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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Class I Drugs Event

Event ID61256
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Feb-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling Firmwww.vitaminbestbuy.com
CityBrewerton
StateNY
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionHard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: American Federal International Living Creature Group and Tibet Gold Source Living Creature Engineering Limited Company, Unit 18, 55 Beijing Road Central, Lhasa, Tibet
Code InfoAll lots.
ClassificationClass I
Reason for RecallMarketed Without an Approved ANDA/NDA: presence of sildenafil
Product Quantity550 boxes
Recall NumberD-1698-2012
Product DescriptionMan King Capsules, 2800 mg, boxes of 5 packets, OTC, Developed by: American Wanbao Pharmaceutical International Group and Hainan Wanbao Biological Engineering Co., Ltd., 27 Heping Road, Haikou, Henan Province, UPC 9 009900 0032328
Code InfoAll lots.
ClassificationClass I
Reason for RecallMarketed Without an Approved ANDA/NDA: presence of sildenafil.
Product Quantity69 boxes
Recall NumberD-1699-2012
Product DescriptionJapan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box, Green algae lipotropic (fat dissolving) agent, OTC, Distributed by Vitaminbestbuy.com, Brewerton, NY
Code InfoAll lots.
ClassificationClass I
Reason for RecallMarketed Without an Approved ANDA/NDA: presence of sibutramine
Product Quantity52 boxes
Recall NumberD-1700-2012

Class I Drugs Event

Event ID62422
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jun-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmBen Venue Laboratories Inc
CityBedford
StateOH
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionVecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg Vials, lyophilized powder per carton, Rx Only, Mfr. By: Ben Venue Laboratories, Bedford, OH 44146: Mfg for: Bedford Labs, Bedford, OH 44146, NDC 55390-039-10.
Code InfoLot #2067134 Exp 5/31/2013, NDC 55390-039-10
ClassificationClass I
Reason for RecallPresence of Particulate Matter
Product Quantity797 boxes/10/20 mg vials
Recall NumberD-1697-2012

Class I Food Event

Event ID63002
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Aug-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmMyoSci Technologies Inc.
CityOceanside
StateCA
CountryUS
Distribution Patternnationwide in the US and worldwide to Canada and United Kingdom.
 

Associated Products

Product DescriptionWhey Protein Concentrate, Net Weight: 1lb (454g)
Code InfoBatch/Lot#0120712
ClassificationClass I
Reason for RecallTrue Nutrition is recalling Whey Protein Isolate, Whey Protein Concentrate, and Hydrolyzed Whey Protein because they contain undeclared milk.
Product Quantity1500 units
Recall NumberF-2367-2012
Product DescriptionWhey Protein Isolate Cold-Filtration, Net Weight: 1lb (454g)
Code InfoBatch/Lot#0030812
ClassificationClass I
Reason for RecallTrue Nutrition is recalling Whey Protein Isolate, Whey Protein Concentrate, and Hydrolyzed Whey Protein because they contain undeclared milk.
Product Quantity200 units
Recall NumberF-2368-2012
Product DescriptionWhey Protein Isolate MicroFiltration, Net Weight: 1lb (454g)
Code InfoBatch/Lot#0040812
ClassificationClass I
Reason for RecallTrue Nutrition is recalling Whey Protein Isolate, Whey Protein Concentrate, and Hydrolyzed Whey Protein because they contain undeclared milk.
Product Quantity100 units
Recall NumberF-2369-2012
Product DescriptionWhey Protein Isolate Cross-Flow Microfiltration, Net Weight: 1lb (454g)
Code InfoBatch/Lot#0730712
ClassificationClass I
Reason for RecallTrue Nutrition is recalling Whey Protein Isolate, Whey Protein Concentrate, and Hydrolyzed Whey Protein because they contain undeclared milk.
Product Quantity300 units
Recall NumberF-2370-2012
Product DescriptionHydrolyzed Whey Protein High Grade, Net Weight: 1lb (454g)
Code InfoBatch/Lot#0680512
ClassificationClass I
Reason for RecallTrue Nutrition is recalling Whey Protein Isolate, Whey Protein Concentrate, and Hydrolyzed Whey Protein because they contain undeclared milk.
Product Quantity200 units
Recall NumberF-2371-2012

Class I Food Event

Event ID63010
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmCucina Fresca, Inc.
CitySeattle
StateWA
CountryUS
Distribution PatternProduct was distributed to Oregon and Washington
 

Associated Products

Product DescriptionCucina Fresca Smoked Tomato Sauce. Product is packaged in a glass jar, net weight 24 oz. The UPC is 8-84337 00522-4
Code InfoLot 11002A and 11002B. Code is deciphered as: First digit = Shift; Second, Third, and Fourth digit = Julian date; Fifth digit = Production year
ClassificationClass I
Reason for RecallSmoked Tomato Sauce was recalled due to undeclared milk. The jars actually contain Cucina Fresca Tomato Vodka Sauce, which contains milk as an ingredient, but was mis-labeled as Smoked Tomato Sauce and the label does not declare milk.
Product Quantity117 cases/6 jars/ 24 oz. total (59 cases to warehouse and 58 cases to retail stores)
Recall NumberF-2359-2012

Class I Food Event

Event ID63032
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSplendid Products
CityBurlingame
StateCA
CountryUS
Distribution PatternNationwide distribution.
 

Associated Products

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

Class I Food Event

Event ID63058
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmGordon Food Service
CityWyoming
StateMI
CountryUS
Distribution Patternrestaurants and GFS retail outlets in Florida
 

Associated Products

Product DescriptionPistachios, Shelled Raw, 4 /2.5 Packed by Tropical Food Nut & Fruit- Orlando, FL 32811
Code InfoGFS Item #866580 10015196182512, Lot 060412, 052912, Best By 02/03/13
ClassificationClass I
Reason for RecallGordon Food Service is recalling Tropical Food Nut & Fruit Shelled Raw Pistachios , because there is potential for the box to be mis-packed with chopped peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.
Product Quantity7 cases by GFS distribution center
Recall NumberF-2390-2012

Class I Food Event

Event ID63061
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jun-11
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmIndalco Foods Corp.
CityMiami
StateFL
CountryUS
Distribution PatternUS
 

Associated Products

Product Description***Dulce De Leche "Del Campo"***Ice Cream "Base" (Flavor)***FB 23546***Mfg. Date***Keep Refrigerated at 40*f***Lot#***Net Wt 55 LBS***Indalco Food Corp., Miami, FLA (305) 620 1444*** Caramel milk spread is packed in white plastic pails of 55 lbs. under the firm's brand name "Del Campo".
Code InfoLot # 721 and Lot # 728
ClassificationClass I
Reason for RecallOn June 28, 2011, Indalco Foods, Corp., Miami, FL initiated a voluntary recall of their product caramel milk spread ice cream base (dulce de leche heladero). Product labeling does not list Milk.
Product Quantity23/ 55 lbs. pails
Recall NumberF-2391-2012

Class I Food Event

Event ID63062
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Aug-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmReady Pac Foods Inc
CityIrwindale
StateCA
CountryUS
Distribution PatternNationwide to following US States and Canada: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Washington D.C., Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, Wyoming, and Canada.
 

Associated Products

Product DescriptionFruit Mixes: 1) Dining In® Super Fruit Medley,10.5oz, UPC 1122508396, Use by date 9/6/2012; 2) Ready Pac® Super Fruit Blend, 6oz , UPC 7774523076, Use by Dates 9/8/2012 or earlier, 9/6/2012 & 9/7/2012; 3) Ready Pac® Super Fruit Medley, 10.5oz, UPC 7774523746, Use by dates 9/8/2012 or earlier, 9/6/2012 & 9/7/2012. Ready Pac® Super Fruit Medley, 298g , UPC 7774524023, Use by dates 9/8/2012 or earlier and 9/8/2012.
Code Info1) Use by date 9/6/2012; 2) Use by dates 9/8/2012 or earlier, 9/6/2012 & 9/7/2012; 3) Use by dates 9/8/2012 or earlier and 9/8/2012
ClassificationClass I
Reason for RecallFirm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup.
Product Quantity1) 65 cases; 2) 160 cases; 3) 1083 cases
Recall NumberF-2378-2012
Product DescriptionMango: 1) Dining In® Mango ,10.5oz , UPC 1122508640, Use by Date 9/7/2012; 2) Wawa® Mango, 8oz, UPC 2619106437, Use by dates 9/6/2012 or earlier.
Code Info1) Use by Date 9/7/2012; 2) Use by dates 9/6/2012 or earlier
ClassificationClass I
Reason for RecallFirm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup.
Product Quantity1) 65 cases; 2) 3542 cases
Recall NumberF-2379-2012
Product DescriptionReady Pac® Fruit Tray Bien®, 907g UPC 7774523415 and Use by date 9/8/2012. Ready Pac® Fruit Tray Bien® 32oz UPC 7774521606, Use by date 9/8/2012 or earlier.
Code InfoUPC 7774523415 Use by date 9/8/2012. UPC 7774521606, Use by date 9/8/2012 or earlier.
ClassificationClass I
Reason for RecallFirm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup
Product Quantity199 cases
Recall NumberF-2380-2012
Product DescriptionReady Pac® Fruit & Chocolate Platter, 40oz , UPC 7774523673, Use by dates 9/6/2012 & 9/7/2012
Code InfoUPC 7774523673, Use by dates 9/6/2012 & 9/7/2012
ClassificationClass I
Reason for RecallFirm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup.
Product Quantity395 cases
Recall NumberF-2381-2012
Product DescriptionReady Pac® Sliced Mango, 10.5oz , UPC 7774523751, Use by dates 9/8/2012 or earlier, 9/6/2012 & 9/7/2012. Ready Pac® Sliced Mango, 32oz, UPC 0000088356, Use by dates 9/6/2012 & 9/7/2012. Ready Pac® Sliced Mango, 32 oz, UPC 7774522859, Use by dates 9/8/2012 or earlier and 9/6/2012 & 9/7/2012.
Code InfoUPC 7774523746, Use by dates 9/8/2012 or earlier, 9/6/2012 & 9/7/2012. UPC 7774524023, Use by dates 9/8/2012 or earlier and 9/8/2012.
ClassificationClass I
Reason for RecallFirm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup.
Product Quantity1544 cases
Recall NumberF-2382-2012
Product DescriptionReady Pac® Mango Fandango", 32oz, UPC 7774524099, Use by dates 9/8/2012 or earlier and 9/6/2012 & 9/7/2012.
Code InfoUse by dates 9/8/2012 or earlier and 9/6/2012 & 9/7/2012.
ClassificationClass I
Reason for RecallFirm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup.
Product Quantity721 cases
Recall NumberF-2383-2012
Product DescriptionReady Pac® Gourmet Fruit Bowl, 64oz , UPC 7774522620, Use by dates 9/9/2012 or earlier and 9/7/2012 & 9/8/2012.
Code InfoUPC 7774522620, Use by dates 9/9/2012 or earlier and 9/7/2012 & 9/8/2012.
ClassificationClass I
Reason for RecallFirm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup.
Product Quantity2945 cases
Recall NumberF-2384-2012
Product DescriptionReady Pac® Sweet Sunshine Platter, 37oz, UPC 7774524204, Use by dates 9/8/2012 or earlier and 9/6/2012 & 9/7/2012.
Code InfoUPC 7774524204, Use by dates 9/8/2012 or earlier and 9/6/2012 & 9/7/2012.
ClassificationClass I
Reason for RecallFirm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup.
Product Quantity515 cases
Recall NumberF-2385-2012
Product DescriptionReady Pac® Seasons Choice", 32oz, UPC 7774524276, Use by dates 9/8/2012 or earlier and 9/7/2012 & 9/8/2012.
Code InfoUPC 7774524276, Use by dates 9/8/2012 or earlier and 9/7/2012 & 9/8/2012.
ClassificationClass I
Reason for RecallFirm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup.
Product Quantity209 cases
Recall NumberF-2386-2012
Product DescriptionStarbucks® Seasonal Harvest Fruit Blend, 6oz, UPC 6211171390, Use by dates 8/22/2012 through 9/7/2012 and 9/4/2012 & 9/5/2012.
Code InfoUPC 6211171390, Use by dates 8/22/2012 through 9/7/2012 and 9/4/2012 & 9/5/2012.
ClassificationClass I
Reason for RecallFirm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup.
Product Quantity19,060 cases
Recall NumberF-2387-2012
Product DescriptionWalmart® Super Fruit Blend, 10oz, UPC 7774523327, Use by dates 9/6/2012 & 9/7/2012.
Code InfoUPC 7774523327, Use by dates 9/6/2012 & 9/7/2012.
ClassificationClass I
Reason for RecallFirm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup.
Product Quantity234 cases
Recall NumberF-2388-2012
Product DescriptionWalmart® Seasonal Blend ,16oz, UPC 7774523761, Use by dates 9/6/2012 & 9/7/2012. Walmart® Seasonal Blend, 32oz, UPC 7774523765, Use by dates 9/6/2012 & 9/7/2012.
Code InfoUPC 7774523761, Use by dates 9/6/2012 & 9/7/2012. UPC 7774523765, Use by dates 9/6/2012 & 9/7/2012.
ClassificationClass I
Reason for RecallFirm is voluntarily recalling, out of an abundance of caution, packaged fruit products containing mangoes, distributed through August 30th 2012, since they contain Daniella Brand mandoes, which have been recalled by supplier Splendid Products, due to potential contamination with Salmonella Braenderup.
Product Quantity676 cases
Recall NumberF-2389-2012

Class I Food Event

Event ID63153
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Sep-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmDawn Food Products, Incorporated
CityDenver
StateCO
CountryUS
Distribution PatternTo Sam's Club locations in UT, OK, TX CA, MO, and WY, USA.
 

Associated Products

Product DescriptionSam's Club Chunky Cinnamon Streusel, Net Wt 25 lb, in white plastic pails, Manufactured for Sam's Club, Bentonville, AR 72716, Best if stored in a cool, dry location between 65 - 75 degrees Farenheit.
Code Info2-203-19-81; 2-203-19-82; 2-203-19-83; 2-223-19-01; 2-223-19-02; 2-223-19-03; 2-223-19-04; 2-236-19-83; 2-236-19-84; 2-236-19-87
ClassificationClass I
Reason for RecallDawn Foods is recalling 251, 25 lb pails of Chunky Cinnamon Streusel due to the omission of the major allergens milk and soy from the finished product label.
Product Quantity251 x 25 lbs pails
Recall NumberF-2394-2012

Class II Biologics Event

Event ID38672
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Apr-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmZLB Bioplasma, Inc.
CityAurora
StateCO
CountryUS
Distribution PatternIL, IN, Germany, Switzerland
 

Associated Products

Product DescriptionSource Plasma
Code Info7020569758;7020569243;7020561213;7020560515;7020559510;7020558871;7020557589;7020556923;7020555960;7020554644;7020554249;7020551927;7020549396;7020548750;7020546254;7020545607;7020543963;7020542709;7020541769;7020541080;7020540134;7020537340;7020536579;7020535741;7020534950;7020533777;7020532633;7020531792;7020530859;7020530108;7020528828;7020528109;7020527346;7020526610;7020525530;7020525122;7020522123;7020521031;7020518895;7020518020;7020516872;7020516410;7020514961;7020514002;7020505987;7020504543;7020501835;7020501348;7020500269;7020499825;7020496782;7020496011;7020495192
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
Product Quantity53 units
Recall NumberB-2336-12

Class II Biologics Event

Event ID39117
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Apr-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Bank of Lancaster County Medical Society
CityLincoln
StateNE
CountryUS
Distribution PatternFL, Austria
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info6554173
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor with a history of multiple high risk behaviors, were distributed.
Product Quantity1 unit
Recall NumberB-2022-12
Product DescriptionBlood and Blood Products for Reprocessing
Code Info6554173
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor with a history of multiple high risk behaviors, were distributed.
Product Quantity1 unit
Recall NumberB-2023-12

Class II Biologics Event

Event ID39899
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Feb-05
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Bank of Lancaster County Medical Society
CityLincoln
StateNE
CountryUS
Distribution PatternNE
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code Info3695222(Part A); 3695222(Part B)
ClassificationClass II
Reason for RecallBlood products, collected using expired control materials, were distributed.
Product Quantity2 units
Recall NumberB-2359-12
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info3695245; 3695218(Part A), 3695218 (Part B) 3695248 (Part A), 3695248 (Part B);
ClassificationClass II
Reason for RecallBlood products, collected using expired control materials, were distributed.
Product Quantity5 units
Recall NumberB-2360-12

Class II Biologics Event

Event ID40583
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Aug-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMary Greeley Medical Center
CityAmes
StateIA
CountryUS
Distribution PatternIA, NY, MO
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info4718843
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tatoo within 12 months of donation, were distributed.
Product Quantity1 unit
Recall NumberB-2295-12
Product DescriptionRed Blood Cells
Code Info4718843
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tatoo within 12 months of donation, were distributed.
Product Quantity1 unit
Recall NumberB-2296-12

Class II Biologics Event

Event ID41475
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Aug-05
Initial Firm Notification of Consignee or Public Visit
Recalling FirmMercy Medical Center Blood Bank
CityCedar Rapids
StateIA
CountryUS
Distribution PatternIA,
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoS9911446
ClassificationClass II
Reason for RecallBlood product, which tested negative for hepatitis, but was collected from a donor who previously tested positive for the antibody to hepatitis B core antigen (anti-HBcore) on two separate occasions, was distributed.
Product Quantity1 unit
Recall NumberB-2445-12

Class II Biologics Event

Event ID41764
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Mar-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center of Greater Kansas City
CityKansas City
StateMO
CountryUS
Distribution PatternKS
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045006019703
ClassificationClass II
Reason for RecallBlood product which did not meet Quality Control specifications was distributed.
Product Quantity1 unit
Recall NumberB-2324-12

Class II Biologics Event

Event ID44312
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Dec-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityOmaha
StateNE
CountryUS
Distribution PatternCO, NE, Switzerland
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code Info09Q 85020
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred, were distributed
Product Quantity1 unit
Recall NumberB-1770-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info09FZ59427; 09GX45894; 09GX47142; 09Q 85020
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred, were distributed
Product Quantity4 units
Recall NumberB-1771-12
Product DescriptionBlood and Blood Products for Reprocessing
Code Info09FZ53427; 09GX45894; 09GX47142
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred, were distributed
Product Quantity3 units
Recall NumberB-1772-12

Class II Biologics Event

Event ID49324
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jul-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMississippi Valley Regional Blood Center
CityDavenport
StateIA
CountryUS
Distribution PatternIowa, Illinois
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW038308071454;W038308071457
ClassificationClass II
Reason for RecallBlood products, which component preparation were not prepared in accordance with specifications, were distributed.
Product Quantity2 Units
Recall NumberB-2353-12

Class II Biologics Event

Event ID50666
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Nov-08
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmAmerican National Red Cross (The)
CityDedham
StateMA
CountryUS
Distribution PatternCA, MA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info004KK58808
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability were not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1745-12
Product DescriptionBlood and Blood Products for Reprocessing
Code Info004KK58808
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability were not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1746-12

Class II Biologics Event

Event ID52053
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Mar-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOne Lambda Inc
CityCanoga Park
StateCA
CountryUS
Distribution PatternUS States CA and NY. Nationwide to: Canada, United Kingdom, Germany, Israel, Spain, Japan, Singapore, and vietnam.
 

Associated Products

Product DescriptionMicro SSPTM Allele Specific HLA Class I DNA Typing Tray - B*35 510(K) Number 8K 960062 Product number SSPR1-35 Product Insert Number SSP_DNAT_PIEN Rev 16
Code InfoProduct Name: Micro SSPTM Allele Specific HLA Class I DNA Typing Tray - B*35 Product Number: SSPR1-35 Lot Number: 002, batch 004 Expiration Date: 10/2013 Product Insert Number: SSP- DNAT-P-I EN Rev 16 510(K) Number BK 960062 Product Code MZI
ClassificationClass II
Reason for RecallHLA typing assay, associated with false negative results, was distributed.
Product Quantity1 unit
Recall NumberB-2457-12

Class II Biologics Event

Event ID55742
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Mar-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOne Lambda Inc
CityCanoga Park
StateCA
CountryUS
Distribution PatternNationwide in the US: OR and IL, and worldwide to Canada, Saudi Arabia/USA, United Kingdom, Germany, Italy, Jordon, Sweden, and Peru.
 

Associated Products

Product DescriptionMicro SSP Allele Specific HLA Class I DNA Typing Tray-AB, Product Number: SSP1-AB, Lot 003, batch 007
Code InfoMicro SSP Allele Specific HLA Class I DNA Typing Tray-AB, Product Number: SSP1-AB, Lot Number 003, batch 007 Expiration August 2013. Product insert Number SSP_DNAT_PI-EN Rev 16; 510(K) Number BK960062; Product Code MZI
ClassificationClass II
Reason for RecallHLA typing assay, associated with false negative results, was distributed.
Product Quantity1 unit
Recall NumberB-2458-12

Class II Biologics Event

Event ID56469
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Jul-10
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCSL Plasma, Inc.
CityHamilton
StateOH
CountryUS
Distribution PatternIL, Switzerland, Germany
 

Associated Products

Product DescriptionSource Plasma
Code Info49400010468, 49400015066, 49400019112, 49400024691, 49400029193,49400038129, 49400040982, 49400074365, 49400079780, 49400020981, 49400028123, 49400031613, 49400051710, 49400071850, 49400072693, 49400074701, 49400017328, 49400027892, 49400032720,49400037759, 49400054663, 49400074496, 49400078673, 49400008974, 49400018099, 49400020762, 49400029484, 49400036852,49400048618, 49400056204, 49400072001, 49400079502, 49400021036, 49400027340,49400031058, 49400037943, 49400029249, 49400035251,49400039922, 49400074648,49400079406, 49400049215, 49400049098, 49400025838,49400037003, 49400054911, 49400076694, 49400035470, 49400053636, 49400073725, 49400074947, 49400017627, 49400024907, 49400027737, 49400035390,49400038356, 49400053353, 49400050742,49400010812,49400015470, 49400019850, 49400025150, 49400015453,49400021992, 49400025109, 49400031980, 49400054487,49400079289, 49400020893, 49400031429, 49400037820, 49400056634, 49400017758, 49400025133, 49400035323, 49400078657, 49400037695, 49400010492,49400041352, 49400079115, 49400005423, 49400011356, 49400013490,49400075886,49400051876, 49400057223, 49400027690, 49400035278, 49400048327,49400056360, 49400076010, 49400027964, 49400020228, 49400024878, 49400037556, 49400057282, 49400071033, 49400077080,4940003152549400036617,49400051374, 49400071789, 49400075747,49400051614,49400055260, 49400074832, 49400049514,49400051606, 4940007834049400015162, 49400029425, 49400037370, 49400050419, 49400061054, 49400070970, 49400076416, 49400032755, 49400039906, 49400052385, 49400072968, 49400079019, 49400030320,49400033723, 49400050064, 49400070364, 49400074664, 49400053880, 49400004017, 49400008544,49400011516, 49400027956, 49400035411, 49400012949, 49400015592, 49400021925,49400025221, 49400034881, 49400052094, 4940007115649400075237,49400051260, 49400072327, 49400077793, 49400039228, 49400051323, 49400077830, 49400012527, 49400016819, 49400021562, 49400031250, 49400034208, 49400050208, 49400076660, 49400039711, 49400055930, 49400061290, 49400074277, 449400079107, 449400003479, 49400007250, 49400009934, 49400015760, 49400018769,49400026320, 49400036086, 49400039519, 49400047893, 49400050670, 49400077320, 49400028473, 49400039076, 49400052326,49400072810, 49400029783, 49400034929, 49400053679, 49400054671, 49400073004, 49400075173,49400031832, 49400038671, 49400041977,49400051681, 49400072095, 49400039720, 49400055949, 49400074242, 49400005407, 49400005466,49400010601,49400013183, 49400019008,49400022549, 49400029652, 49400032843, 49400039930, 49400052617,49400022127, 49400027008, 49400032771, 49400037652, 49400047930, 49400052270, 49400072829, 49400077427, 49400038372, 49400008333, 49400015630,49400022397, 49400073282, 49400006899, 49400017985, 49400023390, 49400026945, 49400034110, 49400011962, 49400015189, 49400021870,49400025010,49400033900, 49400051833, 49400072570, 49400076635, 49400012180, 49400018021, 49400020770, 49400027454, 49400032245, 49400039498, 49400012877, 49400015509, 49400025141, 49400032376, 49400049397, 49400075106, 49400078500, 49400054516, 49400073928, 49400026291,49400031365, 49400036713, 49400012720, 49400021730, 49400034970, 49400074621, 49400016421, 49400019420,49400025950, 49400029345, 49400036465, 49400050929, 49400056440, 49400070030,49400075712, 49400022610, 49400029695, 49400033221,49400073240, 49400016990, 49400020130, 49400026697, 49400056941, 49400075157, 49400078454, 49400052078, 49400016667, 49400023867,49400015170, 49400029450, 49400037361, 49400071041, 49400017010, 49400021263, 449400027884, 49400032448, 49400028983, 49400021466, 49400026540, 49400037020, 49400056845, 49400070591, 49400076504, 49400050961, 49400017360, 449400034232, 49400036490, 49400074410, 49400051032, 49400019702, 49400026718, 49400033539, 49400038620, 49400018460, 49400025002, 49400057012, 49400022960, 49400030418, 49400033651,49400055375,49400070268, 49400020594,49400027841,49400031314, 49400038241, 49400071746, 49400026275,49400020666, 49400027243,49400074226, 449400021140, 49400028991, 49400027753, 49400033862, 49400022186,49400023197, 49400033512, 49400022856, 49400033686, 49400037521, 49400072706, 49400025790, 49400025310, 49400032640, 49400037206, 49400052377, 49400073688, 49400075510, 49400027788, 49400038145, 49400076150, 49400080001, 49400028430,49400053660,49400073733, 49400030207, 49400035438, 49400029839, 49400035294, 49400056423, 49400079430, 49400027593, 49400034865, 49400038380, 49400074138, 49400077507, 49400037708,49400073311, 49400077187, 49400038225, 449400077451, 49400030952, 49400038006, 49400050881,49400075739, 49400033109, 49400074630, 49400077806,49400039674, 49400033969, 449400072351, 49400074146, 49400078796,49400039279, 49400075050, 49400035243, 49400073477, 49400076352, 49400038540, 49400053302, 49400037388, 49400074998, 49400053273, 49400071906, 49400077689, 49400038399, 49400074390, 49400077523,49400054903, 49400071615, 49400074381, 49400074154, 49400079748,49400071990, 49400072546, 49400051358, 49400071826, 49400077110, 49400053484, 49400076070,49400054989, 49400077611, 49400222090, 49400055560, 49400078593, 49400078577, 49400050152, 49400050179, 4940005044, 49400050486, 49400052019, 49400051500
ClassificationClass II
Reason for RecallBlood products, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity401 units
Recall NumberB-2352-12

Class II Biologics Event

Event ID59883
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-May-11
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBloodSource, Inc.
CityRedding
StateCA
CountryUS
Distribution PatternCA, Austria
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW035811140656; W035811140648; W035811140646; W035811140704; W035811140619; W035811140556; WO35811140707;
ClassificationClass II
Reason for RecallBlood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity7 units
Recall NumberB-2340-12
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW035811140557
ClassificationClass II
Reason for RecallBlood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity1 unit
Recall NumberB-2341-12

Class II Biologics Event

Event ID60014
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jul-11
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmDelta Blood Bank
CityStockton
StateCA
CountryUS
Distribution PatternCA.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW128711300920
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2225-12

Class II Biologics Event

Event ID60439
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Sep-11
Initial Firm Notification of Consignee or Public FAX
Recalling FirmDelta Blood Bank
CityStockton
StateCA
CountryUS
Distribution PatternCA.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW128711122482
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-2224-12

Class II Biologics Event

Event ID62139
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Apr-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBlood Centers of the Pacific - Irwin Center
CitySan Francisco
StateCA
CountryUS
Distribution PatternSwitzerland; Austria; Armed Forces Americas, California
 

Associated Products

Product DescriptionPlasma Frozen
Code Info506028927; 506028592;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who gave history which warranted deferral or follow up were distributed.
Product Quantity2 units
Recall NumberB-2204-12
Product DescriptionFresh Frozen Plasma
Code Info506083305;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who gave history which warranted deferral or follow up were distributed.
Product Quantity1 unit
Recall NumberB-2205-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info506030332; 506028927; 506028592; 506077852; 506071807; 506055283; W117009320416Y; W117008302038T; 509238455; 506050613; 506099742; 506088134; 506083305; 504804927; 504804630; 504287307; 500790860;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who gave history which warranted deferral or follow up were distributed.
Product Quantity17 units
Recall NumberB-2206-12

Class II Biologics Event

Event ID62141
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-May-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmWalter L. Shepeard Community Blood Center, Inc.
CityAugusta
StateGA
CountryUS
Distribution PatternGeorgia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW038512101381;
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-2151-12

Class II Devices Event

Event ID62313
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTerumo Cardiovascular Systems Corporation
CityAnn Arbor
StateMI
CountryUS
Distribution PatternWorldwide and US Nationwide Distribution
 

Associated Products

Product DescriptionTerumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
Code InfoCatalog number: 802018 and serial numbers: 00032, 00042, 00056, 00147, 00623, 00700-00764, 00766-00820, and 00823-00847.
ClassificationClass II
Reason for RecallTerumo Cardiovascular Systems (CVS) received two reports of the false back flow alarms for the Terumo® Advanced Perfusion System 1 when there was no tubing in the flow sensor. Terumo CVS' investigation found that the voltage level on a circuit board was improperly set in a population of flow modules for Terumo System 1, the sensor operates correctly if the tubing is installed and it is highly unlikely that the failure would recur. The failure only occurs when there is no tubing installed in the flow sensor, therefore the only risk to the patient is if the false alarm somehow delays the surgical procedure. There are no known reports of patient injury as a result of this issue.
Product Quantity150 units
Recall NumberZ-2443-2012

Class II Devices Event

Event ID62322
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTerumo Cardiovascular Systems Corporation
CityAnn Arbor
StateMI
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and the countries of AUSTRALIA, Singapore, Jordan, Japan, Vietnam, Germany, Russia, Saudi Arabia, BELGIUM, Mexico, and CANADA.
 

Associated Products

Product DescriptionTerumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
Code InfoCatalog number: 802018 and serial numbers: 00122, 00337, 00340, 00343-00389, 00391-00395, 00397-00410, 00437, 00438, and 00488.
ClassificationClass II
Reason for RecallTerumo Cardiovascular Systems (CVS) received one report of a flow module for the Terumo Advanced Perfusion System 1 not displaying blood flow information on the Central Control Monitor or the Centrifugal Control Unit. The tricolor LED on the flow module was not illuminated. Terumo CVS' investigation found that the malfunction was caused by an improper component on a circuit board used in a population of flow modules for Terumo System 1.
Product Quantity72 units
Recall NumberZ-2449-2012

Class II Drugs Event

Event ID62384
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmWatson Laboratories, Inc.
CitySalt Lake City
StateUT
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionFentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only, supplied in single pouches (NDC 0591-3214-54 (pouch)), 5 pouches per carton (NDC 0591-3214-72 (Carton)), Manufactured by Watson laboratories Inc., Corona, CA, Distributed by: Watson, Pharma Inc.
Code InfoLot number 455040A (carton) 455040 (pouch)
ClassificationClass II
Reason for RecallSubpotent; some patches may not contain fentanyl gel
Product Quantity98,088 cartons (5 pouches per carton)
Recall NumberD-1693-2012

Class II Devices Event

Event ID62419
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAlcon Research, LTD.
CityHouston
StateTX
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Greece, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria.
 

Associated Products

Product DescriptionThis voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm), Constellation 23G Total PLUS Pak, Constellation 23G Combined Pack (0.9 mm and 1.1 mm) and 23G Small Parts Kit. Single use 23G non-valved trocar cannulas are used to provide internal access to the ocular cavity during ophthalmic surgery. Single use infusion cannulas are used for the infusion of fluid or air during ophthalmic surgery to maintain intraocular pressure during posterior segment surgeries.
Code Info1) 23G TotalPLUS Pak: Accurus Standalone - 8065750828, 2) 23G Combined Pack 0.9mm: Accurus Standalone - 8065750814, 3) 23G Combined Pack 1.1mm: Accurus Standalone - 8065750816, 4)23G TotalPLUS Pak: Constellation Standalone - 8065751058, 5) 23G Combined Pack 0.9mm: Constellation Standalone -8065751077, 6) 23G Combined Pack 1.1mm: Constellation Standalone - 8065751065. 7) 23G Small Parts Kit - 8065750842. Complete list of lot numbers will be provided with recall recommendation.
ClassificationClass II
Reason for RecallThis medical device correction is related to Alcon products that present a 23G non-valved trocar cannula and infusion cannula together because of an issue regarding the loose fit between the 23G non-valved trocar cannula and infusion cannula that could potentially cause a detachment between the non-valved trocar cannula and infusion cannula during surgery.
Product Quantity30, 413 distributed domestically & 62,906 internationally
Recall NumberZ-2470-2012

Class II Food Event

Event ID62465
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Apr-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmHaldeman Mills
CityManheim
StatePA
CountryUS
Distribution PatternProduct was distributed to specific wholesale and retail outlets within the State of Pennsylvania
 

Associated Products

Product DescriptionBulk Foods, Inc. Yellow Corn Meal, Light Roast, 25 lb; Bulk Foods, Inc. Yellow Corn Meal, Light Roast, 50 lb
Code InfoNo codes; all product "Purchase by date shown 12/29/2012"
ClassificationClass II
Reason for RecallFDA samples of product tested positive for Fumonisin
Product Quantity32,500 lbs
Recall NumberF-2373-2012
Product DescriptionBulk Foods, Inc. Yellow Corn Meal, Regular Roast, 25 lb; Bulk Foods, Inc. Yellow Corn Meal, Regular Roast, 50 lb
Code InfoNo codes; all product "Purchase by date shown 12/29/2012"
ClassificationClass II
Reason for RecallFDA samples of product tested positive for Fumonisin
Product Quantity
Recall NumberF-2374-2012
Product DescriptionBrinser's Best Yellow Corn Meal, 5 lb; Stauffer's Corn Meal, 2 lb
Code InfoNo codes; all product "Purchase by date shown 12/29/2012"
ClassificationClass II
Reason for RecallFDA samples of product tested positive for Fumonisin
Product Quantity
Recall NumberF-2375-2012

Class II Devices Event

Event ID62606
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jul-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmOPTI Medical Systems, Inc
CityRoswell
StateGA
CountryUS
Distribution PatternWorldwide Distribution -- US (nationwide) including the states of AZ, ID, TX and UT., and the countries of Argentina, Bolivia, China, Ecuador, France, Germany Greece, India, Indonesia, Iran, Ireland, Japan, Kuwait, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Nigeria, Poland, Romania, Russia, Saudi Arabia, Singapore, South Africa, Sudan Switzerland, Turkey, United kingdom, Venezuela, and Viet Nam.
 

Associated Products

Product DescriptionBP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH, PCOX2 PO2, lactate (lactic acid), total hemoglobin (tHb), and oxygen saturation (SO2), in heparinized whole blood samples (either arterial or venous) on the OPTI CCA-TS system, in either a clinical setting or point of care locations. Cassettes contain one-time use sensors that are used with the OPTI CCA-TS analyzer to perform in-vitro measurements of blood gases and metabolites. OPTI CCA-TS B-Lac Cassettes are supplied in boxes of 25 and may only used with the OPTI CCA-TS Analyzer.
Code InfoLot numbers: 110650, 114650, 114651, 114652, 114653, 116650, 116652, 117650, 118651, 121650, 121651, 122652, 122652, 122653, 122654, 122655, 122656, 122657, 123654, 123655, 124650, 133650, 134651, 136650, 146650, 149650, 202650, 208650, 208651, 209560, 209651, 211650, 212651, 213650, 214650, 215650, 215651, 221650, 222650 and 224650.
ClassificationClass II
Reason for RecallThe values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters).
Product Quantity895 boxes (25 cassettes per box)
Recall NumberZ-2440-2012

Class II Drugs Event

Event ID62674
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAbbott Laboratories
CityAbbott Park
StateIL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionSynthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-4552-90.
Code Info18265A8, Exp 09/20/2013
ClassificationClass II
Reason for RecallDefective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Product Quantity53,448 Bottles
Recall NumberD-1694-2012
Product DescriptionSynthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-5182-90.
Code InfoLot: 18353A8, Exp 08/31/2013
ClassificationClass II
Reason for RecallDefective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Product Quantity42,596 Bottles
Recall NumberD-1695-2012
Product DescriptionSynthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-9296-90
Code InfoLot: 18355A8, Exp. 09/26/13
ClassificationClass II
Reason for RecallDefective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Product Quantity40,464 Bottles
Recall NumberD-1696-2012

Class II Devices Event

Event ID62830
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmImaging Sciences International, LLC
CityHatfield
StatePA
CountryUS
Distribution PatternWorldwide Distribution - USA including Washington, DC, AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and the country of Canada.
 

Associated Products

Product DescriptionDEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
Code InfoCatalog number 1.008.7932, version numbers 10.0.0 through 10.0.3
ClassificationClass II
Reason for RecallA condition can occur during renumbering of the patient database using the DEXCopy feature. When renumbering is being performed using the DEXCopy feature and multiple patients with an identical name are present, the software will assign all subsequent records to the first patient record, resulting in mixed patient records. In order for this problem to occur several conditions need to be met: 1) DEXIS Imaging Suite versions 10.0.0 - 10.0.3 must be installed, 2) The DEXCopy feature Mus thave been used to renumber the patient database, and 3) Two or more patients with identical names must be present within the database.
Product Quantity366
Recall NumberZ-2463-2012

Class II Drugs Event

Event ID62866
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBracco Diagnostics Inc
CityPrinceton
StateNJ
CountryUS
Distribution PatternNationwide and United Kingdom
 

Associated Products

Product DescriptionCARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Medi-Physics, Inc. South Plainfield, NJ 07080, NDC 0270-0091-01
Code InfoLot numbers 09101-121251 and 09101-121391
ClassificationClass II
Reason for RecallGMP deviation; Sr-82 levels exceeded alert limit specification
Product Quantity54 generators
Recall NumberD-1684-2012

Class II Drugs Event

Event ID62885
StatusCompleted
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMylan Pharmaceuticals Inc.
CityMorgantown
StateWV
CountryUS
Distribution PatternThe product was distributed to KY.
 

Associated Products

Product DescriptionLevetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-5615-05
Code InfoLot ZLMM12063, Exp March 2014
ClassificationClass II
Reason for RecallAdulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.
Product Quantity960 bottles
Recall NumberD-1702-2012

Class II Food Event

Event ID62889
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Apr-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTriton Seafood Co.
CityMedley
StateFL
CountryUS
Distribution PatternProduct was distributed throughout the state of Florida and Texas.
 

Associated Products

Product DescriptionApproximately 5 lb bag of Pre-cooked Conch Fritters labeled in part: "***NEPTUNE'S CONCH FRITTERS PRECOOKED***Ingredients: Conch, Flour, Onions, Milk, Bell Peppers, Eggs, Garlic, Salt, Black Pepper, Lime Juice & Hot Pepper Sauce.***Packed by Triton Seafood Co. Miami, FL 33166***Pack: 125 Units Net Wt. 5# (approx.)***
Code InfoW152BA, W152BB, W153BC, W152BD, W152BE, W162BA, W162BB, W162BC, W162BD, W162BE, W172BA, W172BB, W172BC, W172DB
ClassificationClass II
Reason for RecallTriton Seafood Co recalled their Neptune brand frozen Pre-cooked Conch Fritters and Conch Fritter Batter because the allergen, "Wheat" was not identified on the product label.
Product Quantity89 cases
Recall NumberF-2376-2012
Product DescriptionApproximately 5 lb plastic bucket of Conch Fritter Batter labeled in part: "***NEPTUNE'S CONCH FRITTERS ALL NATURAL***Ingredients: Conch, Flour, Onions, Milk, Bell Peppers, Eggs, Garlic, Salt, Black Pepper, Lime Juice, Hot Pepper Sauce.***Packed by Triton Seafood Co. Miami, FL 33166*** Net Weight 5 lbs.***
Code InfoW152BA, W152BB, W153BC, W152BD, W152BE, W162BA, W162BB, W162BC, W162BD, W162BE, W172BA, W172BB, W172BC, W172DB
ClassificationClass II
Reason for RecallTriton Seafood Co recalled their Neptune brand frozen Pre-cooked Conch Fritters and Conch Fritter Batter because the allergen, "Wheat" was not identified on the product label.
Product Quantity233 cases
Recall NumberF-2377-2012

Class II Devices Event

Event ID62927
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Jan-11
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCordis Corporation
CityMiami Lakes
StateFL
CountryUS
Distribution PatternWorldwide Distribution - USA and Germany
 

Associated Products

Product DescriptionSleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013-09***Cordis*** Sleek***OTW***REF Cat. No. 426-1201X***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***LOT Lot No. 50027149***Use by 2013-09***Sterile***EO***Method of Sterilization: ETO***ClearStream***Clearstream Technologies, Ltd.***Moyne Upper, Enniscorthy Co Wexford, Ireland***Phone: +353-53-92-37111***Fax: +353-53-92-37-100***Made in Ireland***Distributed by: Cordis Cashel***Cahir Road, Cashel, Co. Tipperary, Ireland***Tel: +353--(0)62-70000. The SLEEK OTW Percutaneous Transluminal Angioplasty (PTA) Peripheral Catheter Family is a non-reusable semi-compliant coaxial design catheter with a balloon mounted on its distal tip. The hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon. The catheter shaft is small beneath the balloon achieve low profile. The distal tip is further tapered to accept the appropriate guidewire. Platinum iridium bands serve to locate the balloon under fluoroscopy. A 0.014" (0.356 mm) guidewire is recommended for use with the SLEEK OTW Catheter.
Code Info Lot #50027149
ClassificationClass II
Reason for RecallOn 1/20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688. Product is incorrectly labeled.
Product Quantity5 units
Recall NumberZ-2441-2012
Product DescriptionSleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688***2013-09***Cordis***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***Sterile***EO***Method of Sterilization: ETO***ClearStream***Clearstream Technologies, Ltd.***Moyne Upper, Enniscorthy Co Wexford, Ireland***Phone: +353-53-92-37111***Fax: +353-53-92-37-100***Made in Ireland***Distributed by: Cordis Cashel***Cahir Road, Cashel, Co. Tipperary, Ireland***". The SLEEK OTW Percutaneous Transluminal Angioplasty (PTA) Peripheral Catheter Family is a non-reusable semi-compliant coaxial design catheter with a balloon mounted on its distal tip. The hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon. The catheter shaft is small beneath the balloon achieve low profile. The distal tip is further tapered to accept the appropriate guidewire. Platinum iridium bands serve to locate the balloon under fluoroscopy. A 0.014" (0.356 mm) guidewire is recommended for use with the SLEEK OTW Catheter.
Code InfoLot #50026688.
ClassificationClass II
Reason for RecallOn 1//20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688. Product is incorrectly labeled.
Product Quantity1 unit
Recall NumberZ-2442-2012

Class II Devices Event

Event ID62948
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMc-NEIL-PPC, Inc.
CitySkillman
StateNJ
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionKY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant
Code InfoThe following Lot Numbers were identified: 2721W; 2591W; 2321W; 1681W; 0921W; 0651W; 0471W; 0361W; 0221W; 0041W; 0110H; 0100H; 0090H; 0080H; 0030H; 0179H; 0159H; 0219H and 3489RT.
ClassificationClass II
Reason for RecallJohnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA concerns that the product should have been cleared under a separate medical device application. This voluntary recall is not being conducted on the basis of any consumer safety or product performance issues related to K-Y LIQUIBEADS. JJHP received a Warning Letter on May 23, 2012 indicating that this device, KY Liquibeads Vaginal Moisturizer, is misbranded under the section 502(o) the Act, 21 U.S.C. 352(o), because we did not notify the agency of our intent to introduce the device into commercial distribution, as required by 510(k) of the Act, U.S.C. 360(k). The Warning Letter indicated that changes were made to the predicate device that would require submission of a new 510(k).
Product Quantity818,712
Recall NumberZ-2467-2012

Class II Devices Event

Event ID62965
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmInvacare Corporation
CityElyria
StateOH
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of AUSTRALIA, CANADA, GUAM, ISRAEL, NEW ZEALAND, THAILAND, TRINIDAD AND TOBAGO.
 

Associated Products

Product DescriptionInvacare® I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035. These shower chairs are designed for individuals who require seating support when bathing or showering and provide comfort and safety in the bathtub.
Code Info9780, 9781, 9781-1
ClassificationClass II
Reason for RecallOn August 6, 2012, Invacare voluntarily recalled the Invacare® I-Fit" Shower Chair (Models 9780, 9781, 9781-1) based on the return, quality and adverse event data received.
Product Quantity21,168 chairs
Recall NumberZ-2461-2012

Class II Devices Event

Event ID62979
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmKCI USA, Inc.
CitySan Antonio
StateTX
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria.
 

Associated Products

Product DescriptionBariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. The BariAir Therapy System provides low air-loss pressure management therapy, pulsation, percussion, Turn Assist. flexible patient positioning capabilities and built-in scales for patients weighing 300 Ib* to 850 Ib ([136*-386 kg] including accessories). The BariAir Therapy System is indicated to aid in: " Patients whose body weight and size pose a significant risk or care management issue to the patient or staff during the performance of routine nursing care. " Large patients weighing between 300 Ib* and 850 Ib (136*-386 kg) including accessories. " Large patients who are difficult to turn. " Preventing and treating pressure ulcers. " Large patients requiring percussion therapy.
Code InfoMultiple Serial Numbers with Model Numbers: 404000,405500, 405500RF
ClassificationClass II
Reason for RecallKCI has issued a medical device correction for the BariAir Therapy System Hand Pendent. The BariAir Therapy System is not designed to allow the patient to place the bed into the patient exit position. KCI has received complaints indicating that patients used the hand pendent to inadvertently place the BariAir Therapy System into a pseudo-exit position. In a small number of instances, this allowed the patient to unintentionally exit the therapy system, resulting in some patients receiving minor injuries.
Product Quantity575
Recall NumberZ-2466-2012

Class II Food Event

Event ID62991
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPulmuone Wildwood Inc
CityFullerton
StateCA
CountryUS
Distribution PatternNationwide and Canada.
 

Associated Products

Product DescriptionWildwood Emerald Valley Kitchen Organic Medium Salsa, 30 oz. Pack size 6/30 oz per case, 14 oz Pack size 6/14oz per case, Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC MEDIUM SALSA***MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***"
Code InfoUPC 0-52334-11665-0, Item # 0291623. UPC 0-52334-11653-7, Item # 0291638
ClassificationClass II
Reason for RecallThe firm recalled due to a potential non-safety quality concern related to a particular ingredient that was causing premature spoilage.
Product Quantity 61,288 units
Recall NumberF-2433-2012
Product DescriptionWildwood Emerald Valley Kitchen Organic Mild Salsa, 14 oz. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC MILD SALSA***NET WT. 14 OZ (850g)***MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***"
Code InfoUPC 0-52334-11659-9, Item # 0291628.
ClassificationClass II
Reason for RecallThe firm recalled due to a potential non-safety quality concern related to a particular ingredient that was causing premature spoilage.
Product Quantity21,841 units
Recall NumberF-2434-2012
Product DescriptionWildwood Emerald Valley Kitchen Organic Hot Salsa, 14 oz. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC HOT SALSA***NET WT. 14 OZ (850g)***MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***"
Code InfoUPC 0-52334-11660-5, Item # 0291635.
ClassificationClass II
Reason for RecallThe firm recalled due to a potential non-safety quality concern related to a particular ingredient that was causing premature spoilage.
Product Quantity3,148 units
Recall NumberF-2435-2012
Product DescriptionWildwood Emerald Valley Kitchen Organic Medium Salsa - Canada (containing French in labeling), 397 mL. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC MEDIUM SALSA***NET WT. 397mL, MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***".
Code InfoUPC 0-52334-11659-9, Item # 0291661.
ClassificationClass II
Reason for RecallThe firm recalled due to a potential non-safety quality concern related to a particular ingredient that was causing premature spoilage.
Product Quantity575 units
Recall NumberF-2436-2012
Product DescriptionWildwood Emerald Valley Kitchen Organic Mild Salsa - Canada (containing French in labeling), 397 mL. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC MILD SALSA***NET WT. 397mL, MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***".
Code InfoUPC 0-52334-11653-7, Item # 0291662.
ClassificationClass II
Reason for RecallThe firm recalled due to a potential non-safety quality concern related to a particular ingredient that was causing premature spoilage.
Product Quantity781 units
Recall NumberF-2437-2012
Product DescriptionWildwood Organic Mild Salsa , 14 oz, Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD ORGANIC salsa MILD ***NET WT. 14OZ, MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***".
Code InfoUPC 0-30871-33001-2, Item # 0291710.
ClassificationClass II
Reason for RecallThe firm recalled due to a potential non-safety quality concern related to a particular ingredient that was causing premature spoilage.
Product Quantity602 units
Recall NumberF-2438-2012
Product DescriptionWildwood Organic Medium Salsa , 14 oz, Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD ORGANIC salsa MILD ***NET WT. 14OZ, MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***".
Code InfoUPC 0-30871-33002-9, Item # 0291711.
ClassificationClass II
Reason for RecallThe firm recalled due to a potential non-safety quality concern related to a particular ingredient that was causing premature spoilage.
Product Quantity748 units
Recall NumberF-2439-2012

Class II Devices Event

Event ID63009
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-May-11
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmLinvatec Corp. dba ConMed Linvatec
CityLargo
StateFL
CountryUS
Distribution PatternWorldwide Distribution - US Nationwide and the countries of Canada, DK, HK, IN, IT, KR, MY, RU, CO, VN, ZA.
 

Associated Products

Product Description***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
Code InfoGCT
ClassificationClass II
Reason for RecallLinvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures.
Product Quantity1
Recall NumberZ-2455-2012
Product Description***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
Code InfoGCT
ClassificationClass II
Reason for RecallLinvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures.
Product Quantity57
Recall NumberZ-2456-2012

Class II Devices Event

Event ID63015
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCovidien LP
CityNorth Haven
StateCT
CountryUS
Distribution PatternWorldwide Distribution.
 

Associated Products

Product DescriptionCovidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code: DUET4535. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Code InfoAll lot numbers
ClassificationClass II
Reason for RecallDuet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
Product Quantity433,528 units
Recall NumberZ-2432-2012
Product DescriptionCovidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4535A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Code InfoAll lot numbers
ClassificationClass II
Reason for RecallDuet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.
Product Quantity94,301 units
Recall NumberZ-2433-2012
Product DescriptionCovidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET4548. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Code InfoAll lot numbers
ClassificationClass II
Reason for RecallDuet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.
Product Quantity4,867 units
Recall NumberZ-2434-2012
Product DescriptionCovidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4548A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Code InfoAll lot numbers
ClassificationClass II
Reason for RecallDuet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
Product Quantity104,355 units
Recall NumberZ-2435-2012
Product DescriptionCovidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Product Code: DUET6035. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Code InfoAll lot numbers
ClassificationClass II
Reason for RecallDuet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
Product Quantity22,218 units
Recall NumberZ-2436-2012
Product DescriptionCovidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6035A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Code InfoAll lot numbers
ClassificationClass II
Reason for RecallDuet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
Product Quantity268,022 units
Recall NumberZ-2437-2012
Product DescriptionCovidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET6048. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Code InfoAll lot numbers
ClassificationClass II
Reason for RecallDuet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
Product Quantity15,936 units
Recall NumberZ-2438-2012
Product DescriptionCovidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6048A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Code InfoAll lot numbers
ClassificationClass II
Reason for RecallDuet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.
Product Quantity135,712 units
Recall NumberZ-2439-2012

Class II Biologics Event

Event ID63022
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Aug-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmRocky Mountain Lions Eye Bank
CityAurora
StateCO
CountryUS
Distribution PatternJapan
 

Associated Products

Product DescriptionCornea
Code Info121180100
ClassificationClass II
Reason for RecallCorneas, recovered in a manner that may increase the risk of the introduction, transmission, or spread of communicable diseases, were distributed.
Product Quantity1
Recall NumberB-2522-12

Class II Biologics Event

Event ID63023
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Jun-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLions Eye Bank of Texas
CityHouston
StateTX
CountryUS
Distribution PatternTexas
 

Associated Products

Product DescriptionCornea
Code Info120114100
ClassificationClass II
Reason for RecallExpired human cornea was distributed.
Product Quantity1
Recall NumberB-2521-12

Class II Biologics Event

Event ID63024
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmUpstate New York Transplant Services
CityBuffalo
StateNY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionCornea
Code Info100791OD; 100791OS
ClassificationClass II
Reason for RecallHuman corneas, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity2
Recall NumberB-2520-12

Class II Biologics Event

Event ID63025
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Feb-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmRTI Biologics, Inc.
CityAlachua
StateFL
CountryUS
Distribution PatternOklahoma
 

Associated Products

Product DescriptionTendon
Code Info8169473
ClassificationClass II
Reason for RecallHuman tendon, with a swab culture positive for coagulase-negative Staphylococcus, was distributed.
Product Quantity1
Recall NumberB-2523-12

Class II Biologics Event

Event ID63026
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRTI Biologics, Inc.
CityAlachua
StateFL
CountryUS
Distribution PatternArizona; Pennsylvania; South Carolina; Oregon; Maryland; California; Florida
 

Associated Products

Product DescriptionTendon
Code Info7576144; 7576145; 7576146; 7576147; 7576148; 7576149; 7576150
ClassificationClass II
Reason for RecallHuman tendons, with a culture positive for coagulase negative Staphylococcus, were distributed.
Product Quantity7
Recall NumberB-2524-12

Class II Devices Event

Event ID63044
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Medical Systems (Cleveland) Inc
CityCleveland
StateOH
CountryUS
Distribution PatternWorldwide Distribution - USA including AL, AZ, CA, CO, FL, GA, IL, KS, KY, MI, MS, NJ, NM, NV, NY, OH, TX, WA & WI and internationally to: Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, India, Italy, Japan, Jordan, Mexico, Saudi Arabia, South Korea, Spain, Thailand, Turkey & United Kingdom.
 

Associated Products

Product DescriptionComputed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH. The Brilliance 6, 16 and MX8000 Dual v. Exp are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. GEMINI Dual is an imaging system that combines positron emission tomography (PET) and X-ray computed tomography. The GEMINI produces attenuation and non-attenuation corrected images of the distribution of PET radiopharmaceuticals in the head, body and total body as well as X-ray transmission images of these areas. The PET and CT images are registered and displayed in a fused format to provide combined PET and anatomical data at different angles for interpretation by trained health professionals. The PET and CT portions of the system can be used either as an integrated system or as a stand-alone PET or CT system. GEMINI can provide CT data suitable for use in attenuation correction.
Code InfoSystem Code #: 728130; Serial #: 8128, 8158 & 8369. System Code #: 728256; Serial #: 3695, 3703, 371 &, 3719. System Code #: 728246; Serial #: 3463, 3508, 3519, 3548, 3552, 3591, 3592, 3593, 3603, 3637, 3648, 3654, 3659, 3661, 3675, 3679, 3687, 3692, 5451, 5515, 5543, 5567, 5583, 5586, 5658, 5664, 5675, 5697, 5707, 5749, 5752, 5774, 5807, 5813, 5815, 5845, 5846, 5852, 5866, 5872, 5910, 5963, 5968, 6028, 6036, 6045, 6071 & 6126. System Code #: 882160; Serial #: 97, 102, 103, 105, 106, 107, 109, 110, 111, 113, 114, 115, 116, 117, 118, 121, 122, 123, 124, 125, 126, 127, 131, 132, 133, 134, 135, 136, 137, 139, 140, 141, 143, 144, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, , 63, 164, 165, 167, 1065 & 6119.
ClassificationClass II
Reason for RecallA 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 Quantity112 Units
Recall NumberZ-2451-2012

Class II Food Event

Event ID63046
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmMeijer Distribution, Inc
CityGrand Rapids
StateMI
CountryUS
Distribution PatternUp to 199 Meijer stores located in Illinois, Indiana, Kentucky, Michigan, and Ohio may have received product from Meijer distribution centers.
 

Associated Products

Product DescriptionProduct Name: Walnuts 160z. Brand Name: Markets of Meijer Meijer Distribution, Inc. Grand Rapids, MI49544 UPC 8-8692619782-2
Code InfoLot Number: 08 2150
ClassificationClass II
Reason for RecallThe firm was notified by a produce manager at one of the store locations that some of the bags from this lot of product contain pecans in addition to walnuts. Pecans are not listed in the ingredient statement and are not called out as an allergen.
Product Quantity1,440 units (60 cases, 24 units/case).
Recall NumberF-2372-2012

Class II Biologics Event

Event ID63051
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmViacord Processing Laboratory
CityHebron
StateKY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionUmbilical Cord Blood Stem Cells
Code Info111112016
ClassificationClass II
Reason for RecallUmbilical cord blood stem cells, not tested in accordance with the manufacturer's instructions to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents, were distributed.
Product Quantity1
Recall NumberB-2525-12

Class II Biologics Event

Event ID63052
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLions Eye Institute for Transplant & Research, Inc.
CityTampa
StateFL
CountryUS
Distribution PatternCalifornia; Florida
 

Associated Products

Product DescriptionCornea
Code Info2010063945; 2010063946
ClassificationClass II
Reason for RecallHuman corneas, recovered from a donor whose donor eligibility may have been been determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity2
Recall NumberB-2526-12

Class II Devices Event

Event ID63091
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAlere San Diego, Inc.
CitySan Diego
StateCA
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionAlere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.
Code InfoLot Codes: K51245RB, W51022RB, W51207RB
ClassificationClass II
Reason for RecallAlere San Diego is recalling Alere Triage TOX Drug Screen because there is a possibility that after installing the code chip provided with the affected lots: AMP, BAR, and PCP, the threshold ranges may not be consistently set correctly in all meters.
Product Quantity591 kits
Recall NumberZ-2460-2012

Class II Devices Event

Event ID63092
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAbbott Vascular
CityTemecula
StateCA
CountryUS
Distribution PatternNationwide(US) Distribution and Puerto Rico.
 

Associated Products

Product DescriptionArmada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
Code InfoU.S. Lot #: 737538, 737576, 738162, 738486, 738641, 739286, 739518, 739837, 740078, 740090, 740306, 740310, 740575, 740579, 740583, 740591, 740599, 740824, 740828, 740832, 740836, 742024, 742028, 742032, 742036, 742040, 742234, 742238, 742246, 742250, 742509, 742513, 742517, 742521, 742759, 742767, 742775, 742783, 742932, 742936, 742940, 742944, 742948, 742952, 742956, 743092, 743096, 743100, 743194, 743197, 743203, 743206, 743209, 743212, 743215, 743469, 743473, 743477, 743481, 743489, 743565, 743862, 743866, 743870, 743874, 743878, 743882, 743886, 744277, 744285, 744289, 744293, 744297, 744301, 744361, 744419, 744423, 744427, 744431, 744435, 744525, 744618, 744622, 744626, 744630, 744634, 744874, 744878, 744882, 744886, 744890, 744894, 745237, 745245, 745249, 745253, 745538, 745542, 745547, 745731, 745735, 745743, 745747, 745949, 745953, 745957, 745961, 745965, 745969, 746237, 746249, 746253, 746257, 746358, 746362, 746366, 746370, 746565, 746569, 746767, 746783, 746968, 746972, 746976, 747149, 747153, 747161, 747165, 747326, 747347, 747351, 747545, 747549, 747565, 747736, 747740, 747744, 747753, 747757, 747765, 747899, 747907, 748103, 748107, 748111, 748115, 748119, 748127, 748309, 748317, 748321, 748437, 748473, 748608, 749158, 749174, 749312, 749320, 749324, 749328, 749332, 749336, 749340, 749537, 749582, 749800, 749933, 749937, 749980, 749988, 750000, 750008, 750130, 750134, 750150, 750154, 750315, 750319, 750324, 750332, 750336, 750340, 750344, 750487, 750491, 750495, 750500, 750504, 750508, 750829, 750833, 750845, 751169, 751326, 751334, 751338, 751342, 751529, 751533, 751889, 751897, 752089, 752097, 752349, 752369, 752429, 752441, 752453, 752461, 752619, 752623, 752627, 752639, 752643, 752777, 752781, 752785, 752794, 752798, 752802, 753142, 753150, 753153, 753169, 753173, 753277, 753281, 753285, 753289, 753297, 753481, 753485, 753608, 753726, 753730, 753734, 754054, 754062, 754066, 754070, 754074, 754187, 754191, 754599, 754603, 754607, 754619, 754623, 754783, 754787, 754791, 754795, 754799, 754803, 754948, 755240, 755244, 755431, 755443, 755606, 755610, 755614, 755792, 755818, 755826, 755834, 755838, 755842, 756002, 756006, 756010, 756156, 756160, 756164, 756169, 756173, 756177, 756441, 756445, 756465, 756469, 756473, 756477, 756481, 756662, 756666, 756670, 756694, 756698, 756702, 756868, 756872, 756876, 756880, 756884, 757077, 757081, 757085, 757089, 757260, 757264, 757268, 757280, 757296, 757440, 757456, 757472, 757476, 757676, 757680, 757684, 757692, 757696, 757704, 757708, 757712, 757716, 757890, 757894, 757898, 757902, 757914, 757918, 757922, 757926, 758067, 758071, 758075, 758079, 758083, 758087, 758091, 758095, 758288, 758296, 758300, 758304, 758312, 758316, 758324, 758500, 758504, 758508 ,758528, 758875, 758879, 758883, 758887, 758891, 758895, 758899, 758903, 759090, 759094, 759102, 759106, 759110, 759114, 759118, 759122, 759270, 759278, 759282, 759429, 759433, 759437, 759441, 759445, 759449, 759453, 759457, 759662, 759666, 759670, 759674, 759678, 759682, 759686, 759840, 759848, 759852, 759856, 759864, 759868, 759872, 759876, 759880, 760039, 760047, 760051, 760059, 760063, 760067, 760071, 760075, 760079, 760208, 760212, 760216, 760220, 760224, 760228, 760232, 760236, 760240, 760248, 760458, 760462, 760466, 760470, 760482, 760689, 760693, 760697, 760701, 760705, 760854, 760858, 760862, 760866, 760878, 760882, 761215, 761231, 761243, 761486, 761495, 761499, 761503, 761507, 761511, 761523, 761735, 761739, 761743, 761747, 761752, 761764, 761768, 761932, 761936, 761940, 761944, 761948, 761952, 761960, 762070, 762109, 762113, 762121, 762129, 762133, 762137, 762292, 762296, 762300, 762304, 762308, 762312, 762316, 762320, 762324, 762466, 762474, 762478, 762482, 762486, 762512, 762671, 762679, 762683, 762687, 762691, 762699, 762841, 762845, 762853, 762857, 762861, 762869, 763000, 763008, 763012, 763016, 763024, 763143, 763151, 763155, 763163, 763167, 763171, 763191, 763195, 763203, 763211, 763215, 763220, 763224, 763238, 763242, 763246, 763258, 763262, 763266, 763270, 763306, 763310, 763314, 763318, 763322, 763326, 763330, 763492, 763496, 763499, 763502, 763506, 763610, 763614, 763618, 763626, 763630, 763634, 763638, 763642, 763646, 763770, 763774, 763778, 763782, 763786, 763794, 763798, 763802, 763806, 763894, 763898, 763902, 763906, 763910, 763914, 763918, 763922, 763926, 764075, 764084, 764088, 764130, 764134, 764142, 764146, 764150, 764154, 764158, 764162, 764169, 764193, 764205, 764221, 764229, 764237, 764241, 764269, 764367, 764375, 764379, 764383, 764387, 764395, 764399, 764460, 764476, 764484, 764488, 764492, 764496, 764500, 764508, 764512, 764615, 764619, 764663, 764667, 764680, 764684, 764852, 764869, 765196, 765200, 765226, 765358, 765366, 765370, 765374, 765404, 765431, 765435, 765682, 765906, 766065, 766230, 766246, 766250, 766254, 766262, 766488, 766683, 766691, 766695, 766855, 766859, 766871, 767020, 767024, 767028, 767032, 767040, 767184, 767192, 767212, 767216, 767349, 767361, 767582, 767586, 767728, 767752, 767756, 767760, 767971, 767983, 767987, 768122, 768243, 768248, 768252, 768256, 768260, 768264, 768362, 768378, 768382, 768469, 768473, 768477, 768481, 768485, 768489, 768501, 768505, 768594, 768659, 768667, 768671, 769031, 769035, 769178, 769190, 769346, 769350, 769517, 769521, 769525, 769529, 769541, 769549, 769553, 769861, 769865, 769965, 769973, 769977, 769981, 770130, 770142, 770146, 770154, 770162, 770333, 770345, 770349, 770679, 770699, 770703, 770707, 771042, 771046, 771050, 771208, 771212, 771216, 771220, 771437, 771441, 771667, 771679, 771960, 771968, 772157, 772415, 772560, 772806, 773110, 773114, 774228, 774698.
ClassificationClass II
Reason for RecallAbbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have discovered that some devices may exhibit difficulty inflating and/or deflating.
Product Quantity61,799 units
Recall NumberZ-2450-2012

Class II Devices Event

Event ID63093
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmVarian Medical Systems, Inc. Oncology Systems
CityPalo Alto
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and Internationally. . .
 

Associated Products

Product DescriptionVarian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eyes.
Code InfoCP-08922: LIST OF SERIAL NUMBERS: H480001 ,H480130 ,H480301 ,H480446 ,H480623 ,H480795 ,H480976 ,H481088 ,H481222 ,H481382 ,H481544 ,H481777 ,H481931 ,H480002 ,H480131 ,H480302 ,H480448 ,H480624 ,H480798 ,H480981 ,H481089 ,H481229 ,H481383 ,H481545 ,H481778 ,H481932 ,H480008 ,H480132 ,H480305 ,H480449 ,H480627 ,H480808 ,H480982 ,H481090 ,H481230 ,H481389 ,H481556 ,H481787 ,H481935 ,H480009 ,H480133 ,H480312 ,H480450 ,H480628 ,H480814 ,H480989 ,H481099 ,H481231 ,H481392 ,H481562 ,H481793 ,H481938 ,H480010 ,H480137 ,H480313 ,H480451 ,H480629 ,H480819 ,H480992 ,H481100 ,H481232 ,H481393 ,H481581 ,H481795 ,H481939 ,H480011 ,H480138 ,H480314 ,H480455 ,H480630 ,H480820 ,H480993 ,H481104 ,H481233 ,H481394 ,H481582 ,H481796 ,H481940 ,H480012 ,H480139 ,H480315 ,H480464 ,H480631 ,H480821 ,H480994 ,H481105 ,H481234 ,H481397 ,H481590 ,H481798 ,H481945 ,H480013 ,H480151 ,H480316 ,H480465 ,H480645 ,H480822 ,H480996 ,H481108 ,H481235 ,H481404 ,H481591 ,H481799 ,H481946 ,H480014 ,H480153 ,H480319 ,H480467 ,H480652 ,H480823 ,H480997 ,H481109 ,H481236 ,H481409 ,H481592 ,H481803 ,H481953 ,H480015 ,H480157 ,H480320 ,H480468 ,H480659 ,H480824 ,H480998 ,H481110 ,H481237 ,H481410 ,H481602 ,H481805 ,H482120 ,H480016 ,H480158 ,H480321 ,H480469 ,H480660 ,H480825 ,H481003 ,H481111 ,H481239 ,H481414 ,H481603 ,H481806 ,H482121 ,H480017 ,H480159 ,H480323 ,H480471 ,H480665 ,H480839 ,H481004 ,H481112 ,H481256 ,H481415 ,H481606 ,H481807 ,H482125 ,H480019 ,H480160 ,H480324 ,H480477 ,H480667 ,H480840 ,H481010 ,H481115 ,H481257 ,H481416 ,H481609 ,H481815 ,H482126 ,H480020 ,H480169 ,H480325 ,H480478 ,H480668 ,H480841 ,H481012 ,H481122 ,H481277 ,H481417 ,H481613 ,H481818 ,H482129 ,H480030 ,H480170 ,H480333 ,H480486 ,H480670 ,H480842 ,H481014 ,H481132 ,H481278 ,H481418 ,H481614 ,H481821 ,H482130 ,H480031 ,H480172 ,H480338 ,H480487 ,H480673 ,H480843 ,H481015 ,H481133 ,H481279 ,H481420 ,H481616 ,H481835 ,H482131 ,H480032 ,H480173 ,H480340 ,H480493 ,H480674 ,H480844 ,H481016 ,H481135 ,H481289 ,H481423 ,H481617 ,H481836 ,H482132 ,H480033 ,H480174 ,H480341 ,H480494 ,H480676 ,H480845 ,H481022 ,H481136 ,H481290 ,H481424 ,H481618 ,H481837 ,H482133 ,H480034 ,H480175 ,H480342 ,H480495 ,H480677 ,H480846 ,H481023 ,H481139 ,H481291 ,H481428 ,H481619 ,H481838 ,H482134 ,H480040 ,H480177 ,H480345 ,H480502 ,H480678 ,H480847 ,H481024 ,H481142 ,H481292 ,H481432 ,H481620 ,H481848 ,H482135 ,H480043 ,H480178 ,H480346 ,H480505 ,H480679 ,H480849 ,H481025 ,H481143 ,H481293 ,H481433 ,H481622 ,H481849 ,H482136 ,H480051 ,H480184 ,H480350 ,H480507 ,H480685 ,H480850 ,H481026 ,H481144 ,H481294 ,H481443 ,H481635 ,H481850 ,H482137 ,H480052 ,H480185 ,H480351 ,H480508 ,H480686 ,H480855 ,H481027 ,H481146 ,H481296 ,H481445 ,H481636 ,H481851 ,H482138 ,H480053 ,H480207 ,H480358 ,H480514 ,H480687 ,H480856 ,H481028 ,H481147 ,H481298 ,H481451 ,H481638 ,H481852 ,H482144 ,H480054 ,H480208 ,H480359 ,H480521 ,H480688 ,H480865 ,H481029 ,H481149 ,H481299 ,H481452 ,H481639 ,H481853 ,H482162 ,H480055 ,H480209 ,H480360 ,H480522 ,H480691 ,H480866 ,H481030 ,H481150 ,H481304 ,H481453 ,H481641 ,H481858 ,H482163 ,H480063 ,H480210 ,H480361 ,H480523 ,H480702 ,H480868 ,H481031 ,H481151 ,H481306 ,H481454 ,H481647 ,H481862 ,H482164 ,H480064 ,H480215 ,H480362 ,H480524 ,H480712 ,H480873 ,H481032 ,H481154 ,H481307 ,H481455 ,H481648 ,H481863 ,H482166 ,H480065 ,H480216 ,H480365 ,H480526 ,H480714 ,H480874 ,H481036 ,H481155 ,H481309 ,H481456 ,H481649 ,H481865 ,H482167 ,H480067 ,H480217 ,H480371 ,H480527 ,H480715 ,H480878 ,H481037 ,H481157 ,H481311 ,H481467 ,H481650 ,H481866 ,H482168 ,H480072 ,H480218 ,H480372 ,H480528 ,H480717 ,H480879 ,H481039 ,H481158 ,H481312 ,H481471 ,H481651 ,H481867 ,H482172 ,H480075 ,H480233 ,H480378 ,H480530 ,H480719 ,H480886 ,H481043 ,H481159 ,H481313 ,H481472 ,H481667 ,H481870 ,H482174 ,H480076 ,H480239 ,H480379 ,H480531 ,H480722 ,H480890 ,H481045 ,H481163 ,H481315 ,H481477 ,H481671 ,H481871 ,H482178 ,H480078 ,H480240 ,H480388 ,H480539 ,H480723 ,H480894 ,H481046 ,H481164 ,H481316 ,H481478 ,H481672 ,H481872 ,H482179 ,H480079 ,H480241 ,H480389 ,H480542 ,H480724 ,H480896 ,H481050 ,H481165 ,H481318 ,H481483 ,H481673 ,H481873 ,H482185 ,H480080 ,H480242 ,H480390 ,H480543 ,H480725 ,H480897 ,H481051 ,H481166 ,H481327 ,H481484 ,H481674 ,H481877 ,H482186 ,H480088 ,H480245 ,H480391 ,H480544 ,H480727 ,H480906 ,H481054 ,H481168 ,H481330 ,H481487 ,H481677 ,H481878 ,H482187 ,H480089 ,H480246 ,H480392 ,H480547 ,H480732 ,H480910 ,H481056 ,H481171 ,H481331 ,H481488 ,H481688 ,H481881 ,H482189 ,H480092 ,H480248 ,H480393 ,H480548 ,H480733 ,H480917 ,H481057 ,H481172 ,H481332 ,H481494 ,H481695 ,H481882 ,H482191 ,H480093 ,H480249 ,H480394 ,H480566 ,H480734 ,H480918 ,H481058 ,H481176 ,H481333 ,H481496 ,H481702 ,H481884 ,H482192 ,H480098 ,H480256 ,H480395 ,H480567 ,H480735 ,H480920 ,H481065 ,H481180 ,H481334 ,H481497 ,H481703 ,H481885 ,H482193 ,H480099 ,H480257 ,H480397 ,H480568 ,H480745 ,H480923 ,H481066 ,H481193 ,H481335 ,H481498 ,H481711 ,H481886 ,H482196 ,H480101 ,H480267 ,H480398 ,H480569 ,H480748 ,H480924 ,H481069 ,H481194 ,H481338 ,H481503 ,H481713 ,H481890 ,H482201 ,H480102 ,H480268 ,H480399 ,H480573 ,H480749 ,H480925 ,H481070 ,H481195 ,H481344 ,H481504 ,H481718 ,H481891 ,H482203 ,H480103 ,H480273 ,H480400 ,H480574 ,H480750 ,H480926 ,H481072 ,H481196 ,H481347 ,H481510 ,H481722 ,H481892 ,H482204 ,H480107 ,H480274 ,H480411 ,H480575 ,H480755 ,H480928 ,H481073 ,H481197 ,H481348 ,H481513 ,H481723 ,H481896 ,H482216 ,H480110 ,H480275 ,H480412 ,H480578 ,H480759 ,H480929 ,H481074 ,H481202 ,H481349 ,H481518 ,H481725 ,H481900 ,H482217 ,H480111 ,H480278 ,H480413 ,H480579 ,H480760 ,H480943 ,H481077 ,H481205 ,H481352 ,H481519 ,H481730 ,H481901 ,H482218 ,H480112 ,H480279 ,H480414 ,H480580 ,H480764 ,H480953 ,H481078 ,H481206 ,H481353 ,H481520 ,H481731 ,H481902 ,H482219 ,H480113 ,H480281 ,H480416 ,H480581 ,H480765 ,H480954 ,H481079 ,H481207 ,H481354 ,H481523 ,H481744 ,H481907 ,H482220 ,H480115 ,H480282 ,H480422 ,H480585 ,H480766 ,H480955 ,H481080 ,H481208 ,H481357 ,H481526 ,H481745 ,H481912 ,H482221 ,H480118 ,H480287 ,H480427 ,H480589 ,H480769 ,H480956 ,H481081 ,H481211 ,H481361 ,H481527 ,H481746 ,H481913 ,H482222 ,H480121 ,H480293 ,H480428 ,H480592 ,H480770 ,H480957 ,H481082 ,H481215 ,H481362 ,H481528 ,H481751 ,H481914 ,H482223 ,H480122 ,H480295 ,H480429 ,H480594 ,H480783 ,H480958 ,H481083 ,H481216 ,H481363 ,H481532 ,H481752 ,H481918 ,H482224 ,H480123 ,H480296 ,H480430 ,H480595 ,H480785 ,H480959 ,H481084 ,H481217 ,H481374 ,H481533 ,H481754 ,H481919 ,H482230 ,H480124 ,H480297 ,H480438 ,H480596 ,H480789 ,H480962 ,H481085 ,H481218 ,H481376 ,H481534 ,H481756 ,H481923 ,H482231 ,H480126 ,H480298 ,H480439 ,H480614 ,H480790 ,H480963 ,H481086 ,H481219 ,H481378 ,H481540 ,H481757 ,H481924 ,H482232 ,H480129 ,H480300 ,H480440 ,H480622 ,H480794 ,H480973 ,H481087 ,H481220 ,H481381 ,H481542 ,H481766 ,H481927 ,H482233 ,H482234 ,H482374 ,H482570 ,H482801 ,H483017 ,H483217 ,H483433 ,H483687 ,H483935 ,H484121 ,H484308 ,H484437 ,H484587 ,H482235 ,H482385 ,H482576 ,H482802 ,H483018 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,H48D364 ,H48D473 ,H48D575 ,H48D697 ,H48D798 ,H48D903 ,H48E032 ,H48C758 ,H48C847 ,H48C943 ,H48D054 ,H48D147 ,H48D258 ,H48D365 ,H48D477 ,H48D577 ,H48D698 ,H48D801 ,H48D916 ,H48E033 ,H48C759 ,H48C848 ,H48C944 ,H48D056 ,H48D148 ,H48D259 ,H48D366 ,H48D478 ,H48D580 ,H48D699 ,H48D803 ,H48D917 ,H48E034 ,H48C761 ,H48C849 ,H48C945 ,H48D057 ,H48D149 ,H48D260 ,H48D367 ,H48D479 ,H48D591 ,H48D700 ,H48D804 ,H48D918 ,H48E035 ,H48C762 ,H48C850 ,H48C946 ,H48D058 ,H48D154 ,H48D261 ,H48D368 ,H48D480 ,H48D592 ,H48D701 ,H48D805 ,H48D919 ,H48E036 ,H48C763 ,H48C851 ,H48C948 ,H48D059 ,H48D156 ,H48D262 ,H48D372 ,H48D481 ,H48D593 ,H48D702 ,H48D806 ,H48D924 ,H48E037 ,H48C764 ,H48C854 ,H48C949 ,H48D060 ,H48D159 ,H48D263 ,H48D375 ,H48D482 ,H48D594 ,H48D703 ,H48D807 ,H48D925 ,H48E044 ,H48C765 ,H48C855 ,H48C950 ,H48D061 ,H48D160 ,H48D264 ,H48D378 ,H48D483 ,H48D595 ,H48D704 ,H48D808 ,H48D926 ,H48E045 ,H48C766 ,H48C857 ,H48C951 ,H48D062 ,H48D161 ,H48D276 ,H48D381 ,H48D484 ,H48D599 ,H48D705 ,H48D809 ,H48D927 ,H48E046 ,H48C767 ,H48C859 ,H48C953 ,H48D063 ,H48D162 ,H48D277 ,H48D382 ,H48D486 ,H48D601 ,H48D707 ,H48D810 ,H48D928 ,H48E048 ,H48C768 ,H48C860 ,H48C954 ,H48D064 ,H48D163 ,H48D280 ,H48D383 ,H48D487 ,H48D602 ,H48D708 ,H48D811 ,H48D931 ,H48E050 ,H48C769 ,H48C861 ,H48C957 ,H48D065 ,H48D166 ,H48D281 ,H48D384 ,H48D488 ,H48D603 ,H48D709 ,H48D812 ,H48D932 ,H48E051 ,H48C770 ,H48C864 ,H48C961 ,H48D066 ,H48D168 ,H48D282 ,H48D385 ,H48D489 ,H48D604 ,H48D713 ,H48D813 ,H48D933 ,H48E052 ,H48C771 ,H48C865 ,H48C962 ,H48D067 ,H48D169 ,H48D283 ,H48D386 ,H48D490 ,H48D605 ,H48D714 ,H48D814 ,H48D934 ,H48E054 ,H48C776 ,H48C867 ,H48C965 ,H48D068 ,H48D170 ,H48D284 ,H48D388 ,H48D491 ,H48D606 ,H48D715 ,H48D815 ,H48D936 ,H48E055 ,H48C777 ,H48C868 ,H48C966 ,H48D069 ,H48D173 ,H48D285 ,H48D389 ,H48D497 ,H48D607 ,H48D716 ,H48D816 ,H48D937 ,H48E058 ,H48C780 ,H48C869 ,H48C968 ,H48D070 ,H48D174 ,H48D286 ,H48D390 ,H48D498 ,H48D608 ,H48D718 ,H48D818 ,H48D940 ,H48E059 ,H48C781 ,H48C870 ,H48C969 ,H48D071 ,H48D178 ,H48D287 ,H48D391 ,H48D499 ,H48D609 ,H48D719 ,H48D819 ,H48D941 ,H48E061 ,H48C782 ,H48C874 ,H48C970 ,H48D072 ,H48D179 ,H48D288 ,H48D392 ,H48D500 ,H48D610 ,H48D721 ,H48D820 ,H48D944 ,H48E062 ,H48C783 ,H48C876 ,H48C971 ,H48D073 ,H48D181 ,H48D289 ,H48D395 ,H48D501 ,H48D611 ,H48D722 ,H48D827 ,H48D945 ,H48E063 ,H48C784 ,H48C877 ,H48C972 ,H48D074 ,H48D183 ,H48D290 ,H48D396 ,H48D502 ,H48D612 ,H48D723 ,H48D829 ,H48D948 ,H48E066 ,H48E067 ,H48E187 ,H48E307 ,H48E409 ,H48E516 ,H48E629 ,H48E845 ,H48F039 ,H48F351 ,H48E069 ,H48E188 ,H48E308 ,H48E410 ,H48E517 ,H48E630 ,H48E846 ,H48F040 ,H48F285 ,H48E073 ,H48E189 ,H48E309 ,H48E411 ,H48E518 ,H48E631 ,H48E847 ,H48F052 ,H48F351 ,H48E074 ,H48E190 ,H48E310 ,H48E412 ,H48E519 ,H48E632 ,H48E848 ,H48F053 ,H48E076 ,H48E197 ,H48E312 ,H48E413 ,H48E520 ,H48E633 ,H48E851 ,H48F054 ,H48E077 ,H48E198 ,H48E313 ,H48E414 ,H48E523 ,H48E634 ,H48E854 ,H48F059 ,H48E079 ,H48E199 ,H48E314 ,H48E417 ,H48E524 ,H48E635 ,H48E856 ,H48F063 ,H48E082 ,H48E203 ,H48E315 ,H48E418 ,H48E535 ,H48E636 ,H48E862 ,H48F072 ,H48E083 ,H48E205 ,H48E316 ,H48E421 ,H48E536 ,H48E637 ,H48E864 ,H48F073 ,H48E087 ,H48E206 ,H48E320 ,H48E422 ,H48E537 ,H48E638 ,H48E865 ,H48F074 ,H48E099 ,H48E207 ,H48E321 ,H48E423 ,H48E540 ,H48E643 ,H48E872 ,H48F075 ,H48E100 ,H48E208 ,H48E322 ,H48E424 ,H48E543 ,H48E644 ,H48E873 ,H48F076 ,H48E101 ,H48E209 ,H48E323 ,H48E425 ,H48E546 ,H48E646 ,H48E874 ,H48F077 ,H48E102 ,H48E210 ,H48E325 ,H48E426 ,H48E547 ,H48E647 ,H48E875 ,H48F078 ,H48E103 ,H48E211 ,H48E326 ,H48E427 ,H48E551 ,H48E648 ,H48E876 ,H48F079 ,H48E104 ,H48E212 ,H48E327 ,H48E428 ,H48E552 ,H48E670 ,H48E877 ,H48F080 ,H48E106 ,H48E213 ,H48E328 ,H48E429 ,H48E554 ,H48E671 ,H48E898 ,H48F091 ,H48E109 ,H48E214 ,H48E329 ,H48E430 ,H48E556 ,H48E672 ,H48E904 ,H48F092 ,H48E110 ,H48E215 ,H48E334 ,H48E431 ,H48E559 ,H48E677 ,H48E906 ,H48F106 ,H48E111 ,H48E217 ,H48E336 ,H48E432 ,H48E560 ,H48E678 ,H48E908 ,H48F107 ,H48E112 ,H48E218 ,H48E337 ,H48E433 ,H48E564 ,H48E682 ,H48E909 ,H48F114 ,H48E113 ,H48E219 ,H48E338 ,H48E434 ,H48E569 ,H48E687 ,H48E910 ,H48F115 ,H48E115 ,H48E223 ,H48E339 ,H48E435 ,H48E570 ,H48E688 ,H48E923 ,H48F118 ,H48E116 ,H48E224 ,H48E340 ,H48E436 ,H48E571 ,H48E690 ,H48E924 ,H48F127 ,H48E117 ,H48E225 ,H48E342 ,H48E437 ,H48E572 ,H48E691 ,H48E925 ,H48F128 ,H48E120 ,H48E226 ,H48E343 ,H48E438 ,H48E575 ,H48E692 ,H48E926 ,H48F129 ,H48E121 ,H48E227 ,H48E351 ,H48E439 ,H48E578 ,H48E693 ,H48E935 ,H48F130 ,H48E124 ,H48E228 ,H48E352 ,H48E440 ,H48E579 ,H48E694 ,H48E937 ,H48F133 ,H48E133 ,H48E229 ,H48E354 ,H48E441 ,H48E581 ,H48E695 ,H48E938 ,H48F139 ,H48E135 ,H48E231 ,H48E355 ,H48E446 ,H48E582 ,H48E699 ,H48E939 ,H48F140 ,H48E136 ,H48E232 ,H48E356 ,H48E448 ,H48E585 ,H48E700 ,H48E944 ,H48F141 ,H48E137 ,H48E233 ,H48E357 ,H48E450 ,H48E586 ,H48E701 ,H48E945 ,H48F142 ,H48E138 ,H48E234 ,H48E358 ,H48E452 ,H48E588 ,H48E702 ,H48E946 ,H48F147 ,H48E139 ,H48E238 ,H48E359 ,H48E455 ,H48E594 ,H48E703 ,H48E947 ,H48F148 ,H48E140 ,H48E239 ,H48E360 ,H48E456 ,H48E595 ,H48E704 ,H48E948 ,H48F151 ,H48E141 ,H48E240 ,H48E361 ,H48E457 ,H48E596 ,H48E711 ,H48E952 ,H48F155 ,H48E142 ,H48E241 ,H48E362 ,H48E458 ,H48E597 ,H48E714 ,H48E954 ,H48F166 ,H48E144 ,H48E242 ,H48E363 ,H48E459 ,H48E598 ,H48E715 ,H48E957 ,H48F167 ,H48E145 ,H48E243 ,H48E364 ,H48E464 ,H48E602 ,H48E721 ,H48E961 ,H48F168 ,H48E146 ,H48E244 ,H48E365 ,H48E465 ,H48E603 ,H48E725 ,H48E963 ,H48F169 ,H48E149 ,H48E245 ,H48E366 ,H48E466 ,H48E604 ,H48E726 ,H48E965 ,H48F170 ,H48E150 ,H48E246 ,H48E367 ,H48E467 ,H48E605 ,H48E729 ,H48E967 ,H48F179 ,H48E152 ,H48E247 ,H48E368 ,H48E468 ,H48E607 ,H48E762 ,H48E968 ,H48F180 ,H48E154 ,H48E248 ,H48E369 ,H48E469 ,H48E608 ,H48E763 ,H48E973 ,H48F187 ,H48E155 ,H48E255 ,H48E371 ,H48E470 ,H48E609 ,H48E764 ,H48E974 ,H48F191 ,H48E157 ,H48E269 ,H48E378 ,H48E471 ,H48E610 ,H48E765 ,H48E975 ,H48F192 ,H48E158 ,H48E274 ,H48E379 ,H48E482 ,H48E611 ,H48E766 ,H48E976 ,H48F193 ,H48E159 ,H48E275 ,H48E387 ,H48E483 ,H48E612 ,H48E767 ,H48E992 ,H48F224 ,H48E167 ,H48E276 ,H48E388 ,H48E484 ,H48E614 ,H48E768 ,H48E994 ,H48F225 ,H48E168 ,H48E277 ,H48E390 ,H48E485 ,H48E615 ,H48E772 ,H48E996 ,H48F256 ,H48E169 ,H48E278 ,H48E393 ,H48E486 ,H48E616 ,H48E773 ,H48F012 ,H48F257 ,H48E170 ,H48E291 ,H48E394 ,H48E488 ,H48E618 ,H48E794 ,H48F015 ,H48F258 ,H48E173 ,H48E292 ,H48E395 ,H48E491 ,H48E619 ,H48E812 ,H48F019 ,H48F259 ,H48E174 ,H48E294 ,H48E396 ,H48E492 ,H48E620 ,H48E813 ,H48F020 ,H48F260 ,H48E175 ,H48E295 ,H48E397 ,H48E498 ,H48E621 ,H48E819 ,H48F023 ,H48F261 ,H48E180 ,H48E296 ,H48E398 ,H48E499 ,H48E622 ,H48E824 ,H48F028 ,H48F262 ,H48E181 ,H48E297 ,H48E399 ,H48E507 ,H48E623 ,H48E837 ,H48F032 ,H48F263 ,H48E182 ,H48E298 ,H48E400 ,H48E508 ,H48E624 ,H48E839 ,H48F033 ,H48F264 ,H48E183 ,H48E299 ,H48E401 ,H48E512 ,H48E625 ,H48E841 ,H48F035 ,H48F265 ,H48E184 ,H48E303 ,H48E402 ,H48E513 ,H48E626 ,H48E842 ,H48F036 ,H48F266 ,H48E185 ,H48E305 ,H48E403 ,H48E514 ,H48E627 ,H48E843 ,H48F037 ,H48F267 ,H48E186 ,H48E306 ,H48E408 ,H48E515 ,H48E628 ,H48E844 ,H48F038 ,H48F285
ClassificationClass II
Reason for RecallVarian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned Hounsfield Unit [HU] value can be used for dose calculation when the clock on the Eclipse Client Workstation is not synchronized with the Database/System Server. Treatment of the patient using these values can therefore lead to under or over-dose.
Product Quantity6087
Recall NumberZ-2462-2012

Class II Drugs Event

Event ID63095
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDispensing Solutions, Inc
CitySanta Ana
StateCA
CountryUS
Distribution PatternUS: IN & WI
 

Associated Products

Product DescriptionAtrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metered actuations, Rx only, Packaged Exclusively by: Dispensing Solutions, Inc., Santa Ana, CA --- NDC 68258-8952-01, DSI product #8A0947
Code InfoLot # F23989, F22311
ClassificationClass II
Reason for RecallLabel Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as Ventolin HFA 90 mcg instead of correctly as Atrovent HFA 12.9 grams Inhalation Aerosol
Product Quantity18 Inhalers
Recall NumberD-1691-2012

Class II Devices Event

Event ID63100
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmApplied Medical Resources Corp
CityRancho Santa Margarita
StateCA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa.
 

Associated Products

Product DescriptionEmbolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Description: A4402, 3F-40CM, SYNTEL RT-EMB; A4403, 3F-80CM, SYNTEL RT-EMB; A4404, 4F-40CM, SYNTEL RT-EMB; A4405, 4F-80CM, SYNTEL RT-EMB; A4406, 5F-80CM, SYNTEL RT-EMB; A4407, 6F-80CM, SYNTEL RT-EMB; A4408, 7F-80CM, SYNTEL RT-EMB; A4F00, 2F-60CM (PREM) SYNTEL CATHETER; A4F01, 2F-80CM, (PREM) SYNTEL CATHETER; A4F02, 3F-40CM, (PREM) SYNTEL CATHETER; A4F03, 3F-80CM, (PREM) SYNTEL CATHETER; A4F04, 4F-40CM, (PREM) SYNTEL CATHETER; A4F05, 4F-80CM, (PREM) SYNTEL CATHETER; A4F06, 5F-80CM, (PREM) SYNTEL CATHETER; A4F07, 6F-80CM, (PREM) SYNTEL CATHETER; A4F08, 7F-80CM, (PREM) SYNTEL CATHETER; CE0260ST, L2F-60CM PREM SYNTEL CATH; CE0280ST, L2F-80CM PREM SYNTEL CATH; CE0340ST, 3F-40cm (PREM) SYNTEL CATHETER; CE0380ST, 3F-80CM PREM SYNTEL CATH; CE0440ST, 4F-40CM PREM SYNTEL CATH; CE0480ST, 4F-80CM PREM SYNTEL CATH; CE0580ST, 5F-80CM PREM SYNTEL CATH; CE0680ST, 6F-80cm (PREM) SYNTEL CATHETER; CE0780ST, 7F-80CM PREM SYNTEL CATH; CE0340, 3F-40cm, SYNTEL RT-EMB; CE0380, 3F-80cm, SYNTEL RT-EMB; CE0440, 4F-40cm, SYNTEL RT-EMB; CE0480, 4F-80cm, SYNTEL RT-EMB; CE0580, 5F-80cm, SYNTEL RT-EMB; CE0680, 6F-80cm, SYNTEL RT-EMB; CE0780, 7F-80cm SYNTEL RT-EMB. BARD Embolectomy Catheters are indicated for the removal of emboli and thrombi from the peripheral arterial system. These devices consist of a catheter body with a latex-free balloon on the distal end and an inflation hub on the proximal end.
Code InfoModel Numbers: Lot Numbers A4402: 1157054, 1163804, 1170473. A4403: 1157060, 1162689, 1166031, 1169109. A4404: 1160223, 1163803, 1166725, 1171181. A4405: 1155214, 1157053, 1161472, 1162967, 1164628, 1168912. A4406: 1155428, 1162945, 1167745, 1170042. A4407: 1154478, 1162866, 1168604. A4408: 1163626. A4F00: 1164152, 1164627, 1168666. A4F01: 1156256, 1160007, 1163628, 1168231. A4F02: 1156522, 1161792, 1170399. A4F03: 1155855, 1157052, 1161793, 1160310, 1159725, 1163215, 1163961, 1167855, 1169632, 1164626, 1165853. A4F04: 1155427, 1160221, 1161791, 1156935, 1171883, 1169729, 1167751, 1165778, 1163384, 1172598. A4F05: 1155854, 1154446, 1156936, 1155230, 1161471, 1160222, 1159414, 1161998, 1163216, 1163962, 1167440, 1166463, 1164625, 1165323, 1168911. A4F06: 1155856, 1154435, 1158624, 1161997, 1164149, 1165777, 1169013. A4F07: 1171170, 1156271, 1167414, 1164151. A4F08: 1168855, 1155648. CE0260ST: 1164307, 1168569. CE0280ST: 1164351. CE0340ST: 1164348. CE0380ST: 1164308, 1164337, 1166033, 1169029, 1166281, 1166032. CE0440ST: 1164336, 1168610. CE0480ST: 1164303, 1164302, 1164335, 1164304, 1166468, 1168605, 1166284, 1166283. CE0580ST: 1164345, 1164346, 1168613. CE0680ST: 1164330, 1166470. CE0780ST: 1164354. CE0340: 1166904. CE0380: 1164344. CE0440: 1164347, 1168609. CE0480: 1164343. CE0580: 1164349. CE0680: 1164353 CE0780: 1169926.
ClassificationClass II
Reason for RecallApplied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.
Product Quantity40,238 units for all products in Recall Event
Recall NumberZ-2446-2012
Product DescriptionBiliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BILIARY 5F-40CM CATHETER; A4762, SYNTEL BILIARY 6F-23CM CATHETER; CB052308, SYNTEL BILIARY 5F-23CM CATH; CB054008, SYNTEL BILIARY 5F-40CM CATH; CB062313, SYNTEL BILIARY 6F-23CM CATH. Biliary Catheters are indicated for the removal of stones and ductal debris from the biliary system.
Code InfoModel Numbers: Lot Numbers A4752: 1165670. A4754: 1156762. A4762: 1155852, 1165674. CB052308: 1164350. CB054008: 1164305. CB062313: 1164306.
ClassificationClass II
Reason for RecallApplied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.
Product Quantity40,238 units for all products in Recall Event
Recall NumberZ-2447-2012
Product DescriptionIrrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM; IRR-080-4F, CATHETER, IRRIGATION 4F 80CM; IRR-080-6F, CATHETER, IRRIGATION 6F 80CM. Irrigation Catheters are indicated for irrigation in the peripheral vascular system and biliary tree.
Code InfoModel Numbers: Lot Numbers IRR-023-10F: 1158230. IRR-080-4F: 1156082, 1170185, 1164648. IRR-080-6F: 1158960.
ClassificationClass II
Reason for RecallApplied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.
Product Quantity40,238 units for all products in Recall Event
Recall NumberZ-2448-2012

Class II Devices Event

Event ID63107
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Jul-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLinvatec Corp. dba ConMed Linvatec
CityLargo
StateFL
CountryUS
Distribution PatternWorldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA ,WI and Hawaii., and the countries of Australia Canada, China, Switzerland, Germany, Czech Republic, Denmark, Egypt, Spain, France, South Africa, United Kingdom, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Russia and Saudi Arabia.
 

Associated Products

Product DescriptionCatheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures.
Code InfoCatalog # 24k100 Lot #: 20853-000 20854-000 20855-000 21791-000 22172-000 22414-000 22513-000 22667-000 22724-000 22725-000 23606-000 23912 23912-000 23971-000 24177-000 24296-000 24348-000 24373-000 24476-000 24559-000 24671-000 24703-000 24905-000 25668-000 25794-000 25931-000 26025-000 26041-000 26294-000 26448-000 26486-000 27130-000 27255 27255-000 27322 27520
ClassificationClass II
Reason for RecallConMed Linvatec recalled their 24k Arthroscopy Outflow/Suction Tubing Set (Product Number 24k100)because there is a possibility that the product may have a breach in the Tyvek seal that could potentially compromise the sterility of the contents.
Product Quantity30064 units
Recall NumberZ-2469-2012

Class II Devices Event

Event ID63119
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Healthcare Inc.
CityAndover
StateMA
CountryUS
Distribution PatternWorldwide Distribution--USA (nationwide) and the countries of Australia, Austria, Canada, Chile, Finland, France, Germany, Hungary. Italy, Japan, Latvia, Netherlands, New Zealand. Oman, South Korea, Switzerland and United Kingdom.
 

Associated Products

Product DescriptionPhilips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 712022, 712025 This system is used for making X-ray exposures for diagnostics.
Code InfoSerial Numbers: SN10000053 SN11000644 SN10000648 SN10000649 SN11000226 SN10000703 SN11000032 SN10000407 SN11000105 SN11000112 SN11000212 SN11000231 SN11000030 SN10000468 SN11000146 SN11000217 SN11000238 SN11000407 SN11000154 SN10000297 SN10000515 SN11000129 SN11000266 SN11000412 SN11000442 SN11000063 SN11000441 SN10000416 SN10000414 SN10000424 SN11000034 SN10000018 SN11000050 SN10000113 SN10000442 SN11000057 SN11000419 SN10000482 SN10000670 SN10000690 SN10000689 SN10000694 SN11000461 SN10000544 SN11000095 SN11000329 SN11000464 SN10000554 SN10000635 SN10000107 SN10000413 SN10000557 SN11000092 SN11000100 SN11000118 SN11000145 SN11000161 SN11000193 SN11000194 SN11000228 SN11000294 SN11000371 SN10000038 SN10000101 SN10000102 SN10000641 SN10000664 SN11000027 SN10000537 SN10000650 SN11000130 SN11000142 SN11000216 SN11000269 SN11000286 SN11000288 SN11000311 SN11000320 SN10000363 SN10000246 SN10000512 SN11000033 SN11000053 SN11000080 SN11000271 SN11000478 SN11000474 SN11000013 SN11000005 SN11000008 SN11000004 SN11000141 SN11000007
ClassificationClass II
Reason for RecallThe Wireless Portable Detector (WPD) is not fixed securely inside the Mobile Detector Holder and may fall down
Product Quantity93 Units
Recall NumberZ-2465-2012

Class II Devices Event

Event ID63141
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGreatbatch Medical
CityMinneapolis
StateMN
CountryUS
Distribution PatternDistributed in MA.
 

Associated Products

Product DescriptionBoston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441. To facilitate transvenous introduction of diagnostic / therapeutic catheters into the vasculature and into the chambers of the heart.
Code InfoQ2112752, Q2110939, Q2130137, Q2131250, Q2130212, Q2150143, W2162515, W2163769, W2160626, W2175891, W2172722, W2184492, W2196366, W2184490, W2205843
ClassificationClass II
Reason for RecallDuring the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardiac cryoablation balloon catheters, the internal PTFE sheath liners were found to display varying degrees of damage that could pose an embolic risk to a patient.
Product Quantity787
Recall NumberZ-2459-2012

Class II Food Event

Event ID63150
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Sep-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmM & K Trading Inc
CityLos Angeles
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSeasoned Clams, 240 grams
Code Infonot available.
ClassificationClass II
Reason for RecallM & K Trading is recalling Korean Molluscan Shellfish because the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Product Quantity39 units
Recall NumberF-2396-2012

Class II Devices Event

Event ID63156
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNeomend Inc
CityIrvine
StateCA
CountryUS
Distribution PatternUS Nationwide Distribution
 

Associated Products

Product DescriptionProgel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks (;::2mm) incurred during open resection of lung parenchyma.
Code InfoModel #: PGPS002 Lot #: 111202-002
ClassificationClass II
Reason for RecallProduct was distributed with an incorrect expiration date. Product was labeled with an expiration date of 2013-04 and should have been labeled with 2012-09.
Product Quantity95 units
Recall NumberZ-2454-2012

Class II Devices Event

Event ID63166
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-May-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmToshiba American Medical Systems Inc
CityTustin
StateCA
CountryUS
Distribution PatternNationwide distribution: USA including states of: MA, MD, and NV.
 

Associated Products

Product DescriptionTSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. This device is intended to produce cross sectional volume sets of the anatomy. Additionally the system, when used by a trained professional, is capable of proving data for dynamic and perfusion studies of organs and extremities.
Code InfoItem number TSX-301 A/2D Serial Numbers: 2DA0792004, 2DA07X2005, 2DA07Y2010, 2DA0792002, 2DA07X2008, 2DA0842023.
ClassificationClass II
Reason for RecallThe SureStart function may not operate in the usual manner, and you may obtain abnormal analysis results when using the cerebral blood flow analysis function.
Product Quantity3 units
Recall NumberZ-2468-2012

Class II Devices Event

Event ID63180
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHologic, Inc.
CityBedford
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and the countries of Argentina, Australia,Belgium, Canada, China, Germany, Ecuador, Spain, France, Great Britain, Greece, Hong Kong, Italy, Japan Korea, Lithuvania, Neherlands, qatar, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan, South Africa, and Switzerland.
 

Associated Products

Product DescriptionHologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.
Code InfoSoftware version 4.0 and 4.0.1
ClassificationClass II
Reason for RecallInSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180°around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180° around vertical axis as well as 180° around a horizontal axis.
Product Quantity414 units
Recall NumberZ-2452-2012
Product DescriptionHologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.
Code InfoSoftware version 5.0.1and 5.0.2
ClassificationClass II
Reason for RecallFluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180°around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180° around vertical axis as well as 180° around a horizontal axis.
Product Quantity46 units
Recall NumberZ-2453-2012

Class II Devices Event

Event ID63186
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Oct-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRAYSEARCH LABORATORIES AB
CityStockholm
State
CountrySE
Distribution PatternWorldwide Distribution - USA including CA, KY, MI, NY, OK, OR, SD, and WI. Internationalyl to Canada, Sweden, France, Germany, Australia, Poland, Belgium, and United Kingdom.
 

Associated Products

Product DescriptionSharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists.
Code Infoversion 1.2.1 (build number 1.3.1.10).
ClassificationClass II
Reason for RecallThis notice concerns behavior of the SharePlan that may be unexpected and not clearly described in the user manual. This behavior has not caused patient mistreatment or other incidents. However, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivered treatment. The behavior appears, when importing RFA-files (.asc). In such cases, special notice has to be taken of the coordinate system used. The correction is to modify the labelling.
Product Quantity20 units
Recall NumberZ-2444-2012

Class II Devices Event

Event ID63188
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Sep-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMicro Therapeutics Inc, Dba Ev3 Neurovascular
CityIrvine
StateCA
CountryUS
Distribution PatternWorldwide Distribution - US Nationwide including the states: MN, FL, OR, TX and the countries of: Brazil, Belgium, Czech Republic, Finlind, France, Germany, Netherlands, Poland, and United Kingdom.
 

Associated Products

Product DescriptionUltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
Code InfoLot # 9374298
ClassificationClass II
Reason for RecallThe recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.
Product Quantity36 units
Recall NumberZ-2471-2012
Product DescriptionMarathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
Code InfoLot # 9374210
ClassificationClass II
Reason for RecallThe recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.
Product Quantity23 units total
Recall NumberZ-2472-2012

Class II Drugs Event

Event ID63189
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBaxter Healthcare Corp.
CityRound Lake
StateIL
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product Description5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL AVIVA Container, product code 6E0063, NDC 0338-6346-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Code InfoLot #: a) C841114, C841254, Exp 09/12; C842229, C842898, C843037, C843326, C844209, Exp 10/12; C844456, C844928, C846089, C846246, C847178, Exp 11/12; C848044, C848804, C849869, C849810, C850313, Exp 12/12; C852574, C852673, C853168, C853275, C853473, Exp 01/13; C854331, C855098, C855551, Exp 02/13; C856690, C856815, C857813, Exp 03/13; C858829, C858951, C859884, C860049, C860304, C860304A, C860452, C861138, Exp 04/13; C861252, C861971, C862748, C862854, Exp 05/13; C865576, C865683, C866079, Exp 06/13; C866947, C867283, C867424, C867960, C868455, Exp 07/13; b) C818039, Exp 09/12; C821793, Exp 10/12; C824276, C825679, Exp 11/12; C828350, Exp 12/12; C830323, C832105, Exp 01/13; C834986, C836114, Exp 03/13; C840736, Exp 04/13; C843433, Exp 05/13; C844829, C845784, Exp 06/13; C848333, C850446, C850446A, Exp 07/13; C852376, C852939, Exp 08/13; C856443, C857417, C857656, C858381, Exp 10/13; C858498, C859470, C859652, Exp 11/13; C863365, Exp 12/13; C863738, C863852, C865451, C866392, Exp 01/14; C867846, Exp 02/14
ClassificationClass II
Reason for RecallChemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Product Quantity753,941 containers
Recall NumberD-1686-2012
Product Description10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0163, NDC 0338-6347-03
Code InfoLot #: C832840, Exp 02/13
ClassificationClass II
Reason for RecallChemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Product Quantity2,976 containers
Recall NumberD-1687-2012
Product Description5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0173, NDC 0338-6308-03
Code InfoLot #: C828814, Exp 12/12; C841551, Exp 04/13
ClassificationClass II
Reason for RecallChemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Product Quantity5,064 containers
Recall NumberD-1688-2012
Product Description0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02; b) 500 mL AVIVA Container, product code 6E1323, NDC 0338-6304-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Code InfoLot #: a) C840892, C841007, C841403, Exp 09/12; C842377, C842757, C843748, C843946, Exp 10/12; C844332, C845065, C845198, C845347, C846873, C847301, C847608, Exp 11/12; C848481, C848937, C849554, C850180, Exp 12/12; C850966, C851097, C851212, C852459, C853044, C853614, Exp 01/13; C853747, C854455, C854711, C854836, C854943, C856013, C856138, Exp 02/13; C856948, C858027, Exp 03/13; C858712, C859066, C859199, C859389, C860569, C861021, Exp 04/13; C861856, C862953, C863076, C863183, Exp 05/13; C865188, C865824, C866178, C866178A, Exp 06/13; C867168, C868117, C868570, C868703, Exp 07/13; b) C818187, C819367, Exp 09/12; C821686, Exp 10/12; C823377, Exp 11/12; C826255, C828111, C828228, Exp 12/12; C830455, C830604, Exp 01/13; C832964, C833152, Exp 02/13; C839134, C840587, Exp 04/13; C842740, C843649, Exp 05/13; C844647, C845941, C847038, Exp 06/13; C848184, C849117, C850545, Exp 07/13; C850842, C851568, C852806, Exp 08/13; C853853, C854216, C854216A, C855213, Exp 09/13; C856567, C858142, C858258, Exp 10/13; C858613, C859777, C859777A, C860916, Exp 11/13; C861617, C861724, Exp 12/13; C865311, C866285, Exp 01/14; C866632, C866830, Exp 02/14
ClassificationClass II
Reason for RecallChemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Product Quantity897,496 containers
Recall NumberD-1689-2012
Product DescriptionLactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02; b) 500 mL AVIVA Container, product code 6E2323, NDC 0338-6307-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Code InfoLot #: a) C847749, Exp 11/12; C847897, Exp 12/12; C860668, Exp 04/13; b) C855445, Exp 09/13; C861492, Exp 12/13
ClassificationClass II
Reason for RecallChemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Product Quantity55,664 containers
Recall NumberD-1690-2012

Class II Devices Event

Event ID63197
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc
CityMalvern
StatePA
CountryUS
Distribution PatternNationwide Distribution - USA including Washington, DC and AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI and Puerto Rico.
 

Associated Products

Product DescriptionSiemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager
Code InfoModel numbers: 10276755 (Verio), 10684333 (Verio Dot), 10684334 (Verio Dot upgrade), 10432915 (Skyra), 10655588 (Spectra), and 10433372 (Biograph mMR)
ClassificationClass II
Reason for RecallWhen positioning the Flex Large 4 Coil (part No. 8625761) off-center in left-right direction as it is used for example for hip and shoulder imaging and, in addition at an off-center position with respect to the head-foot direction, the coil can heat up in the area of the electronic housing (white plastic lids).
Product Quantity370
Recall NumberZ-2464-2012

Class II Drugs Event

Event ID63198
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionPropofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA
Code InfoLot No: a) 93-857-DJ, 93-896-DJ, Exp 1SEP2012; 04-515-DJ, Exp 1APR2013; 06-802-DJ, Exp 1JUN2013; b) 01-175-DJ, Exp 1JAN2013; 04-565-DJ, Exp 1APR2013; c) 03-388-DJ, Exp 1MAR2013; The lot number may be followed by 01 or 02
ClassificationClass II
Reason for RecallPresence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.
Product Quantity148,630 vials
Recall NumberD-1685-2012

Class II Drugs Event

Event ID63264
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGlenmark Generics Inc., USA
CityMahwah
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

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

Class III Biologics Event

Event ID39124
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-May-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center of Greater Kansas City
CityKansas City
StateMO
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code InfoW045007045551;W045007050899
ClassificationClass III
Reason for RecallBlood product, for which viral marker testing was incomplete, were distributed.
Product Quantity2 units
Recall NumberB-2310-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045007701266;W045007048992;W045007033136;W045007045551;W045007050899;W045007037595
ClassificationClass III
Reason for RecallBlood product, for which viral marker testing was incomplete, were distributed.
Product Quantity6 units
Recall NumberB-2311-12

Class III Biologics Event

Event ID41467
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jan-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center of Greater Kansas City
CityKansas City
StateMO
CountryUS
Distribution PatternMO
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045005138494
ClassificationClass III
Reason for RecallBlood product, manufactured without additive solution, was distributed.
Product Quantity1 unit
Recall NumberB-2342-12

Class III Biologics Event

Event ID42623
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jul-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternKansas
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Washed
Code InfoW045006059851
ClassificationClass III
Reason for RecallBlood product, with an unacceptable low red cell recovery rate, was distributed.
Product Quantity1 Unit
Recall NumberB-2339-12

Class III Biologics Event

Event ID43018
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Sep-06
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternMO.
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW045006909473
ClassificationClass III
Reason for RecallBlood product, which was exposed to unacceptable temperature during storage, was distributed.
Product Quantity1 unit
Recall NumberB-2326-12

Class III Biologics Event

Event ID43665
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Dec-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityPomona
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info006KK04845, 006KK04846, 006KK04847(Part A), 006KK04847(Part B), 006KR45572
ClassificationClass III
Reason for RecallBlood products, for which no documentation of shipment or storage at appropriate temperatures were distributed.
Product Quantity5 units
Recall NumberB-2343-12

Class III Biologics Event

Event ID45108
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Aug-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternIowa, Missouri, New York.
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoK46171;K46171;K46171
ClassificationClass III
Reason for RecallBlood products, which did not meet the acceptable product specifications for release, were distributed.
Product Quantity3 Units
Recall NumberB-2196-12

Class III Biologics Event

Event ID45358
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Aug-07
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternKansas.
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW045007905565
ClassificationClass III
Reason for RecallIn this situation, blood product was stored where the temperature was not continuously monitored, was distributed.
Product Quantity1 unit
Recall NumberB-2338-12

Class III Biologics Event

Event ID46538
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Dec-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Bank of Lancaster County Medical Society
CityLincoln
StateNE
CountryUS
Distribution PatternAustria; FL; NE
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info8011980
ClassificationClass III
Reason for RecallBlood products, which Viral Testing performed, interpreted, or documented incorrectly, were distributed.
Product Quantity1 unit
Recall NumberB-2355-12
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info3754793;3754792
ClassificationClass III
Reason for RecallBlood products, which Viral Testing performed, interpreted, or documented incorrectly, were distributed.
Product Quantity2 units
Recall NumberB-2356-12

Class III Biologics Event

Event ID47121
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Dec-07
Initial Firm Notification of Consignee or Public Other
Recalling FirmAmerican Red Cross Blood Services
CityOmaha
StateNE
CountryUS
Distribution Patternunknown
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info09Q98860; 09Q98888; 09Q98889
ClassificationClass III
Reason for RecallBlood products, for which storage conditions and shipment information were undocumented, were distributed.
Product Quantity3 units
Recall NumberB-2351-12

Class III Biologics Event

Event ID59514
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Jul-11
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmOctapharma Plasma, Inc.
CityCharlotte
StateNC
CountryUS
Distribution PatternCA, Austria
 

Associated Products

Product DescriptionSource Plasma
Code Info4270034435, 4270033702, 4270032835, 4270032531, 4270031860, 4270031545, 4270030925, 4270030610, 4270029947, 4270029572, 4270029101, 4270028782, 4270028101, 4270027804, 4270027164, 4270026836, 4270026282, 4270025918, 4270025278, 4270024961
ClassificationClass III
Reason for RecallBlood products, collected from a donor, for whom donor suitability was not adequately determined, were distributed.
Product Quantity20 units
Recall NumberB-2354-12

Class III Biologics Event

Event ID60015
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jul-01
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmDelta Blood Bank
CityStockton
StateCA
CountryUS
Distribution PatternIN.
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW128711102646
ClassificationClass III
Reason for RecallBlood product, collected from a donor whose arm preparation was not documented, was distributed.
Product Quantity1 unit
Recall NumberB-2226-12

Class III Devices Event

Event ID62440
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmClark Laboratories, Inc. (dba,Trinity Biotech USA)
CityJamestown
StateNY
CountryUS
Distribution PatternNationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX.
 

Associated Products

Product DescriptionTrinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
Code InfoKit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568
ClassificationClass III
Reason for RecallThe Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range.
Product Quantity810 kits
Recall NumberZ-2445-2012

Class III Drugs Event

Event ID62696
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmMallinckrodt Inc
CityHazelwood
StateMO
CountryUS
Distribution PatternAZ, CT, MO, MS, PA, FL, WA, NC, CA, TX, OK
 

Associated Products

Product DescriptionThallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC 0019N12063) For Intravenous Administration, each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 (no carrier added) at date and time of calibration, 9 mg sodium chloride and 0.9% (v/v) benzyl alcohol as a preservative, RX, Mallinckrodt Inc., St. Louis, MO 63134
Code InfoLot 120-2686, exp. 8/2/12.
ClassificationClass III
Reason for RecallLabeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
Product Quantity12/2.8mCi-vials and 12/6.3mCi-vials
Recall NumberD-1692-2012

Mixed Classification Food Event

Event ID60642
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Nov-11
Initial Firm Notification of Consignee or Public Visit
Recalling FirmMcClures, Inc.
CityGap
StatePA
CountryUS
Distribution PatternProduct was distributed to retail outlets in DE, MD, NJ and PA within the US.
 

Associated Products

Product DescriptionMcClure's Pies & Salads, Inc. Walnut Cinnamon Streusel Cake
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass I
Reason for RecallUndeclared allergens. Ingredient statement lists "nuts" but is not specific for walnuts. Label does say, "Walnut Cinnamon Streusel Cake."
Product Quantity12 cakes
Recall NumberF-2397-2012
Product DescriptionMcClure's Pies & Salads, Inc. Apple Cinnamon Streusel Cake
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass I
Reason for RecallUndeclared allergens. Ingredient statement lists "nuts" but is not specific for walnuts.
Product Quantity138 cakes
Recall NumberF-2398-2012
Product DescriptionMcClure's Pies & Salads, Inc. Marble Cake
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour.
Product Quantity15 cakes
Recall NumberF-2399-2012
Product DescriptionMcClure's Pies & Salads, Inc. German Chocolate Cake
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour.
Product Quantity14 cakes
Recall NumberF-2400-2012
Product DescriptionMcClure's Pies & Salads, Inc. Chocolate Cake
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour.
Product Quantity96 cakes
Recall NumberF-2401-2012
Product DescriptionMcClure's Pies & Salads, Inc. Red Velvet Cake
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour.
Product Quantity31 cakes
Recall NumberF-2402-2012
Product DescriptionMcClure's Pies & Salads, Inc. Black Walnut Cake
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour.
Product Quantity20 cakes
Recall NumberF-2403-2012
Product DescriptionMcClure's Pies & Salads, Inc. Yellow Cake
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour. Also, coloring (yellow #5) is not listed.
Product Quantity402 cakes
Recall NumberF-2404-2012
Product DescriptionMcClure's Pies & Salads, Inc. Lemon Crunch Cake
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "nuts" but is not specific for walnuts. Also, coloring is not listed - Yellow #5
Product Quantity28 cakes
Recall NumberF-2405-2012
Product DescriptionMcClure's Pies & Salads, Inc. Lemon Glazed Cake
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement does not list coloring - Yellow #5.
Product Quantity156 cakes
Recall NumberF-2406-2012
Product DescriptionMcClure's Pies & Salads, Inc. Orange Cake
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity22
Recall NumberF-2407-2012
Product DescriptionMcClure's Pies & Salads, Inc. Apple Dumplings
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product QuantityUnknown
Recall NumberF-2408-2012
Product DescriptionMcClure's Pies & Salads, Inc. French Apple Pie
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity75 pies
Recall NumberF-2409-2012
Product DescriptionMcClure's Pies & Salads, Inc. Peach Pie
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity12 pies
Recall NumberF-2410-2012
Product DescriptionMcClure's Pies & Salads, Inc. Blueberry Pie
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity19 pies
Recall NumberF-2411-2012
Product DescriptionMcClure's Pies & Salads, Inc. Cherry Pie
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity27 pies
Recall NumberF-2412-2012
Product DescriptionMcClure's Pies & Salads, Inc. Apple Pie
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity40 pies
Recall NumberF-2413-2012
Product DescriptionMcClure's Pies & Salads, Inc. Pumpkin Pie
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity97 pies
Recall NumberF-2414-2012
Product DescriptionMcClure's Pies & Salads, Inc. Banana Cream Pie
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity5 pies
Recall NumberF-2415-2012
Product DescriptionMcClure's Pies & Salads, Inc. Cherry Custard Pie
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity3 pies
Recall NumberF-2416-2012
Product DescriptionMcClure's Pies & Salads, Inc. Coconut Custard Pie
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity9 pies
Recall NumberF-2417-2012
Product DescriptionMcClure's Pies & Salads, Inc. Egg Custard Pie
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity7 pies
Recall NumberF-2418-2012
Product DescriptionMcClure's Pies & Salads, Inc. Chocolate Cream Pie
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity20 pies
Recall NumberF-2419-2012
Product DescriptionMcClure's Pies & Salads, Inc. Coconut Cream Pie
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity16 pies
Recall NumberF-2420-2012
Product DescriptionMcClure's Pies & Salads, Inc. Shoo Fly Pie
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity90 pies
Recall NumberF-2421-2012
Product DescriptionMcClure's Pies & Salads, Inc. Chocolate Shoo Fly Pie
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity6 pies
Recall NumberF-2422-2012
Product DescriptionMcClure's Pies & Salads, Inc. Pecan Pie
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass II
Reason for RecallUndeclared allergens. Ingredient statement lists "flour" but is not specific for wheat flour
Product Quantity11 pies
Recall NumberF-2423-2012
Product DescriptionMcClure's Pies & Salads, Inc. Cole Slaw
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass I
Reason for RecallUndeclared allergens. Ingredient statement lists "mayonnaise" but sub-ingredients are not listed for the mayonnaise
Product Quantity30 lbs
Recall NumberF-2424-2012
Product DescriptionMcClure's Pies & Salads, Inc. Macaroni Salad
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass I
Reason for RecallUndeclared allergens. Ingredient statement lists "macaroni" but sub-ingredients for macaroni are not listed
Product Quantity42 lbs
Recall NumberF-2425-2012
Product DescriptionMcClure's Pies & Salads, Inc. Broccoli & Cauliflower Salad
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass I
Reason for RecallUndeclared allergens. Ingredient statement lists "mayonnaise" but sub-ingredients for mayonnaise are not listed. In addition, product label lists cheese but does not list sub-ingredients from the cheese label.
Product Quantity631 lbs
Recall NumberF-2426-2012
Product DescriptionMcClure's Pies & Salads, Inc. Chicken Salad
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass I
Reason for RecallUndeclared allergens. Ingredient statement lists "mayonnaise" but sub-ingredients for mayonnaise are not listed
Product Quantity43 lbs
Recall NumberF-2427-2012
Product DescriptionMcClure's Pies & Salads, Inc. Egg Salad
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass I
Reason for RecallUndeclared allergens. Ingredient statement lists "mayonnaise" but sub-ingredients for mayonnaise are not listed
Product Quantity3 lbs
Recall NumberF-2428-2012
Product DescriptionMcClure's Pies & Salads, Inc. Potato Salad
Code InfoAll product distributed prior to 11/15/2011
ClassificationClass I
Reason for RecallUndeclared allergens. Ingredient statement lists "salad dressing" but sub-ingredients for salad dressing are not listed
Product Quantity36 lbs
Recall NumberF-2429-2012

Mixed Classification Food Event

Event ID62713
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jun-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmDerby City Vending Inc
CityLouisville
StateKY
CountryUS
Distribution PatternProduct was shipped to KY and IN.
 

Associated Products

Product Description"Derby City Vending "Infielder's Breakfast" Biscuit and Gravy, Daybreak Selections, Ingredients: PILLSBURY buttermilk biscuit, PIONEER biscuit gravy mix, PURNELLS sausage***Fresh Thru***Derby City Vending Louisville, KY 40206"
Code InfoProduct is stamped: Fresh Thru 4/21/12 - 6/17/12
ClassificationClass II
Reason for RecallDuring an FDA inspection of the firm on 6/12/2012, the firm was notified that they were missing the following allergen declarations from their labels: soy, milk, eggs and wheat.
Product Quantity1860 plastic tubs
Recall NumberF-2430-2012
Product DescriptionDerby City Vending "Finish Line" Hand Made Chicken Salad Ingredients: 100% whole wheat bread, Fresh hand cut chicken breast, miracle whip, salt, pepper, celery, pickle relish Fresh Thru***Derby City Vending Louisville, KY 40206
Code InfoProduct is stamped: Fresh Thru 4/21/12 - 6/17/12
ClassificationClass I
Reason for RecallDuring an FDA inspection of the firm on 6/12/2012, the firm was notified that they were missing the following allergen declarations from their labels: soy, milk, eggs and wheat.
Product Quantity3,560 Sandwiches
Recall NumberF-2431-2012
Product DescriptionDerby City Vending "Heckuva" Grilled Ham And Swiss Deli Selections Ingredients: Classic Pit-Style Ham, KLOSTERMAN sub bun, Swiss Cheese, mayonaise packet, SYSCO Clasic Redskin Potato Salad Fresh Thru***Derby City Vending Louisville, KY 40206
Code InfoProduct is stamped: Fresh Thru 4/21/12 - 6/17/12
ClassificationClass I
Reason for RecallDuring an FDA inspection of the firm on 6/12/2012, the firm was notified that they were missing the following allergen declarations from their labels: soy, milk, eggs and wheat.
Product Quantity3,142 Sandwiches
Recall NumberF-2432-2012

Mixed Classification Biologics Event

Event ID46539
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Dec-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Bank of Lancaster County Medical Society
CityLincoln
StateNE
CountryUS
Distribution PatternNE; OH; TN; MO; Austria
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info6067919;6070284;6075510
ClassificationClass III
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity3 units
Recall NumberB-2060-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info6066046;6070284;6073935;6075510
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity4 units
Recall NumberB-2061-12
Product DescriptionCryoprecipitated AHF
Code Info6066046
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2062-12
Product DescriptionPlasma Cryoprecipitated Reduced
Code Info6066046
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2063-12
Product DescriptionFresh Frozen Plasma
Code Info6073935
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2064-12

Mixed Classification Biologics Event

Event ID47098
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jan-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross (The)
CityOmaha
StateNE
CountryUS
Distribution PatternNE
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info09GH73273
ClassificationClass III
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2110-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info09GH73273
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2111-12

Mixed Classification Biologics Event

Event ID47614
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Jan-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Bank of Lancaster County Medical Society
CityLincoln
StateNE
CountryUS
Distribution PatternMO; Austria
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info3750331
ClassificationClass III
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2056-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info3750331
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2057-12
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