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Enforcement Report - Week of October 3, 2012

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Biologics Devices Drugs Food / Cosmetics Veterinary

Class I Drugs Event

Event ID	61256
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	23-Feb-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	www.vitaminbestbuy.com
City	Brewerton
State	NY
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: American Federal International Living Creature Group and Tibet Gold Source Living Creature Engineering Limited Company, Unit 18, 55 Beijing Road Central, Lhasa, Tibet
Code Info	All lots.
Classification	Class I
Reason for Recall	Marketed Without an Approved ANDA/NDA: presence of sildenafil
Product Quantity	550 boxes
Recall Number	D-1698-2012

Product Description	Man King Capsules, 2800 mg, boxes of 5 packets, OTC, Developed by: American Wanbao Pharmaceutical International Group and Hainan Wanbao Biological Engineering Co., Ltd., 27 Heping Road, Haikou, Henan Province, UPC 9 009900 0032328
Code Info	All lots.
Classification	Class I
Reason for Recall	Marketed Without an Approved ANDA/NDA: presence of sildenafil.
Product Quantity	69 boxes
Recall Number	D-1699-2012

Product Description	Japan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box, Green algae lipotropic (fat dissolving) agent, OTC, Distributed by Vitaminbestbuy.com, Brewerton, NY
Code Info	All lots.
Classification	Class I
Reason for Recall	Marketed Without an Approved ANDA/NDA: presence of sibutramine
Product Quantity	52 boxes
Recall Number	D-1700-2012

Class I Drugs Event

Event ID	62422
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Jun-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Ben Venue Laboratories Inc
City	Bedford
State	OH
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg Vials, lyophilized powder per carton, Rx Only, Mfr. By: Ben Venue Laboratories, Bedford, OH 44146: Mfg for: Bedford Labs, Bedford, OH 44146, NDC 55390-039-10.
Code Info	Lot #2067134 Exp 5/31/2013, NDC 55390-039-10
Classification	Class I
Reason for Recall	Presence of Particulate Matter
Product Quantity	797 boxes/10/20 mg vials
Recall Number	D-1697-2012

Class I Food/Cosmetics Event

Event ID	63002
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Aug-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	MyoSci Technologies Inc.
City	Oceanside
State	CA
Country	US
Distribution Pattern	nationwide in the US and worldwide to Canada and United Kingdom.

Associated Products

Product Description	Whey Protein Concentrate, Net Weight: 1lb (454g)
Code Info	Batch/Lot#0120712
Classification	Class I
Reason for Recall	True Nutrition is recalling Whey Protein Isolate, Whey Protein Concentrate, and Hydrolyzed Whey Protein because they contain undeclared milk.
Product Quantity	1500 units
Recall Number	F-2367-2012

Product Description	Whey Protein Isolate Cold-Filtration, Net Weight: 1lb (454g)
Code Info	Batch/Lot#0030812
Classification	Class I
Reason for Recall	True Nutrition is recalling Whey Protein Isolate, Whey Protein Concentrate, and Hydrolyzed Whey Protein because they contain undeclared milk.
Product Quantity	200 units
Recall Number	F-2368-2012

Product Description	Whey Protein Isolate MicroFiltration, Net Weight: 1lb (454g)
Code Info	Batch/Lot#0040812
Classification	Class I
Reason for Recall	True Nutrition is recalling Whey Protein Isolate, Whey Protein Concentrate, and Hydrolyzed Whey Protein because they contain undeclared milk.
Product Quantity	100 units
Recall Number	F-2369-2012

Product Description	Whey Protein Isolate Cross-Flow Microfiltration, Net Weight: 1lb (454g)
Code Info	Batch/Lot#0730712
Classification	Class I
Reason for Recall	True Nutrition is recalling Whey Protein Isolate, Whey Protein Concentrate, and Hydrolyzed Whey Protein because they contain undeclared milk.
Product Quantity	300 units
Recall Number	F-2370-2012

Product Description	Hydrolyzed Whey Protein High Grade, Net Weight: 1lb (454g)
Code Info	Batch/Lot#0680512
Classification	Class I
Reason for Recall	True Nutrition is recalling Whey Protein Isolate, Whey Protein Concentrate, and Hydrolyzed Whey Protein because they contain undeclared milk.
Product Quantity	200 units
Recall Number	F-2371-2012

Class I Food/Cosmetics Event

Event ID	63010
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	23-Aug-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Cucina Fresca, Inc.
City	Seattle
State	WA
Country	US
Distribution Pattern	Product was distributed to Oregon and Washington

Associated Products

Product Description	Cucina Fresca Smoked Tomato Sauce. Product is packaged in a glass jar, net weight 24 oz. The UPC is 8-84337 00522-4
Code Info	Lot 11002A and 11002B. Code is deciphered as: First digit = Shift; Second, Third, and Fourth digit = Julian date; Fifth digit = Production year
Classification	Class I
Reason for Recall	Smoked Tomato Sauce was recalled due to undeclared milk. The jars actually contain Cucina Fresca Tomato Vodka Sauce, which contains milk as an ingredient, but was mis-labeled as Smoked Tomato Sauce and the label does not declare milk.
Product Quantity	117 cases/6 jars/ 24 oz. total (59 cases to warehouse and 58 cases to retail stores)
Recall Number	F-2359-2012

Class I Food/Cosmetics Event

Event ID	63032
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Splendid Products
City	Burlingame
State	CA
Country	US
Distribution Pattern	Nationwide distribution.

Associated Products

Product Description	Daniella Mangoes May be identified by Daniella sticker with a PLU code of 3114, 4051, 4311, 4584 or 4959.
Code Info	All fruit had identifying stickers with label "Daniella" and one of the following PLU numbers: 3114, 4051, 4311, 4584 or 4959.
Classification	Class I
Reason for Recall	Firm is recalling certain lots of Daniella brand mangoes because they may be contaminated with Salmonella. Mangoes have been linked to a number of recent cases of salmonellosis in Canada, and may be linked to cases in California and perhaps other states
Product Quantity	~1,200,000 cases shipped to US.
Recall Number	F-2395-2012

Class I Food/Cosmetics Event

Event ID	63058
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Aug-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Gordon Food Service
City	Wyoming
State	MI
Country	US
Distribution Pattern	restaurants and GFS retail outlets in Florida

Associated Products

Product Description	Pistachios, Shelled Raw, 4 /2.5 Packed by Tropical Food Nut & Fruit- Orlando, FL 32811
Code Info	GFS Item #866580 10015196182512, Lot 060412, 052912, Best By 02/03/13
Classification	Class I
Reason for Recall	Gordon Food Service is recalling Tropical Food Nut & Fruit Shelled Raw Pistachios , because there is potential for the box to be mis-packed with chopped peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.
Product Quantity	7 cases by GFS distribution center
Recall Number	F-2390-2012

Class I Food/Cosmetics Event

Event ID	63061
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Jun-11
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Indalco Foods Corp.
City	Miami
State	FL
Country	US
Distribution Pattern	US

Associated Products

Product Description	*Dulce De Leche "Del Campo"Ice Cream "Base" (Flavor)FB 23546Mfg. Date*Keep Refrigerated at 40f*Lot#Net Wt 55 LBSIndalco Food Corp., Miami, FLA (305) 620 1444* Caramel milk spread is packed in white plastic pails of 55 lbs. under the firm's brand name "Del Campo".
Code Info	Lot # 721 and Lot # 728
Classification	Class I
Reason for Recall	On June 28, 2011, Indalco Foods, Corp., Miami, FL initiated a voluntary recall of their product caramel milk spread ice cream base (dulce de leche heladero). Product labeling does not list Milk.
Product Quantity	23/ 55 lbs. pails
Recall Number	F-2391-2012

Class I Food/Cosmetics Event

Event ID	63062
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	31-Aug-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Ready Pac Foods Inc
City	Irwindale
State	CA
Country	US
Distribution Pattern	Nationwide to following US States and Canada: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Washington D.C., Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, Wyoming, and Canada.

Associated Products

Product Description	Fruit Mixes: 1) Dining In® Super Fruit Medley,10.5oz, UPC 1122508396, Use by date 9/6/2012; 2) Ready Pac® Super Fruit Blend, 6oz , UPC 7774523076, Use by Dates 9/8/2012 or earlier, 9/6/2012 & 9/7/2012; 3) Ready Pac® Super Fruit Medley, 10.5oz, UPC 7774523746, Use by dates 9/8/2012 or earlier, 9/6/2012 & 9/7/2012. Ready Pac® Super Fruit Medley, 298g , UPC 7774524023, Use by dates 9/8/2012 or earlier and 9/8/2012.
Code Info	1) Use by date 9/6/2012; 2) Use by dates 9/8/2012 or earlier, 9/6/2012 & 9/7/2012; 3) Use by dates 9/8/2012 or earlier and 9/8/2012
Classification	Class I
Reason for Recall	Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup.
Product Quantity	1) 65 cases; 2) 160 cases; 3) 1083 cases
Recall Number	F-2378-2012

Product Description	Mango: 1) Dining In® Mango ,10.5oz , UPC 1122508640, Use by Date 9/7/2012; 2) Wawa® Mango, 8oz, UPC 2619106437, Use by dates 9/6/2012 or earlier.
Code Info	1) Use by Date 9/7/2012; 2) Use by dates 9/6/2012 or earlier
Classification	Class I
Reason for Recall	Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup.
Product Quantity	1) 65 cases; 2) 3542 cases
Recall Number	F-2379-2012

Product Description	Ready Pac® Fruit Tray Bien®, 907g UPC 7774523415 and Use by date 9/8/2012. Ready Pac® Fruit Tray Bien® 32oz UPC 7774521606, Use by date 9/8/2012 or earlier.
Code Info	UPC 7774523415 Use by date 9/8/2012. UPC 7774521606, Use by date 9/8/2012 or earlier.
Classification	Class I
Reason for Recall	Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup
Product Quantity	199 cases
Recall Number	F-2380-2012

Product Description	Ready Pac® Fruit & Chocolate Platter, 40oz , UPC 7774523673, Use by dates 9/6/2012 & 9/7/2012
Code Info	UPC 7774523673, Use by dates 9/6/2012 & 9/7/2012
Classification	Class I
Reason for Recall	Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup.
Product Quantity	395 cases
Recall Number	F-2381-2012

Product Description	Ready Pac® Sliced Mango, 10.5oz , UPC 7774523751, Use by dates 9/8/2012 or earlier, 9/6/2012 & 9/7/2012. Ready Pac® Sliced Mango, 32oz, UPC 0000088356, Use by dates 9/6/2012 & 9/7/2012. Ready Pac® Sliced Mango, 32 oz, UPC 7774522859, Use by dates 9/8/2012 or earlier and 9/6/2012 & 9/7/2012.
Code Info	UPC 7774523746, Use by dates 9/8/2012 or earlier, 9/6/2012 & 9/7/2012. UPC 7774524023, Use by dates 9/8/2012 or earlier and 9/8/2012.
Classification	Class I
Reason for Recall	Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup.
Product Quantity	1544 cases
Recall Number	F-2382-2012

Product Description	Ready Pac® Mango Fandango", 32oz, UPC 7774524099, Use by dates 9/8/2012 or earlier and 9/6/2012 & 9/7/2012.
Code Info	Use by dates 9/8/2012 or earlier and 9/6/2012 & 9/7/2012.
Classification	Class I
Reason for Recall	Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup.
Product Quantity	721 cases
Recall Number	F-2383-2012

Product Description	Ready Pac® Gourmet Fruit Bowl, 64oz , UPC 7774522620, Use by dates 9/9/2012 or earlier and 9/7/2012 & 9/8/2012.
Code Info	UPC 7774522620, Use by dates 9/9/2012 or earlier and 9/7/2012 & 9/8/2012.
Classification	Class I
Reason for Recall	Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup.
Product Quantity	2945 cases
Recall Number	F-2384-2012

Product Description	Ready Pac® Sweet Sunshine Platter, 37oz, UPC 7774524204, Use by dates 9/8/2012 or earlier and 9/6/2012 & 9/7/2012.
Code Info	UPC 7774524204, Use by dates 9/8/2012 or earlier and 9/6/2012 & 9/7/2012.
Classification	Class I
Reason for Recall	Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup.
Product Quantity	515 cases
Recall Number	F-2385-2012

Product Description	Ready Pac® Seasons Choice", 32oz, UPC 7774524276, Use by dates 9/8/2012 or earlier and 9/7/2012 & 9/8/2012.
Code Info	UPC 7774524276, Use by dates 9/8/2012 or earlier and 9/7/2012 & 9/8/2012.
Classification	Class I
Reason for Recall	Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup.
Product Quantity	209 cases
Recall Number	F-2386-2012

Product Description	Starbucks® Seasonal Harvest Fruit Blend, 6oz, UPC 6211171390, Use by dates 8/22/2012 through 9/7/2012 and 9/4/2012 & 9/5/2012.
Code Info	UPC 6211171390, Use by dates 8/22/2012 through 9/7/2012 and 9/4/2012 & 9/5/2012.
Classification	Class I
Reason for Recall	Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup.
Product Quantity	19,060 cases
Recall Number	F-2387-2012

Product Description	Walmart® Super Fruit Blend, 10oz, UPC 7774523327, Use by dates 9/6/2012 & 9/7/2012.
Code Info	UPC 7774523327, Use by dates 9/6/2012 & 9/7/2012.
Classification	Class I
Reason for Recall	Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup.
Product Quantity	234 cases
Recall Number	F-2388-2012

Product Description	Walmart® Seasonal Blend ,16oz, UPC 7774523761, Use by dates 9/6/2012 & 9/7/2012. Walmart® Seasonal Blend, 32oz, UPC 7774523765, Use by dates 9/6/2012 & 9/7/2012.
Code Info	UPC 7774523761, Use by dates 9/6/2012 & 9/7/2012. UPC 7774523765, Use by dates 9/6/2012 & 9/7/2012.
Classification	Class I
Reason for Recall	Firm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup.
Product Quantity	676 cases
Recall Number	F-2389-2012

Class I Food/Cosmetics Event

Event ID	63153
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Sep-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Dawn Food Products, Incorporated
City	Denver
State	CO
Country	US
Distribution Pattern	To Sam's Club locations in UT, OK, TX CA, MO, and WY, USA.

Associated Products

Product Description	Sam's Club Chunky Cinnamon Streusel, Net Wt 25 lb, in white plastic pails, Manufactured for Sam's Club, Bentonville, AR 72716, Best if stored in a cool, dry location between 65 - 75 degrees Farenheit.
Code Info	2-203-19-81; 2-203-19-82; 2-203-19-83; 2-223-19-01; 2-223-19-02; 2-223-19-03; 2-223-19-04; 2-236-19-83; 2-236-19-84; 2-236-19-87
Classification	Class I
Reason for Recall	Dawn Foods is recalling 251, 25 lb pails of Chunky Cinnamon Streusel due to the omission of the major allergens milk and soy from the finished product label.
Product Quantity	251 x 25 lbs pails
Recall Number	F-2394-2012

Class II Biologics Event

Event ID	38672
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Apr-07
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	ZLB Bioplasma, Inc.
City	Aurora
State	CO
Country	US
Distribution Pattern	IL, IN, Germany, Switzerland

Associated Products

Product Description	Source Plasma
Code Info	7020569758;7020569243;7020561213;7020560515;7020559510;7020558871;7020557589;7020556923;7020555960;7020554644;7020554249;7020551927;7020549396;7020548750;7020546254;7020545607;7020543963;7020542709;7020541769;7020541080;7020540134;7020537340;7020536579;7020535741;7020534950;7020533777;7020532633;7020531792;7020530859;7020530108;7020528828;7020528109;7020527346;7020526610;7020525530;7020525122;7020522123;7020521031;7020518895;7020518020;7020516872;7020516410;7020514961;7020514002;7020505987;7020504543;7020501835;7020501348;7020500269;7020499825;7020496782;7020496011;7020495192
Classification	Class II
Reason for Recall	Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
Product Quantity	53 units
Recall Number	B-2336-12

Class II Biologics Event

Event ID	39117
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Apr-07
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	6554173
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor with a history of multiple high risk behaviors, were distributed.
Product Quantity	1 unit
Recall Number	B-2022-12

Product Description	Blood and Blood Products for Reprocessing
Code Info	6554173
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor with a history of multiple high risk behaviors, were distributed.
Product Quantity	1 unit
Recall Number	B-2023-12

Class II Biologics Event

Event ID	39899
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Feb-05
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced Irradiated
Code Info	3695222(Part A); 3695222(Part B)
Classification	Class II
Reason for Recall	Blood products, collected using expired control materials, were distributed.
Product Quantity	2 units
Recall Number	B-2359-12

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	3695245; 3695218(Part A), 3695218 (Part B) 3695248 (Part A), 3695248 (Part B);
Classification	Class II
Reason for Recall	Blood products, collected using expired control materials, were distributed.
Product Quantity	5 units
Recall Number	B-2360-12

Class II Biologics Event

Event ID	40583
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	23-Aug-05
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Mary Greeley Medical Center
City	Ames
State	IA
Country	US
Distribution Pattern	IA, NY, MO

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	4718843
Classification	Class II
Reason for Recall	Blood products, collected from a donor who received a tatoo within 12 months of donation, were distributed.
Product Quantity	1 unit
Recall Number	B-2295-12

Product Description	Red Blood Cells
Code Info	4718843
Classification	Class II
Reason for Recall	Blood products, collected from a donor who received a tatoo within 12 months of donation, were distributed.
Product Quantity	1 unit
Recall Number	B-2296-12

Class II Biologics Event

Event ID	41475
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Aug-05
Initial Firm Notification of Consignee or Public	Visit

Recalling Firm	Mercy Medical Center Blood Bank
City	Cedar Rapids
State	IA
Country	US
Distribution Pattern	IA,

Associated Products

Product Description	Red Blood Cells
Code Info	S9911446
Classification	Class II
Reason for Recall	Blood product, which tested negative for hepatitis, but was collected from a donor who previously tested positive for the antibody to hepatitis B core antigen (anti-HBcore) on two separate occasions, was distributed.
Product Quantity	1 unit
Recall Number	B-2445-12

Class II Biologics Event

Event ID	41764
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Mar-06
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W045006019703
Classification	Class II
Reason for Recall	Blood product which did not meet Quality Control specifications was distributed.
Product Quantity	1 unit
Recall Number	B-2324-12

Class II Biologics Event

Event ID	44312
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Dec-06
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Fresh Frozen Plasma
Code Info	09Q 85020
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was previously deferred, were distributed
Product Quantity	1 unit
Recall Number	B-1770-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	09FZ59427; 09GX45894; 09GX47142; 09Q 85020
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was previously deferred, were distributed
Product Quantity	4 units
Recall Number	B-1771-12

Product Description	Blood and Blood Products for Reprocessing
Code Info	09FZ53427; 09GX45894; 09GX47142
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was previously deferred, were distributed
Product Quantity	3 units
Recall Number	B-1772-12

Class II Biologics Event

Event ID	49324
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Jul-08
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Mississippi Valley Regional Blood Center
City	Davenport
State	IA
Country	US
Distribution Pattern	Iowa, Illinois

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W038308071454;W038308071457
Classification	Class II
Reason for Recall	Blood products, which component preparation were not prepared in accordance with specifications, were distributed.
Product Quantity	2 Units
Recall Number	B-2353-12

Class II Biologics Event

Event ID	50666
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Nov-08
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	American National Red Cross (The)
City	Dedham
State	MA
Country	US
Distribution Pattern	CA, MA

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	004KK58808
Classification	Class II
Reason for Recall	Blood products, collected from a donor in whom donor suitability were not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-1745-12

Product Description	Blood and Blood Products for Reprocessing
Code Info	004KK58808
Classification	Class II
Reason for Recall	Blood products, collected from a donor in whom donor suitability were not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-1746-12

Class II Biologics Event

Event ID	52053
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Mar-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	One Lambda Inc
City	Canoga Park
State	CA
Country	US
Distribution Pattern	US States CA and NY. Nationwide to: Canada, United Kingdom, Germany, Israel, Spain, Japan, Singapore, and vietnam.

Associated Products

Product Description	Micro SSPTM Allele Specific HLA Class I DNA Typing Tray - B*35 510(K) Number 8K 960062 Product number SSPR1-35 Product Insert Number SSP_DNAT_PIEN Rev 16
Code Info	Product Name: Micro SSPTM Allele Specific HLA Class I DNA Typing Tray - B*35 Product Number: SSPR1-35 Lot Number: 002, batch 004 Expiration Date: 10/2013 Product Insert Number: SSP- DNAT-P-I EN Rev 16 510(K) Number BK 960062 Product Code MZI
Classification	Class II
Reason for Recall	HLA typing assay, associated with false negative results, was distributed.
Product Quantity	1 unit
Recall Number	B-2457-12

Class II Biologics Event

Event ID	55742
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Mar-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	One Lambda Inc
City	Canoga Park
State	CA
Country	US
Distribution Pattern	Nationwide in the US: OR and IL, and worldwide to Canada, Saudi Arabia/USA, United Kingdom, Germany, Italy, Jordon, Sweden, and Peru.

Associated Products

Product Description	Micro SSP Allele Specific HLA Class I DNA Typing Tray-AB, Product Number: SSP1-AB, Lot 003, batch 007
Code Info	Micro SSP Allele Specific HLA Class I DNA Typing Tray-AB, Product Number: SSP1-AB, Lot Number 003, batch 007 Expiration August 2013. Product insert Number SSP_DNAT_PI-EN Rev 16; 510(K) Number BK960062; Product Code MZI
Classification	Class II
Reason for Recall	HLA typing assay, associated with false negative results, was distributed.
Product Quantity	1 unit
Recall Number	B-2458-12

Class II Biologics Event

Event ID	56469
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Jul-10
Initial Firm Notification of Consignee or Public	E-Mail

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

Associated Products

Product Description	Source Plasma
Code Info	49400010468, 49400015066, 49400019112, 49400024691, 49400029193,49400038129, 49400040982, 49400074365, 49400079780, 49400020981, 49400028123, 49400031613, 49400051710, 49400071850, 49400072693, 49400074701, 49400017328, 49400027892, 49400032720,49400037759, 49400054663, 49400074496, 49400078673, 49400008974, 49400018099, 49400020762, 49400029484, 49400036852,49400048618, 49400056204, 49400072001, 49400079502, 49400021036, 49400027340,49400031058, 49400037943, 49400029249, 49400035251,49400039922, 49400074648,49400079406, 49400049215, 49400049098, 49400025838,49400037003, 49400054911, 49400076694, 49400035470, 49400053636, 49400073725, 49400074947, 49400017627, 49400024907, 49400027737, 49400035390,49400038356, 49400053353, 49400050742,49400010812,49400015470, 49400019850, 49400025150, 49400015453,49400021992, 49400025109, 49400031980, 49400054487,49400079289, 49400020893, 49400031429, 49400037820, 49400056634, 49400017758, 49400025133, 49400035323, 49400078657, 49400037695, 49400010492,49400041352, 49400079115, 49400005423, 49400011356, 49400013490,49400075886,49400051876, 49400057223, 49400027690, 49400035278, 49400048327,49400056360, 49400076010, 49400027964, 49400020228, 49400024878, 49400037556, 49400057282, 49400071033, 49400077080,4940003152549400036617,49400051374, 49400071789, 49400075747,49400051614,49400055260, 49400074832, 49400049514,49400051606, 4940007834049400015162, 49400029425, 49400037370, 49400050419, 49400061054, 49400070970, 49400076416, 49400032755, 49400039906, 49400052385, 49400072968, 49400079019, 49400030320,49400033723, 49400050064, 49400070364, 49400074664, 49400053880, 49400004017, 49400008544,49400011516, 49400027956, 49400035411, 49400012949, 49400015592, 49400021925,49400025221, 49400034881, 49400052094, 4940007115649400075237,49400051260, 49400072327, 49400077793, 49400039228, 49400051323, 49400077830, 49400012527, 49400016819, 49400021562, 49400031250, 49400034208, 49400050208, 49400076660, 49400039711, 49400055930, 49400061290, 49400074277, 449400079107, 449400003479, 49400007250, 49400009934, 49400015760, 49400018769,49400026320, 49400036086, 49400039519, 49400047893, 49400050670, 49400077320, 49400028473, 49400039076, 49400052326,49400072810, 49400029783, 49400034929, 49400053679, 49400054671, 49400073004, 49400075173,49400031832, 49400038671, 49400041977,49400051681, 49400072095, 49400039720, 49400055949, 49400074242, 49400005407, 49400005466,49400010601,49400013183, 49400019008,49400022549, 49400029652, 49400032843, 49400039930, 49400052617,49400022127, 49400027008, 49400032771, 49400037652, 49400047930, 49400052270, 49400072829, 49400077427, 49400038372, 49400008333, 49400015630,49400022397, 49400073282, 49400006899, 49400017985, 49400023390, 49400026945, 49400034110, 49400011962, 49400015189, 49400021870,49400025010,49400033900, 49400051833, 49400072570, 49400076635, 49400012180, 49400018021, 49400020770, 49400027454, 49400032245, 49400039498, 49400012877, 49400015509, 49400025141, 49400032376, 49400049397, 49400075106, 49400078500, 49400054516, 49400073928, 49400026291,49400031365, 49400036713, 49400012720, 49400021730, 49400034970, 49400074621, 49400016421, 49400019420,49400025950, 49400029345, 49400036465, 49400050929, 49400056440, 49400070030,49400075712, 49400022610, 49400029695, 49400033221,49400073240, 49400016990, 49400020130, 49400026697, 49400056941, 49400075157, 49400078454, 49400052078, 49400016667, 49400023867,49400015170, 49400029450, 49400037361, 49400071041, 49400017010, 49400021263, 449400027884, 49400032448, 49400028983, 49400021466, 49400026540, 49400037020, 49400056845, 49400070591, 49400076504, 49400050961, 49400017360, 449400034232, 49400036490, 49400074410, 49400051032, 49400019702, 49400026718, 49400033539, 49400038620, 49400018460, 49400025002, 49400057012, 49400022960, 49400030418, 49400033651,49400055375,49400070268, 49400020594,49400027841,49400031314, 49400038241, 49400071746, 49400026275,49400020666, 49400027243,49400074226, 449400021140, 49400028991, 49400027753, 49400033862, 49400022186,49400023197, 49400033512, 49400022856, 49400033686, 49400037521, 49400072706, 49400025790, 49400025310, 49400032640, 49400037206, 49400052377, 49400073688, 49400075510, 49400027788, 49400038145, 49400076150, 49400080001, 49400028430,49400053660,49400073733, 49400030207, 49400035438, 49400029839, 49400035294, 49400056423, 49400079430, 49400027593, 49400034865, 49400038380, 49400074138, 49400077507, 49400037708,49400073311, 49400077187, 49400038225, 449400077451, 49400030952, 49400038006, 49400050881,49400075739, 49400033109, 49400074630, 49400077806,49400039674, 49400033969, 449400072351, 49400074146, 49400078796,49400039279, 49400075050, 49400035243, 49400073477, 49400076352, 49400038540, 49400053302, 49400037388, 49400074998, 49400053273, 49400071906, 49400077689, 49400038399, 49400074390, 49400077523,49400054903, 49400071615, 49400074381, 49400074154, 49400079748,49400071990, 49400072546, 49400051358, 49400071826, 49400077110, 49400053484, 49400076070,49400054989, 49400077611, 49400222090, 49400055560, 49400078593, 49400078577, 49400050152, 49400050179, 4940005044, 49400050486, 49400052019, 49400051500
Classification	Class II
Reason for Recall	Blood products, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity	401 units
Recall Number	B-2352-12

Class II Biologics Event

Event ID	59883
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	31-May-11
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	BloodSource, Inc.
City	Redding
State	CA
Country	US
Distribution Pattern	CA, Austria

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W035811140656; W035811140648; W035811140646; W035811140704; W035811140619; W035811140556; WO35811140707;
Classification	Class II
Reason for Recall	Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity	7 units
Recall Number	B-2340-12

Product Description	Red Blood Cells Leukocytes Reduced Irradiated
Code Info	W035811140557
Classification	Class II
Reason for Recall	Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity	1 unit
Recall Number	B-2341-12

Class II Biologics Event

Event ID	60014
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Jul-11
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W128711300920
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-2225-12

Class II Biologics Event

Event ID	60439
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Sep-11
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W128711122482
Classification	Class II
Reason for Recall	Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
Product Quantity	1 unit
Recall Number	B-2224-12

Class II Biologics Event

Event ID	62139
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Apr-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Blood Centers of the Pacific - Irwin Center
City	San Francisco
State	CA
Country	US
Distribution Pattern	Switzerland; Austria; Armed Forces Americas, California

Associated Products

Product Description	Plasma Frozen
Code Info	506028927; 506028592;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who gave history which warranted deferral or follow up were distributed.
Product Quantity	2 units
Recall Number	B-2204-12

Product Description	Fresh Frozen Plasma
Code Info	506083305;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who gave history which warranted deferral or follow up were distributed.
Product Quantity	1 unit
Recall Number	B-2205-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	506030332; 506028927; 506028592; 506077852; 506071807; 506055283; W117009320416Y; W117008302038T; 509238455; 506050613; 506099742; 506088134; 506083305; 504804927; 504804630; 504287307; 500790860;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who gave history which warranted deferral or follow up were distributed.
Product Quantity	17 units
Recall Number	B-2206-12

Class II Biologics Event

Event ID	62141
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-May-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Walter L. Shepeard Community Blood Center, Inc.
City	Augusta
State	GA
Country	US
Distribution Pattern	Georgia

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W038512101381;
Classification	Class II
Reason for Recall	Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity	1 unit
Recall Number	B-2151-12

Class II Devices Event

Event ID	62313
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Terumo Cardiovascular Systems Corporation
City	Ann Arbor
State	MI
Country	US
Distribution Pattern	Worldwide and US Nationwide Distribution

Associated Products

Product Description	Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
Code Info	Catalog number: 802018 and serial numbers: 00032, 00042, 00056, 00147, 00623, 00700-00764, 00766-00820, and 00823-00847.
Classification	Class II
Reason for Recall	Terumo Cardiovascular Systems (CVS) received two reports of the false back flow alarms for the Terumo® Advanced Perfusion System 1 when there was no tubing in the flow sensor. Terumo CVS' investigation found that the voltage level on a circuit board was improperly set in a population of flow modules for Terumo System 1, the sensor operates correctly if the tubing is installed and it is highly unlikely that the failure would recur. The failure only occurs when there is no tubing installed in the flow sensor, therefore the only risk to the patient is if the false alarm somehow delays the surgical procedure. There are no known reports of patient injury as a result of this issue.
Product Quantity	150 units
Recall Number	Z-2443-2012

Class II Devices Event

Event ID	62322
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Terumo Cardiovascular Systems Corporation
City	Ann Arbor
State	MI
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and the countries of AUSTRALIA, Singapore, Jordan, Japan, Vietnam, Germany, Russia, Saudi Arabia, BELGIUM, Mexico, and CANADA.

Associated Products

Product Description	Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
Code Info	Catalog number: 802018 and serial numbers: 00122, 00337, 00340, 00343-00389, 00391-00395, 00397-00410, 00437, 00438, and 00488.
Classification	Class II
Reason for Recall	Terumo Cardiovascular Systems (CVS) received one report of a flow module for the Terumo Advanced Perfusion System 1 not displaying blood flow information on the Central Control Monitor or the Centrifugal Control Unit. The tricolor LED on the flow module was not illuminated. Terumo CVS' investigation found that the malfunction was caused by an improper component on a circuit board used in a population of flow modules for Terumo System 1.
Product Quantity	72 units
Recall Number	Z-2449-2012

Class II Drugs Event

Event ID	62384
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Watson Laboratories, Inc.
City	Salt Lake City
State	UT
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only, supplied in single pouches (NDC 0591-3214-54 (pouch)), 5 pouches per carton (NDC 0591-3214-72 (Carton)), Manufactured by Watson laboratories Inc., Corona, CA, Distributed by: Watson, Pharma Inc.
Code Info	Lot number 455040A (carton) 455040 (pouch)
Classification	Class II
Reason for Recall	Subpotent; some patches may not contain fentanyl gel
Product Quantity	98,088 cartons (5 pouches per carton)
Recall Number	D-1693-2012

Class II Devices Event

Event ID	62419
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Alcon Research, LTD.
City	Houston
State	TX
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Greece, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria.

Associated Products

Product Description	This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm), Constellation 23G Total PLUS Pak, Constellation 23G Combined Pack (0.9 mm and 1.1 mm) and 23G Small Parts Kit. Single use 23G non-valved trocar cannulas are used to provide internal access to the ocular cavity during ophthalmic surgery. Single use infusion cannulas are used for the infusion of fluid or air during ophthalmic surgery to maintain intraocular pressure during posterior segment surgeries.
Code Info	1) 23G TotalPLUS Pak: Accurus Standalone - 8065750828, 2) 23G Combined Pack 0.9mm: Accurus Standalone - 8065750814, 3) 23G Combined Pack 1.1mm: Accurus Standalone - 8065750816, 4)23G TotalPLUS Pak: Constellation Standalone - 8065751058, 5) 23G Combined Pack 0.9mm: Constellation Standalone -8065751077, 6) 23G Combined Pack 1.1mm: Constellation Standalone - 8065751065. 7) 23G Small Parts Kit - 8065750842. Complete list of lot numbers will be provided with recall recommendation.
Classification	Class II
Reason for Recall	This medical device correction is related to Alcon products that present a 23G non-valved trocar cannula and infusion cannula together because of an issue regarding the loose fit between the 23G non-valved trocar cannula and infusion cannula that could potentially cause a detachment between the non-valved trocar cannula and infusion cannula during surgery.
Product Quantity	30, 413 distributed domestically & 62,906 internationally
Recall Number	Z-2470-2012

Class II Food/Cosmetics Event

Event ID	62465
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Apr-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Haldeman Mills
City	Manheim
State	PA
Country	US
Distribution Pattern	Product was distributed to specific wholesale and retail outlets within the State of Pennsylvania

Associated Products

Product Description	Bulk Foods, Inc. Yellow Corn Meal, Light Roast, 25 lb; Bulk Foods, Inc. Yellow Corn Meal, Light Roast, 50 lb
Code Info	No codes; all product "Purchase by date shown 12/29/2012"
Classification	Class II
Reason for Recall	FDA samples of product tested positive for Fumonisin
Product Quantity	32,500 lbs
Recall Number	F-2373-2012

Product Description	Bulk Foods, Inc. Yellow Corn Meal, Regular Roast, 25 lb; Bulk Foods, Inc. Yellow Corn Meal, Regular Roast, 50 lb
Code Info	No codes; all product "Purchase by date shown 12/29/2012"
Classification	Class II
Reason for Recall	FDA samples of product tested positive for Fumonisin
Product Quantity
Recall Number	F-2374-2012

Product Description	Brinser's Best Yellow Corn Meal, 5 lb; Stauffer's Corn Meal, 2 lb
Code Info	No codes; all product "Purchase by date shown 12/29/2012"
Classification	Class II
Reason for Recall	FDA samples of product tested positive for Fumonisin
Product Quantity
Recall Number	F-2375-2012

Class II Devices Event

Event ID	62606
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Jul-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	OPTI Medical Systems, Inc
City	Roswell
State	GA
Country	US
Distribution Pattern	Worldwide Distribution -- US (nationwide) including the states of AZ, ID, TX and UT., and the countries of Argentina, Bolivia, China, Ecuador, France, Germany Greece, India, Indonesia, Iran, Ireland, Japan, Kuwait, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Nigeria, Poland, Romania, Russia, Saudi Arabia, Singapore, South Africa, Sudan Switzerland, Turkey, United kingdom, Venezuela, and Viet Nam.

Associated Products

Product Description	BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH, PCOX2 PO2, lactate (lactic acid), total hemoglobin (tHb), and oxygen saturation (SO2), in heparinized whole blood samples (either arterial or venous) on the OPTI CCA-TS system, in either a clinical setting or point of care locations. Cassettes contain one-time use sensors that are used with the OPTI CCA-TS analyzer to perform in-vitro measurements of blood gases and metabolites. OPTI CCA-TS B-Lac Cassettes are supplied in boxes of 25 and may only used with the OPTI CCA-TS Analyzer.
Code Info	Lot numbers: 110650, 114650, 114651, 114652, 114653, 116650, 116652, 117650, 118651, 121650, 121651, 122652, 122652, 122653, 122654, 122655, 122656, 122657, 123654, 123655, 124650, 133650, 134651, 136650, 146650, 149650, 202650, 208650, 208651, 209560, 209651, 211650, 212651, 213650, 214650, 215650, 215651, 221650, 222650 and 224650.
Classification	Class II
Reason for Recall	The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters).
Product Quantity	895 boxes (25 cassettes per box)
Recall Number	Z-2440-2012

Class II Drugs Event

Event ID	62674
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Abbott Laboratories
City	Abbott Park
State	IL
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-4552-90.
Code Info	18265A8, Exp 09/20/2013
Classification	Class II
Reason for Recall	Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Product Quantity	53,448 Bottles
Recall Number	D-1694-2012

Product Description	Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-5182-90.
Code Info	Lot: 18353A8, Exp 08/31/2013
Classification	Class II
Reason for Recall	Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Product Quantity	42,596 Bottles
Recall Number	D-1695-2012

Product Description	Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-9296-90
Code Info	Lot: 18355A8, Exp. 09/26/13
Classification	Class II
Reason for Recall	Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Product Quantity	40,464 Bottles
Recall Number	D-1696-2012

Class II Devices Event

Event ID	62830
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Imaging Sciences International, LLC
City	Hatfield
State	PA
Country	US
Distribution Pattern	Worldwide Distribution - USA including Washington, DC, AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and the country of Canada.

Associated Products

Product Description	DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
Code Info	Catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3
Classification	Class II
Reason for Recall	A condition can occur during renumbering of the patient database using the DEXCopy feature. When renumbering is being performed using the DEXCopy feature and multiple patients with an identical name are present, the software will assign all subsequent records to the first patient record, resulting in mixed patient records. In order for this problem to occur several conditions need to be met: 1) DEXIS Imaging Suite versions 10.0.0 - 10.0.3 must be installed, 2) The DEXCopy feature Mus thave been used to renumber the patient database, and 3) Two or more patients with identical names must be present within the database.
Product Quantity	366
Recall Number	Z-2463-2012

Class II Drugs Event

Event ID	62866
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Bracco Diagnostics Inc
City	Princeton
State	NJ
Country	US
Distribution Pattern	Nationwide and United Kingdom

Associated Products

Product Description	CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Medi-Physics, Inc. South Plainfield, NJ 07080, NDC 0270-0091-01
Code Info	Lot numbers 09101-121251 and 09101-121391
Classification	Class II
Reason for Recall	GMP deviation; Sr-82 levels exceeded alert limit specification
Product Quantity	54 generators
Recall Number	D-1684-2012

Class II Drugs Event

Event ID	62885
Status	Completed
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Mylan Pharmaceuticals Inc.
City	Morgantown
State	WV
Country	US
Distribution Pattern	The product was distributed to KY.

Associated Products

Product Description	Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-5615-05
Code Info	Lot ZLMM12063, Exp March 2014
Classification	Class II
Reason for Recall	Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.
Product Quantity	960 bottles
Recall Number	D-1702-2012

Class II Food/Cosmetics Event

Event ID	62889
Status	Terminated
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Apr-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Triton Seafood Co.
City	Medley
State	FL
Country	US
Distribution Pattern	Product was distributed throughout the state of Florida and Texas.

Associated Products

Product Description	Approximately 5 lb bag of Pre-cooked Conch Fritters labeled in part: "*NEPTUNE'S CONCH FRITTERS PRECOOKEDIngredients: Conch, Flour, Onions, Milk, Bell Peppers, Eggs, Garlic, Salt, Black Pepper, Lime Juice & Hot Pepper Sauce.Packed by Triton Seafood Co. Miami, FL 33166Pack: 125 Units Net Wt. 5# (approx.)**
Code Info	W152BA, W152BB, W153BC, W152BD, W152BE, W162BA, W162BB, W162BC, W162BD, W162BE, W172BA, W172BB, W172BC, W172DB
Classification	Class II
Reason for Recall	Triton Seafood Co recalled their Neptune brand frozen Pre-cooked Conch Fritters and Conch Fritter Batter because the allergen, "Wheat" was not identified on the product label.
Product Quantity	89 cases
Recall Number	F-2376-2012

Product Description	Approximately 5 lb plastic bucket of Conch Fritter Batter labeled in part: "*NEPTUNE'S CONCH FRITTERS ALL NATURALIngredients: Conch, Flour, Onions, Milk, Bell Peppers, Eggs, Garlic, Salt, Black Pepper, Lime Juice, Hot Pepper Sauce.Packed by Triton Seafood Co. Miami, FL 33166* Net Weight 5 lbs.***
Code Info	W152BA, W152BB, W153BC, W152BD, W152BE, W162BA, W162BB, W162BC, W162BD, W162BE, W172BA, W172BB, W172BC, W172DB
Classification	Class II
Reason for Recall	Triton Seafood Co recalled their Neptune brand frozen Pre-cooked Conch Fritters and Conch Fritter Batter because the allergen, "Wheat" was not identified on the product label.
Product Quantity	233 cases
Recall Number	F-2377-2012

Class II Devices Event

Event ID	62927
Status	Completed
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	31-Jan-11
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Cordis Corporation
City	Miami Lakes
State	FL
Country	US
Distribution Pattern	Worldwide Distribution - USA and Germany

Associated Products

Product Description	Sleek OTW*REF 426-1201XInflated Balloon Dia/mm1.25Inflated Balloon Length/mm15Usable Catheter Length/cm150* Lot 50027149*2013-09Cordis SleekOTWREF Cat. No. 426-1201XPTA Dilatation CatheterCordisJohnson Johnson CompanyLOT Lot No. 50027149Use by 2013-09SterileEOMethod of Sterilization: ETOClearStreamClearstream Technologies, Ltd.Moyne Upper, Enniscorthy Co Wexford, IrelandPhone: +353-53-92-37111Fax: +353-53-92-37-100Made in IrelandDistributed by: Cordis CashelCahir Road, Cashel, Co. Tipperary, Ireland*Tel: +353--(0)62-70000. The SLEEK OTW Percutaneous Transluminal Angioplasty (PTA) Peripheral Catheter Family is a non-reusable semi-compliant coaxial design catheter with a balloon mounted on its distal tip. The hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon. The catheter shaft is small beneath the balloon achieve low profile. The distal tip is further tapered to accept the appropriate guidewire. Platinum iridium bands serve to locate the balloon under fluoroscopy. A 0.014" (0.356 mm) guidewire is recommended for use with the SLEEK OTW Catheter.
Code Info	Lot #50027149
Classification	Class II
Reason for Recall	On 1/20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688. Product is incorrectly labeled.
Product Quantity	5 units
Recall Number	Z-2441-2012

Product Description	Sleek *OTW Ref 426-1501XInflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150Lot 500266882013-09CordisPTA Dilatation CatheterCordisJohnson Johnson CompanySterileEOMethod of Sterilization: ETOClearStreamClearstream Technologies, Ltd.Moyne Upper, Enniscorthy Co Wexford, IrelandPhone: +353-53-92-37111Fax: +353-53-92-37-100Made in IrelandDistributed by: Cordis CashelCahir Road, Cashel, Co. Tipperary, Ireland*". The SLEEK OTW Percutaneous Transluminal Angioplasty (PTA) Peripheral Catheter Family is a non-reusable semi-compliant coaxial design catheter with a balloon mounted on its distal tip. The hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon. The catheter shaft is small beneath the balloon achieve low profile. The distal tip is further tapered to accept the appropriate guidewire. Platinum iridium bands serve to locate the balloon under fluoroscopy. A 0.014" (0.356 mm) guidewire is recommended for use with the SLEEK OTW Catheter.
Code Info	Lot #50026688.
Classification	Class II
Reason for Recall	On 1//20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688. Product is incorrectly labeled.
Product Quantity	1 unit
Recall Number	Z-2442-2012

Class II Devices Event

Event ID	62948
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	02-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Mc-NEIL-PPC, Inc.
City	Skillman
State	NJ
Country	US
Distribution Pattern	Nationwide Distribution

Associated Products

Product Description	KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant
Code Info	The following Lot Numbers were identified: 2721W; 2591W; 2321W; 1681W; 0921W; 0651W; 0471W; 0361W; 0221W; 0041W; 0110H; 0100H; 0090H; 0080H; 0030H; 0179H; 0159H; 0219H and 3489RT.
Classification	Class II
Reason for Recall	Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA concerns that the product should have been cleared under a separate medical device application. This voluntary recall is not being conducted on the basis of any consumer safety or product performance issues related to K-Y LIQUIBEADS. JJHP received a Warning Letter on May 23, 2012 indicating that this device, KY Liquibeads Vaginal Moisturizer, is misbranded under the section 502(o) the Act, 21 U.S.C. 352(o), because we did not notify the agency of our intent to introduce the device into commercial distribution, as required by 510(k) of the Act, U.S.C. 360(k). The Warning Letter indicated that changes were made to the predicate device that would require submission of a new 510(k).
Product Quantity	818,712
Recall Number	Z-2467-2012

Class II Devices Event

Event ID	62965
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Invacare Corporation
City	Elyria
State	OH
Country	US
Distribution Pattern	Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of AUSTRALIA, CANADA, GUAM, ISRAEL, NEW ZEALAND, THAILAND, TRINIDAD AND TOBAGO.

Associated Products

Product Description	Invacare® I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035. These shower chairs are designed for individuals who require seating support when bathing or showering and provide comfort and safety in the bathtub.
Code Info	9780, 9781, 9781-1
Classification	Class II
Reason for Recall	On August 6, 2012, Invacare voluntarily recalled the Invacare® I-Fit" Shower Chair (Models 9780, 9781, 9781-1) based on the return, quality and adverse event data received.
Product Quantity	21,168 chairs
Recall Number	Z-2461-2012

Class II Devices Event

Event ID	62979
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	KCI USA, Inc.
City	San Antonio
State	TX
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria.

Associated Products

Product Description	BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. The BariAir Therapy System provides low air-loss pressure management therapy, pulsation, percussion, Turn Assist. flexible patient positioning capabilities and built-in scales for patients weighing 300 Ib* to 850 Ib ([136-386 kg] including accessories). The BariAir Therapy System is indicated to aid in: " Patients whose body weight and size pose a significant risk or care management issue to the patient or staff during the performance of routine nursing care. " Large patients weighing between 300 Ib and 850 Ib (136*-386 kg) including accessories. " Large patients who are difficult to turn. " Preventing and treating pressure ulcers. " Large patients requiring percussion therapy.
Code Info	Multiple Serial Numbers with Model Numbers: 404000,405500, 405500RF
Classification	Class II
Reason for Recall	KCI has issued a medical device correction for the BariAir Therapy System Hand Pendent. The BariAir Therapy System is not designed to allow the patient to place the bed into the patient exit position. KCI has received complaints indicating that patients used the hand pendent to inadvertently place the BariAir Therapy System into a pseudo-exit position. In a small number of instances, this allowed the patient to unintentionally exit the therapy system, resulting in some patients receiving minor injuries.
Product Quantity	575
Recall Number	Z-2466-2012

Class II Food/Cosmetics Event

Event ID	62991
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Pulmuone Wildwood Inc
City	Fullerton
State	CA
Country	US
Distribution Pattern	Nationwide and Canada.

Associated Products

Product Description	Wildwood Emerald Valley Kitchen Organic Medium Salsa, 30 oz. Pack size 6/30 oz per case, 14 oz Pack size 6/14oz per case, Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC MEDIUM SALSA*MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833*"
Code Info	UPC 0-52334-11665-0, Item # 0291623. UPC 0-52334-11653-7, Item # 0291638
Classification	Class II
Reason for Recall	The firm recalled due to a potential non-safety quality concern related to a particular ingredient that was causing premature spoilage.
Product Quantity	61,288 units
Recall Number	F-2433-2012

Product Description	Wildwood Emerald Valley Kitchen Organic Mild Salsa, 14 oz. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC MILD SALSA*NET WT. 14 OZ (850g)MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833**"
Code Info	UPC 0-52334-11659-9, Item # 0291628.
Classification	Class II
Reason for Recall	The firm recalled due to a potential non-safety quality concern related to a particular ingredient that was causing premature spoilage.
Product Quantity	21,841 units
Recall Number	F-2434-2012

Product Description	Wildwood Emerald Valley Kitchen Organic Hot Salsa, 14 oz. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC HOT SALSA*NET WT. 14 OZ (850g)MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833**"
Code Info	UPC 0-52334-11660-5, Item # 0291635.
Classification	Class II
Reason for Recall	The firm recalled due to a potential non-safety quality concern related to a particular ingredient that was causing premature spoilage.
Product Quantity	3,148 units
Recall Number	F-2435-2012

Product Description	Wildwood Emerald Valley Kitchen Organic Medium Salsa - Canada (containing French in labeling), 397 mL. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC MEDIUM SALSA*NET WT. 397mL, MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833*".
Code Info	UPC 0-52334-11659-9, Item # 0291661.
Classification	Class II
Reason for Recall	The firm recalled due to a potential non-safety quality concern related to a particular ingredient that was causing premature spoilage.
Product Quantity	575 units
Recall Number	F-2436-2012

Product Description	Wildwood Emerald Valley Kitchen Organic Mild Salsa - Canada (containing French in labeling), 397 mL. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC MILD SALSA*NET WT. 397mL, MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833*".
Code Info	UPC 0-52334-11653-7, Item # 0291662.
Classification	Class II
Reason for Recall	The firm recalled due to a potential non-safety quality concern related to a particular ingredient that was causing premature spoilage.
Product Quantity	781 units
Recall Number	F-2437-2012

Product Description	Wildwood Organic Mild Salsa , 14 oz, Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD ORGANIC salsa MILD *NET WT. 14OZ, MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833*".
Code Info	UPC 0-30871-33001-2, Item # 0291710.
Classification	Class II
Reason for Recall	The firm recalled due to a potential non-safety quality concern related to a particular ingredient that was causing premature spoilage.
Product Quantity	602 units
Recall Number	F-2438-2012

Product Description	Wildwood Organic Medium Salsa , 14 oz, Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD ORGANIC salsa MILD *NET WT. 14OZ, MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833*".
Code Info	UPC 0-30871-33002-9, Item # 0291711.
Classification	Class II
Reason for Recall	The firm recalled due to a potential non-safety quality concern related to a particular ingredient that was causing premature spoilage.
Product Quantity	748 units
Recall Number	F-2439-2012

Class II Devices Event

Event ID	63009
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-May-11
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Linvatec Corp. dba ConMed Linvatec
City	Largo
State	FL
Country	US
Distribution Pattern	Worldwide Distribution - US Nationwide and the countries of Canada, DK, HK, IN, IT, KR, MY, RU, CO, VN, ZA.

Associated Products

Product Description	*REF LS7600Qty 1 EC REP* ConMed Linvatec Xenon Light Source
Code Info	GCT
Classification	Class II
Reason for Recall	Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures.
Product Quantity	1
Recall Number	Z-2455-2012

Product Description	*REF LS7700Qty 1 EC REP* ConMed Linvatec Xenon Universal Light Source
Code Info	GCT
Classification	Class II
Reason for Recall	Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures.
Product Quantity	57
Recall Number	Z-2456-2012

Class II Devices Event

Event ID	63015
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Covidien LP
City	North Haven
State	CT
Country	US
Distribution Pattern	Worldwide Distribution.

Associated Products

Product Description	Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code: DUET4535. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Code Info	All lot numbers
Classification	Class II
Reason for Recall	Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
Product Quantity	433,528 units
Recall Number	Z-2432-2012

Product Description	Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4535A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Code Info	All lot numbers
Classification	Class II
Reason for Recall	Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.
Product Quantity	94,301 units
Recall Number	Z-2433-2012

Product Description	Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET4548. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Code Info	All lot numbers
Classification	Class II
Reason for Recall	Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.
Product Quantity	4,867 units
Recall Number	Z-2434-2012

Product Description	Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4548A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Code Info	All lot numbers
Classification	Class II
Reason for Recall	Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
Product Quantity	104,355 units
Recall Number	Z-2435-2012

Product Description	Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Product Code: DUET6035. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Code Info	All lot numbers
Classification	Class II
Reason for Recall	Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
Product Quantity	22,218 units
Recall Number	Z-2436-2012

Product Description	Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6035A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Code Info	All lot numbers
Classification	Class II
Reason for Recall	Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
Product Quantity	268,022 units
Recall Number	Z-2437-2012

Product Description	Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET6048. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Code Info	All lot numbers
Classification	Class II
Reason for Recall	Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
Product Quantity	15,936 units
Recall Number	Z-2438-2012

Product Description	Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6048A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Code Info	All lot numbers
Classification	Class II
Reason for Recall	Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.
Product Quantity	135,712 units
Recall Number	Z-2439-2012

Class II Biologics Event

Event ID	63022
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Aug-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Rocky Mountain Lions Eye Bank
City	Aurora
State	CO
Country	US
Distribution Pattern	Japan

Associated Products

Product Description	Cornea
Code Info	121180100
Classification	Class II
Reason for Recall	Corneas, recovered in a manner that may increase the risk of the introduction, transmission, or spread of communicable diseases, were distributed.
Product Quantity	1
Recall Number	B-2522-12

Class II Biologics Event

Event ID	63023
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Jun-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Lions Eye Bank of Texas
City	Houston
State	TX
Country	US
Distribution Pattern	Texas

Associated Products

Product Description	Cornea
Code Info	120114100
Classification	Class II
Reason for Recall	Expired human cornea was distributed.
Product Quantity	1
Recall Number	B-2521-12

Class II Biologics Event

Event ID	63024
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Jul-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Upstate New York Transplant Services
City	Buffalo
State	NY
Country	US
Distribution Pattern	New York

Associated Products

Product Description	Cornea
Code Info	100791OD; 100791OS
Classification	Class II
Reason for Recall	Human corneas, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	2
Recall Number	B-2520-12

Class II Biologics Event

Event ID	63025
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Feb-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	RTI Biologics, Inc.
City	Alachua
State	FL
Country	US
Distribution Pattern	Oklahoma

Associated Products

Product Description	Tendon
Code Info	8169473
Classification	Class II
Reason for Recall	Human tendon, with a swab culture positive for coagulase-negative Staphylococcus, was distributed.
Product Quantity	1
Recall Number	B-2523-12

Class II Biologics Event

Event ID	63026
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	31-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	RTI Biologics, Inc.
City	Alachua
State	FL
Country	US
Distribution Pattern	Arizona; Pennsylvania; South Carolina; Oregon; Maryland; California; Florida

Associated Products

Product Description	Tendon
Code Info	7576144; 7576145; 7576146; 7576147; 7576148; 7576149; 7576150
Classification	Class II
Reason for Recall	Human tendons, with a culture positive for coagulase negative Staphylococcus, were distributed.
Product Quantity	7
Recall Number	B-2524-12

Class II Devices Event

Event ID	63044
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Aug-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 AL, AZ, CA, CO, FL, GA, IL, KS, KY, MI, MS, NJ, NM, NV, NY, OH, TX, WA & WI and internationally to: Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, India, Italy, Japan, Jordan, Mexico, Saudi Arabia, South Korea, Spain, Thailand, Turkey & United Kingdom.

Associated Products

Product Description	Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH. The Brilliance 6, 16 and MX8000 Dual v. Exp are Computed Tomography X-Ray Systems that are 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. GEMINI Dual is an imaging system that combines positron emission tomography (PET) and X-ray computed tomography. The GEMINI produces attenuation and non-attenuation corrected images of the distribution of PET radiopharmaceuticals in the head, body and total body as well as X-ray transmission images of these areas. The PET and CT images are registered and displayed in a fused format to provide combined PET and anatomical data at different angles for interpretation by trained health professionals. The PET and CT portions of the system can be used either as an integrated system or as a stand-alone PET or CT system. GEMINI can provide CT data suitable for use in attenuation correction.
Code Info	System Code #: 728130; Serial #: 8128, 8158 & 8369. System Code #: 728256; Serial #: 3695, 3703, 371 &, 3719. System Code #: 728246; Serial #: 3463, 3508, 3519, 3548, 3552, 3591, 3592, 3593, 3603, 3637, 3648, 3654, 3659, 3661, 3675, 3679, 3687, 3692, 5451, 5515, 5543, 5567, 5583, 5586, 5658, 5664, 5675, 5697, 5707, 5749, 5752, 5774, 5807, 5813, 5815, 5845, 5846, 5852, 5866, 5872, 5910, 5963, 5968, 6028, 6036, 6045, 6071 & 6126. System Code #: 882160; Serial #: 97, 102, 103, 105, 106, 107, 109, 110, 111, 113, 114, 115, 116, 117, 118, 121, 122, 123, 124, 125, 126, 127, 131, 132, 133, 134, 135, 136, 137, 139, 140, 141, 143, 144, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, , 63, 164, 165, 167, 1065 & 6119.
Classification	Class II
Reason for Recall	A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
Product Quantity	112 Units
Recall Number	Z-2451-2012

Class II Food/Cosmetics Event

Event ID	63046
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Aug-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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

Associated Products

Product Description	Product Name: Walnuts 160z. Brand Name: Markets of Meijer Meijer Distribution, Inc. Grand Rapids, MI49544 UPC 8-8692619782-2
Code Info	Lot Number: 08 2150
Classification	Class II
Reason for Recall	The firm was notified by a produce manager at one of the store locations that some of the bags from this lot of product contain pecans in addition to walnuts. Pecans are not listed in the ingredient statement and are not called out as an allergen.
Product Quantity	1,440 units (60 cases, 24 units/case).
Recall Number	F-2372-2012

Class II Biologics Event

Event ID	63051
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Jul-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Viacord Processing Laboratory
City	Hebron
State	KY
Country	US
Distribution Pattern	New York

Associated Products

Product Description	Umbilical Cord Blood Stem Cells
Code Info	111112016
Classification	Class II
Reason for Recall	Umbilical cord blood stem cells, not tested in accordance with the manufacturer's instructions to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents, were distributed.
Product Quantity	1
Recall Number	B-2525-12

Class II Biologics Event

Event ID	63052
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Lions Eye Institute for Transplant & Research, Inc.
City	Tampa
State	FL
Country	US
Distribution Pattern	California; Florida

Associated Products

Product Description	Cornea
Code Info	2010063945; 2010063946
Classification	Class II
Reason for Recall	Human corneas, recovered from a donor whose donor eligibility may have been been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	2
Recall Number	B-2526-12

Class II Devices Event

Event ID	63091
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Alere San Diego, Inc.
City	San Diego
State	CA
Country	US
Distribution Pattern	Nationwide Distribution.

Associated Products

Product Description	Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.
Code Info	Lot Codes: K51245RB, W51022RB, W51207RB
Classification	Class II
Reason for Recall	Alere San Diego is recalling Alere Triage TOX Drug Screen because there is a possibility that after installing the code chip provided with the affected lots: AMP, BAR, and PCP, the threshold ranges may not be consistently set correctly in all meters.
Product Quantity	591 kits
Recall Number	Z-2460-2012

Class II Devices Event

Event ID	63092
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Abbott Vascular
City	Temecula
State	CA
Country	US
Distribution Pattern	Nationwide(US) Distribution and Puerto Rico.

Associated Products

Product Description	Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
Code Info	U.S. Lot #: 737538, 737576, 738162, 738486, 738641, 739286, 739518, 739837, 740078, 740090, 740306, 740310, 740575, 740579, 740583, 740591, 740599, 740824, 740828, 740832, 740836, 742024, 742028, 742032, 742036, 742040, 742234, 742238, 742246, 742250, 742509, 742513, 742517, 742521, 742759, 742767, 742775, 742783, 742932, 742936, 742940, 742944, 742948, 742952, 742956, 743092, 743096, 743100, 743194, 743197, 743203, 743206, 743209, 743212, 743215, 743469, 743473, 743477, 743481, 743489, 743565, 743862, 743866, 743870, 743874, 743878, 743882, 743886, 744277, 744285, 744289, 744293, 744297, 744301, 744361, 744419, 744423, 744427, 744431, 744435, 744525, 744618, 744622, 744626, 744630, 744634, 744874, 744878, 744882, 744886, 744890, 744894, 745237, 745245, 745249, 745253, 745538, 745542, 745547, 745731, 745735, 745743, 745747, 745949, 745953, 745957, 745961, 745965, 745969, 746237, 746249, 746253, 746257, 746358, 746362, 746366, 746370, 746565, 746569, 746767, 746783, 746968, 746972, 746976, 747149, 747153, 747161, 747165, 747326, 747347, 747351, 747545, 747549, 747565, 747736, 747740, 747744, 747753, 747757, 747765, 747899, 747907, 748103, 748107, 748111, 748115, 748119, 748127, 748309, 748317, 748321, 748437, 748473, 748608, 749158, 749174, 749312, 749320, 749324, 749328, 749332, 749336, 749340, 749537, 749582, 749800, 749933, 749937, 749980, 749988, 750000, 750008, 750130, 750134, 750150, 750154, 750315, 750319, 750324, 750332, 750336, 750340, 750344, 750487, 750491, 750495, 750500, 750504, 750508, 750829, 750833, 750845, 751169, 751326, 751334, 751338, 751342, 751529, 751533, 751889, 751897, 752089, 752097, 752349, 752369, 752429, 752441, 752453, 752461, 752619, 752623, 752627, 752639, 752643, 752777, 752781, 752785, 752794, 752798, 752802, 753142, 753150, 753153, 753169, 753173, 753277, 753281, 753285, 753289, 753297, 753481, 753485, 753608, 753726, 753730, 753734, 754054, 754062, 754066, 754070, 754074, 754187, 754191, 754599, 754603, 754607, 754619, 754623, 754783, 754787, 754791, 754795, 754799, 754803, 754948, 755240, 755244, 755431, 755443, 755606, 755610, 755614, 755792, 755818, 755826, 755834, 755838, 755842, 756002, 756006, 756010, 756156, 756160, 756164, 756169, 756173, 756177, 756441, 756445, 756465, 756469, 756473, 756477, 756481, 756662, 756666, 756670, 756694, 756698, 756702, 756868, 756872, 756876, 756880, 756884, 757077, 757081, 757085, 757089, 757260, 757264, 757268, 757280, 757296, 757440, 757456, 757472, 757476, 757676, 757680, 757684, 757692, 757696, 757704, 757708, 757712, 757716, 757890, 757894, 757898, 757902, 757914, 757918, 757922, 757926, 758067, 758071, 758075, 758079, 758083, 758087, 758091, 758095, 758288, 758296, 758300, 758304, 758312, 758316, 758324, 758500, 758504, 758508 ,758528, 758875, 758879, 758883, 758887, 758891, 758895, 758899, 758903, 759090, 759094, 759102, 759106, 759110, 759114, 759118, 759122, 759270, 759278, 759282, 759429, 759433, 759437, 759441, 759445, 759449, 759453, 759457, 759662, 759666, 759670, 759674, 759678, 759682, 759686, 759840, 759848, 759852, 759856, 759864, 759868, 759872, 759876, 759880, 760039, 760047, 760051, 760059, 760063, 760067, 760071, 760075, 760079, 760208, 760212, 760216, 760220, 760224, 760228, 760232, 760236, 760240, 760248, 760458, 760462, 760466, 760470, 760482, 760689, 760693, 760697, 760701, 760705, 760854, 760858, 760862, 760866, 760878, 760882, 761215, 761231, 761243, 761486, 761495, 761499, 761503, 761507, 761511, 761523, 761735, 761739, 761743, 761747, 761752, 761764, 761768, 761932, 761936, 761940, 761944, 761948, 761952, 761960, 762070, 762109, 762113, 762121, 762129, 762133, 762137, 762292, 762296, 762300, 762304, 762308, 762312, 762316, 762320, 762324, 762466, 762474, 762478, 762482, 762486, 762512, 762671, 762679, 762683, 762687, 762691, 762699, 762841, 762845, 762853, 762857, 762861, 762869, 763000, 763008, 763012, 763016, 763024, 763143, 763151, 763155, 763163, 763167, 763171, 763191, 763195, 763203, 763211, 763215, 763220, 763224, 763238, 763242, 763246, 763258, 763262, 763266, 763270, 763306, 763310, 763314, 763318, 763322, 763326, 763330, 763492, 763496, 763499, 763502, 763506, 763610, 763614, 763618, 763626, 763630, 763634, 763638, 763642, 763646, 763770, 763774, 763778, 763782, 763786, 763794, 763798, 763802, 763806, 763894, 763898, 763902, 763906, 763910, 763914, 763918, 763922, 763926, 764075, 764084, 764088, 764130, 764134, 764142, 764146, 764150, 764154, 764158, 764162, 764169, 764193, 764205, 764221, 764229, 764237, 764241, 764269, 764367, 764375, 764379, 764383, 764387, 764395, 764399, 764460, 764476, 764484, 764488, 764492, 764496, 764500, 764508, 764512, 764615, 764619, 764663, 764667, 764680, 764684, 764852, 764869, 765196, 765200, 765226, 765358, 765366, 765370, 765374, 765404, 765431, 765435, 765682, 765906, 766065, 766230, 766246, 766250, 766254, 766262, 766488, 766683, 766691, 766695, 766855, 766859, 766871, 767020, 767024, 767028, 767032, 767040, 767184, 767192, 767212, 767216, 767349, 767361, 767582, 767586, 767728, 767752, 767756, 767760, 767971, 767983, 767987, 768122, 768243, 768248, 768252, 768256, 768260, 768264, 768362, 768378, 768382, 768469, 768473, 768477, 768481, 768485, 768489, 768501, 768505, 768594, 768659, 768667, 768671, 769031, 769035, 769178, 769190, 769346, 769350, 769517, 769521, 769525, 769529, 769541, 769549, 769553, 769861, 769865, 769965, 769973, 769977, 769981, 770130, 770142, 770146, 770154, 770162, 770333, 770345, 770349, 770679, 770699, 770703, 770707, 771042, 771046, 771050, 771208, 771212, 771216, 771220, 771437, 771441, 771667, 771679, 771960, 771968, 772157, 772415, 772560, 772806, 773110, 773114, 774228, 774698.
Classification	Class II
Reason for Recall	Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have discovered that some devices may exhibit difficulty inflating and/or deflating.
Product Quantity	61,799 units
Recall Number	Z-2450-2012

Class II Devices Event

Event ID	63093
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Varian Medical Systems, Inc. Oncology Systems
City	Palo Alto
State	CA
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and Internationally. . .

Associated Products

Product Description	Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eyes.
Code Info	CP-08922: LIST OF SERIAL NUMBERS: H480001 ,H480130 ,H480301 ,H480446 ,H480623 ,H480795 ,H480976 ,H481088 ,H481222 ,H481382 ,H481544 ,H481777 ,H481931 ,H480002 ,H480131 ,H480302 ,H480448 ,H480624 ,H480798 ,H480981 ,H481089 ,H481229 ,H481383 ,H481545 ,H481778 ,H481932 ,H480008 ,H480132 ,H480305 ,H480449 ,H480627 ,H480808 ,H480982 ,H481090 ,H481230 ,H481389 ,H481556 ,H481787 ,H481935 ,H480009 ,H480133 ,H480312 ,H480450 ,H480628 ,H480814 ,H480989 ,H481099 ,H481231 ,H481392 ,H481562 ,H481793 ,H481938 ,H480010 ,H480137 ,H480313 ,H480451 ,H480629 ,H480819 ,H480992 ,H481100 ,H481232 ,H481393 ,H481581 ,H481795 ,H481939 ,H480011 ,H480138 ,H480314 ,H480455 ,H480630 ,H480820 ,H480993 ,H481104 ,H481233 ,H481394 ,H481582 ,H481796 ,H481940 ,H480012 ,H480139 ,H480315 ,H480464 ,H480631 ,H480821 ,H480994 ,H481105 ,H481234 ,H481397 ,H481590 ,H481798 ,H481945 ,H480013 ,H480151 ,H480316 ,H480465 ,H480645 ,H480822 ,H480996 ,H481108 ,H481235 ,H481404 ,H481591 ,H481799 ,H481946 ,H480014 ,H480153 ,H480319 ,H480467 ,H480652 ,H480823 ,H480997 ,H481109 ,H481236 ,H481409 ,H481592 ,H481803 ,H481953 ,H480015 ,H480157 ,H480320 ,H480468 ,H480659 ,H480824 ,H480998 ,H481110 ,H481237 ,H481410 ,H481602 ,H481805 ,H482120 ,H480016 ,H480158 ,H480321 ,H480469 ,H480660 ,H480825 ,H481003 ,H481111 ,H481239 ,H481414 ,H481603 ,H481806 ,H482121 ,H480017 ,H480159 ,H480323 ,H480471 ,H480665 ,H480839 ,H481004 ,H481112 ,H481256 ,H481415 ,H481606 ,H481807 ,H482125 ,H480019 ,H480160 ,H480324 ,H480477 ,H480667 ,H480840 ,H481010 ,H481115 ,H481257 ,H481416 ,H481609 ,H481815 ,H482126 ,H480020 ,H480169 ,H480325 ,H480478 ,H480668 ,H480841 ,H481012 ,H481122 ,H481277 ,H481417 ,H481613 ,H481818 ,H482129 ,H480030 ,H480170 ,H480333 ,H480486 ,H480670 ,H480842 ,H481014 ,H481132 ,H481278 ,H481418 ,H481614 ,H481821 ,H482130 ,H480031 ,H480172 ,H480338 ,H480487 ,H480673 ,H480843 ,H481015 ,H481133 ,H481279 ,H481420 ,H481616 ,H481835 ,H482131 ,H480032 ,H480173 ,H480340 ,H480493 ,H480674 ,H480844 ,H481016 ,H481135 ,H481289 ,H481423 ,H481617 ,H481836 ,H482132 ,H480033 ,H480174 ,H480341 ,H480494 ,H480676 ,H480845 ,H481022 ,H481136 ,H481290 ,H481424 ,H481618 ,H481837 ,H482133 ,H480034 ,H480175 ,H480342 ,H480495 ,H480677 ,H480846 ,H481023 ,H481139 ,H481291 ,H481428 ,H481619 ,H481838 ,H482134 ,H480040 ,H480177 ,H480345 ,H480502 ,H480678 ,H480847 ,H481024 ,H481142 ,H481292 ,H481432 ,H481620 ,H481848 ,H482135 ,H480043 ,H480178 ,H480346 ,H480505 ,H480679 ,H480849 ,H481025 ,H481143 ,H481293 ,H481433 ,H481622 ,H481849 ,H482136 ,H480051 ,H480184 ,H480350 ,H480507 ,H480685 ,H480850 ,H481026 ,H481144 ,H481294 ,H481443 ,H481635 ,H481850 ,H482137 ,H480052 ,H480185 ,H480351 ,H480508 ,H480686 ,H480855 ,H481027 ,H481146 ,H481296 ,H481445 ,H481636 ,H481851 ,H482138 ,H480053 ,H480207 ,H480358 ,H480514 ,H480687 ,H480856 ,H481028 ,H481147 ,H481298 ,H481451 ,H481638 ,H481852 ,H482144 ,H480054 ,H480208 ,H480359 ,H480521 ,H480688 ,H480865 ,H481029 ,H481149 ,H481299 ,H481452 ,H481639 ,H481853 ,H482162 ,H480055 ,H480209 ,H480360 ,H480522 ,H480691 ,H480866 ,H481030 ,H481150 ,H481304 ,H481453 ,H481641 ,H481858 ,H482163 ,H480063 ,H480210 ,H480361 ,H480523 ,H480702 ,H480868 ,H481031 ,H481151 ,H481306 ,H481454 ,H481647 ,H481862 ,H482164 ,H480064 ,H480215 ,H480362 ,H480524 ,H480712 ,H480873 ,H481032 ,H481154 ,H481307 ,H481455 ,H481648 ,H481863 ,H482166 ,H480065 ,H480216 ,H480365 ,H480526 ,H480714 ,H480874 ,H481036 ,H481155 ,H481309 ,H481456 ,H481649 ,H481865 ,H482167 ,H480067 ,H480217 ,H480371 ,H480527 ,H480715 ,H480878 ,H481037 ,H481157 ,H481311 ,H481467 ,H481650 ,H481866 ,H482168 ,H480072 ,H480218 ,H480372 ,H480528 ,H480717 ,H480879 ,H481039 ,H481158 ,H481312 ,H481471 ,H481651 ,H481867 ,H482172 ,H480075 ,H480233 ,H480378 ,H480530 ,H480719 ,H480886 ,H481043 ,H481159 ,H481313 ,H481472 ,H481667 ,H481870 ,H482174 ,H480076 ,H480239 ,H480379 ,H480531 ,H480722 ,H480890 ,H481045 ,H481163 ,H481315 ,H481477 ,H481671 ,H481871 ,H482178 ,H480078 ,H480240 ,H480388 ,H480539 ,H480723 ,H480894 ,H481046 ,H481164 ,H481316 ,H481478 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,H48D847 ,H48D976 ,H48C729 ,H48C802 ,H48C900 ,H48C993 ,H48D108 ,H48D206 ,H48D320 ,H48D441 ,H48D527 ,H48D654 ,H48D748 ,H48D850 ,H48D977 ,H48C730 ,H48C803 ,H48C901 ,H48D003 ,H48D111 ,H48D207 ,H48D321 ,H48D445 ,H48D528 ,H48D656 ,H48D749 ,H48D851 ,H48D979 ,H48C733 ,H48C804 ,H48C902 ,H48D004 ,H48D113 ,H48D208 ,H48D323 ,H48D446 ,H48D529 ,H48D657 ,H48D750 ,H48D852 ,H48D981 ,H48C734 ,H48C805 ,H48C903 ,H48D007 ,H48D115 ,H48D209 ,H48D324 ,H48D447 ,H48D531 ,H48D660 ,H48D751 ,H48D854 ,H48D984 ,H48C735 ,H48C806 ,H48C904 ,H48D008 ,H48D116 ,H48D210 ,H48D325 ,H48D448 ,H48D532 ,H48D661 ,H48D752 ,H48D855 ,H48D985 ,H48C736 ,H48C807 ,H48C905 ,H48D009 ,H48D118 ,H48D211 ,H48D326 ,H48D449 ,H48D533 ,H48D662 ,H48D754 ,H48D856 ,H48D986 ,H48C737 ,H48C808 ,H48C907 ,H48D010 ,H48D120 ,H48D214 ,H48D327 ,H48D450 ,H48D534 ,H48D665 ,H48D755 ,H48D860 ,H48D987 ,H48C738 ,H48C809 ,H48C908 ,H48D011 ,H48D121 ,H48D215 ,H48D331 ,H48D451 ,H48D537 ,H48D666 ,H48D758 ,H48D861 ,H48D988 ,H48C739 ,H48C810 ,H48C919 ,H48D012 ,H48D122 ,H48D216 ,H48D332 ,H48D453 ,H48D538 ,H48D669 ,H48D759 ,H48D864 ,H48D989 ,H48C740 ,H48C811 ,H48C920 ,H48D016 ,H48D123 ,H48D222 ,H48D333 ,H48D454 ,H48D539 ,H48D670 ,H48D760 ,H48D866 ,H48D990 ,H48C741 ,H48C812 ,H48C921 ,H48D022 ,H48D124 ,H48D223 ,H48D337 ,H48D455 ,H48D541 ,H48D675 ,H48D761 ,H48D867 ,H48D991 ,H48C742 ,H48C813 ,H48C925 ,H48D025 ,H48D125 ,H48D224 ,H48D346 ,H48D456 ,H48D543 ,H48D676 ,H48D762 ,H48D868 ,H48D992 ,H48C743 ,H48C815 ,H48C926 ,H48D026 ,H48D126 ,H48D225 ,H48D347 ,H48D457 ,H48D544 ,H48D683 ,H48D763 ,H48D869 ,H48D993 ,H48C744 ,H48C824 ,H48C927 ,H48D027 ,H48D127 ,H48D233 ,H48D348 ,H48D458 ,H48D546 ,H48D684 ,H48D770 ,H48D870 ,H48D996 ,H48C745 ,H48C829 ,H48C930 ,H48D028 ,H48D128 ,H48D235 ,H48D349 ,H48D459 ,H48D547 ,H48D685 ,H48D771 ,H48D871 ,H48D999 ,H48C746 ,H48C832 ,H48C931 ,H48D029 ,H48D129 ,H48D239 ,H48D350 ,H48D460 ,H48D548 ,H48D686 ,H48D772 ,H48D872 ,H48E002 ,H48C747 ,H48C833 ,H48C932 ,H48D034 ,H48D130 ,H48D240 ,H48D351 ,H48D461 ,H48D549 ,H48D688 ,H48D773 ,H48D873 ,H48E004 ,H48C748 ,H48C834 ,H48C934 ,H48D035 ,H48D131 ,H48D246 ,H48D352 ,H48D462 ,H48D550 ,H48D689 ,H48D774 ,H48D874 ,H48E009 ,H48C749 ,H48C835 ,H48C935 ,H48D039 ,H48D132 ,H48D247 ,H48D353 ,H48D463 ,H48D556 ,H48D690 ,H48D775 ,H48D875 ,H48E012 ,H48C750 ,H48C836 ,H48C936 ,H48D040 ,H48D133 ,H48D248 ,H48D354 ,H48D464 ,H48D557 ,H48D691 ,H48D776 ,H48D876 ,H48E016 ,H48C751 ,H48C837 ,H48C937 ,H48D044 ,H48D134 ,H48D249 ,H48D355 ,H48D465 ,H48D558 ,H48D692 ,H48D777 ,H48D889 ,H48E017 ,H48C753 ,H48C838 ,H48C938 ,H48D047 ,H48D136 ,H48D250 ,H48D356 ,H48D467 ,H48D566 ,H48D693 ,H48D778 ,H48D890 ,H48E018 ,H48C754 ,H48C839 ,H48C939 ,H48D049 ,H48D137 ,H48D251 ,H48D361 ,H48D469 ,H48D572 ,H48D694 ,H48D779 ,H48D891 ,H48E020 ,H48C755 ,H48C840 ,H48C940 ,H48D050 ,H48D138 ,H48D252 ,H48D362 ,H48D470 ,H48D573 ,H48D695 ,H48D780 ,H48D892 ,H48E023 ,H48C756 ,H48C841 ,H48C941 ,H48D052 ,H48D143 ,H48D253 ,H48D363 ,H48D471 ,H48D574 ,H48D696 ,H48D791 ,H48D897 ,H48E028 ,H48C757 ,H48C842 ,H48C942 ,H48D053 ,H48D146 ,H48D254 ,H48D364 ,H48D473 ,H48D575 ,H48D697 ,H48D798 ,H48D903 ,H48E032 ,H48C758 ,H48C847 ,H48C943 ,H48D054 ,H48D147 ,H48D258 ,H48D365 ,H48D477 ,H48D577 ,H48D698 ,H48D801 ,H48D916 ,H48E033 ,H48C759 ,H48C848 ,H48C944 ,H48D056 ,H48D148 ,H48D259 ,H48D366 ,H48D478 ,H48D580 ,H48D699 ,H48D803 ,H48D917 ,H48E034 ,H48C761 ,H48C849 ,H48C945 ,H48D057 ,H48D149 ,H48D260 ,H48D367 ,H48D479 ,H48D591 ,H48D700 ,H48D804 ,H48D918 ,H48E035 ,H48C762 ,H48C850 ,H48C946 ,H48D058 ,H48D154 ,H48D261 ,H48D368 ,H48D480 ,H48D592 ,H48D701 ,H48D805 ,H48D919 ,H48E036 ,H48C763 ,H48C851 ,H48C948 ,H48D059 ,H48D156 ,H48D262 ,H48D372 ,H48D481 ,H48D593 ,H48D702 ,H48D806 ,H48D924 ,H48E037 ,H48C764 ,H48C854 ,H48C949 ,H48D060 ,H48D159 ,H48D263 ,H48D375 ,H48D482 ,H48D594 ,H48D703 ,H48D807 ,H48D925 ,H48E044 ,H48C765 ,H48C855 ,H48C950 ,H48D061 ,H48D160 ,H48D264 ,H48D378 ,H48D483 ,H48D595 ,H48D704 ,H48D808 ,H48D926 ,H48E045 ,H48C766 ,H48C857 ,H48C951 ,H48D062 ,H48D161 ,H48D276 ,H48D381 ,H48D484 ,H48D599 ,H48D705 ,H48D809 ,H48D927 ,H48E046 ,H48C767 ,H48C859 ,H48C953 ,H48D063 ,H48D162 ,H48D277 ,H48D382 ,H48D486 ,H48D601 ,H48D707 ,H48D810 ,H48D928 ,H48E048 ,H48C768 ,H48C860 ,H48C954 ,H48D064 ,H48D163 ,H48D280 ,H48D383 ,H48D487 ,H48D602 ,H48D708 ,H48D811 ,H48D931 ,H48E050 ,H48C769 ,H48C861 ,H48C957 ,H48D065 ,H48D166 ,H48D281 ,H48D384 ,H48D488 ,H48D603 ,H48D709 ,H48D812 ,H48D932 ,H48E051 ,H48C770 ,H48C864 ,H48C961 ,H48D066 ,H48D168 ,H48D282 ,H48D385 ,H48D489 ,H48D604 ,H48D713 ,H48D813 ,H48D933 ,H48E052 ,H48C771 ,H48C865 ,H48C962 ,H48D067 ,H48D169 ,H48D283 ,H48D386 ,H48D490 ,H48D605 ,H48D714 ,H48D814 ,H48D934 ,H48E054 ,H48C776 ,H48C867 ,H48C965 ,H48D068 ,H48D170 ,H48D284 ,H48D388 ,H48D491 ,H48D606 ,H48D715 ,H48D815 ,H48D936 ,H48E055 ,H48C777 ,H48C868 ,H48C966 ,H48D069 ,H48D173 ,H48D285 ,H48D389 ,H48D497 ,H48D607 ,H48D716 ,H48D816 ,H48D937 ,H48E058 ,H48C780 ,H48C869 ,H48C968 ,H48D070 ,H48D174 ,H48D286 ,H48D390 ,H48D498 ,H48D608 ,H48D718 ,H48D818 ,H48D940 ,H48E059 ,H48C781 ,H48C870 ,H48C969 ,H48D071 ,H48D178 ,H48D287 ,H48D391 ,H48D499 ,H48D609 ,H48D719 ,H48D819 ,H48D941 ,H48E061 ,H48C782 ,H48C874 ,H48C970 ,H48D072 ,H48D179 ,H48D288 ,H48D392 ,H48D500 ,H48D610 ,H48D721 ,H48D820 ,H48D944 ,H48E062 ,H48C783 ,H48C876 ,H48C971 ,H48D073 ,H48D181 ,H48D289 ,H48D395 ,H48D501 ,H48D611 ,H48D722 ,H48D827 ,H48D945 ,H48E063 ,H48C784 ,H48C877 ,H48C972 ,H48D074 ,H48D183 ,H48D290 ,H48D396 ,H48D502 ,H48D612 ,H48D723 ,H48D829 ,H48D948 ,H48E066 ,H48E067 ,H48E187 ,H48E307 ,H48E409 ,H48E516 ,H48E629 ,H48E845 ,H48F039 ,H48F351 ,H48E069 ,H48E188 ,H48E308 ,H48E410 ,H48E517 ,H48E630 ,H48E846 ,H48F040 ,H48F285 ,H48E073 ,H48E189 ,H48E309 ,H48E411 ,H48E518 ,H48E631 ,H48E847 ,H48F052 ,H48F351 ,H48E074 ,H48E190 ,H48E310 ,H48E412 ,H48E519 ,H48E632 ,H48E848 ,H48F053 ,H48E076 ,H48E197 ,H48E312 ,H48E413 ,H48E520 ,H48E633 ,H48E851 ,H48F054 ,H48E077 ,H48E198 ,H48E313 ,H48E414 ,H48E523 ,H48E634 ,H48E854 ,H48F059 ,H48E079 ,H48E199 ,H48E314 ,H48E417 ,H48E524 ,H48E635 ,H48E856 ,H48F063 ,H48E082 ,H48E203 ,H48E315 ,H48E418 ,H48E535 ,H48E636 ,H48E862 ,H48F072 ,H48E083 ,H48E205 ,H48E316 ,H48E421 ,H48E536 ,H48E637 ,H48E864 ,H48F073 ,H48E087 ,H48E206 ,H48E320 ,H48E422 ,H48E537 ,H48E638 ,H48E865 ,H48F074 ,H48E099 ,H48E207 ,H48E321 ,H48E423 ,H48E540 ,H48E643 ,H48E872 ,H48F075 ,H48E100 ,H48E208 ,H48E322 ,H48E424 ,H48E543 ,H48E644 ,H48E873 ,H48F076 ,H48E101 ,H48E209 ,H48E323 ,H48E425 ,H48E546 ,H48E646 ,H48E874 ,H48F077 ,H48E102 ,H48E210 ,H48E325 ,H48E426 ,H48E547 ,H48E647 ,H48E875 ,H48F078 ,H48E103 ,H48E211 ,H48E326 ,H48E427 ,H48E551 ,H48E648 ,H48E876 ,H48F079 ,H48E104 ,H48E212 ,H48E327 ,H48E428 ,H48E552 ,H48E670 ,H48E877 ,H48F080 ,H48E106 ,H48E213 ,H48E328 ,H48E429 ,H48E554 ,H48E671 ,H48E898 ,H48F091 ,H48E109 ,H48E214 ,H48E329 ,H48E430 ,H48E556 ,H48E672 ,H48E904 ,H48F092 ,H48E110 ,H48E215 ,H48E334 ,H48E431 ,H48E559 ,H48E677 ,H48E906 ,H48F106 ,H48E111 ,H48E217 ,H48E336 ,H48E432 ,H48E560 ,H48E678 ,H48E908 ,H48F107 ,H48E112 ,H48E218 ,H48E337 ,H48E433 ,H48E564 ,H48E682 ,H48E909 ,H48F114 ,H48E113 ,H48E219 ,H48E338 ,H48E434 ,H48E569 ,H48E687 ,H48E910 ,H48F115 ,H48E115 ,H48E223 ,H48E339 ,H48E435 ,H48E570 ,H48E688 ,H48E923 ,H48F118 ,H48E116 ,H48E224 ,H48E340 ,H48E436 ,H48E571 ,H48E690 ,H48E924 ,H48F127 ,H48E117 ,H48E225 ,H48E342 ,H48E437 ,H48E572 ,H48E691 ,H48E925 ,H48F128 ,H48E120 ,H48E226 ,H48E343 ,H48E438 ,H48E575 ,H48E692 ,H48E926 ,H48F129 ,H48E121 ,H48E227 ,H48E351 ,H48E439 ,H48E578 ,H48E693 ,H48E935 ,H48F130 ,H48E124 ,H48E228 ,H48E352 ,H48E440 ,H48E579 ,H48E694 ,H48E937 ,H48F133 ,H48E133 ,H48E229 ,H48E354 ,H48E441 ,H48E581 ,H48E695 ,H48E938 ,H48F139 ,H48E135 ,H48E231 ,H48E355 ,H48E446 ,H48E582 ,H48E699 ,H48E939 ,H48F140 ,H48E136 ,H48E232 ,H48E356 ,H48E448 ,H48E585 ,H48E700 ,H48E944 ,H48F141 ,H48E137 ,H48E233 ,H48E357 ,H48E450 ,H48E586 ,H48E701 ,H48E945 ,H48F142 ,H48E138 ,H48E234 ,H48E358 ,H48E452 ,H48E588 ,H48E702 ,H48E946 ,H48F147 ,H48E139 ,H48E238 ,H48E359 ,H48E455 ,H48E594 ,H48E703 ,H48E947 ,H48F148 ,H48E140 ,H48E239 ,H48E360 ,H48E456 ,H48E595 ,H48E704 ,H48E948 ,H48F151 ,H48E141 ,H48E240 ,H48E361 ,H48E457 ,H48E596 ,H48E711 ,H48E952 ,H48F155 ,H48E142 ,H48E241 ,H48E362 ,H48E458 ,H48E597 ,H48E714 ,H48E954 ,H48F166 ,H48E144 ,H48E242 ,H48E363 ,H48E459 ,H48E598 ,H48E715 ,H48E957 ,H48F167 ,H48E145 ,H48E243 ,H48E364 ,H48E464 ,H48E602 ,H48E721 ,H48E961 ,H48F168 ,H48E146 ,H48E244 ,H48E365 ,H48E465 ,H48E603 ,H48E725 ,H48E963 ,H48F169 ,H48E149 ,H48E245 ,H48E366 ,H48E466 ,H48E604 ,H48E726 ,H48E965 ,H48F170 ,H48E150 ,H48E246 ,H48E367 ,H48E467 ,H48E605 ,H48E729 ,H48E967 ,H48F179 ,H48E152 ,H48E247 ,H48E368 ,H48E468 ,H48E607 ,H48E762 ,H48E968 ,H48F180 ,H48E154 ,H48E248 ,H48E369 ,H48E469 ,H48E608 ,H48E763 ,H48E973 ,H48F187 ,H48E155 ,H48E255 ,H48E371 ,H48E470 ,H48E609 ,H48E764 ,H48E974 ,H48F191 ,H48E157 ,H48E269 ,H48E378 ,H48E471 ,H48E610 ,H48E765 ,H48E975 ,H48F192 ,H48E158 ,H48E274 ,H48E379 ,H48E482 ,H48E611 ,H48E766 ,H48E976 ,H48F193 ,H48E159 ,H48E275 ,H48E387 ,H48E483 ,H48E612 ,H48E767 ,H48E992 ,H48F224 ,H48E167 ,H48E276 ,H48E388 ,H48E484 ,H48E614 ,H48E768 ,H48E994 ,H48F225 ,H48E168 ,H48E277 ,H48E390 ,H48E485 ,H48E615 ,H48E772 ,H48E996 ,H48F256 ,H48E169 ,H48E278 ,H48E393 ,H48E486 ,H48E616 ,H48E773 ,H48F012 ,H48F257 ,H48E170 ,H48E291 ,H48E394 ,H48E488 ,H48E618 ,H48E794 ,H48F015 ,H48F258 ,H48E173 ,H48E292 ,H48E395 ,H48E491 ,H48E619 ,H48E812 ,H48F019 ,H48F259 ,H48E174 ,H48E294 ,H48E396 ,H48E492 ,H48E620 ,H48E813 ,H48F020 ,H48F260 ,H48E175 ,H48E295 ,H48E397 ,H48E498 ,H48E621 ,H48E819 ,H48F023 ,H48F261 ,H48E180 ,H48E296 ,H48E398 ,H48E499 ,H48E622 ,H48E824 ,H48F028 ,H48F262 ,H48E181 ,H48E297 ,H48E399 ,H48E507 ,H48E623 ,H48E837 ,H48F032 ,H48F263 ,H48E182 ,H48E298 ,H48E400 ,H48E508 ,H48E624 ,H48E839 ,H48F033 ,H48F264 ,H48E183 ,H48E299 ,H48E401 ,H48E512 ,H48E625 ,H48E841 ,H48F035 ,H48F265 ,H48E184 ,H48E303 ,H48E402 ,H48E513 ,H48E626 ,H48E842 ,H48F036 ,H48F266 ,H48E185 ,H48E305 ,H48E403 ,H48E514 ,H48E627 ,H48E843 ,H48F037 ,H48F267 ,H48E186 ,H48E306 ,H48E408 ,H48E515 ,H48E628 ,H48E844 ,H48F038 ,H48F285
Classification	Class II
Reason for Recall	Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned Hounsfield Unit [HU] value can be used for dose calculation when the clock on the Eclipse Client Workstation is not synchronized with the Database/System Server. Treatment of the patient using these values can therefore lead to under or over-dose.
Product Quantity	6087
Recall Number	Z-2462-2012

Class II Drugs Event

Event ID	63095
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Dispensing Solutions, Inc
City	Santa Ana
State	CA
Country	US
Distribution Pattern	US: IN & WI

Associated Products

Product Description	Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metered actuations, Rx only, Packaged Exclusively by: Dispensing Solutions, Inc., Santa Ana, CA --- NDC 68258-8952-01, DSI product #8A0947
Code Info	Lot # F23989, F22311
Classification	Class II
Reason for Recall	Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as Ventolin HFA 90 mcg instead of correctly as Atrovent HFA 12.9 grams Inhalation Aerosol
Product Quantity	18 Inhalers
Recall Number	D-1691-2012

Class II Devices Event

Event ID	63100
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Applied Medical Resources Corp
City	Rancho Santa Margarita
State	CA
Country	US
Distribution Pattern	Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa.

Associated Products

Product Description	Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Description: A4402, 3F-40CM, SYNTEL RT-EMB; A4403, 3F-80CM, SYNTEL RT-EMB; A4404, 4F-40CM, SYNTEL RT-EMB; A4405, 4F-80CM, SYNTEL RT-EMB; A4406, 5F-80CM, SYNTEL RT-EMB; A4407, 6F-80CM, SYNTEL RT-EMB; A4408, 7F-80CM, SYNTEL RT-EMB; A4F00, 2F-60CM (PREM) SYNTEL CATHETER; A4F01, 2F-80CM, (PREM) SYNTEL CATHETER; A4F02, 3F-40CM, (PREM) SYNTEL CATHETER; A4F03, 3F-80CM, (PREM) SYNTEL CATHETER; A4F04, 4F-40CM, (PREM) SYNTEL CATHETER; A4F05, 4F-80CM, (PREM) SYNTEL CATHETER; A4F06, 5F-80CM, (PREM) SYNTEL CATHETER; A4F07, 6F-80CM, (PREM) SYNTEL CATHETER; A4F08, 7F-80CM, (PREM) SYNTEL CATHETER; CE0260ST, L2F-60CM PREM SYNTEL CATH; CE0280ST, L2F-80CM PREM SYNTEL CATH; CE0340ST, 3F-40cm (PREM) SYNTEL CATHETER; CE0380ST, 3F-80CM PREM SYNTEL CATH; CE0440ST, 4F-40CM PREM SYNTEL CATH; CE0480ST, 4F-80CM PREM SYNTEL CATH; CE0580ST, 5F-80CM PREM SYNTEL CATH; CE0680ST, 6F-80cm (PREM) SYNTEL CATHETER; CE0780ST, 7F-80CM PREM SYNTEL CATH; CE0340, 3F-40cm, SYNTEL RT-EMB; CE0380, 3F-80cm, SYNTEL RT-EMB; CE0440, 4F-40cm, SYNTEL RT-EMB; CE0480, 4F-80cm, SYNTEL RT-EMB; CE0580, 5F-80cm, SYNTEL RT-EMB; CE0680, 6F-80cm, SYNTEL RT-EMB; CE0780, 7F-80cm SYNTEL RT-EMB. BARD Embolectomy Catheters are indicated for the removal of emboli and thrombi from the peripheral arterial system. These devices consist of a catheter body with a latex-free balloon on the distal end and an inflation hub on the proximal end.
Code Info	Model Numbers: Lot Numbers A4402: 1157054, 1163804, 1170473. A4403: 1157060, 1162689, 1166031, 1169109. A4404: 1160223, 1163803, 1166725, 1171181. A4405: 1155214, 1157053, 1161472, 1162967, 1164628, 1168912. A4406: 1155428, 1162945, 1167745, 1170042. A4407: 1154478, 1162866, 1168604. A4408: 1163626. A4F00: 1164152, 1164627, 1168666. A4F01: 1156256, 1160007, 1163628, 1168231. A4F02: 1156522, 1161792, 1170399. A4F03: 1155855, 1157052, 1161793, 1160310, 1159725, 1163215, 1163961, 1167855, 1169632, 1164626, 1165853. A4F04: 1155427, 1160221, 1161791, 1156935, 1171883, 1169729, 1167751, 1165778, 1163384, 1172598. A4F05: 1155854, 1154446, 1156936, 1155230, 1161471, 1160222, 1159414, 1161998, 1163216, 1163962, 1167440, 1166463, 1164625, 1165323, 1168911. A4F06: 1155856, 1154435, 1158624, 1161997, 1164149, 1165777, 1169013. A4F07: 1171170, 1156271, 1167414, 1164151. A4F08: 1168855, 1155648. CE0260ST: 1164307, 1168569. CE0280ST: 1164351. CE0340ST: 1164348. CE0380ST: 1164308, 1164337, 1166033, 1169029, 1166281, 1166032. CE0440ST: 1164336, 1168610. CE0480ST: 1164303, 1164302, 1164335, 1164304, 1166468, 1168605, 1166284, 1166283. CE0580ST: 1164345, 1164346, 1168613. CE0680ST: 1164330, 1166470. CE0780ST: 1164354. CE0340: 1166904. CE0380: 1164344. CE0440: 1164347, 1168609. CE0480: 1164343. CE0580: 1164349. CE0680: 1164353 CE0780: 1169926.
Classification	Class II
Reason for Recall	Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.
Product Quantity	40,238 units for all products in Recall Event
Recall Number	Z-2446-2012

Product Description	Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BILIARY 5F-40CM CATHETER; A4762, SYNTEL BILIARY 6F-23CM CATHETER; CB052308, SYNTEL BILIARY 5F-23CM CATH; CB054008, SYNTEL BILIARY 5F-40CM CATH; CB062313, SYNTEL BILIARY 6F-23CM CATH. Biliary Catheters are indicated for the removal of stones and ductal debris from the biliary system.
Code Info	Model Numbers: Lot Numbers A4752: 1165670. A4754: 1156762. A4762: 1155852, 1165674. CB052308: 1164350. CB054008: 1164305. CB062313: 1164306.
Classification	Class II
Reason for Recall	Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.
Product Quantity	40,238 units for all products in Recall Event
Recall Number	Z-2447-2012

Product Description	Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM; IRR-080-4F, CATHETER, IRRIGATION 4F 80CM; IRR-080-6F, CATHETER, IRRIGATION 6F 80CM. Irrigation Catheters are indicated for irrigation in the peripheral vascular system and biliary tree.
Code Info	Model Numbers: Lot Numbers IRR-023-10F: 1158230. IRR-080-4F: 1156082, 1170185, 1164648. IRR-080-6F: 1158960.
Classification	Class II
Reason for Recall	Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.
Product Quantity	40,238 units for all products in Recall Event
Recall Number	Z-2448-2012

Class II Devices Event

Event ID	63107
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Jul-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Linvatec Corp. dba ConMed Linvatec
City	Largo
State	FL
Country	US
Distribution Pattern	Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA ,WI and Hawaii., and the countries of Australia Canada, China, Switzerland, Germany, Czech Republic, Denmark, Egypt, Spain, France, South Africa, United Kingdom, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Russia and Saudi Arabia.

Associated Products

Product Description	Catheter Irrigation Set labeled in part: *24K Arthroscopy Outflow/Suction Tubing Set* This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures.
Code Info	Catalog # 24k100 Lot #: 20853-000 20854-000 20855-000 21791-000 22172-000 22414-000 22513-000 22667-000 22724-000 22725-000 23606-000 23912 23912-000 23971-000 24177-000 24296-000 24348-000 24373-000 24476-000 24559-000 24671-000 24703-000 24905-000 25668-000 25794-000 25931-000 26025-000 26041-000 26294-000 26448-000 26486-000 27130-000 27255 27255-000 27322 27520
Classification	Class II
Reason for Recall	ConMed Linvatec recalled their 24k Arthroscopy Outflow/Suction Tubing Set (Product Number 24k100)because there is a possibility that the product may have a breach in the Tyvek seal that could potentially compromise the sterility of the contents.
Product Quantity	30064 units
Recall Number	Z-2469-2012

Class II Devices Event

Event ID	63119
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Philips Healthcare Inc.
City	Andover
State	MA
Country	US
Distribution Pattern	Worldwide Distribution--USA (nationwide) and the countries of Australia, Austria, Canada, Chile, Finland, France, Germany, Hungary. Italy, Japan, Latvia, Netherlands, New Zealand. Oman, South Korea, Switzerland and United Kingdom.

Associated Products

Product Description	Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 712022, 712025 This system is used for making X-ray exposures for diagnostics.
Code Info	Serial Numbers: SN10000053 SN11000644 SN10000648 SN10000649 SN11000226 SN10000703 SN11000032 SN10000407 SN11000105 SN11000112 SN11000212 SN11000231 SN11000030 SN10000468 SN11000146 SN11000217 SN11000238 SN11000407 SN11000154 SN10000297 SN10000515 SN11000129 SN11000266 SN11000412 SN11000442 SN11000063 SN11000441 SN10000416 SN10000414 SN10000424 SN11000034 SN10000018 SN11000050 SN10000113 SN10000442 SN11000057 SN11000419 SN10000482 SN10000670 SN10000690 SN10000689 SN10000694 SN11000461 SN10000544 SN11000095 SN11000329 SN11000464 SN10000554 SN10000635 SN10000107 SN10000413 SN10000557 SN11000092 SN11000100 SN11000118 SN11000145 SN11000161 SN11000193 SN11000194 SN11000228 SN11000294 SN11000371 SN10000038 SN10000101 SN10000102 SN10000641 SN10000664 SN11000027 SN10000537 SN10000650 SN11000130 SN11000142 SN11000216 SN11000269 SN11000286 SN11000288 SN11000311 SN11000320 SN10000363 SN10000246 SN10000512 SN11000033 SN11000053 SN11000080 SN11000271 SN11000478 SN11000474 SN11000013 SN11000005 SN11000008 SN11000004 SN11000141 SN11000007
Classification	Class II
Reason for Recall	The Wireless Portable Detector (WPD) is not fixed securely inside the Mobile Detector Holder and may fall down
Product Quantity	93 Units
Recall Number	Z-2465-2012

Class II Devices Event

Event ID	63141
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Greatbatch Medical
City	Minneapolis
State	MN
Country	US
Distribution Pattern	Distributed in MA.

Associated Products

Product Description	Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441. To facilitate transvenous introduction of diagnostic / therapeutic catheters into the vasculature and into the chambers of the heart.
Code Info	Q2112752, Q2110939, Q2130137, Q2131250, Q2130212, Q2150143, W2162515, W2163769, W2160626, W2175891, W2172722, W2184492, W2196366, W2184490, W2205843
Classification	Class II
Reason for Recall	During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardiac cryoablation balloon catheters, the internal PTFE sheath liners were found to display varying degrees of damage that could pose an embolic risk to a patient.
Product Quantity	787
Recall Number	Z-2459-2012

Class II Food/Cosmetics Event

Event ID	63150
Status	Terminated
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Sep-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	M & K Trading Inc
City	Los Angeles
State	CA
Country	US
Distribution Pattern	California

Associated Products

Product Description	Seasoned Clams, 240 grams
Code Info	not available.
Classification	Class II
Reason for Recall	M & K Trading is recalling Korean Molluscan Shellfish because the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity	39 units
Recall Number	F-2396-2012

Class II Devices Event

Event ID	63156
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Neomend Inc
City	Irvine
State	CA
Country	US
Distribution Pattern	US Nationwide Distribution

Associated Products

Product Description	Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks (;::2mm) incurred during open resection of lung parenchyma.
Code Info	Model #: PGPS002 Lot #: 111202-002
Classification	Class II
Reason for Recall	Product was distributed with an incorrect expiration date. Product was labeled with an expiration date of 2013-04 and should have been labeled with 2012-09.
Product Quantity	95 units
Recall Number	Z-2454-2012

Class II Devices Event

Event ID	63166
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-May-08
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Toshiba American Medical Systems Inc
City	Tustin
State	CA
Country	US
Distribution Pattern	Nationwide distribution: USA including states of: MA, MD, and NV.

Associated Products

Product Description	TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. This device is intended to produce cross sectional volume sets of the anatomy. Additionally the system, when used by a trained professional, is capable of proving data for dynamic and perfusion studies of organs and extremities.
Code Info	Item number TSX-301 A/2D Serial Numbers: 2DA0792004, 2DA07X2005, 2DA07Y2010, 2DA0792002, 2DA07X2008, 2DA0842023.
Classification	Class II
Reason for Recall	The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis results when using the cerebral blood flow analysis function.
Product Quantity	3 units
Recall Number	Z-2468-2012

Class II Devices Event

Event ID	63180
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Hologic, Inc.
City	Bedford
State	MA
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia,Belgium, Canada, China, Germany, Ecuador, Spain, France, Great Britain, Greece, Hong Kong, Italy, Japan Korea, Lithuvania, Neherlands, qatar, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan, South Africa, and Switzerland.

Associated Products

Product Description	Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.
Code Info	Software version 4.0 and 4.0.1
Classification	Class II
Reason for Recall	InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180°around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180° around vertical axis as well as 180° around a horizontal axis.
Product Quantity	414 units
Recall Number	Z-2452-2012

Product Description	Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.
Code Info	Software version 5.0.1and 5.0.2
Classification	Class II
Reason for Recall	Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180°around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180° around vertical axis as well as 180° around a horizontal axis.
Product Quantity	46 units
Recall Number	Z-2453-2012

Class II Devices Event

Event ID	63186
Status	Completed
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Oct-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	RAYSEARCH LABORATORIES AB
City	Stockholm
State
Country	SE
Distribution Pattern	Worldwide Distribution - USA including CA, KY, MI, NY, OK, OR, SD, and WI. Internationalyl to Canada, Sweden, France, Germany, Australia, Poland, Belgium, and United Kingdom.

Associated Products

Product Description	SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists.
Code Info	version 1.2.1 (build number 1.3.1.10).
Classification	Class II
Reason for Recall	This notice concerns behavior of the SharePlan that may be unexpected and not clearly described in the user manual. This behavior has not caused patient mistreatment or other incidents. However, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivered treatment. The behavior appears, when importing RFA-files (.asc). In such cases, special notice has to be taken of the coordinate system used. The correction is to modify the labelling.
Product Quantity	20 units
Recall Number	Z-2444-2012

Class II Devices Event

Event ID	63188
Status	Completed
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	23-Sep-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Micro Therapeutics Inc, Dba Ev3 Neurovascular
City	Irvine
State	CA
Country	US
Distribution Pattern	Worldwide Distribution - US Nationwide including the states: MN, FL, OR, TX and the countries of: Brazil, Belgium, Czech Republic, Finlind, France, Germany, Netherlands, Poland, and United Kingdom.

Associated Products

Product Description	UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
Code Info	Lot # 9374298
Classification	Class II
Reason for Recall	The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.
Product Quantity	36 units
Recall Number	Z-2471-2012

Product Description	Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
Code Info	Lot # 9374210
Classification	Class II
Reason for Recall	The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.
Product Quantity	23 units total
Recall Number	Z-2472-2012

Class II Drugs Event

Event ID	63189
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Baxter Healthcare Corp.
City	Round Lake
State	IL
Country	US
Distribution Pattern	Nationwide and Puerto Rico

Associated Products

Product Description	5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL AVIVA Container, product code 6E0063, NDC 0338-6346-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Code Info	Lot #: a) C841114, C841254, Exp 09/12; C842229, C842898, C843037, C843326, C844209, Exp 10/12; C844456, C844928, C846089, C846246, C847178, Exp 11/12; C848044, C848804, C849869, C849810, C850313, Exp 12/12; C852574, C852673, C853168, C853275, C853473, Exp 01/13; C854331, C855098, C855551, Exp 02/13; C856690, C856815, C857813, Exp 03/13; C858829, C858951, C859884, C860049, C860304, C860304A, C860452, C861138, Exp 04/13; C861252, C861971, C862748, C862854, Exp 05/13; C865576, C865683, C866079, Exp 06/13; C866947, C867283, C867424, C867960, C868455, Exp 07/13; b) C818039, Exp 09/12; C821793, Exp 10/12; C824276, C825679, Exp 11/12; C828350, Exp 12/12; C830323, C832105, Exp 01/13; C834986, C836114, Exp 03/13; C840736, Exp 04/13; C843433, Exp 05/13; C844829, C845784, Exp 06/13; C848333, C850446, C850446A, Exp 07/13; C852376, C852939, Exp 08/13; C856443, C857417, C857656, C858381, Exp 10/13; C858498, C859470, C859652, Exp 11/13; C863365, Exp 12/13; C863738, C863852, C865451, C866392, Exp 01/14; C867846, Exp 02/14
Classification	Class II
Reason for Recall	Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Product Quantity	753,941 containers
Recall Number	D-1686-2012

Product Description	10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0163, NDC 0338-6347-03
Code Info	Lot #: C832840, Exp 02/13
Classification	Class II
Reason for Recall	Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Product Quantity	2,976 containers
Recall Number	D-1687-2012

Product Description	5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0173, NDC 0338-6308-03
Code Info	Lot #: C828814, Exp 12/12; C841551, Exp 04/13
Classification	Class II
Reason for Recall	Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Product Quantity	5,064 containers
Recall Number	D-1688-2012

Product Description	0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02; b) 500 mL AVIVA Container, product code 6E1323, NDC 0338-6304-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Code Info	Lot #: a) C840892, C841007, C841403, Exp 09/12; C842377, C842757, C843748, C843946, Exp 10/12; C844332, C845065, C845198, C845347, C846873, C847301, C847608, Exp 11/12; C848481, C848937, C849554, C850180, Exp 12/12; C850966, C851097, C851212, C852459, C853044, C853614, Exp 01/13; C853747, C854455, C854711, C854836, C854943, C856013, C856138, Exp 02/13; C856948, C858027, Exp 03/13; C858712, C859066, C859199, C859389, C860569, C861021, Exp 04/13; C861856, C862953, C863076, C863183, Exp 05/13; C865188, C865824, C866178, C866178A, Exp 06/13; C867168, C868117, C868570, C868703, Exp 07/13; b) C818187, C819367, Exp 09/12; C821686, Exp 10/12; C823377, Exp 11/12; C826255, C828111, C828228, Exp 12/12; C830455, C830604, Exp 01/13; C832964, C833152, Exp 02/13; C839134, C840587, Exp 04/13; C842740, C843649, Exp 05/13; C844647, C845941, C847038, Exp 06/13; C848184, C849117, C850545, Exp 07/13; C850842, C851568, C852806, Exp 08/13; C853853, C854216, C854216A, C855213, Exp 09/13; C856567, C858142, C858258, Exp 10/13; C858613, C859777, C859777A, C860916, Exp 11/13; C861617, C861724, Exp 12/13; C865311, C866285, Exp 01/14; C866632, C866830, Exp 02/14
Classification	Class II
Reason for Recall	Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Product Quantity	897,496 containers
Recall Number	D-1689-2012

Product Description	Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02; b) 500 mL AVIVA Container, product code 6E2323, NDC 0338-6307-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Code Info	Lot #: a) C847749, Exp 11/12; C847897, Exp 12/12; C860668, Exp 04/13; b) C855445, Exp 09/13; C861492, Exp 12/13
Classification	Class II
Reason for Recall	Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Product Quantity	55,664 containers
Recall Number	D-1690-2012

Class II Devices Event

Event ID	63197
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Siemens Medical Solutions USA, Inc
City	Malvern
State	PA
Country	US
Distribution Pattern	Nationwide Distribution - USA including Washington, DC and AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI and Puerto Rico.

Associated Products

Product Description	Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager
Code Info	Model numbers: 10276755 (Verio), 10684333 (Verio Dot), 10684334 (Verio Dot upgrade), 10432915 (Skyra), 10655588 (Spectra), and 10433372 (Biograph mMR)
Classification	Class II
Reason for Recall	When positioning the Flex Large 4 Coil (part No. 8625761) off-center in left-right direction as it is used for example for hip and shoulder imaging and, in addition at an off-center position with respect to the head-foot direction, the coil can heat up in the area of the electronic housing (white plastic lids).
Product Quantity	370
Recall Number	Z-2464-2012

Class II Drugs Event

Event ID	63198
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-Aug-12
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA
Code Info	Lot No: a) 93-857-DJ, 93-896-DJ, Exp 1SEP2012; 04-515-DJ, Exp 1APR2013; 06-802-DJ, Exp 1JUN2013; b) 01-175-DJ, Exp 1JAN2013; 04-565-DJ, Exp 1APR2013; c) 03-388-DJ, Exp 1MAR2013; The lot number may be followed by 01 or 02
Classification	Class II
Reason for Recall	Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.
Product Quantity	148,630 vials
Recall Number	D-1685-2012

Class II Drugs Event

Event ID	63264
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Jul-12
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430; NDC 68462-190-01.
Code Info	Lot #: 02112930, 02112934, 02112941, Exp 09/14; 2112985, 02112986, 02113334, Exp 10/14; 02113360, 02113372, 02113420, 02113606, 02113663, 02113664, Exp 11/14.
Classification	Class II
Reason for Recall	Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
Product Quantity	unknown
Recall Number	D-1701-2012

Class III Biologics Event

Event ID	39124
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	02-May-07
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Community Blood Center of Greater Kansas City
City	Kansas City
State	MO
Country	US
Distribution Pattern	Missouri

Associated Products

Product Description	Fresh Frozen Plasma
Code Info	W045007045551;W045007050899
Classification	Class III
Reason for Recall	Blood product, for which viral marker testing was incomplete, were distributed.
Product Quantity	2 units
Recall Number	B-2310-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W045007701266;W045007048992;W045007033136;W045007045551;W045007050899;W045007037595
Classification	Class III
Reason for Recall	Blood product, for which viral marker testing was incomplete, were distributed.
Product Quantity	6 units
Recall Number	B-2311-12

Class III Biologics Event

Event ID	41467
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Jan-06
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W045005138494
Classification	Class III
Reason for Recall	Blood product, manufactured without additive solution, was distributed.
Product Quantity	1 unit
Recall Number	B-2342-12

Class III Biologics Event

Event ID	42623
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Jul-06
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	Red Blood Cells Leukocytes Reduced Washed
Code Info	W045006059851
Classification	Class III
Reason for Recall	Blood product, with an unacceptable low red cell recovery rate, was distributed.
Product Quantity	1 Unit
Recall Number	B-2339-12

Class III Biologics Event

Event ID	43018
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Sep-06
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W045006909473
Classification	Class III
Reason for Recall	Blood product, which was exposed to unacceptable temperature during storage, was distributed.
Product Quantity	1 unit
Recall Number	B-2326-12

Class III Biologics Event

Event ID	43665
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Dec-06
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	American National Red Cross (The)
City	Pomona
State	CA
Country	US
Distribution Pattern	California

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	006KK04845, 006KK04846, 006KK04847(Part A), 006KK04847(Part B), 006KR45572
Classification	Class III
Reason for Recall	Blood products, for which no documentation of shipment or storage at appropriate temperatures were distributed.
Product Quantity	5 units
Recall Number	B-2343-12

Class III Biologics Event

Event ID	45108
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Aug-07
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	K46171;K46171;K46171
Classification	Class III
Reason for Recall	Blood products, which did not meet the acceptable product specifications for release, were distributed.
Product Quantity	3 Units
Recall Number	B-2196-12

Class III Biologics Event

Event ID	45358
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Aug-07
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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	W045007905565
Classification	Class III
Reason for Recall	In this situation, blood product was stored where the temperature was not continuously monitored, was distributed.
Product Quantity	1 unit
Recall Number	B-2338-12

Class III Biologics Event

Event ID	46538
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Dec-07
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	8011980
Classification	Class III
Reason for Recall	Blood products, which Viral Testing performed, interpreted, or documented incorrectly, were distributed.
Product Quantity	1 unit
Recall Number	B-2355-12

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	3754793;3754792
Classification	Class III
Reason for Recall	Blood products, which Viral Testing performed, interpreted, or documented incorrectly, were distributed.
Product Quantity	2 units
Recall Number	B-2356-12

Class III Biologics Event

Event ID	47121
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Dec-07
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	American Red Cross Blood Services
City	Omaha
State	NE
Country	US
Distribution Pattern	unknown

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	09Q98860; 09Q98888; 09Q98889
Classification	Class III
Reason for Recall	Blood products, for which storage conditions and shipment information were undocumented, were distributed.
Product Quantity	3 units
Recall Number	B-2351-12

Class III Biologics Event

Event ID	59514
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Jul-11
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Octapharma Plasma, Inc.
City	Charlotte
State	NC
Country	US
Distribution Pattern	CA, Austria

Associated Products

Product Description	Source Plasma
Code Info	4270034435, 4270033702, 4270032835, 4270032531, 4270031860, 4270031545, 4270030925, 4270030610, 4270029947, 4270029572, 4270029101, 4270028782, 4270028101, 4270027804, 4270027164, 4270026836, 4270026282, 4270025918, 4270025278, 4270024961
Classification	Class III
Reason for Recall	Blood products, collected from a donor, for whom donor suitability was not adequately determined, were distributed.
Product Quantity	20 units
Recall Number	B-2354-12

Class III Biologics Event

Event ID	60015
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Jul-01
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	W128711102646
Classification	Class III
Reason for Recall	Blood product, collected from a donor whose arm preparation was not documented, was distributed.
Product Quantity	1 unit
Recall Number	B-2226-12

Class III Devices Event

Event ID	62440
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Clark Laboratories, Inc. (dba,Trinity Biotech USA)
City	Jamestown
State	NY
Country	US
Distribution Pattern	Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX.

Associated Products

Product Description	Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
Code Info	Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568
Classification	Class III
Reason for Recall	The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range.
Product Quantity	810 kits
Recall Number	Z-2445-2012

Class III Drugs Event

Event ID	62696
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Jul-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Mallinckrodt Inc
City	Hazelwood
State	MO
Country	US
Distribution Pattern	AZ, CT, MO, MS, PA, FL, WA, NC, CA, TX, OK

Associated Products

Product Description	Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC 0019N12063) For Intravenous Administration, each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 (no carrier added) at date and time of calibration, 9 mg sodium chloride and 0.9% (v/v) benzyl alcohol as a preservative, RX, Mallinckrodt Inc., St. Louis, MO 63134
Code Info	Lot 120-2686, exp. 8/2/12.
Classification	Class III
Reason for Recall	Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
Product Quantity	12/2.8mCi-vials and 12/6.3mCi-vials
Recall Number	D-1692-2012

Mixed Classification Food/Cosmetics Event

Event ID	60642
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-Nov-11
Initial Firm Notification of Consignee or Public	Visit

Recalling Firm	McClures, Inc.
City	Gap
State	PA
Country	US
Distribution Pattern	Product was distributed to retail outlets in DE, MD, NJ and PA within the US.

Associated Products

Product Description	McClure's Pies & Salads, Inc. Walnut Cinnamon Streusel Cake
Code Info	All product distributed prior to 11/15/2011
Classification	Class I
Reason for Recall	Undeclared allergens. Ingredient statement lists "nuts" but is not specific for walnuts. Label does say, "Walnut Cinnamon Streusel Cake."
Product Quantity	12 cakes
Recall Number	F-2397-2012

Product Description	McClure's Pies & Salads, Inc. Apple Cinnamon Streusel Cake
Code Info	All product distributed prior to 11/15/2011
Classification	Class I
Reason for Recall	Undeclared allergens. Ingredient statement lists "nuts" but is not specific for walnuts.
Product Quantity	138 cakes
Recall Number	F-2398-2012

Product Description	McClure's Pies & Salads, Inc. Marble Cake
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour.
Product Quantity	15 cakes
Recall Number	F-2399-2012

Product Description	McClure's Pies & Salads, Inc. German Chocolate Cake
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour.
Product Quantity	14 cakes
Recall Number	F-2400-2012

Product Description	McClure's Pies & Salads, Inc. Chocolate Cake
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour.
Product Quantity	96 cakes
Recall Number	F-2401-2012

Product Description	McClure's Pies & Salads, Inc. Red Velvet Cake
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour.
Product Quantity	31 cakes
Recall Number	F-2402-2012

Product Description	McClure's Pies & Salads, Inc. Black Walnut Cake
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour.
Product Quantity	20 cakes
Recall Number	F-2403-2012

Product Description	McClure's Pies & Salads, Inc. Yellow Cake
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour. Also, coloring (yellow #5) is not listed.
Product Quantity	402 cakes
Recall Number	F-2404-2012

Product Description	McClure's Pies & Salads, Inc. Lemon Crunch Cake
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "nuts" but is not specific for walnuts. Also, coloring is not listed - Yellow #5
Product Quantity	28 cakes
Recall Number	F-2405-2012

Product Description	McClure's Pies & Salads, Inc. Lemon Glazed Cake
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement does not list coloring - Yellow #5.
Product Quantity	156 cakes
Recall Number	F-2406-2012

Product Description	McClure's Pies & Salads, Inc. Orange Cake
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity	22
Recall Number	F-2407-2012

Product Description	McClure's Pies & Salads, Inc. Apple Dumplings
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity	Unknown
Recall Number	F-2408-2012

Product Description	McClure's Pies & Salads, Inc. French Apple Pie
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity	75 pies
Recall Number	F-2409-2012

Product Description	McClure's Pies & Salads, Inc. Peach Pie
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity	12 pies
Recall Number	F-2410-2012

Product Description	McClure's Pies & Salads, Inc. Blueberry Pie
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity	19 pies
Recall Number	F-2411-2012

Product Description	McClure's Pies & Salads, Inc. Cherry Pie
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity	27 pies
Recall Number	F-2412-2012

Product Description	McClure's Pies & Salads, Inc. Apple Pie
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity	40 pies
Recall Number	F-2413-2012

Product Description	McClure's Pies & Salads, Inc. Pumpkin Pie
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity	97 pies
Recall Number	F-2414-2012

Product Description	McClure's Pies & Salads, Inc. Banana Cream Pie
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity	5 pies
Recall Number	F-2415-2012

Product Description	McClure's Pies & Salads, Inc. Cherry Custard Pie
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity	3 pies
Recall Number	F-2416-2012

Product Description	McClure's Pies & Salads, Inc. Coconut Custard Pie
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity	9 pies
Recall Number	F-2417-2012

Product Description	McClure's Pies & Salads, Inc. Egg Custard Pie
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity	7 pies
Recall Number	F-2418-2012

Product Description	McClure's Pies & Salads, Inc. Chocolate Cream Pie
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity	20 pies
Recall Number	F-2419-2012

Product Description	McClure's Pies & Salads, Inc. Coconut Cream Pie
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity	16 pies
Recall Number	F-2420-2012

Product Description	McClure's Pies & Salads, Inc. Shoo Fly Pie
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity	90 pies
Recall Number	F-2421-2012

Product Description	McClure's Pies & Salads, Inc. Chocolate Shoo Fly Pie
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity	6 pies
Recall Number	F-2422-2012

Product Description	McClure's Pies & Salads, Inc. Pecan Pie
Code Info	All product distributed prior to 11/15/2011
Classification	Class II
Reason for Recall	Undeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity	11 pies
Recall Number	F-2423-2012

Product Description	McClure's Pies & Salads, Inc. Cole Slaw
Code Info	All product distributed prior to 11/15/2011
Classification	Class I
Reason for Recall	Undeclared allergens. Ingredient statement lists "mayonnaise" but sub-ingredients are not listed for the mayonnaise
Product Quantity	30 lbs
Recall Number	F-2424-2012

Product Description	McClure's Pies & Salads, Inc. Macaroni Salad
Code Info	All product distributed prior to 11/15/2011
Classification	Class I
Reason for Recall	Undeclared allergens. Ingredient statement lists "macaroni" but sub-ingredients for macaroni are not listed
Product Quantity	42 lbs
Recall Number	F-2425-2012

Product Description	McClure's Pies & Salads, Inc. Broccoli & Cauliflower Salad
Code Info	All product distributed prior to 11/15/2011
Classification	Class I
Reason for Recall	Undeclared allergens. Ingredient statement lists "mayonnaise" but sub-ingredients for mayonnaise are not listed. In addition, product label lists cheese but does not list sub-ingredients from the cheese label.
Product Quantity	631 lbs
Recall Number	F-2426-2012

Product Description	McClure's Pies & Salads, Inc. Chicken Salad
Code Info	All product distributed prior to 11/15/2011
Classification	Class I
Reason for Recall	Undeclared allergens. Ingredient statement lists "mayonnaise" but sub-ingredients for mayonnaise are not listed
Product Quantity	43 lbs
Recall Number	F-2427-2012

Product Description	McClure's Pies & Salads, Inc. Egg Salad
Code Info	All product distributed prior to 11/15/2011
Classification	Class I
Reason for Recall	Undeclared allergens. Ingredient statement lists "mayonnaise" but sub-ingredients for mayonnaise are not listed
Product Quantity	3 lbs
Recall Number	F-2428-2012

Product Description	McClure's Pies & Salads, Inc. Potato Salad
Code Info	All product distributed prior to 11/15/2011
Classification	Class I
Reason for Recall	Undeclared allergens. Ingredient statement lists "salad dressing" but sub-ingredients for salad dressing are not listed
Product Quantity	36 lbs
Recall Number	F-2429-2012

Mixed Classification Food/Cosmetics Event

Event ID	62713
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Jun-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Derby City Vending Inc
City	Louisville
State	KY
Country	US
Distribution Pattern	Product was shipped to KY and IN.

Associated Products

Product Description	"Derby City Vending "Infielder's Breakfast" Biscuit and Gravy, Daybreak Selections, Ingredients: PILLSBURY buttermilk biscuit, PIONEER biscuit gravy mix, PURNELLS sausage*Fresh Thru*Derby City Vending Louisville, KY 40206"
Code Info	Product is stamped: Fresh Thru 4/21/12 - 6/17/12
Classification	Class II
Reason for Recall	During an FDA inspection of the firm on 6/12/2012, the firm was notified that they were missing the following allergen declarations from their labels: soy, milk, eggs and wheat.
Product Quantity	1860 plastic tubs
Recall Number	F-2430-2012

Product Description	Derby City Vending "Finish Line" Hand Made Chicken Salad Ingredients: 100% whole wheat bread, Fresh hand cut chicken breast, miracle whip, salt, pepper, celery, pickle relish Fresh Thru***Derby City Vending Louisville, KY 40206
Code Info	Product is stamped: Fresh Thru 4/21/12 - 6/17/12
Classification	Class I
Reason for Recall	During an FDA inspection of the firm on 6/12/2012, the firm was notified that they were missing the following allergen declarations from their labels: soy, milk, eggs and wheat.
Product Quantity	3,560 Sandwiches
Recall Number	F-2431-2012

Product Description	Derby City Vending "Heckuva" Grilled Ham And Swiss Deli Selections Ingredients: Classic Pit-Style Ham, KLOSTERMAN sub bun, Swiss Cheese, mayonaise packet, SYSCO Clasic Redskin Potato Salad Fresh Thru***Derby City Vending Louisville, KY 40206
Code Info	Product is stamped: Fresh Thru 4/21/12 - 6/17/12
Classification	Class I
Reason for Recall	During an FDA inspection of the firm on 6/12/2012, the firm was notified that they were missing the following allergen declarations from their labels: soy, milk, eggs and wheat.
Product Quantity	3,142 Sandwiches
Recall Number	F-2432-2012

Mixed Classification Biologics Event

Event ID	46539
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Dec-07
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Community Blood Bank of Lancaster County Medical Society
City	Lincoln
State	NE
Country	US
Distribution Pattern	NE; OH; TN; MO; Austria

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	6067919;6070284;6075510
Classification	Class III
Reason for Recall	Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity	3 units
Recall Number	B-2060-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	6066046;6070284;6073935;6075510
Classification	Class II
Reason for Recall	Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity	4 units
Recall Number	B-2061-12

Product Description	Cryoprecipitated AHF
Code Info	6066046
Classification	Class II
Reason for Recall	Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-2062-12

Product Description	Plasma Cryoprecipitated Reduced
Code Info	6066046
Classification	Class II
Reason for Recall	Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-2063-12

Product Description	Fresh Frozen Plasma
Code Info	6073935
Classification	Class II
Reason for Recall	Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-2064-12

Mixed Classification Biologics Event

Event ID	47098
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Jan-08
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	09GH73273
Classification	Class III
Reason for Recall	Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-2110-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	09GH73273
Classification	Class II
Reason for Recall	Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-2111-12

Mixed Classification Biologics Event

Event ID	47614
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-Jan-08
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Community Blood Bank of Lancaster County Medical Society
City	Lincoln
State	NE
Country	US
Distribution Pattern	MO; Austria

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	3750331
Classification	Class III
Reason for Recall	Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-2056-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	3750331
Classification	Class II
Reason for Recall	Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-2057-12

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