Mini Sandwich Creme cookies because they contain undeclared milk and egg.
Product Quantity	12,000 cases (720,000 units) of the 3.025 oz & 3,378 cases (202,000 units) of the 1.71 oz
Recall Number	F-0877-2013

Product Description	Grandma's Peanut Butter Mini Sandwich Creme Cookies, Net WT. 1.71 oz, Frito-Lay, Inc. Plano, TX 75024
Code Info	GRANDMA'S Peanut Butter Mini Sandwich Creme cookies have a sell-by date of May 21, 2013 or earlier and UPC code of 28400-00901. The sell-by date is located on the front of the package.
Classification	Class I
Reason for Recall	The firm is recalling GRANDMA'S Peanut Butter Sandwich Creme cookies and GRANDMA'S Peanut Butter Mini Sandwich Creme cookies because they contain undeclared milk and egg.
Product Quantity
Recall Number	F-0878-2013

Class I Devices Event

Event ID	63698
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-Nov-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Bausch and Lomb, Incorporated
City	Aliso Viejo
State	CA
Country	US
Distribution Pattern	Worldwide distribution: USA including DC and PR; and countries of: Canada and Mexico accounts not available at this time.

Associated Products

Product Description	Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) ophthalmic viscosurgical device. The 27G disposable cannula is attached to the syringe standard luer fitting to deliver the Amvis or Amvis Plus during use as a surgical aid in opthalmic anterior or posterior segment procedures.
Code Info	B100003G B100015A B100015D B100023A B100023B B100023C B100023D B100023E B100039D B100039F B100046A B100046B B100046C B100058A B100069A B110027D B110028C B110048A B110048D B110056A B120011D B120016A D100008B D100009A D100011A D100011B D100011C D100016B D100016C D100022A D100022B D100022C D100022D D100026A D100026C D100026D D100026E D100030A D100030B D100030C D100035A D100035C D100035D D100043A D100043B D100043C D100044B D100044C D100044D D100044E D100045A D100045B D100045C D100059A D100059B D100059C D100060A D100060B D100061A D100061B D100080A D100081A D100081AS D110015A D110015B D110016A D110045A D110046A D110047A D110070A D110071A D110072A D110090A D110090B D110091A D110092A D110108A D110108B D110108BR D120015A D120015B D120027A D120028A D120029A D120029B D120038B D120039A D120068A D120068B 023632 023633 023639 023640 023647 023801 023811 023863 023886 023897 023920 023933 023972 024022 024025 024028 024257 024323 024436 C10003B E090105A D090095B D090096A D090096C D090097C D090097D Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L)
Classification	Class I
Reason for Recall	Some disposable cannulas (with 4-digit lot numbers) provided with the Amvisc or Amvisc Plus OVD are not properly engaging to the Luer-Lock on the Amvisc and Amvisc Plus sterile glass syringes. The cannulas may leak viscoelastic material or detach from the syringe during injection. In rare incidents, detachment has resulted in serious patient injury.
Product Quantity	2,342,294
Recall Number	Z-0672-2013

Class I Food/Cosmetics Event

Event ID	63839
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Dec-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Sugar Flowers Plus
City	Glendale
State	CA
Country	US
Distribution Pattern	Nationwide.

Associated Products

Product Description	Pastillage (gum paste) Flowers
Code Info	Rose - Pink UPC code: 8 38437 00003 0
Classification	Class I
Reason for Recall	Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.
Product Quantity
Recall Number	F-0899-2013

Product Description	Pastillage (gum paste) Flowers
Code Info	Rose - Yellow UPC code: 8 38437 00001 6
Classification	Class I
Reason for Recall	Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.
Product Quantity
Recall Number	F-0900-2013

Product Description	Pastillage (gum paste) Flowers
Code Info	Rose - Red UPC code: 8 38437 00002 3
Classification	Class I
Reason for Recall	Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.
Product Quantity
Recall Number	F-0901-2013

Product Description	Pastillage (gum paste) Flowers
Code Info	Rose - Blue UPC code: 8 38437 00004 7
Classification	Class I
Reason for Recall	Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.
Product Quantity
Recall Number	F-0902-2013

Product Description	Pastillage (gum paste) Flowers
Code Info	Cymbidium - W/M UPC Code: 8 38437 00010 8
Classification	Class I
Reason for Recall	Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.
Product Quantity
Recall Number	F-0903-2013

Product Description	Pastillage (gum paste) Flowers
Code Info	Cattleya - W/P UPC code: 8 38437 00011 5
Classification	Class I
Reason for Recall	Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.
Product Quantity
Recall Number	F-0904-2013

Product Description	Pastillage (gum paste) Flowers
Code Info	Gladiolus - A/W UPC ocde: 8 38437 00012 2
Classification	Class I
Reason for Recall	Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.
Product Quantity
Recall Number	F-0905-2013

Product Description	Pastillage (gum paste) Flowers
Code Info	Gladiolus - P/BUR UPC code: 8 38437 00013 9
Classification	Class I
Reason for Recall	Sugar Flowers Plus Inc of Glendale, CA is recalling Cake Decors Pastillage (gum paste) Flowers because of the undeclared use of egg white wash as a glue for the inner petals of flowers.
Product Quantity
Recall Number	F-0906-2013

Class I Food/Cosmetics Event

Event ID	63910
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Dec-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Ocean Beauty Seafoods, LLC
City	Seattle
State	WA
Country	US
Distribution Pattern	Nationwide to distributors and retailers in AZ, CA, CO, CT, MA, NH, NJ, NY, OR, PA, RI, TX and WA.

Associated Products

Product Description	Cold-smoked salmon in vacuum plastic bags that are partially clear and partially colored black, white, gold and pink, labeled in part: front panel: *NATHAN'S TRADITIONAL DELICATESSEN NOVA SALMON CLASSIC SMOKEDNET WT 3 OZ (85g) back panel: NATHAN'S TRADITIONAL DELICATESSEN NOVA SALMON CLASSIC SMOKEDThis salmon can be frozen for up to 45 days. Thaw under refrigeration. Once opened, keep refrigerated and be sure to enjoy within five days. Keep refrigerated at 38F or below.0 73030 80368 2**INGREDIENTS: ATLANTIC SALMON (COLOR ADDED), SALT, SUGAR, PRESERVATIVES (SODIUM BENZOATE, SODIUM ERYTHORBATE, SODIUM NITRITE), FD&C YELLOW #5, YELLOW #6, RED #40, BLUE #1, AND NATURAL HARDWOOD SMOKE. DISTRIBUTED BY OCEAN BEAUTY SEAFOODS LLC, SEATTLE, WA 98119 WWW.OCEANBEAUTY.COM FARM RAISED PRODUCT OF CHILE A white stick-on label, affixed to the top left hand corner of the back panel, reads: top line: M228208 middle line left to right: 07 09 285 12 14 09 and bottom line: 10632
Code Info	Pack Date: 285 UPC: 0 73030 80368 2;
Classification	Class I
Reason for Recall	Ocean Beauty Seafood's sample was found positive for Listeria monocytogenes.
Product Quantity	272 cases - 12/3 ounce packages per case. The press release had reported 275 cases had been distributed, but that was incorrect.
Recall Number	F-0913-2013

Product Description	Cold-smoked salmon in vacuum plastic that are partially clear and partially colored blue, yellow, white, labeled in part: front panel: *Lascco BRAND SLICED SMOKED NOVA SALMON NET WT 4 OZ (113g) PERISHABLE. KEEP REFRIGERATED AT 38F OR COLDER. back panel: Lascco BRAND SLICED SMOKED NOVA SALMON0 72840 01751 7*INGREDIENTS: ATLANTIC SALMON (COLOR ADDED), SALT, SUGAR, PRESERVATIVES (SODIUM BENZOATE, SODIUM ERYTHORBATE, SODIUM NITRITE), FD&C YELLOW #5, YELLOW #6, RED #40, BLUE #1, AND NATURAL HARDWOOD SMOKE. DISTRIBUTED BY OCEAN BEAUTY SEAFOODS LLC, SEATTLE, WA 98119 WWW.OCEANBEAUTY.COM FARM RAISED PRODUCT OF CHILE A white stick-on label, affixed to the top left hand corner of the back panel, reads: top line: M228208 middle line left to right: 07 09 285 12 14 09 and bottom line: 10632
Code Info	Pack Date: 285 UPC: 0 72840 01757 7
Classification	Class I
Reason for Recall	Ocean Beauty Seafood's sample was found positive for Listeria monocytogenes.
Product Quantity	95 cases - 12/4 ounce packages per case. The press release reported 96 cases distributed, but that was incorrect.
Recall Number	F-0914-2013

Class I Food/Cosmetics Event

Event ID	63948
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Dec-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Cap Sur Mer, Inc.
City	L'etang Du Nord
State
Country	CA
Distribution Pattern	Portsmouth, NH; Raynham, MA; Taunton, MA

Associated Products

Product Description	Nautifish Frozen Cooked Lobster Meat. CKL 12 X 11.3 oz. Metal Cans. 12 items/case. Keep Frozen.
Code Info	Dates of Manufacture: 10/5/12, 11/4/12, 11/5/12, 11/6/12, 11/7/12. Date Codes: 12 309 to 12 312, Lot #50979 R, Product #12834. Date Code: 12 279. Lot #48213 R, Product number: 12834
Classification	Class I
Reason for Recall	This product was found with Listeria monocytogenes through laboratory analysis.
Product Quantity	244 cases of 12 X 11.3oz cans
Recall Number	F-0907-2013

Product Description	Apollo Frozen Cooked Lobster Meat. BCKL Lobster Meat 6X2 lb, plastic bags, 6 individual items per case, keep frozen
Code Info	Date of Manufacture: 10/05/12; Lot # 11244
Classification	Class I
Reason for Recall	The product or a previous product from this date code was found with Listeria monocytogenes through laboratory analysis.
Product Quantity	101 cases - 6 X 2lb per case
Recall Number	F-0908-2013

Product Description	Captain Homard Frozen Cooked Lobster Meat. Broken Tail Meat, 6X2 lb, plastic bags, 6 individual items per case. Keep Frozen.
Code Info	Date of Manufacture: 10/05/12, 11/05/12, 11/06/12, 11/07/12. Date Code: 12 279: #48293 R; #16046; 12 310, 12 311, 12 312 Lot# 50028 R
Classification	Class I
Reason for Recall	The product or a previous product from this date code was found with Listeria monocytogenes through laboratory analysis.
Product Quantity	12 Cases - 6 X 2lb plastic bags/case
Recall Number	F-0909-2013

Product Description	Frozen Cooked Lobster Tail Meat. Nautifish. 2 lb plastic bags, 6 items/case. Keep Frozen
Code Info	Date of Manufacture: 10/05/12. Date Code 12 279; Product Number: 339538
Classification	Class I
Reason for Recall	The product or a previous product from this date code was found with Listeria monocytogenes through laboratory analysis.
Product Quantity	3 cases- 6 X 2 lb plastic bags/case
Recall Number	F-0910-2013

Product Description	Frozen Cooked Lobster Meat. Salad Meat 6 X 2 lb. plastic bags, 6 individual items per case. Captain Homard and Apollo. Keep Frozen
Code Info	Date of Manufacture: 11/04/12, 11/05/12, 11/06/12, 11/07/12; Date Code: 12 309 - 12 312; Lot #50019 and 50432R for Captain Homard; Lot #50020 for Appolo Product #15721
Classification	Class I
Reason for Recall	This product was found with Listeria monocytogenes through laboratory analysis.
Product Quantity	780 cases - 6 X 2lb plastic bags/case
Recall Number	F-0911-2013

Product Description	Frozen Cooked Lobster Meat. TCK Nautifish 6 X 2 lbs. Plastic Bags, 6 individual per case. Keep Frozen
Code Info	Date of Manufacture: 11/05/12, 11/06/12; Date Code: 12 310 - 12 311. Lot #50022 R, Product # 339 703
Classification	Class I
Reason for Recall	The product or a previous product from this date code was found with Listeria monocytogenes through laboratory analysis.
Product Quantity	13 cases - 6 X 2 lb plastic bags per case
Recall Number	F-0912-2013

Class I Food/Cosmetics Event

Event ID	64030
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Jan-13
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Somersault Snack Co., LLC
City	Sausalito
State	CA
Country	US
Distribution Pattern	Nationwide and Canada

Associated Products

Product Description	Somersault brand Cinnamon Crunch. Crunchy nuggets baked with sunflower seeds and toasted grains. Sunflower seed snack. .5 oz, 1 oz., 2 oz., 6 oz., and 16 oz.
Code Info	Cinnamon Crunch 12ct; 6oz. Case Code10-8-98403-002-27-4;Product Code 8-98403-002-27-7; Sell By: 8/30/2013 or earlier Cinnamon Crunch 16ct; 2oz.Case Code10-8-98403-002-27-4; Product Code8-98403-002-27-7; Sell By: 8/30/2013 or earlier Cinnamon Crunch 100ct; 0.5oz., Case Code10-8-98403-002-24-3; Product Code 8-98403-002-24-6; Sell By: 8/30/2013 or earlier Cinnamon Crunch 36ct; 1oz.Case Code10-8-98403-002-23-6; Product Code 8-98403-002-22-2; Sell By: 8/30/2013 or earlier, Cinnamon Crunch 50ct; 1oz., Case Code 10-8-98403-002-22-9; Product Code 8-98403-002-22-2; Sell By: 8/30/2013 or earlier Cinnamon Crunch Bulk 8ct; 16oz. (for samples only, no case and product code)Sell By: 8/30/2013 or earlier Shipper 36ct; 1oz. SS CC, Case Code10-8-98403-002-26-7; Product Code 8-98403-002-22-2; Sell By: 8/30/2013 or earlier
Classification	Class I
Reason for Recall	During ingredient review for kosher certification, the firm discovered that the finished product package did not bear a milk allergen declaration, although a flavor ingredient was found to contain milk
Product Quantity	36,757 cases
Recall Number	F-0879-2013

Class I Food/Cosmetics Event

Event ID	64046
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Jan-13
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Woodstock Farms
City	Edison
State	NJ
Country	US
Distribution Pattern	Alabama, Connecticut, Florida, Georgia, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Vermont, Virginia, Wisconsin, and District of Columbia

Associated Products

Product Description	Woodstock All Natural Tamari Almonds, 7.5 OZ in a gusseted re-sealable poly bag.
Code Info	Best By: 10/24/13 Lot: 12298 UPC# 0-42563-00838-3
Classification	Class I
Reason for Recall	Undeclared soy ingredient on mislabeled back panel. While the Tamari Almonds contain soy, the ingredient statement does not include soy. In addition, the nutrition facts and UPC# are incorrect which corresponds to another almond product. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume this product.
Product Quantity	67 cases, each containing 8 packages per shipping case
Recall Number	F-0886-2013

Class II Biologics Event

Event ID	39136
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Jun-07
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	American National Red Cross (The)
City	Omaha
State	NE
Country	US
Distribution Pattern	PA

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	09FN91160
Classification	Class II
Reason for Recall	Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Product Quantity	1 unit
Recall Number	B-0171-13

Class II Biologics Event

Event ID	39579
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Jan-05
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	LifeServe Blood Center
City	Sioux City
State	IA
Country	US
Distribution Pattern	South Dakota, Austria

Associated Products

Product Description	Red Blood Cells
Code Info	1970058
Classification	Class II
Reason for Recall	Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity	1 unit
Recall Number	B-0406-13

Product Description	Blood and Blood Products for Reprocessing
Code Info	1970058
Classification	Class II
Reason for Recall	Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity	1 unit
Recall Number	B-0407-13

Class II Biologics Event

Event ID	39636
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Jan-05
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	LifeServe Blood Center
City	Sioux City
State	IA
Country	US
Distribution Pattern	IA, SD

Associated Products

Product Description	Red Blood Cells (Apheresis) Leukocytes Reduced
Code Info	1959203;1959203
Classification	Class II
Reason for Recall	Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
Product Quantity	2 units
Recall Number	B-0473-13

Class II Biologics Event

Event ID	39765
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Feb-05
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Red Blood Cells
Code Info	11FM49562
Classification	Class II
Reason for Recall	Blood product, positive for the S-antigen but labeled as S-antigen negative, was distributed.
Product Quantity	1 unit
Recall Number	B-0364-13

Class II Biologics Event

Event ID	40317
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-May-05
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	011LF20539
Classification	Class II
Reason for Recall	Blood product, with platelet yield that exceeded the manufacturer's limit for the product to be stored in one bag, was distributed.
Product Quantity	1 Unit
Recall Number	B-0167-13

Class II Biologics Event

Event ID	41296
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Dec-05
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Red Blood Cells
Code Info	LX44682
Classification	Class II
Reason for Recall	Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Product Quantity	1 Unit
Recall Number	B-0173-13

Class II Biologics Event

Event ID	43372
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Oct-06
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Baylor University Medical Center - Transfusion Service Center
City	Dallas
State	TX
Country	US
Distribution Pattern	TX

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced Irradiated
Code Info	49GN54061
Classification	Class II
Reason for Recall	Blood product, labeled with an incorrect expiration date, was distributed.
Product Quantity	1 unit
Recall Number	B-0363-13

Class II Biologics Event

Event ID	45352
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Jul-07
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Red Blood Cells
Code Info	4066720
Classification	Class II
Reason for Recall	Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1 unit
Recall Number	B-0372-13

Class II Biologics Event

Event ID	47050
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Dec-07
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W045007915604
Classification	Class II
Reason for Recall	Blood product, which was possibly contaminated with Propionibacterium species, was distributed.
Product Quantity	1 Unit
Recall Number	B-0366-13

Class II Biologics Event

Event ID	47138
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	02-Jan-08
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W045007915029 Part 1 ;W045007915029 Part 2
Classification	Class II
Reason for Recall	Blood products, which were possibly contaminated with Propionibacterium species, were distributed.
Product Quantity	2 Units
Recall Number	B-0365-13

Class II Biologics Event

Event ID	47987
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Mar-08
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Red Blood Cells (Apheresis) Leukocytes Reduced
Code Info	W045008007317 Part A ;W045008007317 Part B
Classification	Class II
Reason for Recall	Blood products, which failed to meet the minimum specification for product volume, were distributed
Product Quantity	2 Units
Recall Number	B-0367-13

Class II Biologics Event

Event ID	48910
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Jun-08
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	21KM96454
Classification	Class II
Reason for Recall	Blood product, collected from a donor who reported post donation illness, was distributed.
Product Quantity	1 component
Recall Number	B-0166-13

Class II Biologics Event

Event ID	49326
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	02-Jul-08
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	Platelets Pheresis Leukocytes Reduced Irradiated
Code Info	21KT41666; 21KT41666
Classification	Class II
Reason for Recall	Blood products, labeled as leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
Product Quantity	2 components
Recall Number	B-0168-13

Class II Biologics Event

Event ID	49869
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Aug-08
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced Irradiated
Code Info	21FP45176
Classification	Class II
Reason for Recall	Blood products, labeled as leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
Product Quantity	1 component
Recall Number	B-0169-13

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	21FP45176
Classification	Class II
Reason for Recall	Blood products, labeled as leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
Product Quantity	1 component
Recall Number	B-0170-13

Class II Biologics Event

Event ID	49930
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Aug-08
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Interstate Blood Bank Inc Mo
City	Saint Louis
State	MO
Country	US
Distribution Pattern	Austria

Associated Products

Product Description	Source Plasma
Code Info	LZ090296; LZ089770
Classification	Class II
Reason for Recall	Blood products, collected from a donor who did not have a complete physical examination, were distributed.
Product Quantity	2 Units
Recall Number	B-0077-13

Class II Biologics Event

Event ID	50052
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Sep-08
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	21LZ02870; 21LZ07089; 21LZ10267; 21LZ14250.
Classification	Class II
Reason for Recall	Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
Product Quantity	4
Recall Number	B-0174-13

Class II Biologics Event

Event ID	50418
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Oct-08
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Red Blood Cells (Apheresis) Leukocytes Reduced
Code Info	21LQ32862, 21LQ32862
Classification	Class II
Reason for Recall	Blood product, collected from a donor with an unacceptably low hemoglobin, was distributed.
Product Quantity	2 components
Recall Number	B-0458-13

Class II Drugs Event

Event ID	62237
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Aug-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	James G. Cole, Inc.
City	Hood River
State	OR
Country	US
Distribution Pattern	Product was distributed nationwide and Canada

Associated Products

Product Description	I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
Code Info	N/A
Classification	Class II
Reason for Recall	Lack of Assurance of Sterility: The product is being recalled because the product label does not state sterile in accordance with 21 CFR Part 200.50(a)(1), Ophthalmic Preparations and Dispensers, and it is not in compliance with 21 CFR Part 349, Ophthalmic Drug Products for Over-The-Counter Use.
Product Quantity	253 bottles
Recall Number	D-129-2013

Class II Devices Event

Event ID	62719
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	DePuy Spine, Inc.
City	Raynham
State	MA
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and internationally to Belgium, Egypt, Ireland, Italy, Portugal, and the UK.

Associated Products

Product Description	DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expedium Offset Spinal Construct.
Code Info	All lots
Classification	Class II
Reason for Recall	A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potentially resulting in the instrument recording torque values outside of the specification.
Product Quantity	140 units
Recall Number	Z-0685-2013

Class II Devices Event

Event ID	63393
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-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 AZ, CA, CO, IL, IL, IN, MA, ME, MI, MO, NC, NJ, NY, OR, TN, TX, VA and WI and the countries of Austria, Canada, China, France, India, Ireland, Italy, Japan, Netherlands, Norway, Spain, Switzerland, Thailand and United Kingdom.

Associated Products

Product Description	Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace Portal 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. The portal (together with the scanner) provides image processing and display through software applications that process, analyze, display, quantify and interpret medical images/data.
Code Info	Model #728269; Serial #s: 79906, 79921, 79927, 79937, 80007, 80026, 80031, 80040, 80058, 80062, 80066, 80069, 80087, 80110, 80121, 80155, 80167, 80168, 80169, 80174, 80192, 80193, 80195, 80201, 80208, 80209, 80219, 80227, 80228, 80230, 80252, 80258, 80266, 80280, 80289, 80293, 80294, 80315, 80322, 80328, 80333, 80340, 80341, 80348, 80360, 80375, 80385, 80387, 80394, 80398, 80416, 80421, 80422, 80429, 80447, 80451, 80460, 80474, 80482, 80484, 80485, 80492, 80497, 80505, 80516, 80578, 80585, 80591, 80629, 80646, 80658, 80681, 80704, 80709, 80711, 80720, 80723, 80743, 80749, 80751, 80831, 80835, 80866, 80878, 80908, 80909, 80911, 80914, 80916, 80930, 80931, 80944, 80974, 80992, 80999, 81023, 81025, 81034, 81045, 81071, 81099, 81101, 81107, 81117, 81126, 81136, 95382 & 95592.
Classification	Class II
Reason for Recall	Philips was notified that when performing post processing with the Brilliance Workspace Portal platform with software versions 2.6.1.4, the coronary arteries in the rendered image are segmented automatically. However, the center line is not extracted or highlighted upon hovering and making it impossible to activate the vessel and choose the appropriate name (label) from the drop-down menu.
Product Quantity	108 units
Recall Number	Z-0675-2013

Class II Biologics Event

Event ID	63417
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	LifeShare Blood Centers
City	Texarkana
State	TX
Country	US
Distribution Pattern	Louisiana

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W036511025390
Classification	Class II
Reason for Recall	Blood product, collected from a donor who emigrated from an area considered endemic for malaria, was distributed.
Product Quantity	1 unit
Recall Number	B-0373-13

Class II Devices Event

Event ID	63771
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Nov-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Perkinelmer
City	Waltham
State	MA
Country	US
Distribution Pattern	Nationwide Distribution.

Associated Products

Product Description	NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. (Table 1 of Attachment 2) details the analytes measured by the kit. Quantitative analysis of amino acids, free carnitine and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that may aid in the screening of newborns for one or more of several metabolic disorders. This kit is to be used for in vitro diagnostic use only, by trained, qualified laboratory personnel.
Code Info	Lot Numbers: 617341, 619236
Classification	Class II
Reason for Recall	Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Product Quantity	180 kits (20 plates/kit)
Recall Number	Z-0686-2013

Product Description	NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes ) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.
Code Info	Lot Numbers: 617253 , 617346, 618494 , 618653, 618764 , 619453
Classification	Class II
Reason for Recall	Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Product Quantity	819 kits (10 plates/kit)
Recall Number	Z-0687-2013

Product Description	NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.
Code Info	Lot Numbers: 618201, 619200, 618263
Classification	Class II
Reason for Recall	Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Product Quantity	3029-0010 =1562 kits (10 plats/kit) and 3029-001B=13 kits (50plates/kit)
Recall Number	Z-0688-2013

Product Description	DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010
Code Info	Lot Numbers: 618609
Classification	Class II
Reason for Recall	Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Product Quantity	56 kits (100 plates/kit)
Recall Number	Z-0689-2013

Product Description	Microplate, truncated V-bottomed lots included in the above listed products Product Number: 1380 5465. DBS Microplate is a general purpose 96 well microplate used in the preparation and examination of specimens from the human body.
Code Info	Lot Numbers: 616792 , 617141 , 617980 , 618319, 618664, 618831, 619175
Classification	Class II
Reason for Recall	Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Product Quantity
Recall Number	Z-0690-2013

Class II Devices Event

Event ID	63817
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Dec-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 IN, OH and OR; and the countries: Australia, Belgium, China, Israel, and Sweden.

Associated Products

Product Description	Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Code Info	Brilliance CT X-RAY System - Model/System Code #728231, Serial Number distributed in the U.S. was: 9654. Ingenuity CT X-Ray System - Model/System Code #728326 - Serial Numbers distributed in the U.S. were: 300018, and 300003. The remaining Serial Numbers distributed overseas were: 91003, 95130, 95157, 95504, and Serial Numbers: 300010, and 300030 .
Classification	Class II
Reason for Recall	Software anomalies. Philips Medical Systems recalled their Brilliance 64 running software v4.0.0xx516 and their Ingenuity CT running software v4.0.0xx518 due to software issues detected in these CT scanning systems. If these issues were to re-occur they could pose the risk of injury to patients undergoing scans; device users; or device service personnel.
Product Quantity	A total of nine (9) units were distributed (3 units in the U.S & 6 units overseas)
Recall Number	Z-0674-2013

Class II Food/Cosmetics Event

Event ID	63851
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Unilever United States, Inc.
City	Englewood Cliffs
State	NJ
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Knorr Pasta Sides Cheesy Bacon Macaroni Net Wt. 3.8 oz, (107 g) Unilever Englewood Cliffs, NJ 07632 USA Made in Canada from domestic and imported ingredients Case SCC 10041000082488 UPC 4100008248
Code Info	Sept1113BUO Sept1213BUO
Classification	Class II
Reason for Recall	Knorr Pasta Sides Cheesy Bacon Macaroni may contain soy as a different product mix was inadvertently packaged in the Cheesy Bacon Macaroni pouch.
Product Quantity	16,500 puches
Recall Number	F-0880-2013

Class II Devices Event

Event ID	63863
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Oct-12
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
Code Info	Catalog number 4933-1-001, Lot number Z02804, Z08348, Z08350, Z12549, Z16753. Catalog number 4933-1-002, Lot number Z08351, Z12554, Z16246, Z16752. Catalog number 4933-1-003 Lot Number Z08349, Z09344, Z12551, Z16996.
Classification	Class II
Reason for Recall	Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients.
Product Quantity	476 units
Recall Number	Z-0695-2013

Class II Veterinary Event

Event ID	63880
Status	Ongoing
Product Type	Veterinary
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Hospira Inc.
City	Lake Forest
State	IL
Country	US
Distribution Pattern	Alabama, Colorado, District of Columbia, Florida, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Minnesota, Missouri, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Virginia.

Associated Products

Product Description	Plum A+ Single Channel Infusion Pump with Module for Veterinary Use Only; Hospira, Inc., Lake Forest, IL 60045; list number 60529, module 60530-04
Code Info	List number 60529, serial numbers 14315003, 14315004, 14315005, 14315008, 14315009, 14315011, 14315012, 14315013, 14315014, 14315015, 14315017, 14315018, 14315019, 14315020, 14315022, 14315023, 14315025, 14315026, 14315027, 14315028, 14315029, 14315030, 14315031, 14315034, 14315035, 14315036, 14315037, 14315038, 14315040, 14315041, 14315043, 14315044, 14315045, 14315046, 14315047, 14315048, 14315049, 14315050, 14315051, 14315052, 14315053, 14315054, 14315055, 14315056, 14315057, 14315058, 14315059, 14315061, 14315062, 14315063, 14315064, 14315066, 14315067, 14315069, 14315070, 14315071, 14315072, 14315073, 14315074, 14315075, 14315076, 14315077, 14315078, 14315079, 14315080, 14315081, 14315082, 14315083, 14315084, 14315085, 14315086, 14315087, 14315088, 14315089, 14315090, 14315091, 14315092, 14315093, 14315094, 14315095, 14315096, 14315097, 14315098, 14315099, 14315100, 14315101, 14315103, 14315104, 14315105, 14315106, 14315109, 14315110, 14315111, 14315112, 14315113, 14315114, 14315116, 14315117, 14315118, 14315119, 14315120, 14315121, 14315123, 14315124, 14315125, 14315126, 14315127, 14315128, 14315129, 14315130, 14315131, 14315132, 14315133, 14315134, 14315135, 14315136, 14315137, 14315138, 14315139, 14315140, 14315141, 14315142, 14315143, 14315145, 14315146, 14315147, 14315148, 14315149, 14315150, 14315151, 14315152, 14315153, 14315154, 14315155, 14315156, 14315157, 14315158, 14315159, 14315160, 14315161, 14315162, 14315163, 14315164, 14315165, 14315166, 14315167, 14315168, 14315169, 14315170, 14315171, 14315172, 14315173, 14315174, 14315175, 14315176, 14315177, 14315178, 14315179, 14315180, 14315181, 14315182, 14315183, 14315184, 14315185, 14315186, 14315187, 14315188, 14315189, 14315190, 14315191, 14315192, 14315193, 14315194, 14315195, 14315196, 14315197, 14315198, 14315199, 14315200, 14315201, 14315202, 14315203, 14315204, 14315205, 14315207, 14315208, 14315209, 14315210, 14315211, 14315212, 14315213, 14315214, 14315215, 14315216, 14315217, 14315218, 14315219, 14315220, 14315221, 14315223, 14315224, 14315225, 14315226, 14315227, 14315228, 14315229, 14315230, 14315231, 14315232, 14315233, 14315234, 14315235, 14315236, 14315237, 14315238, 14315239, 14315240, 14315241, 14315242, 14315243, 14315244, 14315245, 14315246, 14315247, 14315248, 14315249, 14315250, 14315251, 14315252, 14315253, 14315254, 14315255, 14315256, 14315257, 14315258, 14315259, 14315260, 14315261, 14315262, 14315263, 14315264, 14315265, 14315266, 14315267, 14315268, 14315269, 14315270, 14315271, 14315272, 14315273, 14315274, 14315275, 14315276, 14315277, 14315278, 14315279, 14315280, 14315281, 14315282, 14315283, 14315284, 14315285, 14315286, 14315287, 14315288, 14315289, 14315290, 14315291, 14315293, 14315294, 14315295, 14315296, 14315297, 14315298, 14315299, 14315300, 14315301, 14315302, 14315303, 14315304, 14315305, 14315306, 14315307, 14315308, 14315309, 14315310, 14315311, 14315312, 14315313, 14315314, 14315315, 14315316, 14315317, 14315318, 14315319, 14315320, 14315321, 14315322, 14315323, 14315324, 14315325, 14315326, 14315327, 14315328, 14315329, 14315330, 14315331, 14315332, 14315333, 14315334, 14315335, 14315336, 14315337, 14315338, 14315339, 14315340, 14315341, 14315342, 14315343, 14315344, 14315345, 14315346, 14315347, 14315348, 14315349, 14315350, 14315351, 14315352, 14315353, 14315354, 14315355, 14315356, 14315357, 14315358, 14315359, 14315360, 14315361, 14315362, 14315363, 14315364, 14315365, 14315366, 14315367, 14315368, 14315369, 14315370, 14315371, 14315372, 14315373, 14315374, 14315375, 14315376, 14315377, 14315378, 14315379, 14315380, 14315381, 14315382, 14315383, 14315384, 14315385, 14315386, 14315387, 14315388, 14315389, 14315390, 14315391, 14315392, 14315393, 14315394, 14315395, 14315396, 14315397, 14315398, 14315399, 14315400, 14315401, 14315402, 14315403, 14315404, 14315405, 14315406, 14315407, 14315408, 14315409, 14315410, 14315411, 14315412, 14315413, 14315414, 14315415, 14315416, 14315417, 14315418, 14315419, 14315420, 14315421, 14315422, 14315423, 14315424, 14315425, 14315426, 14315427, 14315428, 14315429, 14315430, 14315431, 14315432, 14315433, 14315434, 14315435, 14315436, 14315437, 14315438, 14315439, 14315440, 14315441, 14315442, 14315443, 14315444, 14315445, 14315446, 14315447, 14315448, 14315449, 14315450, 14315451, 14315452, 14315453, 14315454, 14315455, 14315456, 14315457, 14315458, 14315459, 14315460, 14315461, 14315462, 14315463, 14315464, 14315465, 14315466, 14315467, 14315468, 14315469, 14315470, 14315471, 14315472, 14315473, 14315474, 14315475, 14315476, 14315477, 14315478, 14315479, 14315480, 14315481, 14315482, 14315483, 14315484, 14315485, 14315486, 14315487, 14315488, 14315489, 14315490, 14315491
Classification	Class II
Reason for Recall	The volume control knob on some Plum A+ infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.
Product Quantity	467 pumps
Recall Number	V-119-2013

Class II Devices Event

Event ID	63931
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Spacelabs Healthcare, Llc
City	Issaquah
State	WA
Country	US
Distribution Pattern	Worldwide Distribution-USA including Puerto Rico and the states of California, Florida, Iowa, Illinois, Louisiana, Michigan, Minnesota, North Carolina, South Carolina, Texas, and Washington, and the countries of Argentina, Mexico, France, and India.

Associated Products

Product Description	Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The Smart Disclosure product collects patient waveforms, alarms, vital signs, and 12-lead reports. A 24-hour waveform acquisition is standard, with an upgrade option to 72 hours. The product provides basic trends in both tabular and graphical format, along with a retrospective ECG analysis. The analysis may be defined by patient, and the data may be presented in multiple formats, including a rhythm, a histogram, and a summary view. Standard reports are available from Smart Disclosure, including saved events, disclosure, trends, histogram, and summary. The Spacelabs Smart Disclosure System, Model 92810 is indicated for use in clinical situations where there is a need for review of physiological waveform information and alarm events up to 72 hours after the fact. Smart Disclosure is also indicated in those situations where a retrospective analysis of monitoring patients' ECG waveform data, that can be annotated and edited, is desired. The intended use of the Spacelabs Smart Disclosure is to interface with the Spacelabs monitoring network, providing the user with a means of recalling waveform information and performing retrospective analysis. The most recent 72 hours of monitored patient ECG waveform data can be analyzed, with each analysis limited to 24 hours or less.
Code Info	ICS G2 Smart Disclosure Model 92810, Version 4.03. There are no serial numbers.
Classification	Class II
Reason for Recall	Displaying or printing of an incorrect waveform for the time indicated in the printout or display in the Spacelabs Healthcare Intesys Clinical Suite (ICS) G2, Version 4.03, Clinical Access portion of Smart Disclosure, Model 92810.
Product Quantity	17 in US and 6 International
Recall Number	Z-0694-2013

Class II Food/Cosmetics Event

Event ID	63943
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Dec-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Naturally Fresh Inc.
City	Atlanta
State	GA
Country	US
Distribution Pattern	U.S.

Associated Products

Product Description	Marketside, Chunky Bleu Cheese Dressing, Net Wt. 14 fl. oz (414)mL, Manufactured For Marketside, a division of Wal-Mart Stores, Inc., Bentonville, AR 72716.
Code Info	Lot code 81H09062; Best By 01/04/13; UPC 6 81131 02900 1
Classification	Class II
Reason for Recall	Undeclared Allergen: Dairy
Product Quantity	978 cases
Recall Number	F-0885-2013

Class II Drugs Event

Event ID	63966
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	L. Perrigo Co.
City	Allegan
State	MI
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Prednisone tablets, USP, 10mg, Rx Only, Units of Use, NDC: a) 45802-303-67, 48-count Cartons, b) 45802-303-21, 21-count Cartons, Manufactured by: West-Ward Pharmaceutical Corporation, Eastown, NJ 07724, Distributed by: Perrigo, Allegan, MI 49040.
Code Info	Lot #s: a) 2DV1238, Exp10/13; 2CV0623, 2CV0625, Exp 11/13; b) 2DV1239, Exp 10/13; 2CV0627, Exp 11/13
Classification	Class II
Reason for Recall	Presence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of this product, West-Ward Pharmaceuticals. This is a sub-recall due to tablets contaminated with trace amounts of food-grade lubricant, as well as stainless steel inclusions
Product Quantity	86,616 Tablets
Recall Number	D-125-2013

Class II Food/Cosmetics Event

Event ID	63995
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Dec-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Dollar Tree Distribution, Inc.
City	Chesapeake
State	VA
Country	US
Distribution Pattern	Nationwide and Canada

Associated Products

Product Description	Candy Canes, Peppermint Flavor, 5 oz boxes, packed 12 individually candy canes/box, and labeled in part *Distributed by Greenbriar International, Inc., Chesapeake, VA 23320, MADE IN CHINA*
Code Info	Batch number: YT-0112003 01880-001 120521 01880-001 120605
Classification	Class II
Reason for Recall	Candy product may contain metal and/or plastic pieces embedded in the candy.
Product Quantity	3,147,956 boxes
Recall Number	F-0882-2013

Product Description	Candy Canes, Cherry Flavor, 5 oz boxes, packed 12 candy canes/box, and labeled in part *Distributed by Greenbriar International, Inc., Chesapeake, VA 23320, MADE IN CHINA*
Code Info	Batch number: 01880-001 120504
Classification	Class II
Reason for Recall	Candy product may contain metal and/or plastic pieces embedded in the candy.
Product Quantity	1,257,120 boxes
Recall Number	F-0883-2013

Class II Food/Cosmetics Event

Event ID	64006
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Dec-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Local Baking, Co, Inc. T/A Joey's Fine Foods
City	Newark
State	NJ
Country	US
Distribution Pattern	New York and New Jersey

Associated Products

Product Description	JOEY'S GOURMET LEMON CAKE; NET WT 3 oz. (85 g); UPC 026104613403; Joey's Fine Foods, Inc., Newark, NJ 07104; 973-482-1400
Code Info	All lots
Classification	Class II
Reason for Recall	Product contains undeclared FD&C Yellow #5.
Product Quantity	160 cases (12, 3-oz. units in each)
Recall Number	F-0881-2013

Class II Devices Event

Event ID	64007
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Jan-13
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Terumo Cardiovascular Systems Corporation
City	Ann Arbor
State	MI
Country	US
Distribution Pattern	Nationwide and worldwide: AL , AR , AZ , CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , ME , MI, MO , NC , ND , NV , NY , OH , OK , PA , SD , TN , TX , UT , VA , WA , and WI. Bahrain, BRAZIL, CANADA, CHILE, Honduras, Singapore, Taiwan, Trinidad and Tobago, and UNITED ARAB EMIRATES (UAE).

Associated Products

Product Description	Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 in (24 cm) long The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Code Info	Lot number: 0677286 and Catalog number: 13010.
Classification	Class II
Reason for Recall	Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
Product Quantity	6830 total units for all products
Recall Number	Z-0666-2013

Product Description	Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Code Info	Lot number: 0677284 and Catalog number: 13020
Classification	Class II
Reason for Recall	Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
Product Quantity	6830 total all products
Recall Number	Z-0667-2013

Product Description	Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Code Info	Lot number: 067728 and 0681074 and Catalog number: 13030
Classification	Class II
Reason for Recall	Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
Product Quantity	6830 total all products
Recall Number	Z-0668-2013

Product Description	Sarns high-flow aortic arch cannula, 5.2 mm (16 Fr) OD with 3/8in connector, 7.5in (19 cm) long The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Code Info	Lot number: 0677294, 0680693, 0682187 and Catalog number: 12315
Classification	Class II
Reason for Recall	Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
Product Quantity	6830 total all products
Recall Number	Z-0669-2013

Product Description	Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Code Info	Lot number: 0680122, 0680751and Catalog number: 12325
Classification	Class II
Reason for Recall	Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
Product Quantity	6830 total all products
Recall Number	Z-0670-2013

Product Description	Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long, with X coating surface The Sarns High Flow Aortic Arch Cannula and Sarns Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Code Info	Lot number: 0677299 and Catalog number: 12325X
Classification	Class II
Reason for Recall	Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
Product Quantity	6830 total all products
Recall Number	Z-0671-2013

Class II Food/Cosmetics Event

Event ID	64012
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-Dec-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	S & M International Inc
City	Bayonne
State	NJ
Country	US
Distribution Pattern	NY, MI, PA, KY, West Virginia

Associated Products

Product Description	Yangsheng Eggs Preserved Duck Eggs Content 6 pcs Net Wt: approx 12.69 oz (360g) S&M (USA) Enterprise Corp Rm3 8/F., Yuexiu Bldg., 160-174 Lockhart Road, Wan Chai, HK Distributed by : S & M Int'l Inc 100 Pulaski ST., Bayonne NJ 07002 Product of China UPC 6949682803551
Code Info	Lot YS12-02A
Classification	Class II
Reason for Recall	Preserved Duck Eggs do not meet pH standard of 10 for boiled/preserved eggs.
Product Quantity	855 cases (24 individual packages of eggs)
Recall Number	F-0884-2013

Class II Devices Event

Event ID	64039
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Quanta System, S.p.A.
City	Solbiate Olona (VA)
State
Country	IT
Distribution Pattern	Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall.

Associated Products

Product Description	Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision, excision, ablation, vaporization of soft tissue for general dermatology. Ruby 694nm: Cutting, vaporization and ablation of soft tissue; Tattoo removal; Treatment of benign pigmented lesions.
Code Info	All codes and devices are applicable.
Classification	Class II
Reason for Recall	Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.
Product Quantity	75 units
Recall Number	Z-0691-2013

Product Description	Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions; Inflammatory acne
Code Info	All codes and devices are applicable.
Classification	Class II
Reason for Recall	Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.
Product Quantity	12 units
Recall Number	Z-0692-2013

Product Description	Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coagulation and hemostasis of benign vascular lesions (e.g. port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins, scars, straie and psoriasis; Treatment of benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments; Treatment of facial wrinkles (e.g. periocular and periorbital); Removal of unwanted hair, for the stable longterm, or permanent, hair reduction, including Fitzpatrick IVI and suntanned skin types; For the treatment of pseudofolliculitis barbae (PFB); Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; For use on all skin types (Fitzpatrick IVI) including tanned skin. Alexandrite 755 nm: Coagulation and hemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types 1VI, including suntanned skin types; Pigmented lesions; Wrinkles. Nd: YAG 1320 nm: General surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue; Treatment of periorbital and periocular wrinkles, fine lines and wrinkles, treatment of back acne and atrophic acne scars. IPL: Permanent hair reduction; Photocoagulation of dermatological vascular lesion (i.e. face telangiectasia); Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions.
Code Info	All codes and devices are applicable.
Classification	Class II
Reason for Recall	Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.
Product Quantity	22 units
Recall Number	Z-0693-2013

Class III Biologics Event

Event ID	38551
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Feb-09
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Penrose-St Franc Health Services Blood Bank
City	Colorado Springs
State	CO
Country	US
Distribution Pattern	CO

Associated Products

Product Description	Blood and Blood Products for reprocessing
Code Info	2284245; 2285158
Classification	Class III
Reason for Recall	Blood products, collected from a donor who was not asked follow-up questions regarding increased risk for vCJD, were distributed.
Product Quantity	2
Recall Number	B-0175-13

Class III Biologics Event

Event ID	49181
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-May-08
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	BioLife Plasma Services LP
City	Independence
State	MO
Country	US
Distribution Pattern	CA

Associated Products

Product Description	Source Plasma
Code Info	08IMOB1579; 08IMOA6642; 08IMOA3960
Classification	Class III
Reason for Recall	Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Product Quantity	3 units
Recall Number	B-0072-13

Class III Drugs Event

Event ID	61725
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Apr-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Teva Pharmaceuticals USA, Inc.
City	Sellersville
State	PA
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88
Code Info	Lot number 6A007046V, exp 07/12
Classification	Class III
Reason for Recall	Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life
Product Quantity	13,232 bottles
Recall Number	D-128-2013

Class III Devices Event

Event ID	63768
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Fresenius Medical Care Holdings, Inc.
City	Waltham
State	MA
Country	US
Distribution Pattern	US Nationwide Distribution

Associated Products

Product Description	Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Code Info	Lot Numbers: 12NXGF001, 12NXGF003, 12NXGF006, 12NXGF007, 12NXGF013,, 12NXGF015, 12NXGF016, 12NXGF017, 12PXGF001, 12PXGF003, 12PXGF005, 12PXGF007, 12PXGF009, 12PXGF012, 12PXGF013, 12PXGF015, 12PXGF016
Classification	Class III
Reason for Recall	GranuFlo Dry Acid Concentrate may show discoloration
Product Quantity	101,108 units
Recall Number	Z-0676-2013

Product Description	Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD2201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Code Info	Lot Numbers:12NXGF004, 12NXGF008, 12PXGF010, 12PXGF014
Classification	Class III
Reason for Recall	GranuFlo Dry Acid Concentrate may show discoloration
Product Quantity	17,782 units
Recall Number	Z-0677-2013

Product Description	Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL Catalog Number: OFD3251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Code Info	Lot Numbers:12NXGF002, 12NXGF014, 12PXGF006,
Classification	Class III
Reason for Recall	GranuFlo Dry Acid Concentrate may show discoloration
Product Quantity	14,240 units
Recall Number	Z-0678-2013

Product Description	Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5GAL Catalog Number: OFD2231-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Code Info	Lot Numbers:12NXGF005, 12NXGF019, 12PXGF008
Classification	Class III
Reason for Recall	GranuFlo Dry Acid Concentrate may show discoloration
Product Quantity	13,409 units
Recall Number	Z-0679-2013

Product Description	Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD1201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Code Info	Lot Number:12NXGF009
Classification	Class III
Reason for Recall	GranuFlo Dry Acid Concentrate may show discoloration
Product Quantity	5 units
Recall Number	Z-0680-2013

Product Description	Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .16.5GAL Catalog Number: OFD2225-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Code Info	Lot Numbers:12NXGF011, 12PXGF004
Classification	Class III
Reason for Recall	GranuFlo Dry Acid Concentrate may show discoloration
Product Quantity	5,689 units
Recall Number	Z-0681-2013

Product Description	Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2223-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Code Info	Lot Number:12NXGF012
Classification	Class III
Reason for Recall	GranuFlo Dry Acid Concentrate may show discoloration
Product Quantity	2493 units
Recall Number	Z-0682-2013

Product Description	Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca 1.0Mg .16.5GAL Catalog Number: OFD3201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Code Info	Lot Number:12PXGF017
Classification	Class III
Reason for Recall	GranuFlo Dry Acid Concentrate may show discoloration
Product Quantity	670 units
Recall Number	Z-0683-2013

Product Description	Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2325-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Code Info	Lot Number:12PXGF002
Classification	Class III
Reason for Recall	GranuFlo Dry Acid Concentrate may show discoloration
Product Quantity	2711 units
Recall Number	Z-0684-2013

Class III Drugs Event

Event ID	63952
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Boehringer Ingelheim Roxane Inc
City	Columbus
State	OH
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.
Code Info	Lot #160017A, Exp 04/2013.
Classification	Class III
Reason for Recall	Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
Product Quantity	3,553 bottles
Recall Number	D-126-2013

Class III Drugs Event

Event ID	64085
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Dec-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Upsher Smith Laboratories, Inc.
City	Maple Grove
State	MN
Country	US
Distribution Pattern	Nationwide and Puerto Rico

Associated Products

Product Description	Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upsher-Smith Laboratories, Inc., Minneapolis, MN 55447, NDC 0245-0182-11.
Code Info	Lot #: 310162, Exp 09/14
Classification	Class III
Reason for Recall	Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
Product Quantity	11,316 bottles
Recall Number	D-127-2013

Mixed Classification Food/Cosmetics Event

Event ID	63843
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Fresh Unlimited Inc
City	Sidney
State	OH
Country	US
Distribution Pattern	Product was shipped to the folloiwng states: AL, FL, GA, IL, IN, KY, MI, NC, NY, OH, PA, TN, VA, WI & WV.

Associated Products

Product Description	Red Apple Slices 2.4 oz, Item #71746, 20 oz, Item # 71729 14 oz, Item # 71735. Item #71729 is sold under the brand name Sonic UPC 95829 20000. The other two packages are in clear plastic bags.
Code Info	2 oz Use By 11/30/12 Item #71729, UPC 95829 2000, 2 oz, Use By 12/3/12, Item #71746; & 14 oz, Use By 12/3/12 & 12/6/12 Item # 71735.
Classification	Class II
Reason for Recall	Possible contamination with Listeria monocytogenes.
Product Quantity	Item #71729-359 cs/18/2 oz bags, Item #71746-127 cs/24/2 oz bags & Item #71735-127 cs/6/14 oz bags
Recall Number	F-0887-2013

Product Description	Sliced Green Apples READY TO EAT 14 oz Innerlock Bag UPC 95829 20042 Use By: 12/3/12, Item #71736
Code Info	Item #71736, Use By 12/3/2012 and 12/6/2012
Classification	Class I
Reason for Recall	Possible contamination with Listeria monocytogenes.
Product Quantity	291 cs/6/14 oz bags
Recall Number	F-0888-2013

Product Description	Celery Stick 2, 80/2 oz clear plastic bag, Item #70648 USED BY: 11/21/12
Code Info	Use by 11/21/12 Item# 70648
Classification	Class II
Reason for Recall	Possible contamination with Listeria monocytogenes.
Product Quantity	68 cs/80/2 oz bags
Recall Number	F-0889-2013

Product Description	Carrot coin 1/4 & 80/2oz bag Item #70263 BEST USED BY 11/21/12 TC: 1 317 2359 15:43
Code Info	Use by 11/21/12 Item# 70263
Classification	Class II
Reason for Recall	Possible contamination with Listeria monocytogenes.
Product Quantity	6 cs/80/2 oz bags
Recall Number	F-0890-2013

Product Description	Red Grapes 80/1.5 oz (3,402g) bag Item #71305 BEST USED BY: 11/21/12
Code Info	Use by 11/21/12 Item #71305
Classification	Class II
Reason for Recall	Possible contamination with Listeria monocytogenes.
Product Quantity	6 cs/80/1.5 oz bags
Recall Number	F-0891-2013

Product Description	Pineapple Chunks 80/2 oz (4.536g) bag Item #71607, BEST USED BY: 11/21/12 TC: 1 217 2359
Code Info	Use by 11/21/12
Classification	Class II
Reason for Recall	Possible contamination with Listeria monocytogenes.
Product Quantity	Item #7160763 cs/80/2 oz bags
Recall Number	F-0892-2013

Product Description	Red Apples DICED 3/4 & 5/1# (4,536G) bag Item #71707 Ingredients: Apples (Apples, Calcium Ascorbate), BEST USED BY: 11/25/12 TC: 1 317 2359 15:40 PRODUCT OF: USA
Code Info	Use by 11/25/12 Item #71707
Classification	Class II
Reason for Recall	Possible contamination with Listeria monocytogenes.
Product Quantity	143 cs/5/1 lb bags
Recall Number	F-0893-2013

Product Description	Green Pepper Strips 3/8 & 80/2oz (4,536g) bag Item #73032 BEST USED BY: 11/21/12 TC: 1 317 2359 15:45
Code Info	Use by 11/21/12 Item #73032
Classification	Class II
Reason for Recall	Possible contamination with Listeria monocytogenes.
Product Quantity	22 cs/80/2 oz bags
Recall Number	F-0894-2013

Product Description	Radish Sliced 80/2oz bag Item #74605 BEST USED BY: 11/21/12 TC: 1 317 2359 15:45
Code Info	Use by 11/21/12
Classification	Class II
Reason for Recall	Possible contamination with Listeria monocytogenes.
Product Quantity	2 cs/80/2 oz (4,536g) bags
Recall Number	F-0895-2013

Product Description	Holiday Fruit Delight Kit 5.1875 lbs (2,353g) INGREDIENTS: APPLES*RED GRAPES, STRAWBERRY GLAZEMARSHMELLOW**WALNUTS, ALLERGENS: WALNUTS (TREE NUTS) BEST USED BY 11/23/12 TC: 13171319 15:42
Code Info	Use by 11/23/12 ITEM #74707
Classification	Class II
Reason for Recall	Possible contamination with Listeria monocytogenes.
Product Quantity	6 cs/5.1875 lb bags
Recall Number	F-0896-2013

Product Description	Waldorf Salad Kit 5.19lb (2,345g) bag Item #74802 INGREDIENTS: APPLES*MAYONNAISE*CELERY, WALNUTS CONTAINS: SOYBEAN OIL, EGG, TREE NUTS (WALNUTS) BEST USED BY: 11/23/12 TC: 13171319 15:43
Code Info	Use by 11/23/12 Item #74802
Classification	Class II
Reason for Recall	Possible contamination with Listeria monocytogenes.
Product Quantity	75 cs/5.19 lb bags
Recall Number	F-0897-2013

Product Description	SHREDDED BROCCOLI FRUIT SALAD 6.19# (2,807 g) Ingredients: Broccoli, Cauliflower, Apples, Pears, Cole Slaw Dressing*CranberryRaisins CONTAINS: Soybean, egg BEST USED BY: 11/23/12 TC: 13171319 15:59**
Code Info	Use by 11/23/12 Item #74880
Classification	Class II
Reason for Recall	Possible contamination with Listeria monocytogenes.
Product Quantity	10 cs/6.19 lb bags
Recall Number	F-0898-2013

Mixed Classification Biologics Event

Event ID	38910
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Jun-07
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	ARC Blood Services, New England Region
City	Dedham
State	MA
Country	US
Distribution Pattern	CA, MA, ME, NH, NY

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced Plasma Frozen
Code Info	04FF62346, 04FF62348, 04FF62357, 04FF62358, 04FF62362, 04FF62364, 04FF62373, 04FF62376, 04FF62386, 04FF62389, 04FF62393, 04FF62402, 04FF62403, 04FF62405, 04FF62407, 04FF62412, 04FF62419, 04FF62421, 04FF62424, 04FF62426, 04FF62525, 04FF62530, 04FJ19204, 04FJ19228, 04FJ19233, 04FJ19236, 04FJ19245, 04FJ19247, 04FJ19253, 04FJ19263, 04FJ19270, 04FJ19272, 04FJ19277, 04FJ19281, 04FJ19284, 04FJ19295, 04FJ19297, 04FJ19303, 04FJ19312, 04FJ19317, 04FJ19324, 04FJ19333, 04FJ19337, 04FJ19488, 04FJ19500, 04FJ19505, 04FJ19507, 04FJ19591,
Classification	Class II
Reason for Recall	Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed
Product Quantity	48
Recall Number	B-0368-13

Product Description	Red Blood Cells Rejuvenated Irradiated
Code Info	04FJ19207, 04FJ19217, 04FJ19220, 04FJ19224. 04FJ19230, 04FJ19476,04FJ19487, 04FJ19595, 04FJ19601
Classification	Class II
Reason for Recall	Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed
Product Quantity	9
Recall Number	B-0369-13

Product Description	Plasma Frozen
Code Info	04FF62362,04FF62364,04FJ19247,04FJ19324
Classification	Class II
Reason for Recall	Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed
Product Quantity	4
Recall Number	B-0370-13

Product Description	Blood and Blood Products for Reprocessing
Code Info	04FF62350, 04FF62352, 04FF62357, 04FF62358, 04FF62376, 04FF62386,04FF62396, 04FF62405, 04FF62407,04FF62421, 04FF62424, 04FJ19204, 04FJ19228, 04FJ19230, 04FJ19233, 04FJ19245, 04FJ19270, 04FJ19272,04FJ19277. 04FJ19284, 04FJ19295, 04FJ19317, 04FJ19333, 04FJ19495 04FJ19500, 04FJ19504, 04FJ19507
Classification	Class III
Reason for Recall	Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed
Product Quantity	27
Recall Number	B-0371-13

Mixed Classification Biologics Event

Event ID	45119
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Jul-06
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	American National Red Cross (The)
City	Omaha
State	NE
Country	US
Distribution Pattern	PA, CO and CA

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	009FE12874; 09FQ21836
Classification	Class II
Reason for Recall	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2 units
Recall Number	B-0177-13

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	009GZ05786; 009GZ06597
Classification	Class II
Reason for Recall	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2 units
Recall Number	B-0178-13

Product Description	Blood and Blood Products for Reprocessing
Code Info	009FE12874; 09FQ21836
Classification	Class III
Reason for Recall	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2 units
Recall Number	B-0179-13

Mixed Classification Biologics Event

Event ID	47684
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Feb-08
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	21GV34559; 21KV00196; 21KV00328.
Classification	Class III
Reason for Recall	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity	3 components
Recall Number	B-0180-13

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	21GV34559; 21KV00196; 21KV00328.
Classification	Class II
Reason for Recall	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity	3 components
Recall Number	B-0181-13

Mixed Classification Biologics Event

Event ID	49720
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-Jul-08
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	011GT77158; 011FX17525
Classification	Class II
Reason for Recall	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2 Units
Recall Number	B-0182-13

Product Description	Plasma Frozen
Code Info	011GT77158
Classification	Class II
Reason for Recall	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity	1 Unit
Recall Number	B-0183-13

Product Description	Blood and Blood Products for Reprocessing
Code Info	011FX17525
Classification	Class III
Reason for Recall	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity	1 Unit
Recall Number	B-0184-13

Mixed Classification Biologics Event

Event ID	49899
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Aug-08
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	011FZ82900
Classification	Class II
Reason for Recall	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity	1 Unit
Recall Number	B-0185-13

Product Description	Blood and Blood Products for Reprocessing
Code Info	011FZ82900
Classification	Class III
Reason for Recall	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity	1 Unit
Recall Number	B-0186-13

Mixed Classification Biologics Event

Event ID	50030
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Aug-08
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	American National Red Cross (The)
City	Portland
State	OR
Country	US
Distribution Pattern	Maryland and California

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	21LZ09600
Classification	Class II
Reason for Recall	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity	1 component
Recall Number	B-0459-13

Product Description	Cryoprecipitated AHF
Code Info	21LZ09600
Classification	Class II
Reason for Recall	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity	1 component
Recall Number	B-0460-13

Product Description	Blood and Blood Products for Reprocessing
Code Info	21LZ09600
Classification	Class III
Reason for Recall	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity	1 component
Recall Number	B-0461-13

Mixed Classification Biologics Event

Event ID	50567
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Nov-08
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	011GG65599
Classification	Class II
Reason for Recall	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity	1 Unit
Recall Number	B-0187-13

Product Description	Cryoprecipitated AHF
Code Info	011GG65599
Classification	Class II
Reason for Recall	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity	1 Unit
Recall Number	B-0188-13

Product Description	Blood and Blood Products for Reprocessing
Code Info	011GG65599
Classification	Class III
Reason for Recall	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity	1 Unit
Recall Number	B-0189-13

Mixed Classification Biologics Event

Event ID	50593
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Oct-08
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	American National Red Cross (The)
City	Portland
State	OR
Country	US
Distribution Pattern	Massachusetts and California.

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	21FV31979
Classification	Class II
Reason for Recall	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity	1 component
Recall Number	B-0462-13

Product Description	Blood and Blood Products for Reprocessing
Code Info	21FV31979
Classification	Class III
Reason for Recall	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity	1 component
Recall Number	B-0463-13

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