Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links

Enforcement Report - Week of September 26, 2012

-

Your browser settings indicate that JavaScript is currently disabled. Some features on this page may require the use of JavaScript. You may need to enable JavaScript in order to enjoy the full functionality of this page.

PRODUCT VIEW EVENT VIEW PRINT-FRIENDLY VIEW PENDING MORE INFO DOWNLOAD CSV

Biologics Devices Drugs Food / Cosmetics Veterinary

Class I Food/Cosmetics Event

Event ID	61944
Status	Completed
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-May-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Hocean Inc
City	City Of Commerce
State	CA
Country	US
Distribution Pattern	Distributed to wholesale distributors and Asian grocery stores nationwide to US states: California, Texas, Oregon, Nebraska, Georgia, Florida, Colorado, Oklahoma, Washington, New Mexico, Ohio, Arizona, Tennessee, North Carolina, and Virginia.

Associated Products

Product Description	Nitre powder. Brand "Selected Product", 4oz plastic bags, UPC 0 45027 97918 2.
Code Info	The product does not bear any manufacturing codes. All product on the market at the time the recall was initiated on 5/25/2012 is subject to recall.
Classification	Class I
Reason for Recall	FDA analysis of the product found that the product consisted of mainly sodium nitrite. The product's label failed to bear adequate directions for use as required in 21 CFR 172.175. Failure to provide these directions for use may result in overuse that can pose an life-threatening hazard to health.
Product Quantity	50 cases with 100, 4-oz packages per case
Recall Number	F-2356-2012

Class I Devices Event

Event ID	62132
Status	Completed
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Sep-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Custom Medical Specialties, Inc.
City	Pine Level
State	NC
Country	US
Distribution Pattern	US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.

Associated Products

Product Description	CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info	20182-1006
Classification	Class I
Reason for Recall	The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
Product Quantity	5 cases
Recall Number	Z-2349-2012

Product Description	CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info	15011-0904 and 16363-0908
Classification	Class I
Reason for Recall	The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Product Quantity	3 cases
Recall Number	Z-2350-2012

Product Description	CMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info	15287-0905, 15974-0906, 17052-0910
Classification	Class I
Reason for Recall	The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Product Quantity	6 cases
Recall Number	Z-2351-2012

Product Description	CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info	14161-0901
Classification	Class I
Reason for Recall	The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Product Quantity	3 cases
Recall Number	Z-2352-2012

Product Description	CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info	20144-1006, 19702-1005
Classification	Class I
Reason for Recall	The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Product Quantity	7 cases
Recall Number	Z-2353-2012

Product Description	CMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info	14163-0901
Classification	Class I
Reason for Recall	The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Product Quantity	75 cases
Recall Number	Z-2354-2012

Product Description	CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology Drainage Pack containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info	14267-0901, 14452-0902, 15205-0904, 16147-0907, 16690-0909, 17431-0911, 17708-0912, 17913-1001, 18240-1002, 18308-1002, 18345-1002, 18511-1002, 18739-1003, 18829-1003
Classification	Class I
Reason for Recall	The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Product Quantity	195 cases
Recall Number	Z-2355-2012

Product Description	CMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info	15924-0906, 16975-0910, 17709-0912
Classification	Class I
Reason for Recall	The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Product Quantity	15 cases
Recall Number	Z-2356-2012

Product Description	CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info	16661-0909, 16662-0909, 17272-0910, 17566-0911, 17566-0911, 17923-1001, 18188-1001, 18195-1001, 18793-1003, 19158-1004
Classification	Class I
Reason for Recall	The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Product Quantity	538 cases
Recall Number	Z-2357-2012

Product Description	CMS-4975 HSG Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info	19134-1004
Classification	Class I
Reason for Recall	The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Product Quantity	4 cases
Recall Number	Z-2358-2012

Product Description	CMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info	19850-1006
Classification	Class I
Reason for Recall	The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Product Quantity	8 cases
Recall Number	Z-2359-2012

Product Description	BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Code Info	14255-0901
Classification	Class I
Reason for Recall	The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Product Quantity	75 cases & 60 Bottles for reps
Recall Number	Z-2360-2012

Class I Food/Cosmetics Event

Event ID	62789
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Aug-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Vaqueria Tres Monjitas, Inc.
City	San Juan
State	PR
Country	US
Distribution Pattern	PR only

Associated Products

Product Description	"Tres Monjitas*Pineapple and guava beverageDistribuido por Vaquería Tres Monjitas Inc**" Package sizes: gallons, 1/2 gallons, quarts, 14 oz and 8 oz.
Code Info	No codes
Classification	Class I
Reason for Recall	Juice beverage contains undeclared allergenic sub-ingredient (sodium caseinate).
Product Quantity	44,764 units
Recall Number	F-2360-2012

Class I Food/Cosmetics Event

Event ID	62846
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Aug-12
Initial Firm Notification of Consignee or Public	Visit

Recalling Firm	Singh And Singh Distributors Inc.
City	Carteret
State	NJ
Country	US
Distribution Pattern	New Jersey and New York

Associated Products

Product Description	Crispy Punjabi Cookies, By TWI Foods, Net Wt. 800g/1.76 lb, Manufactured by TWI Foods, Inc. 1-866-9-CRISPY, www.crispyjustbaked.com, UPC 627265001520, Product of Canada.
Code Info	Manufacturing Date 01/SEP/11; Use Before 31/AUG/12
Classification	Class I
Reason for Recall	Product contains milk products and labeling does not declare milk as an ingredient. Milk is an allergen.
Product Quantity	48 cases (14 clamshells/case)
Recall Number	F-2328-2012

Class I Food/Cosmetics Event

Event ID	62849
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Indian Foods & Spices, LLC
City	Rahway
State	NJ
Country	US
Distribution Pattern	New Jersey, New York and Pennsylvania.

Associated Products

Product Description	Crispy Punjabi Cookies, By TWI Foods, Net Wt. 800g/1.76 lb, Manufactured by TWI Foods, Inc. 1-866-9-CRISPY, www.crispyjustbaked.com, UPC 627265001520, Product of Canada.
Code Info	Manufacturing Date 20/JUL/12; Use Before 19/JUL/13.
Classification	Class I
Reason for Recall	This recall has been initiated as a precaution due to Non-Declared Milk. Certain packages may be packaged with ingredient statements not labeled to include the milk ingredient.
Product Quantity	96 Cases (14 packages/case)
Recall Number	F-2327-2012

Class I Food/Cosmetics Event

Event ID	62963
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Aug-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Chamberlain Farms Inc.
City	Owensville
State	IN
Country	US
Distribution Pattern	Indiana, Kentucky, Missouri, Illinois, and Iowa with further shipment including Tennessee, Ohio, and Wisconsin. Counties involved include Vanderburgh, Warrick, Gibson, and Dubois County, Indiana, and Wabash County,Illinois.

Associated Products

Product Description	Whole Cantaloupe. Both unlabeled and labeled "MIDWEST BEST" PRODUCE INC. HOMEGROWN CANTALOUPE #4319 PRODUCT OF THE USA
Code Info	none or #4319
Classification	Class I
Reason for Recall	Chamberlain Farm Produce, Inc., of Owensville, Indiana, is voluntarily recalling all of its cantaloupes from the 2012 growing season that may remain in the marketplace. This recall is occurring because of concern some that cantaloupes may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
Product Quantity	222,172
Recall Number	F-2357-2012

Class I Food/Cosmetics Event

Event ID	62972
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Aug-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Spence & Co., Ltd.
City	Brockton
State	MA
Country	US
Distribution Pattern	CO, FL, NC, GA, DE, PA, MD, NJ,NY, VA, OH, NV, OK, WY, KY, TN, CO.

Associated Products

Product Description	Spence & Co Ltd brand 8oz Smoked Salmon Trim
Code Info	Lot Number: 6704701
Classification	Class I
Reason for Recall	Product tested positive for Listeria monocytogenes
Product Quantity	119 units
Recall Number	F-2329-2012

Product Description	Wellsley Farms 1 LB Nova Salmon
Code Info	Lot Number: 6704701
Classification	Class I
Reason for Recall	Product tested positive for Listeria monocytogenes
Product Quantity	596 units
Recall Number	F-2330-2012

Class I Food/Cosmetics Event

Event ID	63049
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Aug-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Triple B Corporation - Charlie's Produce
City	Seattle
State	WA
Country	US
Distribution Pattern	Distributed in Alaska and Washington.

Associated Products

Product Description	Fresh Tropical Fruit Mix has the Item # 027-01480, and the UPC is 0 45009 01480 1. Haggen Label reads in part "HAGGAEN'S ORIGINAL * Tropical Mixed Fruit * Ingredients: Fresh Pineapple, Papaya, Mango & Kiwi *Distributed with Pride by: Haggen, Inc., Bellingham, WA * Net Weight 8 oz. ( 227 g.)***".
Code Info	Use-By date range 7/21/12-8/29/12
Classification	Class I
Reason for Recall	Daniella brand mangos are recalled because they may be contaminated with Salmonella.
Product Quantity	29 cases (1-8 oz pkg per case)
Recall Number	F-2361-2012

Product Description	Cut Tropical Mixed Fruit has the item #028-00165 and the UPC is 0 45009 00165 8. Metropolitan Market Label is read in part " Cut Mango / Papaya w/ Lime Net Weight 10 oz (284 g.) Distributed By metropolitan market * Seattle, WA*".
Code Info	Use By 7/21/12 through 8/29/12
Classification	Class I
Reason for Recall	Daniella brand mangos are recalled because they may be contaminated with Salmonella.
Product Quantity	6 cases ( 6-10 oz per case)
Recall Number	F-2362-2012

Product Description	Cut Seasonal Fruit -Item # 028-00172 - Net Weight 20 oz UPC 045009 00172 6; Cut Seasonal Fruit - Item # 028-00173 - Net Weight 10 oz UPC 0 45009 00173 3; Label reads in part "CUT SEASONAL FRUIT Ingredients: Pineapple, Mango, Papaya, Strawberries, Grapes & Kiwi* Distributed By metropolitan market * Seattle, WA*"; Seasonal Fruit - Item # 028-06037 - Net Weight 10 oz UPC 0 45009 06037 2; Seasonal Fruit - Item # 028-06454 - Net Weight 20 oz UPC 0 45009 06454 7. Label reads in part "SEASONAL FRUIT Ingredients: Pineapple, Mango, Papaya, Strawberries, Grapes & Kiwi* Produced by: Real Foods * Kent, WA*" Use By 7/21/12 through 8/29/12
Code Info	Use By 7/21/12 through 8/29/12
Classification	Class I
Reason for Recall	Daniella brand mangos are recalled because they have the potential to be contaminated with Salmonella.
Product Quantity	100 cs [Metro Market (MM) 20 oz - 12 cs (4 pk/cs); MM 10 oz - 24 cs (6 pk/cs);Real Foods 10 oz - 57 cs (4 pk/cs); Real Foods 20 oz - 7 cs (4 pk/cs)]
Recall Number	F-2363-2012

Product Description	Seasonal Berries with the Item # 028-02071 and the UPC for case 0 45009 02063 5, UPC for package 0 45009 02017 8; Case label reads in part "*ALASKA CARROT Seasonal Berries 6/8 oz * Packed By: Charlie's Produce, Anchorage, AK*"; Package label reads in part "Seasonal Berries Blueberry: USA Strawberry, Mango: Mexico Kiwi: New Zealand" . Seasonal Berries with the item # 028-02063, and the UPC for case 0 45009 02063 5, UPC for package 0 45009 0206305; Case label reads in part "ALASKA CARROT Seasonal Berries 6/16oz Packed By: Charlie's Produce, Anchorage, AK"; Package label reads in part " 16 oz Seasonal Berries Blueberry: USA Pineapple: Costa Rica Mango: Mexico Kiwi: New Zealand*" .
Code Info	Use By 7/21/12 through 8/31/12
Classification	Class I
Reason for Recall	Daniella brand mangos are recalled because they have the potential to be contaminated with Salmonella.
Product Quantity	203 cs total - 8 oz - 133 cs (6 pk/cs); 16 oz - 70 (6 pk/cs)
Recall Number	F-2364-2012

Product Description	Fruit Bowls: 1) Seasonal Fruit Bowl (Walmart) Item # 028-06480*" and the UPC of the package is 0 45009 06480 6 and Case UPC is 0 45009 06480 6. Case label reads in part "ALASKA CARROT Seasonal Fruit Bowl 6/40 oz Packed By: Charlie's Produce, Anchorage, AK" Use By 7/21/12 through 8/31/12; Package label reads in part " Fruit Bowl Gold Pineapple, Cantaloupe, Red Grapes, Strawberry Mango and Kiwi * PRODUCT OF: Blueberry: USA Strawberry: Mexico Mango: Mexico Kiwi: New Zealand 2) Gourmet Fruit Bowl has the Item # 028-006693, and UPC 6 97327 06693 4. Label reads in part "* ALASKA CARROT * FRESH Sliced FRUIT * ANCHORAGE, AK" " 64oz Gourmet Fruit Bowl Gold Pineapple, Cantaloupe, Red Grapes, Strawberry Mango and Kiwi" "PRODUCT OF: Pineapple - COSTA RICA Cantaloupe - USA Red Grapes - USA Mangoes - Mexico Kiwi - NEW ZELAND Strawberry - USA " "* Packed By: Charlie's Produce, Anchorage, AK***".
Code Info	1) Use By 7/21/12 through 8/31/12; 2) Use By 7/21/12 through 9/05/12
Classification	Class I
Reason for Recall	Daniella brand mangos are recalled because they have the potential to be contaminated with Salmonella.
Product Quantity	1) 193 cs; 2) 361 cs (6 pk/cs)
Recall Number	F-2365-2012

Product Description	Fruit Cup has Item # 028-07140, and the UPC 0 45009 07140 8. Label reads in part "* ALASKA CARROT Fruit Cup Mango / Red Grape 42/4 oz * Packed By: Charlie's Produce, Anchorage, AL***". Use By 8/22/12 through 9/01/12.
Code Info	Use By 8/22/12 through 9/01/12
Classification	Class I
Reason for Recall	Daniella brand mangos are recalled because they have the potential to be contaminated with Salmonella.
Product Quantity	323 cs
Recall Number	F-2366-2012

Class I Food/Cosmetics Event

Event ID	63054
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Aug-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	World Food LLC.
City	Orlando
State	FL
Country	US
Distribution Pattern	Products were distributed in FL only.

Associated Products

Product Description	Tropical Salsa Product is labeled in part: "*FRESHGarden HighwayFresh Party Favorites!PERISHABLEKEEP REFRIGERATEDTropical SalsaNet Wt. 11 oz (312 g)Best if Sold ByRenaissance Food Group LLCRancho Cordova, CA 956701-888-4 -HWYFUNwww.gardenhighway.com**"
Code Info	8/31/12 and 9/1/12
Classification	Class I
Reason for Recall	World Foods, LLC, Florida is recalling multiple cut fruit and salsa products that contain Daniella Mangoes distributed by Splendid Products that have the potential to be contaminated with Salmonella. The products were distributed in Florida only.
Product Quantity	83 lbs
Recall Number	F-2332-2012

Product Description	Fresh Fruit Product is labeled in part: "*Fresh Island Medley1 LB (454g)Best If Sold ByIngredients: Pineapple, Mango, Papaya.Packed in its own juiceDistributed by: Winn-Dixie Stores Inc. Jacksonville, FL 32254For Nutrition Information Call 1-888-449-9386P-0090 21140 01696 6PERISHABLE KEEP REFRIGERATED**"
Code Info	8/30/12 and 8/31/12
Classification	Class I
Reason for Recall	World Foods, LLC, Florida is recalling multiple cut fruit and salsa products that contain Daniella Mangoes distributed by Splendid Products that have the potential to be contaminated with Salmonella. The products were distributed in Florida only.
Product Quantity	60 lbs
Recall Number	F-2333-2012

Product Description	Fresh Fruit Product is labeled in part: "*Fruit Burst Bowl1 LB (454g)Best If Sold ByIngredients: Watermelon, Cantaloupe, Pineapple, Honeydew, Grapes, Mango, Blueberries.Packed in its own juiceDistributed by: Winn-Dixie Stores Inc. Jacksonville, FL 32254For Nutrition Information Call 1-888-449-9386P-0090 21140 01701 7PERISHABLE KEEP REFRIGERATED**" Recalled Products: UPC 0 21140 01701 7 1 LB and UPC 0 21149 01707 9 1.5 LB
Code Info	1 lb: 8/30/12 and 8/31/12 1.5 lb: 8/30/12 and 8/31/12
Classification	Class I
Reason for Recall	World Foods, LLC, Florida is recalling multiple cut fruit and salsa products that contain Daniella Mangoes distributed by Splendid Products that have the potential to be contaminated with Salmonella. The products were distributed in Florida only.
Product Quantity	4,310 lbs
Recall Number	F-2334-2012

Class I Food/Cosmetics Event

Event ID	63068
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	F & S Produce Co., Inc. (Site II)
City	Deerfield
State	NJ
Country	US
Distribution Pattern	CT, DE, MA, MD, ME, NH, NJ, NY, PA, RI, VA, FL and Washington D.C.

Associated Products

Product Description	Mango Spears: 1) Delish Mango Spears Net Wt. 5 oz. (142 g) Enjoy by: 8/28/2012 and before Prepared for Walgreens Inc. Deerfield, Illinois 60015 Distributed by Walgreens UPC 0 49022 53700 2; Delish Mango Spears 1 lb .(454 g) UPC 0 49022 58823 3 2) Mango Spears Best if Sold By: 08/28/12 and before 16 oz (1 lb) Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716
Code Info	Enjoy by: 8/28/2012 and before
Classification	Class I
Reason for Recall	F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity	1) 2,370 units; 750 units
Recall Number	F-2335-2012

Product Description	Delish Pineapple, Mango and cantaloupe Spears Net Wt. 5 oz. Enjoy by: 8/28/2012 and before Prepared for: Walgreens Inc. Deerfield, Illinois, 60015 Distributed by Walgreens UPC 0 49022 537019
Code Info	Enjoy by: 8/28/2012 and before UPC 0-49022-53701-9
Classification	Class I
Reason for Recall	F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity	1,640 units
Recall Number	F-2336-2012

Product Description	Delish Fruit Burst 10 oz.(283 g) Enjoy by: 8/28/12 Distributed by: Walgreen Co. 200 Wilmot Road, Deerfield, IL 60015 Distributed by Walgreens UPC 049022 55862 5
Code Info	Enjoy by: 8/28/2012 UPC 0 49022 55862 5
Classification	Class I
Reason for Recall	F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity	4,658 units
Recall Number	F-2337-2012

Product Description	Delish Tropical Medley 10 oz.(283 g) Enjoy by: 8/28/12 and before Distributed by: Walgreen Co. 200 Wilmot Road, Deerfield, IL 60015 Distributed by Walgreens UPC 04 902253699 9
Code Info	Enjoy by: 8/28/2012 and before UPC 0 4902253699 9
Classification	Class I
Reason for Recall	F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity	285 units
Recall Number	F-2338-2012

Product Description	Delish Mango & Berry Mix 10 oz.(283 g) Enjoy by: 8/28/12 Distributed by: Walgreen Co. 200 Wilmot Road, Deerfield, IL 60015 Distributed by Walgreens UPC 0 49022 63779 5
Code Info	Enjoy by: 8/28/2012 UPC 0 49022 63779 5
Classification	Class I
Reason for Recall	F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity	180 units
Recall Number	F-2339-2012

Product Description	Garden Highway Fresh Fruit Mango Medley 1 lb .(454 g) Best if sold by: 8/28/12 and before Renaissance Food Group LLC Rancho Cordova, CA 95670 UPC 8 26766 21437 2
Code Info	Best if sold by: 8/28/12 and before UPC 8 26766 21437 2
Classification	Class I
Reason for Recall	F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity	78 units
Recall Number	F-2340-2012

Product Description	Garden Highway Tropical Mango Spinach Salad with Zesty Orange Vinaigrette 7 oz .(198 g) Best if sold by: 8/28/12 and before Distributed by: Renaissance Food Group LLC Rancho Cordova, CA 95670 UPC 8 26766 801850 5
Code Info	Best if sold by:8/28/12 and before UPC 8 26766 801850 5
Classification	Class I
Reason for Recall	F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity	60 units
Recall Number	F-2341-2012

Product Description	Garden Pure Fresh Cut Mango 9 oz .(255 g) Best By: 08/28/12 and before Packed by F& S Produce Co. Inc. Headquarters, Rosehayn, NJ 06532 UPC 8 01172 20149 5
Code Info	Best By: 08/28/12 and before UPC 8 01172 20149 5
Classification	Class I
Reason for Recall	F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity	2,148 units
Recall Number	F-2342-2012

Product Description	Fresh Cut Fruit Mango Chunks 1/5 lbs Best Use By: 08/28/12 and before F& S Produce Co. Inc. Headquarters, Rosenhayn, NJ 08532 No UPC
Code Info	Best if sold by: 8/28/12 and before No UPC
Classification	Class I
Reason for Recall	F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity	142 units
Recall Number	F-2343-2012

Product Description	Garden Pure Mixed Fruit Net Wt. 48 oz (1.36 kg) Best By: 8/28/12 and before F& S Produce Co. Inc. Headquarters, Rosenhayn, NJ 08532 6 001172 00264 1
Code Info	Best By: 8/28/12 and before 6 001172 00264 1
Classification	Class I
Reason for Recall	F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity	652 units
Recall Number	F-2344-2012

Product Description	Garden Pure Holiday Fruit Bowl 4 lbs (1.81kg) Best By: 8/28/12 and before F& S Produce Co. Inc. Headquarters, Rosenhayn, NJ 08532 UPC 6 01172 00264 1
Code Info	Best By: 8/28/12 and before UPC 6 01172 00264 1
Classification	Class I
Reason for Recall	F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity	330 units
Recall Number	F-2345-2012

Product Description	SIgnature Cafe Fruit Basket Medley, 30 oz, Use By: AUG 28 12 and before Distributed by Lucerne Foods, Inc., PO Box 99, Pleasonton, CA 94566-0009 1-877-232-4271 UPC 0 2113006918 7
Code Info	Use By: AUG 28 12 and before UPC 0 2113006918 7
Classification	Class I
Reason for Recall	F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity	5,556 units
Recall Number	F-2346-2012

Product Description	Trader Joe's Tropical Fruit Medley, 16 oz, Best By: 08/28/12 and before Dist. & Sold exclusively by: Trader Joe's, Monorovia, CA 91016 UPC 00949361
Code Info	Best By: 08/28/12 and before UPC 00949361
Classification	Class I
Reason for Recall	F&S Produce Co., Inc. of Rosenhayn, NJ is initiating a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes, with a code date that is on or before August 28, 2012, as a result of a FDA recall by Splendid Products because Daniella brand mangoes distributed by this firm may be contaminated with Salmonella.
Product Quantity	4,836 units
Recall Number	F-2347-2012

Class I Food/Cosmetics Event

Event ID	63076
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	31-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Somersault Snack Co., LLC
City	Sausalito
State	CA
Country	US
Distribution Pattern	CA, NH, NV, RI, MD, PA, TN, FL, CT. WA, TX, NJ, MN, IN, GA.

Associated Products

Product Description	Somersaults Crunchy Nuggets baked with sunflower seed and toasted grains. Pacific Sea Salt Flavor, Net Wt. 6 oz. UPC 8-98403 00201-7;
Code Info	Sell By Date MAR1113 G6.
Classification	Class I
Reason for Recall	Consumer complaints and subsequent investigation found that packages of Pacific Sea Salt snack crackers had some Santa Fe Salsa snack crackers mixed in. Santa Fe Salsa crackers contain milk protein which is not declared on the ingredient labeling.
Product Quantity	418 cases of 12.6oz packages
Recall Number	F-2331-2012

Class II Biologics Event

Event ID	35009
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	23-Feb-06
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	SCC Soft Computer
City	Palm Harbor
State	FL
Country	US
Distribution Pattern	Product was distributed to 85 consignees within the United States and 2 Canadian consignees.

Associated Products

Product Description	Product is SoftBank software (versions 21.4.2 to 23.0.0).
Code Info	SoftBank Version 21.4.2 with 3.1.2 ASCII base; SoftBank Version 21.4.3 with 3.1.3 ASCII base; SoftBank Version 21.4.3 with 3.1.4 ASCII base; SoftBank Version 21.4.4 with 3.1.4 ASCII base; SoftBank Version 22.4.0 with 3.1.3 ASCII base; SoftBank Version 22.4.1 with 3.1.4 ASCII base; SoftBank Version 23.0.0 with 3.1.4 ASCII base; SoftBank Version 23.0.0 with 3.2.0 ASCII base; SoftBank Version 23.0.0 with 3.2.3 ASCII base; SoftBank Version 23.0.0 with 3.2.4 ASCII base
Classification	Class II
Reason for Recall	Software, with a glitch or defect, was distributed.
Product Quantity	10 Units
Recall Number	B-2337-12

Class II Biologics Event

Event ID	38787
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	23-Feb-07
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Red Blood Cells
Code Info	1280475
Classification	Class II
Reason for Recall	Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Product Quantity	1 unit
Recall Number	B-2267-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	1295730
Classification	Class II
Reason for Recall	Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Product Quantity	1 unit
Recall Number	B-2268-12

Class II Biologics Event

Event ID	38788
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Mar-07
Initial Firm Notification of Consignee or Public	Letter

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

Associated Products

Product Description	Red Blood Cells
Code Info	4198405, 4200938
Classification	Class II
Reason for Recall	Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Product Quantity	2 units
Recall Number	B-2213-12

Class II Biologics Event

Event ID	38789
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Apr-07
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Red Blood Cells
Code Info	3549179, 3547437
Classification	Class II
Reason for Recall	Blood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed.
Product Quantity	2 units
Recall Number	B-2122-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	9038318
Classification	Class II
Reason for Recall	Blood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed.
Product Quantity	1 unit
Recall Number	B-2123-12

Product Description	Recovered Plasma
Code Info	9038318, 3547437
Classification	Class II
Reason for Recall	Blood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed.
Product Quantity	2 units
Recall Number	B-2124-12

Class II Biologics Event

Event ID	38790
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-May-07
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	6054316
Classification	Class II
Reason for Recall	Blood product, with a low platelet count, was distributed.
Product Quantity	1 unit
Recall Number	B-2126-12

Class II Biologics Event

Event ID	38791
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Jun-07
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	6054666
Classification	Class II
Reason for Recall	Blood product, with a low platelet count, was distributed.
Product Quantity	1 unit
Recall Number	B-2344-12

Class II Biologics Event

Event ID	40459
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Jun-05
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	02LC59689
Classification	Class II
Reason for Recall	Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Product Quantity	1 unit
Recall Number	B-2266-12

Class II Biologics Event

Event ID	41043
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Aug-05
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Biomat USA, Inc.
City	Seattle
State	WA
Country	US
Distribution Pattern	Spain

Associated Products

Product Description	Source Plasma
Code Info	330060575, 330060732, 330061380, 330061712
Classification	Class II
Reason for Recall	Blood products, collected from a donor who received a tattoo within one year of donation, were distributed.
Product Quantity	4 units
Recall Number	B-2217-12

Class II Biologics Event

Event ID	41780
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Feb-06
Initial Firm Notification of Consignee or Public	E-Mail

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	02LJ48701
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity	1 unit
Recall Number	B-2451-12

Product Description	Recovered Plasma
Code Info	02LJ48701
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity	1 unit
Recall Number	B-2452-12

Class II Biologics Event

Event ID	42835
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Jul-06
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	CSL Plasma Inc
City	Omaha
State	NE
Country	US
Distribution Pattern	Germany, Switzerland, IL, NC

Associated Products

Product Description	Source Plasma
Code Info	4210087445, 4210086539, 4210085985, 4210084967, 4210084427, 4210083400, 4210082857, 4210081860, 4210081310, 4210080472, 4210080007, 4210078342, 4210077910, 4210076935, 4210076450, 4210075537, 4210075213, 4210074270, 4210073891, 4210073088, 4210072653, 4210071612, 4210071224, 4210070322, 4210069960, 4210069078, 4210068483, 4210067206, 4210066479, 4210065781, 4210064777, 4210063218, 4210062738, 4210061939, 4210061350, 4210060514, 4210060086, 4210059008, 4210058606, 4210057603, 4210057170, 4210055403, 4210054727, 4210053865, 04210053444
Classification	Class II
Reason for Recall	Blood products, collected from a donor who did not have a physical examination, were distributed.
Product Quantity	45 units
Recall Number	B-2125-12

Class II Biologics Event

Event ID	50573
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Jul-08
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Source Plasma
Code Info	370055602
Classification	Class II
Reason for Recall	Blood product, collected from a donor who did not have a complete physical examination, was distributed.
Product Quantity	1 unit
Recall Number	B-2495-12

Class II Biologics Event

Event ID	54066
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Oct-09
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	Csl Plasma Inc
City	Boca Raton
State	FL
Country	US
Distribution Pattern	IL

Associated Products

Product Description	Source Plasma
Code Info	4100385656, 4100384401, 4100382991, 4100378926, 4100377543, 4100376601, 4100372446, 4100367994, 4100366798, 4100365448, 4100362864, 4100360304, 4100357558, 4100356358, 4100341534, 4100337267, 4100328589, 4100323411, 4100315386, 4100299217, 4100288682, 4100283746, 4100280969
Classification	Class II
Reason for Recall	Blood products, collected from a donor who received a piercing within one year of donation, were distributed.
Product Quantity	23 units
Recall Number	B-2215-12

Class II Biologics Event

Event ID	54208
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Nov-09
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	Csl Plasma Inc
City	Boca Raton
State	FL
Country	US
Distribution Pattern	IL

Associated Products

Product Description	Source Plasma
Code Info	4100390029, 4100388970, 4100388493, 4100387277, 4100386693, 4100384472, 4100382876, 4100381825, 4100380949, 4100379320, 4100378814, 4100377047, 4100376495, 4100374637, 4100374066, 4100372123, 4100371499, 4100367023, 4100366099, 4100364569, 4100363343, 4100361829, 4100360661, 4100359312, 4100357701, 4100356440, 4100355151, 4100354324, 4100352193, 4100351244, 4100349719, 4100348960, 4100347312, 4100346498, 4100344650, 4100343847, 4100342040, 4100341196, 4100339642, 4100338055, 4100337306, 4100335571, 4100334696, 4100332958, 4100332137, 4100330514, 4100329685, 4100328112, 4100327320, 4100325907, 4100323557, 4100322764, 4100321304, 4100320369, 4100319028, 4100317970, 4100316746, 4100315642, 4100313416, 4100311769, 4100310871, 4100309219, 4100307559, 4100306536, 4100304555, 4100303355, 4100302051, 4100301021, 4100298987, 4100297752, 4100296643, 4100295022, 4100294463, 4100292817, 4100291830, 4100290225
Classification	Class II
Reason for Recall	Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity	76 units
Recall Number	B-2216-12

Class II Biologics Event

Event ID	54209
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Nov-09
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	Csl Plasma Inc
City	Boca Raton
State	FL
Country	US
Distribution Pattern	IL

Associated Products

Product Description	Source Plasma
Code Info	4100392051, 4100391500, 4100389118, 4100388452, 4100387385, 4100386645, 4100385652, 4100384768, 4100382850, 4100382474, 4100380926, 4100380407, 4100378762, 4100378159, 4100376439, 4100375784, 4100373987, 4100373333, 4100371396, 4100370969, 4100369129, 4100368322, 4100366367, 4100365648, 4100363580, 4100362777, 4100360899, 4100360181, 4100358258, 4100357376, 4100355646, 4100354819, 4100352727, 4100351938, 4100350267, 4100349445, 4100347445, 4100346605, 4100344801, 4100343970, 4100342162, 4100341325, 4100339782, 4100339283, 4100337032, 4100336269, 4100334446, 4100333691, 4100332065, 4100331442
Classification	Class II
Reason for Recall	Blood products, collected from a donor who did not have a complete physical examination, were distributed.
Product Quantity	50 units
Recall Number	B-2214-12

Class II Devices Event

Event ID	54705
Status	Completed
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Feb-10
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Steris Corporation
City	Mentor
State	OH
Country	US
Distribution Pattern	Worldwide Distribution - US Nationwide including District of Columbia and Puerto Rico and the following countries: American Samoa, Argentina, Australia, Bahrain, Bangladesh, Bermuda, Brazil, Canada, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Germany, Greece, Guam, Hong Kong, India, Indonesia, Israel, Italy, Japa, Jordan, Kazakhstan, Korea, Kuwait, Lebanon , Libya , Malaysia , Mexico, Morocco, New Zealand, Panama, Peru, Philippines , Poland, Portugal, Qatar, Russia, Saudi Arabia , Singapore, South Africa, Spain, Sri Lanka, Taiwan, Thailand, Trinidad and Tobago, Turkey & United Kingdom.

Associated Products

Product Description	A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. Product Usage: Product provides a flexible, easy-to-use, articulated posturing of a patient for either general, I.A., or specialized surgical procedures. There are movable components and accessories intended for use during diagnostic examinations or surgical procedures to support and position a patient.
Code Info	B420702032 to 0402110097
Classification	Class II
Reason for Recall	Customers may be storing objects on the base and/or around the column of the surgical table. This prohibited practice and misuse known by the customers can damage the override switch assembly located at the top of the column cover. Depending upon the nature and severity of the damage to the electronics of the table, it is possible that the table could move without prompting by an operator .
Product Quantity	11,044 Units
Recall Number	Z-2402-2012

Class II Biologics Event

Event ID	61097
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Jan-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Upstate New York Transplant Services, Inc.
City	Buffalo
State	NY
Country	US
Distribution Pattern	Alabama, Venezuela

Associated Products

Product Description	Cornea
Code Info	110112OS; 110112OD
Classification	Class II
Reason for Recall	Corneas, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	2
Recall Number	B-2432-12

Class II Biologics Event

Event ID	62300
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	23-Apr-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Blood Systems, Inc
City	Billings
State	MT
Country	US
Distribution Pattern	Products were distributed to four domestic consignees including blood bank and health care facilities, located in Montana State. One of the four consignees responded that the unit was transfused.

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced Irradiated
Code Info	W0423110455999
Classification	Class II
Reason for Recall	Blood products, collected from a donor with a history of malaria, were distributed.
Product Quantity	1 unit
Recall Number	B-2357-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W042311056937V; W0423110503973; W042311040445E
Classification	Class II
Reason for Recall	Blood products, collected from a donor with a history of malaria, were distributed.
Product Quantity	3 units
Recall Number	B-2358-12

Class II Drugs Event

Event ID	62320
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Jun-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Dukal Corp.
City	Ronkonkoma
State	NY
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective concentration), over the counter; supplied in 10 (item 2633), 50 (items 0204 and 02040 [sold in Canada only]) and 100 (item 0271) wipes per box distributed by ZEE MEDICAL, INC., Irvine, CA
Code Info	Antiseptic wipes shipped since July 02, 2009. Lots: JT14509, JT15209, JT20609, JT20909, JT23709, JT27809, JT32809, JT00710, JT15810, JT18310, JT18810, JT23210, JT25810, JT27610, JT31510, JT35610, JT35911, JT04811, JT05311, JT11811, JT15211, JT15911, JT18211, JT18211, JT21511-1, JT26311, JT30711, JT22011-1, JT01012, JT04112, JT06512, JT07512, JT07710, JT14509, JT15209, JT21409, JT20609, JT33009, JT00710, JT18810, JT23210, JT35911, JT05311, JT11811, JT26311, JT01012, JT14509, JT15209, JT20609, JT15209, JT23709, JT27809, JT00710, JT00710, JT18310, JT18810, JT23210, JT23210, JT27610, JT31510, JT05809, JT14509, JT15209, JT21209, JT27809, JT12510, JT15810, JT18310, JT11811, JT13211, JT15911, JT35911, JT01012, JT30711
Classification	Class II
Reason for Recall	Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)
Product Quantity
Recall Number	D-1675-2012

Product Description	Dukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.133% w/v, Item 854-1000 contains 1000 individually packaged swabs per box. Item 854 contains 200 individually packaged swabs per box. Packaging labeled with Dukal Corporation, Hauppauge, NY 11788 --- NDC 65517-00031
Code Info	Antiseptic wipes shipped since July 02, 2009. Lots: JT34808, JT08209, JT15209, JT32809, JT00610, JT27610, JT05311, JT18211, JT22711-1, JT26411, JT01012, JT00610, JT14511, JT22011, JT30711
Classification	Class II
Reason for Recall	Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)
Product Quantity
Recall Number	D-1676-2012

Class II Biologics Event

Event ID	62358
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Memorial Blood Centers
City	Saint Paul
State	MN
Country	US
Distribution Pattern	Minnesota

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	1427905
Classification	Class II
Reason for Recall	Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity	1 unit
Recall Number	B-2131-12

Class II Biologics Event

Event ID	62361
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	02-Mar-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	HCSC-Blood Center
City	Bethlehem
State	PA
Country	US
Distribution Pattern	Pennsylvania

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W050912009497
Classification	Class II
Reason for Recall	Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-2128-12

Product Description	Fresh Frozen Plasma
Code Info	W050912009497
Classification	Class II
Reason for Recall	Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-2129-12

Class II Devices Event

Event ID	62391
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Aug-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Biomet, Inc.
City	Warsaw
State	IN
Country	US
Distribution Pattern	Nationwide Distribution-including the states of WA, IN, AK, PA, GA, SD, KS, NY, VA, AR, AL, OH, WI, MA, and CA.

Associated Products

Product Description	JUGGERKNOT IN·GUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the JuggerKnot 2.9mm Suture Anchor is to be placed. The JuggerKnot 2.9mm Suture Anchor is intended to be used to attach soft tissue to bone.
Code Info	REF. 912064 LOT 121040, 497540, 839530
Classification	Class II
Reason for Recall	Investigation found that the current design of the product allows the press-fit of the knob/shaft interface to be overcome by the impaction force of a mallet, causing the knob to potentially unfasten and slide down the shaft.
Product Quantity	62
Recall Number	Z-2399-2012

Class II Drugs Event

Event ID	62459
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Hospira Inc.
City	Lake Forest
State	IL
Country	US
Distribution Pattern	Nationwide, including Puerto Rico and Guam. Product was also distributed internationally to Australia, Belgium, Canada, France, Germany, Korea, Malaysia, New Zealand, Norway, Pakistan, Philippines, Portugal, Singapore, Sweden, Thailand and Vietnam

Associated Products

Product Description	Carboplatin Injection, 10 mg/mL, 45 mL Multi-Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-50 (Hospira label), NDC 61703-360-50 (Novoplus label)
Code Info	lot numbers Y061711AA, exp FEB 2013 and Y061711AB, exp FEB 2013 rest of world lots being recalled: list M1685A001, lots numbers Y151686AB, exp MAY 2013 and Y131686AA, exp MAR 2013; list M1723A001, lot number Y121686AF, exp SEP 2013; list M1686ADE1, lot numbers Y121686AA, exp SEP 2013 and Y151686AC, exp NOV 2013; list M1686AFR1, lot numbers Y121686AG, exp SEP 2013 and Y131686AB, exp SEP 2013; list M1714A001, lot number Y121686AC, exp SEP 2013; list M1686ANO3, lot number Y121686AE, exp SEP 2013; list M1686ASE2, lot number Y121686AB, exp SEP 2013
Classification	Class II
Reason for Recall	The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Product Quantity	30,582 vials
Recall Number	D-1679-2012

Product Description	Cytarabine Injection, 20 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; NDC 61703-303-46
Code Info	lot numbers Y131994AA, exp AUG 2013; Y141994AA, exp SEP 2013; Y151994AA, exp SEP 2013; Y161994AA, exp NOV 2013; Y171994AA, exp NOV 2013 and Y181994AA, exp NOV 2013
Classification	Class II
Reason for Recall	The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Product Quantity	210 vials
Recall Number	D-1680-2012

Product Description	Methotrexate Injection, USP, 25 mg/mL, 40 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; NDC 61703-408-41
Code Info	lot number Y064457AA, exp OCT 2013 Rest of world lot numbers: list M4457A001, lot number Y054457AB, exp SEP 2013
Classification	Class II
Reason for Recall	The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Product Quantity	34,572 vials
Recall Number	D-1681-2012

Product Description	Paclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; N DC 61703-342-50
Code Info	lot numbers Y096865AA, exp AUG 2013; Y106865AA, exp AUG 2013; Y116865AA, exp AUG 2013; Y126865AA, exp SEP 2013; Y136865AA, exp SEP 2013; Y146865AA, exp SEP 2013; Y156865AA, exp OCT 2013; Y166865AA, exp NOV 2013; Y176865AA, exp NOV 2013; and Y186865AA, exp DEC 2013
Classification	Class II
Reason for Recall	The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Product Quantity	131,264 vials
Recall Number	D-1682-2012

Class II Biologics Event

Event ID	62468
Status	Ongoing
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Life Technologies, Inc.
City	Brown Deer
State	WI
Country	US
Distribution Pattern	Nationwide and CANADA

Associated Products

Product Description	B17 SSP UniTray® Kit, REF 472303 and 472313; B Locus High Res SSP UniTray® Kit , REF 4730010 and 4730110; AllSet Gold SSP HLA-B17 High Res Kit, Prod.no. 541120D, AllSet Gold SSP HLA-B Locus High Res Kit , Prod.no. 54020D.
Code Info	. 472303 (B17 SSP UniTray Kit): 004743203, 004825654, 004904114, 004944916, 0041047204 472313 (B17 SSP UniTray Kit with Taq Polymerase) 004743203794936, 004743203824725, 004743203867126, 004825654862612, 004825654902239, 004825654903448, 004825654908705, 004825654933983 004904114936659, 004904114943927, 004904114989957, 004904114991724 0049449161006545, 0049449161029905, 0049449161036926, 00410472041097465 4730010 (B Locus High Res SSP UniTray Kit) 008709385, 008757730, 008800850, 008839301, 008873000, 009910766, 009984375 0101103786 4730110 (B Locus High Res SSP UniTray Kit with Taq Polymerase) 008709385760267, 008709385764018, 008709385764321, 008709385770871, 008839301892884, 008839301895965, 008839301900752, 008839301903610, 008709385786802, 008709385790179, 008709385791195, 008709385791779, 008709385792235, 008709385794392, 008709385799832, 008757730812167, 008757730825400, 008757730826478, 008757730827309, 008757730832868, 008757730835072, 008800850838882, 008800850842278, 008800850845743, 008800850849098, 008800850853960, 008800850857260, 008 800850 859419 008800850864238, 008800850874250, 008839301884136, 008839301891810, 008839301907862, 008839301923305, 008873000925324, 008873000940462, 008873000942042, 009910766979658, 009910766990558, 0099107661007232, 0099107661013361, 0099107661016456, 0099107661029333, 0099107661032390, 0099107661038471, 0099107661046552, 0099107661048423, 0099107661070124, 0099843751071655, 0099843751077181, 0099843751112028, 0099843751112356, 0099843751113862, 01011037861143513, 01011037861148166 541120D (AllSet Gold SSP HLA-B17 High Res Kit - 10 Tests) 004744187, 004841439, 0041030324 54020D (AllSet Gold SSP HLA-B Locus High Res Kit - 10 Tests) 008707067, 008775767, 008796669, 008839303, 009910772, 009979631
Classification	Class II
Reason for Recall	HLA typing assay, associated with false negative results, was distributed.
Product Quantity	6 Units
Recall Number	B-2385-12

Class II Devices Event

Event ID	62494
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	BD Biosciences, Systems & Reagents
City	San Jose
State	CA
Country	US
Distribution Pattern	Worldwide Distribution -- USA (nationwide) including the countries of Australia, Belgium, Canada, Chile, Korea, Mexico, Singapore and Taiwan.

Associated Products

Product Description	BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention.
Code Info	Catalog number: 335775; Lot number 33412.
Classification	Class II
Reason for Recall	Incorrect version of the CD was included with BD FACS 7 Color Setup Beads.
Product Quantity	96 kits
Recall Number	Z-2397-2012

Class II Food/Cosmetics Event

Event ID	62565
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Jan-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Atico International USA, Inc.
City	Ft Lauderdale
State	FL
Country	US
Distribution Pattern	Milwaukee, WI

Associated Products

Product Description	Roundy's Rich Fields Butter Cookies. Product is labeled in part: Side of tin: "*RICH FIELDS* Butter Cookies*NET WT 12 OZ (340g)See Bottom Panel for Nutritional Information" Bottom of tin: "Nutrition Facts Serving Size 4 Cookies (30g)INGREDIENTS: Wheat Flour, Sugar, Butter, Eggs, Salt, Soy Lecithin (Emulsifier) Leavening Agent (Sodium bicarbonate), Artificial Flavor.Contains Egg, Milk, Wheat, SoyManufactured in a facility that process peanuts and tree nuts.Distributed By: ATICO INTERNATIONAL USA, INC. FT. LAUDERDALE, FL 33301MADE IN CHINA* ROUNDY'S*2050498 84118 12366 6**"
Code Info	Best by Date Jun 24, 2012 and Batch #047 06 25
Classification	Class II
Reason for Recall	Atico International USA, Inc. is recalling Roundy's Rich Fields Butter Cookies due to Toxigenic Bacillus cereus found in a sample tested by FDA.
Product Quantity	22068
Recall Number	F-2298-2012

Class II Food/Cosmetics Event

Event ID	62737
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Jul-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	San Francisco Herb & Natural Food Company
City	Fremont
State	CA
Country	US
Distribution Pattern	Nationwide and Canada.

Associated Products

Product Description	Carob Raw Powder Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	P351, Lot 120056.
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	xx
Recall Number	F-2299-2012

Product Description	Chicory Root Roasted Granules Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	G440, Lot 120056.
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	xx
Recall Number	F-2300-2012

Product Description	Green Tea, Gunpowder C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	C837, lot 100181.
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	xx
Recall Number	F-2301-2012

Product Description	Fennel Seed, Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	W170, Lot 110155
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	xx
Recall Number	F-2302-2012

Product Description	Hops Flower; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	W890, Lot 110020
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	xx
Recall Number	F-2303-2012

Product Description	Marigold Petals Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	W1087, Lot 100196.
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	xx
Recall Number	F-2304-2012

Product Description	Lavender Flower Medium Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	W985, Lot 120033; Also lot 110200 and 120004. W980, Lot 110200
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	xx
Recall Number	F-2305-2012

Product Description	Olive Leaf Organic Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	W01119, Lot 090286.
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	xx
Recall Number	F-2306-2012

Product Description	Paprika Sweet Powder; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	P1251, Lot 090048
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	xx
Recall Number	F-2307-2012

Product Description	Parsley Leaf C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	C1255, Lot 110107.
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	xx
Recall Number	F-2308-2012

Product Description	Pau D'Arco Bark C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	C1270, Lot 100266.
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	xx
Recall Number	F-2309-2012

Product Description	Rose Hips Organic Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	W01430, Lot 090324.
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	xx
Recall Number	F-2310-2012

Product Description	Rosemary Leaf Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	Product No. W1445, Lot 010017. Product No. A330, Lot 110197, 110226, 120004.
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	xx
Recall Number	F-2311-2012

Product Description	Senna Pods Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	W1520, Lot 110220.
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	xx
Recall Number	F-2312-2012

Product Description	Spearmint Leaf Organic C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	CO1565, Lot 110171.
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	xx
Recall Number	F-2313-2012

Product Description	Thyme Leaf C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	C1631, Lot 110197.
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	xx
Recall Number	F-2314-2012

Product Description	Olive Leaf Organic; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	Lot 100275.
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	xx
Recall Number	F-2315-2012

Product Description	Paprika Sweet Flakes; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	Lot 100032.
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	xx
Recall Number	F-2316-2012

Product Description	Licorice Root, WHL; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	Lot 120019.
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	xx
Recall Number	F-2317-2012

Product Description	Peppermint lf, org C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	Lot 110171.
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	xx
Recall Number	F-2318-2012

Product Description	Tea green, Gun Powder, C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	Lot 100101.
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	xx
Recall Number	F-2319-2012

Product Description	Tea black, China T/B Cut; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	Lot 100981.
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	all
Recall Number	F-2320-2012

Product Description	Organic Yerba Mate; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	Lot GTA10-01/12..
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	all
Recall Number	F-2321-2012

Product Description	Peppermint Leaf Organic, Large Cut; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	Lot 100275.
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	all
Recall Number	F-2322-2012

Product Description	Spearmint LF/CS; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	Lot 110125.
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	all
Recall Number	F-2323-2012

Product Description	Mullein Leaf, Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	Lot 110200.
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	all
Recall Number	F-2324-2012

Product Description	Peppermint Leaf Organic C/S Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	Lot 110171, Product No. CO1310
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	all
Recall Number	F-2325-2012

Product Description	Spearmint Leaf C/S Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
Code Info	Product No. C1565, Lot No. 110128
Classification	Class II
Reason for Recall	CA Department of Public Health inspectors found a pervasive infestation of mice in the facility.
Product Quantity	all
Recall Number	F-2326-2012

Class II Devices Event

Event ID	62738
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	23-Apr-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Roche Molecular Systems, Inc.
City	Branchburg
State	NJ
Country	US
Distribution Pattern	Nationwide (USA) Distribution

Associated Products

Product Description	Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.
Code Info	05666678001
Classification	Class II
Reason for Recall	When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK software v3.2 series (AL v3.2) there is a potential for wrong results to be assigned to an order.
Product Quantity	1292 instruments
Recall Number	Z-2403-2012

Class II Devices Event

Event ID	62765
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	DePuy Orthopaedics, Inc.
City	Warsaw
State	IN
Country	US
Distribution Pattern	Nationwide Distribution including the states of MA, TX, OH, CA, and NC.

Associated Products

Product Description	S-Rom® Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch are placed into a nylon outer pouch and sealed. This is then placed into a folding carton, labeled, and shrink-wrapped. Description: Total Hip System Poly Dial® Liner is part of the S-ROM® Total Hip System. The Liner is fitted inside the acetabular shell; and is the bearing surface for the Head on the S-ROM® stem. The S-ROM liner is used for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Intended Use: Total Hip System Poly Dial Liner is part of the S-Rom Total Hip System. The Liner is fitted inside the acetabular shell; and is the bearing surface for the Head on the S-Rom® stem. The S Rom liner is used for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Code Info	Catalogue Lot Number 87-5987 3189424 3312166 3340992 3402685
Classification	Class II
Reason for Recall	Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of four lots of the S-ROM" liner because the Carton label has an Incorrect Color Code Series Designation. We have received one complaint regarding this issue.
Product Quantity	12 liners
Recall Number	Z-2414-2012

Class II Food/Cosmetics Event

Event ID	62786
Status	Terminated
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Dec-09
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	GMP Laboratories of America Inc
City	Anaheim
State	CA
Country	US
Distribution Pattern	US States nationwide.

Associated Products

Product Description	Dietary supplement. Product is labeled as :" Rescue Me*911 Damage Controlbrantley living herbal formulasHERBAL SUPPLEMENT 15 INDIVIDUAL PACKETS 4 VEGAN CAPSULES PER PACKET (2-368mg/2-584mg Each)DISTRIBUTED EXCLUSIVELY BY: Living Herbal Pharmacy, LLC PO Box 56-2410, Miami, FL 33256-2410**".
Code Info	LOT 2448 BEST BY 10/12
Classification	Class II
Reason for Recall	The firm recalled because the product lot contained mispackaged product wherein some capsules were missing from the finished packaged product.
Product Quantity	1027 boxes
Recall Number	F-2297-2012

Class II Devices Event

Event ID	62850
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Bio-Rad Laboratories
City	Redmond
State	WA
Country	US
Distribution Pattern	Worldwide distribution: USA (nationwide) and countries of: Canada, South Africa, and Zimbabwe.

Associated Products

Product Description	The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.
Code Info	All lots distributed from May 5, 2007
Classification	Class II
Reason for Recall	Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result in elevated Optical Densities (OD) in some samples such that a negative sample could elevate to a grey zone or low positive result.
Product Quantity	7,400 (approximately)- All lots since distribution date May 9, 2007
Recall Number	Z-2398-2012

Class II Devices Event

Event ID	62867
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Covidien LLC
City	Sunnyvale
State	CA
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Israel, Jordan, Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Venezuela and UK.

Associated Products

Product Description	HALO Flex Energy Generators Manufactured by BÂRRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085. The HALO Flex Energy Generator is indicated for use for the coagulation of soft tissue. The HALO Flex System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus, including Barrett's Esophagus.
Code Info	Model numbers 1190A-115A and 1190A-230A; all serial numbers.
Classification	Class II
Reason for Recall	Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore can not be used for patient care.
Product Quantity	617 generators
Recall Number	Z-2379-2012

Class II Food/Cosmetics Event

Event ID	62873
Status	Terminated
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Apr-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	R & S Mexican Food Products, Inc
City	Glendale
State	AZ
Country	US
Distribution Pattern	4 direct accounts in AZ. No international or outside states.

Associated Products

Product Description	R&S Mexican Food Products, Inc. Tomato/Basil Pressed Tortillas, 1 Dozen. Packaged in sealed flexible plastic bag.
Code Info	No UPC or manufacturing code used.
Classification	Class II
Reason for Recall	Product contains undeclared FD&C Yellow # 6.
Product Quantity	unknown
Recall Number	F-2348-2012

Class II Devices Event

Event ID	62884
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Aug-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Philips Healthcare Inc.
City	Andover
State	MA
Country	US
Distribution Pattern	Worldwide Distribution - USA including OH and WA and the country of Canada

Associated Products

Product Description	Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
Code Info	Lot or Serial Numbers With affected M-cabinet CXA; Serial number; 11-K0003; 12-B0001, 12-B0002; 12-B0003
Classification	Class II
Reason for Recall	Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm.
Product Quantity	4 systems
Recall Number	Z-2384-2012

Class II Devices Event

Event ID	62894
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Instrumentation Laboratory Co.
City	Bedford
State	MA
Country	US
Distribution Pattern	Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, REPUBLIC OF LUXEMBOURG, MACAU, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SLOVAKIA (Slovak Republic), SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TURKEY, UNITED KINGDOM, URUGUAY and VIETNAM.

Associated Products

Product Description	Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Code Info	Serial Number range:03110101 through 11111174 Distributed from: Nov 2003 to Nov 2011
Classification	Class II
Reason for Recall	Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
Product Quantity	1074 units
Recall Number	Z-2387-2012

Product Description	Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Code Info	Serial Number range: 09080100 through12060403 Distributed between: Aug 2009 to Jun 2012
Classification	Class II
Reason for Recall	Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
Product Quantity	304 units
Recall Number	Z-2388-2012

Product Description	Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Code Info	Serial Number range: 06020101 through 10080662 Distributed between: Feb 2006 to Aug 2010
Classification	Class II
Reason for Recall	Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
Product Quantity	562 units
Recall Number	Z-2389-2012

Product Description	Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Code Info	Serial Number range: 08120100 through 12060145 Distributed between: Dec 2008 to Jun 2012
Classification	Class II
Reason for Recall	Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
Product Quantity	46 units
Recall Number	Z-2390-2012

Product Description	Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Code Info	Serial Number range: 08010100 through 12062270 Distributed between: Jan 2008 to Jun 2012
Classification	Class II
Reason for Recall	Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
Product Quantity	2171 units
Recall Number	Z-2391-2012

Product Description	Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Code Info	Serial Number range: 09120101 through 12060240 Distributed between: Dec 2009 to Jun 2012
Classification	Class II
Reason for Recall	Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
Product Quantity	140 units
Recall Number	Z-2392-2012

Class II Devices Event

Event ID	62899
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Tedan Surgical Innovations Llc
City	Sugar Land
State	TX
Country	US
Distribution Pattern	Worldwide distribution: USA (nationwide) and countries of : Australia and Taiwan.

Associated Products

Product Description	Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction Screws are intended for the distraction in the anterior approach to the cervical spine. Sterile XL Screws are intended for the fixation of the blade to the vertebral body to prohibit drifting in the extreme lateral approach to the lumbar spine.
Code Info	Lot numbers: 019715, 019716, 019942, 019943, 019977, 019978, 020102, 020103, 020104, 020105, 020106, 020107, 020108, 020609, 020782, 021539, 021663, 022097, 022098, 022099, 022122, 022123, 022124, 022371, 022372, 022790, 022791, 022792, 022794, 022795, 022796, 022827, 022828, and 023266.
Classification	Class II
Reason for Recall	This letter is to notify you that several of our sterile screw products are being voluntarily recalled. Product sterility may be compromised due to a mechanical failure of the protective packaging tube. Tube end plugs may dislodge creating the potential for the screw to come out of the protective tube and then the sharp end of the screw pierce the outer sterile barrier pouch.
Product Quantity	12,065 Sterile Distraction Screws (2413 boxes); 384 Sterile XL Screws (128 boxes) in distribution
Recall Number	Z-2385-2012

Class II Devices Event

Event ID	62917
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Aug-12
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	Elekta, Inc.
City	Norcross
State	GA
Country	US
Distribution Pattern	Nationwide Distribution including AL, AZ, CA, CO, CT, FL, GA, IL, IA, MD, MA, MI, MN, NE, NV, NJ, NM, NY, ND, OH, OK, OR, PA, VA, SC, TN TX, WA, WV, WI and Puerto

Associated Products

Product Description	Precise Digital Accelerator Delivery of radiation to defined target volumes
Code Info	151587, 105932, 151574, 151363, 151076, 151110, 151369, 151504, 105941, 151418, 151674, 151566, 151259, 151636, 151568, 151390, 151258, 151584, 151391, 151317, 151522, 151055, 151423, 151507, 151623, 151627, 151640, 151479, 151340, 151178, 151467, 151514, 151051, 151411, 151216, 151430, 151173, 151616, 151595, 151141, 151433, 151611, 151151, 151653, 151515, 151360, 151675, 151538, 151024, 151523, 151521, 151260, 151519, 151432, 151410, 151371, 151084, 151435, 151387, 151530, 151328, 151176, 151080, 151626, 151567, 151598, 151601, 151269, 151396, 151557, 151558, 105982, 151160, 151634, 151394, 151398, 151540, 151632, 151446, 151301, 151038, 151441, 151256, 151168, 151156, 151157, 151155, 151579, 151412, 105984, 151053, 151359, 151585, 151326, 151327, 151443, 151250, 151130, 151245, 151416, 151664, 151672, 151074, 151352, 151298, 151545, 151628, 105803, 151362, 151073
Classification	Class II
Reason for Recall	There have been a small number of instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.
Product Quantity	110
Recall Number	Z-2405-2012

Class II Devices Event

Event ID	62939
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Zoe Medical Incorporated
City	Topsfield
State	MA
Country	US
Distribution Pattern	Nationwide distribution: WA only.

Associated Products

Product Description	Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature.
Code Info	Serial Numbers: FFD3291, FFD3292, FFD3293, FFD3294, FFD3295, FFD3296, FFD3297, FFD3298, FFD3299, FFD3300, FFD3301, FFD3302, FFD3303, FFD3304, FFD3306, FFD3307, FFD3308, FFD3309, FFD3310, FFD3312, FFD3313, FFD3314, FFD3315, FFD3316,FFD3317, FFD3318, FFD3319, FFD3320, FFD3321, FFD3579, FFD3771, FFD3772, FFD3814, FFD3815, FFD3817
Classification	Class II
Reason for Recall	Unit fails to power up, resulting in an equipment alarm
Product Quantity	35 units
Recall Number	Z-2380-2012

Class II Food/Cosmetics Event

Event ID	62962
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Aug-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Protica, Inc
City	Whitehall
State	PA
Country	US
Distribution Pattern	Nationwide distribution - product was distributed to direct accounts in AL, AZ, FL, IL, IN, KY, MN, MO, MS, NY OH, OK, RI, SC, TX and VA.

Associated Products

Product Description	ProBalance Protein To Go(TM), Milk Chocolate Shake, Dietary Supplement, Net Wt 2.5 fl oz (Responsible firm on labeling: Pro Balance LLC, 4070 Tampa Road, Oldsmar, FL 34677)
Code Info	Lot numbers PP04024109A, PP04024109B, PP04024109C, PP04024109D, PP04024109E, PP04024109F, PP04024109G, PP04424113, PP04724115, PP08924121, PP10324131A, PP10324131B, PP11624134B, PP11624134C, PP11624134A, PP12424139, PP12924140, PP15924145B, and PP15924145A.
Classification	Class II
Reason for Recall	Product not sufficiently acidified (equilibrium pH higher than 4.6), therefore it has the potential to be contaminated with Clostridium botulinum
Product Quantity	233,114 bottles
Recall Number	F-2349-2012

Product Description	ProBalance Protein To Go(TM), Caffeinated French Vanilla Latte, Dietary Supplement, Net Wt 2.5 fl oz (Responsible firm on labeling: Pro Balance LLC, 4070 Tampa Road, Oldsmar, FL 34677)
Code Info	Lot numbers PP25114066A, PP25114066B, PP28414079, PP29114086, PP34014103, PP04424112, PP09324122, PP09524125, PP10224129, PP11524133A, PP11524133B, PP11524133C, PP12224138A, PP12224138B, PP12224138, PP12924141, PP15924146A, and PP16024146B.
Classification	Class II
Reason for Recall	Product not sufficiently acidified (equilibrium pH higher than 4.6), therefore it has the potential to be contaminated with Clostridium botulinum
Product Quantity	230,000 bottles
Recall Number	F-2350-2012

Product Description	Protein Wave 15 grams of protein, Tropical Fruit Gelatin (Responsible firm on label: Nutritional Resources, Inc., 5003 Wrightsboro Road, Grovetown, GA 30813)
Code Info	Lot number PP12426123
Classification	Class II
Reason for Recall	Product not sufficiently acidified (equilibrium pH higher than 4.6), therefore it has the potential to be contaminated with Clostridium botulinum
Product Quantity	2,928 cups
Recall Number	F-2351-2012

Product Description	Protein Shots, Orange Sunshine Flavor, 2.9 fl oz (Responsible firm on label: Body Choice Nutrition, Inc., 1595 Peachtree Park Way, Suite 204, Cumming, GA 30041)
Code Info	Lot number PP35412924
Classification	Class II
Reason for Recall	Product not sufficiently acidified (equilibrium pH higher than 4.6), therefore it has the potential to be contaminated with Clostridium botulinum
Product Quantity	6,912 vials
Recall Number	F-2352-2012

Class II Drugs Event

Event ID	62971
Status	Completed
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Nov-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Carefusion 213, Llc
City	El Paso
State	TX
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA
Code Info	Product code 260415, Lot#: 48225
Classification	Class II
Reason for Recall	Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
Product Quantity	67,775 Applicators
Recall Number	D-1674-2012

Class II Devices Event

Event ID	62978
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	Integra LifeSciences Corporation
City	Plainsboro
State	NJ
Country	US
Distribution Pattern	Worldwide distribution: USA (Nationwide) and countries of: Argentina, Australia, Belgium, Canada, China, Czec, Denmark, France, Hong Kong, Hungary, Italy, Japan, Malaysia, Philippines, Singapore, Spain, South Africa, and UK.

Associated Products

Product Description	Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CTIMR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes
Code Info	All lot numbers from 2002 to current
Classification	Class II
Reason for Recall	T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. When the T-handle on the HRAIM intubation hoop is tightened, the T-handle could stop in a vertical position that prevents the CRWPRECISE and certain models of the CRW-ASL from seating properly on the head ring although it appears to be fully seated
Product Quantity	175 units
Recall Number	Z-2428-2012

Product Description	Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CT/MR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes
Code Info	All lot numbers from 2002 to current
Classification	Class II
Reason for Recall	T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. When the T-handle on the HRAIM intubation hoop is tightened, the T-handle could stop in a vertical position that prevents the CRWPRECISE and certain models of the CRW-ASL from seating properly on the head ring although it appears to be fully seated
Product Quantity	188 units
Recall Number	Z-2429-2012

Class II Food/Cosmetics Event

Event ID	62980
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Aug-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Tunnel Farms
City	Swanquarter
State	NC
Country	US
Distribution Pattern	NC

Associated Products

Product Description	Watermelon, labeled IT'S WATERMELON TIME!, Produce of USA, Seedless, #4032.
Code Info	PLU 4032, Bill of Lading numbers: 8601, 8492, 27541, 27542, 27543, 27544 and 9276.
Classification	Class II
Reason for Recall	Unapproved pesticide residue was detected.
Product Quantity	7 loads (15,750 melons)
Recall Number	F-2358-2012

Class II Food/Cosmetics Event

Event ID	62984
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Aug-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	American Licorice Co
City	Union City
State	CA
Country	US
Distribution Pattern	Nationwide distribution.

Associated Products

Product Description	Red Vines Black Licorice Twists; No preservatives and Always Fat Free Packaged in the following configurations: One Pound Pac: Red and white Plastic bag with a window to display licorice twists. UPC 0 41364 00283 5; 5 oz Black Licorice Tray Pack; UPC 4136451277 and 4136450277; 7 oz Black Licorice Laydown Bag: UPC 4136454347: 8 oz Jumbo Black twists hanging bag; UPC 4136400231; 2.5 oz Black Licorice Bar; 4 lb Black Licorice Jar, UPC 413400103; Ingredients: Molasses, Wheat Flour, corn Syrup, Caramel Coloring, Licorice Extract, Salt and Anise Flavor. American Licorice Company Union City, CA
Code Info	All candy
Classification	Class II
Reason for Recall	CA Dept. of Public Health collected random samples of Red Vines Black Licorice and found elevated levels of lead in the product.
Product Quantity	`1.5 million pounds, all varieties
Recall Number	F-2148-2012

Product Description	RED VINES Mixed Bites; Red and Black licorice mixed bites. UPC: 4136400288 and 4136451277. Family Mix Half Pallet; UPD 4136421697; Family Mix PDQ; UPC 4136455297; Mixed Original Red/Black Licorice Bag Pallet; UPC 413466283; Family Mix 1/4 pallet; UPC 4136424097; 96/5 ox mixed floor display; UPC 4136454279; Mixed 4 lb Jar Pallet 120 original Red/30 Black licorice; UPC 4136421543; Family Mix Pallet: UPC 3146436097; American Licorice Company Union City, CA
Code Info	All candy
Classification	Class II
Reason for Recall	CA Dept. of Public Health collected random samples of Red Vines Black Licorice and found elevated levels of lead in the product.
Product Quantity	~1.5 million pounds- all varieties
Recall Number	F-2154-2012

Product Description	Original Snaps Classic Chewy Candy; packed in 5.5 oz bags, 4.5 oz theatre box and 12 oz. tins. UPC 5.5 oz - 4136408300; 4.5 oz Theatre Box UPC 4136408302; Theatre box shipper UPC 4136408295. 12 oz tin UPC 4136408299; American Licorice Company Union City, CA
Code Info	All candy
Classification	Class II
Reason for Recall	CA Dept. of Public Health collected random samples of Red Vines Black Licorice and found elevated levels of lead in the product.
Product Quantity	~1,5 million pounds, all products
Recall Number	F-2167-2012

Class II Food/Cosmetics Event

Event ID	62985
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Aug-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Friendly Ice Cream Corp.
City	Wilbraham
State	MA
Country	US
Distribution Pattern	Maine, New Hampshire, Vermont, Connecticut, Massachusetts, Rhode Island, New York, New Jersey, Pennsylvania, Delaware, Maryland, Virginia, Florida

Associated Products

Product Description	Friendly's Sundae Nut Football Limited Edition, 48 oz. carton UPC :0-29839-00530-7
Code Info	Lot Codes: WC5 06/20/13 XXXX XXXXXX and WC5 07/08/13 XXXX XXXXXX
Classification	Class II
Reason for Recall	Product contains foreign material
Product Quantity	59, 052 cartons
Recall Number	F-2353-2012

Product Description	Friendly's Fudge Nut Brownie Sundae Extreme, 48 oz. carton UPC: 0-29839-00657-1
Code Info	Lot Code: WC5 06/01/13 XXXX XXXXXX
Classification	Class II
Reason for Recall	Product contains foreign material
Product Quantity	19,860 cartons
Recall Number	F-2354-2012

Product Description	Friendly's Brand Nutty Caramel Crunch Sundae, 6 0z. UPC: 0-29839-00050 Weis Crunchy Caramel Nut Sundae, 6 0z cup UPC 0-41497-01573-3
Code Info	Lot Code: 06/11/13
Classification	Class II
Reason for Recall	Product contains foreign material
Product Quantity	86,136 cups
Recall Number	F-2355-2012

Class II Devices Event

Event ID	63001
Status	Completed
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Jun-10
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Kimberly-Clark Corporation
City	Roswell
State	GA
Country	US
Distribution Pattern	Nationwide Distribution including AL, AK, AZ, CA, CO, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, ME, MA, MI, MN, MS, MO, NE, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WI.

Associated Products

Product Description	Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk.
Code Info	Lots AW916102A
Classification	Class II
Reason for Recall	The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube.
Product Quantity	277 units
Recall Number	Z-2415-2012

Product Description	Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk.
Code Info	Lots AW916002A, AW916102D
Classification	Class II
Reason for Recall	The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube.
Product Quantity	766 units
Recall Number	Z-2416-2012

Class II Devices Event

Event ID	63004
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Aug-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	ZOLL Medical Corporation
City	Chelmsford
State	MA
Country	US
Distribution Pattern	Worldwide Distribution - US Nationwide including the states of: LA, MA, ME, NC, ND, NE, OH and the country of Germany.

Associated Products

Product Description	Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in synchronized mode to terminate certain atrial and ventricular tachycardias and other arrhythmias resistant to drug therapy. The X Series may be used for cardiac pacing in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The X Series may be used for the monitoring a patients electrocardiogram (ECG).
Code Info	Serial Numbers: AR11J000164, AR12E000853, AR12E000856, AR12E000868, AR12E000920, AR12E000922, AR12E000923, AR12E000931, AR12E000944 AR12F001100, AR12F001298,
Classification	Class II
Reason for Recall	Shipped with incorrect software
Product Quantity	11 units
Recall Number	Z-2401-2012

Class II Devices Event

Event ID	63007
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Spacelabs Healthcare, Llc
City	Issaquah
State	WA
Country	US
Distribution Pattern	Worldwide Distribution.

Associated Products

Product Description	Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission. Through this network, a patient's data may be displayed at the bedside monitor, central station or clinical information system.
Code Info	Domestic - 1493-000275, 1493-000276, 1493-000277, 1493-002469, 1493-002616, 1493-003358, 1493-003359, 1493-003667, 1493-003668, 1493-003669, 1493-003670, 1493-003671, 1493-003672, 1493-003673, 1493-003674, 1493-003675, 1493-003676, 1493-003677, 1493-003678, 1493-003679, 1493-003680, 1493-003681, 1493-003682, 1493-003683, 1493-003684, 1493-003685, 1493-003686, 1493-003687, 1493-003688, 1493-003693, 1493-003694, 1493-003695, 1493-003696, 1493-003697, 1493-003879, 1493-003880, 1493-003881, 1493-003882, 1493-003883, 1493-003884, 1493-003885, 1493-003886, 1493-003887, 1493-003888, 1493-003889, 1493-003890, 1493-003891, 1493-003892, 1493-003893, 1493-003894, 1493-003895, 1493-003896, 1493-003897, 1493-003898, 1493-003899, 1493-003900, 1493-003901, 1493-003902, 1493-003903, 1493-003904, 1493-003905, 1493-003906, 1493-003907, 1493-003908, 1493-003909, 1493-003914, 1493-003915, 1493-003916, 1493-003917, 1493-003918, 1493-003919, 1493-003920, 1493-003921, 1493-003922, 1493-003923, 1493-003924, 1493-003925, 1493-003926, 1493-003927, 1493-003928, 1493-003929, 1493-003930, 1493-003931, 1493-003932, 1493-003933, 1493-003934, 1493-003935, 1493-003936, 1493-003937, 1493-003938, 1493-003939, 1493-003940, 1493-003941, 1493-003942, 1493-003943, 1493-003944, 1493-003945, 1493-003957, 1493-003958, 1493-003959, 1493-003960, 1493-003961, 1493-003962, 1493-003963, 1493-003964, 1493-003965, 1493-003985, 1493-004007, 1493-004011, 1493-004023, 1493-004026, 1493-004027, 1493-004028, 1493-004029, 1493-004030, 1493-004031, 1493-004032, 1493-004033, 1493-004034, 1493-004043, 1493-004044, 1493-004047, 1493-004048, 1493-004050, 1493-004051, 1493-004052, 1493-004053, 1493-004054, 1493-004055, 1493-004056, 1493-004058, 1493-004060, 1493-004064, 1493-004067, 1493-004068, 1493-004069, 1493-004070, 1493-004071, 1493-004075, 1493-004084, 1493-004085, 1493-004086, 1493-004106, 1493-004112, 1493-004113, 1493-004114, 1493-004115, 1493-004116, 1493-004117, 1493-004118, 1493-004119, 1493-004120, 1493-004121, 1493-004122, 1493-004123, 1493-004124, 1493-004125, 1493-004126, 1493-004127, 1493-004128, 1493-004130, 1493-004158, 1493-004159, 1493-004160, 1493-004161, 1493-004162, 1493-004163, 1493-004164, 1493-004172, 1493-004173, 1493-004174, 1493-004175, 1493-004176, 1493-004177, 1493-004178, 1493-004179, 1493-004180, 1493-004181, 1493-004182, 1493-004183, 1493-004184, 1493-004185, 1493-004205, 1493-004206, 1493-004207, 1493-004208, 1493-004209, 1493-004210, 1493-004211, 1493-004212, 1493-004214, 1493-004215, 1493-004216, 1493-004217, 1493-004218, 1493-004219, 1493-004220, 1493-004221, 1493-004222, 1493-004223, 1493-004224, 1493-004225, 1493-004226, 1493-004227, 1493-004228, 1493-004229, 1493-004230, 1493-004231, 1493-004232, 1493-004233, 1493-004234, 1493-004235, 1493-004236, 1493-004237, 1493-004238, 1493-004239, 1493-004240, 1493-004241, 1493-004242, 1493-004243, 1493-004256, 1493-004257, 1493-004258, 1493-004259, 1493-004260, 1493-004261, 1493-004262, 1493-004263, 1493-004264, 1493-004265, 1493-004266, 1493-004267, 1493-004268, 1493-004269, 1493-004270, 1493-004271, 1493-004272, 1493-004273, 1493-004274, 1493-004275, 1493-004276, 1493-004277, 1493-004278, 1493-004279, 1493-004280, 1493-004281, 1493-004282, 1493-004283, 1493-004284, 1493-004285, 1493-004286, 1493-004287, 1493-004288, 1493-004289, 1493-004290, 1493-004291, 1493-004292, 1493-004293, 1493-004294, 1493-004295, 1493-004296, 1493-004297, 1493-004298, 1493-004299, 1493-004301, 1493-004302, 1493-004306, 1493-004307, 1493-004308, 1493-004309, 1493-004310, 1493-004311, 1493-004312, 1493-004313, 1493-004314, 1493-004315, 1493-004316, 1493-004317, 1493-004318, 1493-004319, 1493-004320, 1493-004321, 1493-004322, 1493-004323, 1493-004324, 1493-004325, 1493-004326, 1493-004327, 1493-004328, 1493-004329, 1493-004330, 1493-004331, 1493-004332, 1493-004333, 1493-004334, 1493-004335, 1493-004336, 1493-004337, 1493-004338, 1493-004339, 1493-004340, 1493-004341, 1493-004342, 1493-004343, 1493-004344, 1493-004345, 1493-004346, 1493-004347, 1493-004348, 1493-004349, 1493-004350, 1493-004351, 1493-004352, 1493-004353, 1493-004354, 1493-004355, 1493-004356, 1493-004357, 1493-004358, 1493-004359, 1493-004360, 1493-004361, 1493-004362, 1493-004363, 1493-004364, 1493-004365, 1493-004366, 1493-004367, 1493-004368, 1493-004369, 1493-004370, 1493-004371, 1493-004372, 1493-004373, 1493-004374, 1493-004375, 1493-004376, 1493-004377, 1493-004378, 1493-004379, 1493-004380, 1493-004381, 1493-004382, 1493-004383, 1493-004384, 1493-004385, 1493-004405, 1493-004406, 1493-004407, and 1493-004408. International - 1493-002941, 1493-003666, 1493-003689, 1493-003690, 1493-003691, 1493-003692, 1493-003910, 1493-003911, 1493-003912, 1493-003913, 1493-003946, 1493-003947, 1493-003948, 1493-003949, 1493-003950, 1493-003951, 1493-003952, 1493-003953, 1493-003954, 1493-003955, 1493-003956, 1493-003966, 1493-003967, 1493-003968, 1493-003969, 1493-003970, 1493-003971, 1493-003972, 1493-003973, 1493-003974, 1493-003975, 1493-003976, 1493-003977, 1493-003978, 1493-003979, 1493-003980, 1493-003981, 1493-003982, 1493-003983, 1493-003984, 1493-003986, 1493-003987, 1493-003988, 1493-003989, 1493-003990, 1493-003991, 1493-003992, 1493-003993, 1493-003994, 1493-003995, 1493-003996, 1493-003997, 1493-003998, 1493-003999, 1493-004000, 1493-004001, 1493-004002, 1493-004003, 1493-004004, 1493-004005, 1493-004008, 1493-004009, 1493-004010, 1493-004012, 1493-004013, 1493-004014, 1493-004015, 1493-004016, 1493-004017, 1493-004018, 1493-004019, 1493-004020, 1493-004021, 1493-004022, 1493-004024, 1493-004025, 1493-004035, 1493-004036, 1493-004037, 1493-004038, 1493-004039, 1493-004040, 1493-004041, 1493-004042, 1493-004045, 1493-004046, 1493-004065, 1493-004066, 1493-004072, 1493-004073, 1493-004074, 1493-004076, 1493-004078, 1493-004079, 1493-004080, 1493-004081, 1493-004083, 1493-004087, 1493-004088, 1493-004089, 1493-004090, 1493-004091, 1493-004092, 1493-004093, 1493-004094, 1493-004095, 1493-004096, 1493-004097, 1493-004098, 1493-004099, 1493-004100, 1493-004101, 1493-004102, 1493-004103, 1493-004104, 1493-004105, 1493-004107, 1493-004108, 1493-004109, 1493-004110, 1493-004111, 1493-004129, 1493-004131, 1493-004132, 1493-004133, 1493-004134, 1493-004135, 1493-004136, 1493-004137, 1493-004138, 1493-004139, 1493-004140, 1493-004141, 1493-004142, 1493-004143, 1493-004144, 1493-004145, 1493-004146, 1493-004147, 1493-004148, 1493-004149, 1493-004150, 1493-004151, 1493-004152, 1493-004153, 1493-004154, 1493-004155, 1493-004165, 1493-004166, 1493-004167, 1493-004168, 1493-004169, 1493-004170, 1493-004171, 1493-004186, 1493-004187, 1493-004188, 1493-004189, 1493-004190, 1493-004191, 1493-004192, 1493-004193, 1493-004194, 1493-004195, 1493-004196, 1493-004197, 1493-004198, 1493-004199, 1493-004200, 1493-004201, 1493-004202, 1493-004203, 1493-004204, 1493-004300, 1493-004304, 1493-004305, and 670-1350-00.
Classification	Class II
Reason for Recall	There is a potential failure of the Integrated Module Housing causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing.
Product Quantity	527 units total; 350 US and 177 International
Recall Number	Z-2382-2012

Class II Devices Event

Event ID	63011
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Aug-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Haag-Streit USA Inc
City	Mason
State	OH
Country	US
Distribution Pattern	Worldwide distribution: USA (nationwide) including states of: AR, CA, CT, FL, GA, IA, IL, LA, MA, MI, MN, MS, NJ, NV, NY, OH, OR, PA, SC, SD, WA, WI, and WV; and to the countries of Jamaica, Puerto Rico, and Mexico.

Associated Products

Product Description	Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.
Code Info	Model Octopus 101. SN: 119, 136, 165, 166, 221, 222, 225, 236, 243, 273, 277, 279, 370, 371, 392, 507, 541, 553, 570, 602, 603, 611, 620, 622, 661, 667, 668, 687, 690, 726, 741, 744, 794, 796, 1054, 1214, 1275, 1276, 1277, 1313, 1322, 1326, 1380, 1402, 1404, 1413, 1414, 1436, 1437, 1459, 1460, 1489, 1490, 1491, 1492, 1560, 1561, 1607, 1608, 1625, 1626, 1706, 1710, 1852
Classification	Class II
Reason for Recall	The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101.
Product Quantity	64 units
Recall Number	Z-2411-2012

Class II Devices Event

Event ID	63014
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-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, Nationwide (US) including the states AL, AR, CA, FL, GA, IL, IN, MS, NJ, NV, NY, OH, PA, and VA and the countries of Albania, Argentina, Australia, Belgium, Brazil, Chile, China, Colombia, Dominican Republic, Ecuador, France, Germany, Greece, India, Indonesia, Ireland, Italy, Jordan, Lebanon, Malawi, Mexico, Nepal, Netherlands, Oman, Palestine, Philippines, Poland, Romania, Russia, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Turkey, Uganda, and Venezuela.

Associated Products

Product Description	MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system.
Code Info	System Code #, 728131, Serial #: EP16E090001-EP16E090004, EP16E090006-EP16E090015, EP16E100001- EP16E100004, EP16E100006, EP16E100008- EP16E100063, EP16E100067, EP16E100069- EP16E100113, EP16E110001- EP16E110065, EP16E110067-EP16E110070, EP16E110074-EP16E110075, EP16E110077-EP16E110078, EP16E110080, EP16E110083- EP16E110085, EP16E110088- EP16E110112, EP16E110115- EP16E110119, EP16E120001- EP16E120014, EP16E120016, EP16EB110003- EP16ER100007, EP16ER110003, EP16ER110006, P16C080001, P16C080002, P16C090001, P16C100001-P16C100015, P16C100017, P16C100018, P16C110001- P16C110008, P16C110011-P16C110037, P16C120001-P16C120003, P16C120006, P16C120007, P16E080005, P16E080007, P16E080008, P16E080012, P16E090002-P16E090021, P16E090024-P16E090028, P16E100002, P16EF80010, P16EM08003, and P16EM09002-P16EM09004. System Code #, 728132, Serial #: EP16E100005, EP16E100007, EP16E110066, EP16ER100003-EP16ER100005, EP16ER100008, EP16ER110004, EP16ER110005, and EP16ER110007-EP16ER110024.
Classification	Class II
Reason for Recall	On August 24, 2012 the firm recalled the MX 16-slice after discovering that 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	328 units
Recall Number	Z-2386-2012

Class II Devices Event

Event ID	63016
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Sekisui Diagnostics Llc
City	Stamford
State	CT
Country	US
Distribution Pattern	Nationwide distribution: USA including states of: FL, IN, IL, and WA.

Associated Products

Product Description	Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. Catalog Number: 101201 For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use.
Code Info	Lot Numbers: 120425 and 120601
Classification	Class II
Reason for Recall	SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This will reduce the slope of the standard curve requiring the user to make more frequent sample dilutions.
Product Quantity	699 kits
Recall Number	Z-2431-2012

Class II Devices Event

Event ID	63033
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-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.

Associated Products

Product Description	Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Code Info	LIST OF SERIAL NUMBERS: H140863 ,H294608 ,H294669 ,H294732 ,H140865 ,H294610 ,H294670 ,H294733 ,H140866 ,H294611 ,H294671 ,H294734 ,H140867 ,H294612 ,H294672 ,H294735 ,H140868 ,H294613 ,H294673 ,H294736 ,H140869 ,H294614 ,H294674 ,H294737 ,H140870 ,H294615 ,H294675 ,H294738 ,H140871 ,H294616 ,H294676 ,H294739 ,H140872 ,H294617 ,H294677 ,H294740 ,H140873 ,H294618 ,H294678 ,H294741 ,H140874 ,H294619 ,H294679 ,H294742 ,H140875 ,H294620 ,H294680 ,H294743 ,H140876 ,H294621 ,H294681 ,H294744 ,H140877 ,H294622 ,H294682 ,H294745 ,H140878 ,H294623 ,H294683 ,H294746 ,H140879 ,H294624 ,H294684 ,H294747 ,H140880 ,H294625 ,H294685 ,H294748 ,H140881 ,H294626 ,H294686 ,H294749 ,H140882 ,H294627 ,H294687 ,H294750 ,H140883 ,H294628 ,H294688 ,H294751 ,H140884 ,H294629 ,H294689 ,H294752 ,H140885 ,H294630 ,H294690 ,H294753 ,H140886 ,H294631 ,H294691 ,H294754 ,H140887 ,H294632 ,H294692 ,H294755 ,H140888 ,H294633 ,H294693 ,H294756 ,H140889 ,H294634 ,H294694 ,H294757 ,H140890 ,H294635 ,H294695 ,H294758 ,H140891 ,H294636 ,H294696 ,H294759 ,H140892 ,H294637 ,H294697 ,H294760 ,H140893 ,H294638 ,H294698 ,H294761 ,H140895 ,H294639 ,H294699 ,H294762 ,H140896 ,H294640 ,H294700 ,H294763 ,H140897 ,H294641 ,H294701 ,H294764 ,H140898 ,H294642 ,H294702 ,H294765 ,H140899 ,H294643 ,H294704 ,H294766 ,H140900 ,H294644 ,H294705 ,H294767 ,H181175 ,H294645 ,H294706 ,H294768 ,H181176 ,H294646 ,H294707 ,H294769 ,H181177 ,H294647 ,H294708 ,H294770 ,H181178 ,H294648 ,H294709 ,H294771 ,H181179 ,H294649 ,H294710 ,H294772 ,H181180 ,H294650 ,H294711 ,H181181 ,H294651 ,H294712 ,H181182 ,H294652 ,H294713 ,H181183 ,H294653 ,H294714 ,H181184 ,H294654 ,H294715 ,H181185 ,H294655 ,H294716 ,H181186 ,H294656 ,H294717 ,H181187 ,H294657 ,H294718 ,H181188 ,H294658 ,H294719 ,H181189 ,H294659 ,H294720 ,H181190 ,H294660 ,H294722 ,H181191 ,H294661 ,H294723 ,H181192 ,H294662 ,H294724 ,H182000 ,H294663 ,H294726 ,H182001 ,H294664 ,H294727 ,H182002 ,H294665 ,H294728 ,H182003 ,H294666 ,H294729 ,H182005 ,H294667 ,H294730 ,H294607 ,H294668 ,H294731
Classification	Class II
Reason for Recall	Some X-jaws (lower collimator jaw) carriers were manufactured with the incorrect metal alloy, which can potentially cause the jaw carrier to crack. If both jaw carriers on the same X-jaw were to crack, the jaw would be able to move freely in the closed direction. In this case, the deviation of the jaw position will not be detected by the position readout interlock circuitry; Treatment after such a failure occurs may lead to an under-dose of the intended target volume. This condition was found on some machines.
Product Quantity
Recall Number	Z-2383-2012

Class II Devices Event

Event ID	63069
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Davol, Inc., Subs. C. R. Bard, Inc.
City	Warwick
State	RI
Country	US
Distribution Pattern	Nationwide Distribution.

Associated Products

Product Description	Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
Code Info	Lot # HUWE1779
Classification	Class II
Reason for Recall	Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh product
Product Quantity	49 units
Recall Number	Z-2412-2012

Product Description	Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
Code Info	Lot # HUWE1780
Classification	Class II
Reason for Recall	Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh
Product Quantity	49 units
Recall Number	Z-2413-2012

Class II Devices Event

Event ID	63078
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Hospira Inc.
City	Lake Forest
State	IL
Country	US
Distribution Pattern	Worldwide Distribution-USA (nationwide) and the countries of Saudi Arabia, Canada and Barbados.

Associated Products

Product Description	Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections.
Code Info	250 mL size - Lot 11179DW, Exp, Date 1NOV2013, 11195DW, Exp. Date 1NOV2013 and 93854DW, Exp. Date 1SEP2012 - 1000 mL size - Lot 92835DW, Exp. Date 1AUG2012, Lot 96090DW, Exp. Date 1DEC2012, and Lot 96098DW, Exp. Date 1DEC2012
Classification	Class II
Reason for Recall	Embedded iron oxide glass defect which may have the potential to break off into the solution.
Product Quantity	191,094 units
Recall Number	Z-2395-2012

Class II Devices Event

Event ID	63089
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Smith & Nephew Inc
City	Memphis
State	TN
Country	US
Distribution Pattern	Worldwide Distribution-USA (nationwide) including the states of CA, FL, GA, IL, IN, MA, NC, NJ, NY, OH, OK, PA, TN, TX, and WA, and the country of Canada.

Associated Products

Product Description	12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS.
Code Info	Lot Numbers: 12FTM0017A, 12FTM0017B, 12FTM0017C, 12FTM0019A. 12FTM0019B, 12FTM0019C, 12FTM0019D, 12FTM0020A, 12FTM0020B, 12FTM0020C, 12FTM0021A, 12FTM0021B, and 12FTM0021C
Classification	Class II
Reason for Recall	Modular necks were manufactured out of specification by a vendor; the taper provide is undersized.
Product Quantity	70 units
Recall Number	Z-2427-2012

Class II Devices Event

Event ID	63098
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Vascular Solutions, Inc.
City	Maple Grove
State	MN
Country	US
Distribution Pattern	Worldwide distribution: USA (nationwide) including states of: AZ, AR, CA, CT, DE, FL, GA, ID, IL IN , KY, LA,MD, MN, MO, NV, NM, NY, OH, PA, SC, TN, TX, VA, WA, and WV; and countries of: Italy and Korea. Italy, Korea

Associated Products

Product Description	Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.
Code Info	lots 27686, 27293, 22446
Classification	Class II
Reason for Recall	Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal from Guardian II (Model 8210) and Guardian II NC (Model FH102) Hemostasis Valve which poses a risk of product contamination.
Product Quantity	3500 units
Recall Number	Z-2400-2012

Class II Devices Event

Event ID	63110
Status	Completed
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-May-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, and OR. Internationally to Canada, Belgium, United Kingdom, Australia, France, Germany, and Poland.

Associated Products

Product Description	The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10. 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	SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10).
Classification	Class II
Reason for Recall	This field notice concerns two behaviors of the SharePlan (Multiple Fraction Groups and Depth Offset) that may be unexpected and are not clearly described in the user manual. None of these behaviors have 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.
Product Quantity	15 units
Recall Number	Z-2378-2012

Class II Devices Event

Event ID	63129
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Steris Corporation
City	Mentor
State	OH
Country	US
Distribution Pattern	Worldwide Distribution--USA (nationwide) including the states of AL, CA, CO, CT, FL, GA, IA, IN, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK,OR, PA, RI, SC, TX, UT, VA, WA, WI, WV and WY. and the country of Canada.

Associated Products

Product Description	Verify® Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor, OH 44060 The Verify Bowie-Dick Test Card consists of a card printed on one side with bars of chemical indicator ink. On the opposite side of the card, space is provided for critical cycle information to be recorded. The card is laminated inside a thin clear plastic enclosure. The enclosure has two holes in it to allow air removal and steam penetration. The preassembled test is used to evaluate the effectiveness of air removal from the sterilizer chamber during prevacuum pulse steam sterilizer cycle. Following a prevacuum cycle, the chemical bars of the Bowie-Dick Test card uniformly darken indicating that residual air has been sufficiently removed to allow complete steam penetration into the test card. If air is trapped in the card during the exposure phase of the cycle, the color change of the bars will be incomplete or uneven. Thus the card can provide an immediate indication of inadequate removal of air during a cycle. The Bowie-Dick Type test is performed in an empty chamber each day the sterilizer is to be used, usually before the first sterilization cycle.
Code Info	Model #S3098, Serial #"s: H20013, H20014, and H20016.
Classification	Class II
Reason for Recall	STERIS has learned that the Verify Bowie Dick Test Cards are not performing to product specifications. Specifically, test cards have resulted in false fail results when sterilizer performance is within acceptable ranges.
Product Quantity	629 cards
Recall Number	Z-2417-2012

Class II Devices Event

Event ID	63142
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Apr-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Steris Corporation
City	Mentor
State	OH
Country	US
Distribution Pattern	Worldwide Distribution - US Nationwide including the states of: AL, AR, CA, CO, CT, FL, HI, ID, IL, IN, IA, KY, LA, MA, MD, ME, MI, MN, MO, MS, NV, NYH, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WI & WV and countries of: Australia, Canada, China, India, Korea, Mexico, Panama and Thailand.

Associated Products

Product Description	STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. It accommodates all general surgical procedures including but not limited to, cardiac and vascular, endoscopic, gynecology, urology, nephrectomy, neurology, ophthalmologic, orthopedics and other procedures requiring intraoperative fluoroscopic C-arm imaging and also supports laparoscopic surgical technique for the largest surgical patients. The 5085SRT table is a variation of the 5085 table that enables patient transport on hard level surfaces within the surgical suite (from pre-operative areas to the operating room and again from the operating room to post operative recovery).
Code Info	Serial numbers from 0403809001 to 0408612102
Classification	Class II
Reason for Recall	STERIS has learned from Customer feedback and field service experience that damage from external impact to the table hydraulic column can cause the stainless steel shroud sections covering the table hydraulic column to become misaligned; if the damage is severe, the up/down movement of the table may be impeded. In addition, the table hand control may indicate that the table floor locks are unlocked when in fact the floor locks are engaged.
Product Quantity	379 tables
Recall Number	Z-2426-2012

Class II Devices Event

Event ID	63146
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Asahi Kasei Medical Co., Ltd., Okatomi Plant
City	Nobeoka-shi
State
Country	JP
Distribution Pattern	REXEED SX: Worldwide Distribution - USA including TN and the countries of Japan and Germany REXEED LX: Worldwide Distribution - USA including TN and Germany

Associated Products

Product Description	Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter
Code Info	Lot numbers: 194349, 193T45, 193U46, 194H4R, 294S59, 295V68, 295Z5L, 29626X, and 296J6U
Classification	Class II
Reason for Recall	Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products.
Product Quantity	55,632 units
Recall Number	Z-2418-2012

Product Description	Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter
Code Info	Lot numbers: 193S43, 193V47, 193W48, 1948E, 19494F, 194J4S, 194K4T, 294N4U, 296F6Q, 29767F, 297J7U, 297U87, 299199, 29929X, 29939Y, and 299X9H
Classification	Class II
Reason for Recall	Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products.
Product Quantity	152,016 units
Recall Number	Z-2419-2012

Product Description	Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter
Code Info	Lot numbers: 193J3R, 193M3T, and 294Q57
Classification	Class II
Reason for Recall	Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products.
Product Quantity	30,408 units
Recall Number	Z-2420-2012

Product Description	Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter
Code Info	Lot numbers: 295W67, 295Y5K, 29656B, 296E6P, 296N72, and 296Y6J
Classification	Class II
Reason for Recall	Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products.
Product Quantity	80,208 units
Recall Number	Z-2421-2012

Product Description	Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter
Code Info	Lot number: 296S77
Classification	Class II
Reason for Recall	Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products.
Product Quantity	1,536 units
Recall Number	Z-2422-2012

Product Description	Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter
Code Info	Lot number: 296T78
Classification	Class II
Reason for Recall	Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products.
Product Quantity	24 units
Recall Number	Z-2423-2012

Product Description	Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter
Code Info	Lot numbers: 193P3V and 295P62
Classification	Class II
Reason for Recall	Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products.
Product Quantity	5184 units
Recall Number	Z-2424-2012

Class III Biologics Event

Event ID	40008
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Mar-05
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	11GW59870, 11GW59871, 11GW59874, 11GW59876
Classification	Class III
Reason for Recall	Blood products, tested using the Hematastat equipment that was missing the daily quality control records, were distributed.
Product Quantity	4 units
Recall Number	B-2494-12

Class III Biologics Event

Event ID	42282
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-May-06
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	CSL Plasma
City	Lexington
State	KY
Country	US
Distribution Pattern	IL, Germany

Associated Products

Product Description	Source Plasma
Code Info	4040029292, 4040029296, 4040029301, 4040029294, 4040029304, 4040029297, 4040029289, 4040029298, 4040029299, 4040029305, 4040035505, 4040035512, 4040035517, 4040035522, 4040035523, 4040030105, 4040029306, 4040030109, 4040030111, 4040030114, 4040030115, 4040030116, 4040030117, 4040030118, 4040030225, 4040030228, 4040030232, 4040030302, 4040030306, 4040030308, 4040030309, 4040030310, 4040030311, 4040030312, 4040030313, 4040030314, 4040030315, 4040030316, 4040030317, 4040030318, 4040030319, 4040030320
Classification	Class III
Reason for Recall	Blood products, which may have reached unacceptable temperatures during storage, were distributed.
Product Quantity	42 units
Recall Number	B-2121-12

Class III Biologics Event

Event ID	44222
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Dec-06
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Hoxworth Blood Center University of Cincinnati Medical Center
City	Cincinnati
State	OH
Country	US
Distribution Pattern	OH

Associated Products

Product Description	Platelets Pooled
Code Info	0090059
Classification	Class III
Reason for Recall	Blood product, for which the quality control testing was incomplete, was distributed.
Product Quantity	1 unit
Recall Number	B-2328-12

Class III Biologics Event

Event ID	44296
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Jan-07
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Bio-Blood Components, Inc.
City	Columbus
State	OH
Country	US
Distribution Pattern	CA

Associated Products

Product Description	Source Plasma
Code Info	06BOHA0323
Classification	Class III
Reason for Recall	Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1 unit
Recall Number	B-2327-12

Class III Biologics Event

Event ID	44298
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Jan-07
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	American National Red Cross (The)
City	Toledo
State	OH
Country	US
Distribution Pattern	OH

Associated Products

Product Description	Plasma Frozen
Code Info	50LW55055
Classification	Class III
Reason for Recall	Blood products, manufactured from a whole blood unit that may have had an extended collection time, were distributed.
Product Quantity	1 unit
Recall Number	B-2329-12

Class III Biologics Event

Event ID	49625
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Jul-08
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	American Red Cross Blood Services
City	Wichita
State	KS
Country	US
Distribution Pattern	KS, OK

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced Irradiated
Code Info	02P96564, 02P96666, 02P96637, 02P96670, 02P96626, 02P96598, 02P96566, 02LS01159
Classification	Class III
Reason for Recall	Blood products, which may have reached an unacceptable temperature during storage, were distributed.
Product Quantity	8 units
Recall Number	B-2210-12

Class III Biologics Event

Event ID	50428
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Jul-08
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Source Plasma
Code Info	370060133, 370060924, 370061166, 370061723, 370063443, 370063689, 370064569, 370066763, 370069527, 370071330, 370072723, 370073353
Classification	Class III
Reason for Recall	Blood products, collected from a donor who was previously deferred, were distributed.
Product Quantity	12 units
Recall Number	B-2496-12

Class III Biologics Event

Event ID	62353
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-May-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	The Blood Connection, Inc.
City	Piedmont
State	SC
Country	US
Distribution Pattern	Michigan, South Carolina

Associated Products

Product Description	Fresh Frozen Plasma (Apheresis)
Code Info	W121611912691, W121611907470
Classification	Class III
Reason for Recall	Blood products, which were not frozen within six hours of collection, were distributed.
Product Quantity	2 units
Recall Number	B-2218-12

Class III Biologics Event

Event ID	62363
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Apr-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Amer. National Red Cross-Greater Chesapeake & Potomac Reg.
City	Baltimore
State	MD
Country	US
Distribution Pattern	Maryland

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	53H10237
Classification	Class III
Reason for Recall	Blood product, which was incorrectly labeled as negative for the N red cell antigen, was distributed.
Product Quantity	1 unit
Recall Number	B-2127-12

Class III Biologics Event

Event ID	62376
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-Apr-12
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Recovered Plasma
Code Info	011LQ82629
Classification	Class III
Reason for Recall	Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity	1 unit
Recall Number	B-2120-12

Class III Devices Event

Event ID	62577
Status	Completed
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	31-Dec-10
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Kimberly-Clark Corporation
City	Roswell
State	GA
Country	US
Distribution Pattern	US (nationwide) including the states of CA, CO, LA, NM, OK, TX and WA.

Associated Products

Product Description	ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Code Info	Product Code: 95221-35, Unit Code: 90372
Classification	Class III
Reason for Recall	The impacted product was not intended for commercial distribution to end users.
Product Quantity	32 cases
Recall Number	Z-2425-2012

Class III Devices Event

Event ID	62736
Status	Completed
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Mar-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Impact Instrumentation, Inc.
City	West Caldwell
State	NJ
Country	US
Distribution Pattern	Nationwide distribution: USA including states of: FL and OH.

Associated Products

Product Description	Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers.
Code Info	Model 324JL S/N 120142 and S/N 120144
Classification	Class III
Reason for Recall	A shipment mix-up took place.
Product Quantity	2 devices
Recall Number	Z-2430-2012

Class III Devices Event

Event ID	62897
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Siemens Healthcare Diagnostics, Inc
City	East Walpole
State	MA
Country	US
Distribution Pattern	Worldwide Distribution - US Nationwide and the countries of: Canada, Argentina, Australia, Bangaldesh,Brazil, Chile, China, Columbia, Croatia, Ecuduar, Egypt, Hong Kong, India, Israel,Japan, Korea, Maylasia, New Zealand, Mexico, Peru, Philipines, Pakistan, Saudia Arabia, Singapore, Thailand, Taiwan, Viet Nam, South Africa and UK.

Associated Products

Product Description	ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP Prolactin assay: For in vitro diagnostic use in the quantitative determination of prolactin in serum using the ADVIA Centaur System. ADVIA Centaur Calibrator B: For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur® Systems: Digoxin, FSH, TotallgE, LH, LH2, Prolactin, Total hCG, and TSH
Code Info	US: 2 Pack Ref: 00649625: Lot Numbers/Exp Date: Dec 2, 2012: 78813A30 79982A30 81013A30 82021B30 82767B30 83453C30 85447D30 87319A40 Exp Date:April 9, 2013 85598A40 85708A40 86098A40 87319A40 87979B40 88809B40 89351C40 91750C40 (6 pack) Ref. 00652707: Lot Numbers/Exp Date: Dec 2 2012 79354A30 80802A30 81892B30 82815B30 83741D30 84186A40 Exp. Date April, 8, 2013 85599A40 86191A40 88102B40 89717C40 91383C40 (6 Pack) Ref: 00654254 79714A30 Exp Date Dec 2, 2012 82370A30 84274A30 85512E30 OUS: 2 pack REF: 00650577 78319A29 Exp Dec 2, 2102 78487A29 79024A29 79403A29 79770B29 79981B29 82935B29 85735C29 00654130 Ref: 00654130 (6 pack) 78321A29 Exp Dec 2,2102 79197A29 83314C29
Classification	Class III
Reason for Recall	ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40
Product Quantity	15, 455 kits
Recall Number	Z-2409-2012

Product Description	ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination of follicle-stimulating hormone (FSH) in serum using the ADVIA Centaur and ADVIA Centaur XP systems
Code Info	US: 2 Pack Ref: 00649625: Lot Numbers/Exp Date: Dec 2, 2012: 78813A30 79982A30 81013A30 82021B30 82767B30 83453C30 85447D30 87319A40 Exp Date:April 9, 2013 85598A40 85708A40 86098A40 87319A40 87979B40 88809B40 89351C40 91750C40 (6 pack) Ref. 00652707: Lot Numbers/Exp Date: Dec 2 2012 79354A30 80802A30 81892B30 82815B30 83741D30 84186A40 Exp. Date April, 8, 2013 85599A40 86191A40 88102B40 89717C40 91383C40 (6 Pack) Ref: 00654254 79714A30 Exp Date Dec 2, 2012 82370A30 84274A30 85512E30 OUS: 2 pack REF: 00650577 78319A29 Exp Dec 2, 2102 78487A29 79024A29 79403A29 79770B29 79981B29 82935B29 85735C29 00654130 Ref: 00654130 (6 pack) 78321A29 Exp Dec 2,2102 79197A29 83314C29
Classification	Class III
Reason for Recall	ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40
Product Quantity	15,445 kits
Recall Number	Z-2410-2012

Class III Devices Event

Event ID	63006
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-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 - US Nationwide including the states of: AL, CA, GA, MA, MD, NC, OH, PA, TX, and WA; and to the following countries of: Algeria, Oman, Australia, Brazil, China, Saudi Arabia, United Arab Emirates, and India.

Associated Products

Product Description	The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Code Info	System Code #, 728246, Serial #, 6462, 6447, 6495, 6514, 6467, 6482, 6473, 6544, 6439, 6453, 6436, 6536, 6448, 6449, 6471, 6498, 6502, 6504, 6452, 6510, 6508, 6438, 6513, 6456, 6505, 6457, 6442, 6454, 6461, 6469, 6485, 6458, 6475, 6487, 6531, 6520, 6490, 6470, 6437, 6497, 6481, 6489, 6488, 6455, 6543, 6499, 6493, 6443, 6463, 6476, 6477, 6478, 6526, 6545, 6546, 6518, 6491, 6450, 6451, 6468, 6464, 6466, 6459, 6472, 6444, 6445, 6529, 6530, 6440, 6532, 6515, 6486, 6507, 6512, 6483, 6524, 6480, 6479, 6509, 6460, 6441, 6465, 6474, 6484, 6492, 6503, 6511, 6517, 6519, 6523, 6525, 6549, 6555
Classification	Class III
Reason for Recall	Philips was notified that the system logout in software version 2.3.6 is now longer and may sometimes fail to logout, requiring a forced system restart or hard shutdown with the power button.
Product Quantity	93 units
Recall Number	Z-2404-2012

Class III Drugs Event

Event ID	63080
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Sep-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Apace KY LLC
City	Fountain Run
State	KY
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30
Code Info	Lot: DL11600 Exp Date: 06/13
Classification	Class III
Reason for Recall	Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.
Product Quantity	81,516 bottles
Recall Number	D-1683-2012

Class III Devices Event

Event ID	63105
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-Aug-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Amsino Medical USA
City	Nashville
State	TN
Country	US
Distribution Pattern	Distributed to one customer in Illinois.

Associated Products

Product Description	0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.
Code Info	KH03752
Classification	Class III
Reason for Recall	One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL.
Product Quantity	196,400 units
Recall Number	Z-2393-2012

Product Description	0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.
Code Info	KH03752
Classification	Class III
Reason for Recall	One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL.
Product Quantity	unknown
Recall Number	Z-2394-2012

Class III Drugs Event

Event ID	63160
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Sandoz Incorporated
City	Broomfield
State	CO
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781- 5249-92,
Code Info	Lot numbers: BJ3338; BJ3339; BJ 3340; BJ3341; BJ3342; BJ6282; BJ7192; BM8498; BJ7202; BJ7203, Exp 12/12
Classification	Class III
Reason for Recall	Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Product Quantity	43,060 x 90 count bottles
Recall Number	D-1677-2012

Product Description	Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5248-92
Code Info	Lot numbers: KW10J511, KW10J512, KW10J513, KW10J514, KW10J515, BJ3167, BJ3172, BJ3177, BJ3179, BJ3188, BJ3182. Exp. 09/12
Classification	Class III
Reason for Recall	Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Product Quantity	41,761bottles.
Recall Number	D-1678-2012

Mixed Classification Biologics Event

Event ID	48860
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-May-08
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Recovered Plasma
Code Info	02LP18662
Classification	Class III
Reason for Recall	Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-2454-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	02LP18662
Classification	Class II
Reason for Recall	Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-2455-12

Mixed Classification Biologics Event

Event ID	62064
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-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; California

Associated Products

Product Description	Plasma Frozen Cryoprecipitated Reduced
Code Info	W117009159701N;
Classification	Class II
Reason for Recall	Blood products, collected from a donor with a history reactive results for HCV, were distributed.
Product Quantity	1 unit
Recall Number	B-1941-12

Product Description	Red Blood Cells Leukocytes Reduced Irradiated
Code Info	W117010196924W;
Classification	Class II
Reason for Recall	Blood products, collected from a donor with a history reactive results for HCV, were distributed.
Product Quantity	1 unit
Recall Number	B-1942-12

Product Description	Plasma Frozen
Code Info	W117011455152N;
Classification	Class II
Reason for Recall	Blood products, collected from a donor with a history reactive results for HCV, were distributed.
Product Quantity	1 unit
Recall Number	B-1943-12

Product Description	Cryoprecipitated AHF, Pooled
Code Info	W117009159701N; W117010100874Y; W1170114435834;
Classification	Class II
Reason for Recall	Blood products, collected from a donor with a history reactive results for HCV, were distributed.
Product Quantity	3 units
Recall Number	B-1944-12

Product Description	Blood and Blood Products for Reprocessing
Code Info	W117010196924W; W1170114417093;
Classification	Class III
Reason for Recall	Blood products, collected from a donor with a history reactive results for HCV, were distributed.
Product Quantity	2 units
Recall Number	B-1945-12

Product Description	Fresh Frozen Plasma
Code Info	W117009194370I; W117009125131Y; W117011426472Y; W1170101117358;
Classification	Class II
Reason for Recall	Blood products, collected from a donor with a history reactive results for HCV, were distributed.
Product Quantity	4 units
Recall Number	B-1946-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W117009159701N; W117009125131Y; W117009194370I; W117011426472Y; W1170101117358; W117011455152N; W1170114417093;
Classification	Class II
Reason for Recall	Blood products, collected from a donor with a history reactive results for HCV, were distributed.
Product Quantity	7 units
Recall Number	B-1947-12

Mixed Classification Biologics Event

Event ID	62354
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-May-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Blood Assurance Inc
City	Chattanooga
State	TN
Country	US
Distribution Pattern	Tennessee, Georgia, Indiana

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W043212033535 (2 units)
Classification	Class II
Reason for Recall	Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity	2 units
Recall Number	B-2135-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W043211081628
Classification	Class II
Reason for Recall	Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-2136-12

Product Description	Recovered Plasma
Code Info	W043211081628
Classification	Class III
Reason for Recall	Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-2137-12

Mixed Classification Biologics Event

Event ID	62362
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Feb-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	HCSC-Blood Center
City	Bethlehem
State	PA
Country	US
Distribution Pattern	Pennsylvania, Korea, New Jersey

Associated Products

Product Description	Recovered Plasma
Code Info	W050912012863
Classification	Class II
Reason for Recall	Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-2345-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W050912012863, W050912013540
Classification	Class II
Reason for Recall	Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity	2 units
Recall Number	B-2346-12

Product Description	Fresh Frozen Plasma
Code Info	W050912009254
Classification	Class III
Reason for Recall	Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-2347-12

Product Description	Red Blood Cells
Code Info	W050912010131
Classification	Class III
Reason for Recall	Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-2348-12

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W050912013552
Classification	Class II
Reason for Recall	Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-2349-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W050912011703, W050912009254
Classification	Class III
Reason for Recall	Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity	2 units
Recall Number	B-2350-12

Mixed Classification Biologics Event

Event ID	62412
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Apr-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	American National Red Cross
City	Columbus
State	OH
Country	US
Distribution Pattern	Ohio, California

Associated Products

Product Description	Recovered Plasma
Code Info	16GR73221
Classification	Class III
Reason for Recall	Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity	1 unit
Recall Number	B-2112-12

Product Description	Cryoprecipitated AHF, Pooled
Code Info	16GR73221 (pool ID: 16N54970)
Classification	Class II
Reason for Recall	Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity	1 unit
Recall Number	B-2113-12

-

-