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U.S. Department of Health and Human Services

Enforcement Report - Week of October 10, 2012

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Class I Food Event

Event ID62964
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Aug-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmJ F C International Inc
CityLos Angeles
StateCA
CountryUS
Distribution PatternDistributed nationwide. No international
 

Associated Products

Product DescriptionFurikake (a Japanese rice seasoning of seaweed flakes with toppings/seasonings). JFC Brand Furikake-Seto Fumi, 1.7 oz. Packaged in a clear glass jar with plastic twist lid.
Code InfoLot code/Best before date of 04.05.2014 (stamped on top of the lid).
ClassificationClass I
Reason for RecallThe firm recalled the product due to undeclared eggs, soybeans, and wheat. UPC/Bar code 0 11152 41464
Product Quantityunknown
Recall NumberF-0008-2013

Class I Food Event

Event ID62986
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 FirmTriple B Corporation
CitySpokane
StateWA
CountryUS
Distribution PatternProduct was distributed in Idaho, Montana, and Washington
 

Associated Products

Product DescriptionSliced White Mushroom, Champ's Mushroom, net wt. 8 oz. The UPC is 0 33383 67600 5.
Code InfoDate Code PO 11AUG2012. Date code is the "packed on" date and product has a 10 days shelf life with the pack on date being day one.
ClassificationClass I
Reason for RecallChamps 8 oz Sliced White Mushrooms are recalled due to potential contamination of Listeria monocytogenes.
Product Quantity48 cases/12 packages/8 oz
Recall NumberF-2449-2012

Class I Food Event

Event ID62996
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSpokane Produce, Inc.
CitySpokane
StateWA
CountryUS
Distribution PatternWashington, Idaho, Montana, Oregon, Wyoming and 9 military bases.
 

Associated Products

Product DescriptionChamp's Sliced White Mushrooms, 227 g/8 oz, in a styrofoam container with shrink wrap, UPC 0 33383 67600 5. Labeled in part: "CHAMP'S MUSHROOMS Sliced White Mushrooms, Product of Canada, 227g/8 oz, 0 33383 67600 5 KEEP REFRIGERATED
Code InfoPacked on Date is PO 11AUG2012. The Best Before is 22AUG2012. Date code is the packed on date and product has a 10 day shelf life with the pack on date being day one.
ClassificationClass I
Reason for RecallProduct recalled due to potential contamination with Listeria monocytogenes.
Product Quantity140 cases (1,260 - 8 ounce containers)
Recall NumberF-0013-2013

Class I Food Event

Event ID62997
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 FirmOakshire Mushroom Sales, Llc
CityKennett Square
StatePA
CountryUS
Distribution PatternDistributed to a single account (Albertson's).
 

Associated Products

Product DescriptionDole brand Sliced Mushrooms, Net Wt. 8 OZ. (227G), UPC: 0 33383 67600 5, in a plastic container over-wrapped with plastic film. Labeled in part: Dole Sliced Mushrooms, Distributed by Oakshire Mushroom Sales, LLC under license Kennett Square, PA 19348 1-866-355-2077, Product of Canada
Code Info"33 6" - represents the week of year plus one day of week. Code is etched on label near "Distributed by" text.
ClassificationClass I
Reason for RecallProduct recalled due to potential contamination of Listeria monocytogenes.
Product Quantity160 cases w/ 12 - 8 ounce containers per case.
Recall NumberF-0012-2013

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 ID63063
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Aug-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmTaylor Farms, Inc.
CitySwedesboro
StateNJ
CountryUS
Distribution PatternOne sole wholesale customer - Wawa Inc., Wawa, PA 19063
 

Associated Products

Product DescriptionWawa Mango Net Wt. 8 oz (227 g) Distributed by Wawa, Inc. Wawa, PA 19063 UPC 726191069267
Code InfoLot numbers 226, 227, 228, 229, 230, 232, 233, 234, 235, 236, 237 Product number 10305 Expiration Date 08/19/12 08/20/12 08/21/12 08/22/12 08/23/12 08/25/12 08/26/12 08/27/12 08/28/12 08/29/12 08/30/12
ClassificationClass I
Reason for RecallTaylor Farms New Jersey is voluntarily recalling specific code dates of the following products due to containing Daniella Brand mangoes or potentially being processed on common equipment with the Daniella Brand mangoes. since Daniella Brand mangoes were identified by the CFIA as having the potential to be contaminated with Salmonella Braenderup, and are subject to a prior recall posted by CFIA and FDA.
Product Quantity1325 retail units
Recall NumberF-0015-2013
Product DescriptionWawa pineapples, strawberries & mango Net. Wt. 9 oz. rigid plastic tray Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191061155
Code InfoLot numbers 226, 227, 228, 229 Expiration Dates 08/19/12, 08/20/12, 08/21/12, 08/22/12
ClassificationClass I
Reason for RecallTaylor Farms New Jersey is voluntarily recalling specific code dates of the following products due to containing Daniella Brand mangoes or potentially being processed on common equipment with the Daniella Brand mangoes since Daniella Brand mangoes were identified by the CFIA as having the potential to be contaminated with Salmonella Braenderup, and are subject to a prior recall posted by CFIA and FDA.
Product Quantity588 units
Recall NumberF-0016-2013
Product DescriptionWawa pineapple Net Wt. 7 oz (198 g) rigid plastic tray Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191069328
Code InfoLot 226, 227, 228, 229, 230, 232, 233, 234, 235, 236, 237 Product number 10303 Expiration Dates 8/19/12, 8/20/12, 8/21/12, 8/22/12, 8/23/12, 8/25/12, 8/26/12, 8/27/12, 8/28/12, 8/29/12, 8/30/12
ClassificationClass I
Reason for RecallTaylor Farms New Jersey is voluntarily recalling specific code dates of the following products due to containing Daniella Brand mangoes or potentially being processed on common equipment with the Daniella Brand mangoes since Daniella Brand mangoes were identified by the CFIA as having the potential to be contaminated with Salmonella Braenderup, and are subject to a prior recall posted by CFIA and FDA.
Product Quantity1034 units
Recall NumberF-0017-2013
Product DescriptionWawa melon mix Net Wt 11 oz (312 g) in rigid plastic trays Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191061148
Code InfoLot Numbers 226, 227, 228, 229, 230, 232, 233, 234, 235, 236, 237 Product Code 10308 Expiration Dates 08/19/12, 08/20/12, 08/21/12, 08/22/12, 08/23/12, 08/25/12, 08/26/12, 08/27/12, 08/28/12, 08/29/12, 08/30/12
ClassificationClass I
Reason for RecallTaylor Farms New Jersey is voluntarily recalling specific code dates of the following products due to containing Daniella Brand mangoes or potentially being processed on common equipment with the Daniella Brand mangoes since Daniella Brand mangoes were identified by the CFIA as having the potential to be contaminated with Salmonella Braenderup, and are subject to a prior recall posted by CFIA and FDA.
Product Quantity2790 units
Recall NumberF-0018-2013
Product DescriptionWawa Large mixed fruit Net Wt 12 oz (340 g) in rigid plastic trays Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191069250. Wawa Small mixed fruit Net Wt 7.5 oz (213 g) in rigid plastic trays Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191069243
Code InfoLarge: Lot # 226, 227, 228, 229, 230, 232, 233, 234, 235, 236, 237. Product Code 10307. Expiration Dates 08/19/12, 08/20/12, 08/21/12, 08/22/12, 08/23/12, 08/25/12, 08/26/12, 08/27/12, 08/28/12, 08/29/12, 08/30/12 Small: Lot #226, 227, 228, 229, 230, 232, 233, 234, 235, 236, 237 Product Code 10306. Expiration Dates 08/19/12, 08/20/12, 08/21/12, 08/22/12, 08/23/12, 08/25/12, 08/26/12, 08/27/12, 08/28/12, 08/29/12, 08/30/12
ClassificationClass I
Reason for RecallTaylor Farms New Jersey is voluntarily recalling specific code dates of the following products due to containing Daniella Brand mangoes or potentially being processed on common equipment with the Daniella Brand mangoes since Daniella Brand mangoes were identified by the CFIA as having the potential to be contaminated with Salmonella Braenderup, and are subject to a prior recall posted by CFIA and FDA.
Product QuantityLarge 1963 units. Small 857 units
Recall NumberF-0019-2013
Product DescriptionWawa watermelon Net Wt 8 oz (227 g) in rigid plastic trays Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191069274
Code InfoLot Numbers 226, 227, 228, 229, 230, 232, 233, 234, 235, 236, 237 Product Code 10302 Expiration Dates 08/19/12, 08/20/12, 08/21/12, 08/22/12, 08/23/12, 08/25/12, 08/26/12, 08/27/12, 08/28/12, 08/29/12, 08/30/12
ClassificationClass I
Reason for RecallTaylor Farms New Jersey is voluntarily recalling specific code dates of the following products due to containing Daniella Brand mangoes or potentially being processed on common equipment with the Daniella Brand mangoes since Daniella Brand mangoes were identified by the CFIA as having the potential to be contaminated with Salmonella Braenderup, and are subject to a prior recall posted by CFIA and FDA.
Product Quantity
Recall NumberF-0020-2013
Product DescriptionWawa mixed fruit with kiwi Net Wt 9.7 oz (275 g) in rigid plastic trays Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191069304
Code InfoLot Numbers 226, 227, 228, 229, 230, 232, 233 Product Code 10311 Expiration Dates 08/19/12, 08/20/12, 08/21/12, 08/22/12, 08/23/12, 08/25/12, 08/26/12, 08/27/12
ClassificationClass I
Reason for RecallTaylor Farms New Jersey is voluntarily recalling specific code dates of the following products due to containing Daniella Brand mangoes or potentially being processed on common equipment with the Daniella Brand mangoes since Daniella Brand mangoes were identified by the CFIA as having the potential to be contaminated with Salmonella Braenderup, and are subject to a prior recall posted by CFIA and FDA.
Product Quantity1189 units
Recall NumberF-0021-2013
Product DescriptionWawa mango and yogurt parfait Wt 7.5 oz (213 g) in rigid plastic trays Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191070751
Code InfoLot Numbers 226, 227, 228, 229, 230, 232, 233, 234, 235, 236, 237 Product Code 10301 Expiration Dates 08/23/12, 08/24/12, 08/25/12, 08/26/12, 08/27/12, 08/29/12, 08/30/12, 09/01/12, 09/02/12, 09/03/12
ClassificationClass I
Reason for RecallTaylor Farms New Jersey is voluntarily recalling specific code dates of the following products due to containing Daniella Brand mangoes or potentially being processed on common equipment with the Daniella Brand mangoes since Daniella Brand mangoes were identified by the CFIA as having the potential to be contaminated with Salmonella Braenderup, and are subject to a prior recall posted by CFIA and FDA.
Product Quantity494 units
Recall NumberF-0022-2013

Class I Food Event

Event ID63065
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmPacific Coast Fruit Company
CityPortland
StateOR
CountryUS
Distribution PatternDistributed to deli retailers in Oregon, Washington, Idaho and Alaska.
 

Associated Products

Product DescriptionVA Kit New Gourmet Fruit Salad 7.75#. Item # 70006, UPC is 0 20728 70006 8. Label reads in part "***VA KIT NEW GOURMET FRUIT SALAD 7.75# *** Ingredients: INGREDIENTS: Watermelon, Honeydew, Cantaloupe, Mangos, Kiwi, Blue Berries. *** Pacific Coast Fruit Portland, OR 97232 ***".
Code InfoBest if Used By July 26 to August 30.
ClassificationClass I
Reason for RecallDaniella brand mangos are recalled because they may be contaminated with Salmonella.
Product Quantity833 cs
Recall NumberF-2392-2012
Product DescriptionMango & Cucumber Salsa item # 71784 UPC 0 20728 71784 4, Best if Used By July 30 to September 2; Label reads in part "***MANGO 7 CUCUMBER SALSA ***Ingredients: Mangos, English Cucumber, Pineapple Vinaigrette: Vinegar (Cider, Distilled), Water, Soybean Oil, High Fructose corn Syrup, Brown Sugar, Honey, Dijon Mustard (Water, Mustard Seed, Vinegar, Salt, White Wine, Citric Acid, Tartaric Acid, Spices), Corn Syrup, Mango Puree, Pineapple Juice Concentrate, Tomato Paste, Sugar, Salt Mustard Flour, Xanthan Gum, Garlic Powder, Onion Powder, Spices, Chipotle Peppers, Red Bell Peppers, Potassium Sorbate and Calcium Disodium EDTA used to Protect Quality, Molasses, Color Added, Tamarind, Natural Flavor, Red Bell Pepper, Shallots, Jalapeno Peppers, Cilantro. CONTAINS: SOY. *** Pacific Coast Fruit Portland, OR 97232***"
Code InfoBest if Used By July 30 to September 3
ClassificationClass I
Reason for RecallDaniella brand mangos are recalled because they may be contaminated with Salmonella.
Product Quantity660 cs
Recall NumberF-2393-2012

Class I Food Event

Event ID63084
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmKerry Foods
CityBeloit
StateWI
CountryUS
Distribution PatternThe product was distributed to UT.
 

Associated Products

Product DescriptionKerry Organic Pure 900, Organic Soy Protein Isolate, Item #722234.454, packaged in 20-kg. bags. The firm name on the label is Kerry China, Shanghai, China.
Code InfoLot #O4120710
ClassificationClass I
Reason for RecallThe product may be contaminated with Salmonella.
Product Quantity118/20-kg. bags
Recall NumberF-0007-2013

Class I Food Event

Event ID63097
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmFreshPoint Central California, Inc.
CityTurlock
StateCA
CountryUS
Distribution PatternCA only
 

Associated Products

Product DescriptionMango Peeled Halved and Cored, wrapped in plastic and refrigerated. Distributed by FreshPoint Central California, Turlock, CA
Code InfoWM7990, LM8575, GM8838, GM9132, VM9531, NN0110; LN0393, FN0707
ClassificationClass I
Reason for RecallNotified by supplier of recall of Daniella brand mangoes due to potential contamination with Salmonella Braenderup.
Product Quantity423
Recall NumberF-0009-2013
Product DescriptionMango Chunks, 5# tub Distributed by FreshPoint Central California, Turlock, CA
Code InfoJM8266, MM8817, GM8838, PM9441, NN0094, LN0393, XN0763
ClassificationClass I
Reason for RecallNotified by supplier of recall of Daniella brand mangoes due to potential contamination with Salmonella Braenderup.
Product Quantity17
Recall NumberF-0010-2013

Class I Food Event

Event ID63117
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGills Onions, LLC
CityOxnard
StateCA
CountryUS
Distribution Patternnationwide in the US
 

Associated Products

Product Description3/16" Slivered Red Onions, 1/5 lb; 1/4" Slivered Red Onions, 2/5lb, 4/5lb;
Code Infolot codes: 42RNA3A1235, 22RBC1A1235.
ClassificationClass I
Reason for RecallGills Onions is recalling diced and slivered onions because it may be contaminated with Listeria monocytogenes
Product Quantity115 units
Recall NumberF-2441-2012
Product Description1/4" Slivered Yellow Onions, 2/5lb, 4/5lb. 1/8" Slivered Yellow Onions, 2/5lb, 4/5lb. 3/16" Slivered Yellow Onions, 2/5lb, 5/2lb, 4/5lb. 3/8" Slivered Yellow Onions, 2/5 lb. 3/8" Slivered Julienne Yellow Onions, 4/5lb.
Code Infolot codes: 22YAW1A1235, 22YAN1A1235, 22YAO1B1235, 22YAN1B1235, 22YAV1B1235.
ClassificationClass I
Reason for RecallGills Onions is recalling diced and slivered onions because it may be contaminated with Listeria monocytogenes
Product Quantity
Recall NumberF-2442-2012
Product Description1/4" Diced Red Onions, 5lb, 2/5lb, 4/5lb; 3/8" Diced Red Onions, 2/5 lb, 4/5lb;
Code Infolot codes: 42RNA3A1235, 22RBC1A1235.
ClassificationClass I
Reason for RecallGills Onions is recalling diced and slivered onions because it may be contaminated with Listeria monocytogenes
Product Quantity
Recall NumberF-2443-2012
Product Description1/2" Diced Yellow Onions, 2/5lb, 4/5lb, 20lb. 1/4" Diced Yellow Onions, 1/5 lb, 2/5lb, 4/5lb. 1/8" Diced Yellow Onions, 4/5lb. 3/16" Diced Yellow Onions, 4/5lb. 3/8" Diced Yellow Onions, 1/5lb, 2/5lb, 4/5lb.
Code Infolot codes: 22YAW1A1235, 22YAN1A1235, 22YAO1B1235, 22YAN1B1235, 22YAV1B1235.
ClassificationClass I
Reason for RecallGills Onions is recalling diced and slivered onions because it may be contaminated with Listeria monocytogenes
Product Quantity4,573 units
Recall NumberF-2444-2012

Class I Food Event

Event ID63176
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmDfi Marketing Inc
CityFresno
StateCA
CountryUS
Distribution PatternNation wide: Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maine, Michigan, Minnesota, Missouri, Nevada, New York, Oklahoma, Tennessee, Texas, Virginia Foreign: Mexico
 

Associated Products

Product DescriptionCantaloupes are packed in 6ct, 9ct, 12ct, 15ct, 18ct, cardboard cartons with the DFI Brand. "826 California Westside" is also stamped on outside of the carton. Each cantaloupe also has a DFI brand sticker on it.
Code Info"826" is the packing date.
ClassificationClass I
Reason for RecallCantaloupes were tested by USDA MDP and found to be positive for salmonella.
Product Quantity344, 310 melons
Recall NumberF-0014-2013

Class I Food Event

Event ID63259
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCoast Citrus Dist
CitySan Diego
StateCA
CountryUS
Distribution PatternUs states: FL, NY, CO, NJ, KS, PA, AZ, IL, TX, AL, GA, MN, MD, MA, NC, TN, OH, CA, MO, ND, SC, and VA.
 

Associated Products

Product DescriptionCoast Tropical Brand Whole Mangoes, Kent & Keitt's varieties, 10 lb box. The recalled mangos were sold between July 7, and August 30, 2012 and can be identified by the brand sticker along with one of the following numbers: 3114, 4051, 4311, 4584, and 4959 and the words PRODUCT OF MEXICO. Packed in carboard open carton tray.
Code InfoThe recalled mangos were sold between July 7, and August 30, 2012 and can be identified by the brand sticker along with one of the following numbers: 3114, 4051, 4311, 4584, and 4959 and the words PRODUCT OF MEXICO.
ClassificationClass I
Reason for RecallThe mangoes, packed at Agricola Daniella, in Sinaloa, Mexico, that have the potential to be contaminated with Salmonella Branderup.
Product Quantity2,630,663 boxes
Recall NumberF-0011-2013

Class II Biologics Event

Event ID39452
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Dec-04
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services L.P.
CityCoralville
StateIA
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionSource Plasma
Code Info04IIAB0679, 04IIAB0310, 04IIAB0087
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was subsequently deferred after testing positive for anti-HCV, were distributed.
Product Quantity3 units
Recall NumberB-1951-12

Class II Biologics Event

Event ID39682
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jan-05
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCommunity Blood Center of Greater Kansas City
CityKansas City
StateMO
CountryUS
Distribution PatternRI
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW045004107030
ClassificationClass II
Reason for RecallBlood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Product Quantity1 unit
Recall NumberB-1952-12

Class II Biologics Event

Event ID40063
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Apr-05
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCommunity Blood Center of Greater Kansas City
CityKansas City
StateMO
CountryUS
Distribution PatternRI
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW045004088676
ClassificationClass II
Reason for RecallBlood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Product Quantity1 unit
Recall NumberB-1950-12

Class II Biologics Event

Event ID41664
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Jan-06
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc
CityColumbia
StateSC
CountryUS
Distribution PatternIL
 

Associated Products

Product DescriptionSource Plasma
Code Info6120053442, 6120043181, 6120051422, 6120050821, 6120050300, 6120050014, 6120047372, 6120046804, 6120046168, 6120046011, 6120045275, 6120045028, 6120044540. 6120044313, 6120042420, 6120042213, 6120040730, 6120040492, 6120039991, 6120040951, 6120040354, 6120039959, 6120035621, 6120045544, 6120045544, 6120043214, 6120042474, 6120041053, 6120040873, 6120040122, 6120039254, 6120038595, 6120038364, 6120037874
ClassificationClass II
Reason for RecallBlood products, collected from donors whose physical examination documentation was incomplete, were distributed.
Product Quantity34 units
Recall NumberB-2264-12

Class II Biologics Event

Event ID42410
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jun-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternIowa; Missouri; Switzerland.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoGT77849; C73312;
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity2 Units
Recall NumberB-2307-12
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoGT77849; C77312;
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity2 Units
Recall NumberB-2308-12

Class II Biologics Event

Event ID46563
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Nov-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBlood Bank of San Bernardino and Riverside Counties
CitySan Bernardino
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoGW78214
ClassificationClass II
Reason for RecallBlood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-1953-12

Class II Biologics Event

Event ID48766
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Mar-08
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc
CityCharlotte
StateNC
CountryUS
Distribution PatternIL & Switzerland
 

Associated Products

Product DescriptionSource Plasma
Code Info4180295599, 4180293457, 4180292748, 4180291210, 4180290494, 4180288898, 4180287380, 4180286664, 4180285136, 4180283611, 4180282862, 4180281289, 4180280660, 4180279234, 4180277146, 4180274840, 4180274123, 4180272549, 4180270820, 4180270301, 4180269252, 4180251088, 4180250297, 4180248757, 4180248007, 4180246535, 4180245777
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose physical examination was incomplete, were distributed.
Product Quantity27 units
Recall NumberB-2166-12

Class II Biologics Event

Event ID49223
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jun-08
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAmerican National Red Cross (The)
CityRio Piedras
StatePR
CountryUS
Distribution PatternPR and GA
 

Associated Products

Product DescriptionRed Blood Cells
Code Info54KG30772
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1994-12
Product DescriptionPlatelets
Code Info54KG30772
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1995-12

Class II Devices Event

Event ID61780
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAnimas Corporation
CityWest Chester
StatePA
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) including 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, V, VT, WA, WI, WV, WY and Washington, DC and countries of: Austria, Australia, Canada, Czech Republic, France, Finland, Germany, Hungary, Israel, Italy, Mexico, New Zealand, Puerto Rico, Spain, and United Kingdom.
 

Associated Products

Product DescriptionIR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
Code InfoOneTouch(R) Ping(TM) Glucose Management Systems - Part Numbers 101420-00, 101421-00, 101422-00, 101424-00, 101425-00, 100430-00, 100431-00, 100432-00, 100434-00, 100435-00, 101420-98, 101421-98, 101422-98, 101424-98, and 101425-98; Animas(R) 2020 Insulin Infusion Pumps - Part numbers 101370-00, 101371-00, 101372-00, 101374-00, 101375-00, 100380-00, 100381-00, 100382-00, 100384-00, and 100385-00; Animas(R) IR 1250 (1200 Plus) Insulin Infusion Pumps -- Part numbers 100250-00, 100251-00, and 100252-00; and Animas(R) IR 1200 Insulin Infusion Pumps - Part numbers 100200-00, 100201-00, and 100202-00. Serial numbers -- will be provided.
ClassificationClass II
Reason for RecallWear of the keypad that may lead to damage such as tearing or peeling of the edge of the keypad from the pump.
Product Quantity236,470
Recall NumberZ-0005-2013

Class II Devices Event

Event ID61796
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-May-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmStanley Security Solutions, Inc.
CityLincoln
StateNE
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and the countries of Canada and Great Britain.
 

Associated Products

Product DescriptionTabs Professional Monitor, includes one wall bracket, Model 25022. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
Code InfoSerial numbers 235388 thru 268275
ClassificationClass II
Reason for RecallThe monitor may fail to sound an alarm
Product Quantity2,754 units
Recall NumberZ-2488-2012
Product DescriptionTabs Professional Monitor, without wall bracket, Model 25023. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
Code InfoSerial numbers 236662 thru 265692
ClassificationClass II
Reason for RecallThe monitor may fail to sound an alarm
Product Quantity4,749 units
Recall NumberZ-2489-2012
Product DescriptionTabs Professional Monitor, without pull cord or wall bracket, Model 25025. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
Code InfoSerial numbers 236920 thru 241732
ClassificationClass II
Reason for RecallThe monitor may fail to sound an alarm
Product Quantity176 units
Recall NumberZ-2490-2012
Product DescriptionTabs Professional Voice + Monitor, includes one wall bracket, Model 25222. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
Code InfoSerial numbers 228837 thru 268768
ClassificationClass II
Reason for RecallThe monitor may fail to sound an alarm
Product Quantity4,148 units
Recall NumberZ-2491-2012
Product DescriptionTabs Professional Voice + Monitor, with wire bracket, Model 25223. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
Code InfoSerial numbers 236348 thru 347416
ClassificationClass II
Reason for RecallThe monitor may fail to sound an alarm
Product Quantity12,111 units
Recall NumberZ-2492-2012

Class II Devices Event

Event ID62110
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Apr-11
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmZimmer, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea.
 

Associated Products

Product Description00789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220 VerSys Femoral Head Provisional 22mm -2 00789502230 VerSys Femoral Head Provisional 22mm +3 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Code InfoAll lots distributed from lot 69998600 (2/20/1996) to present
ClassificationClass II
Reason for RecallComplaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (i.e. stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. Fourteen (14) of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. Provisional head dislodging may result from a number of combined factors, including patient BMI, patient soft tissue tension, incision size, and mating taper fit of the provisional.
Product Quantity231641 all sizes
Recall NumberZ-2473-2012
Product Description00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0 00789502603 VerSys Femoral Head Provisional 26mm +3.5 00789502604 VerSys Femoral Head Provisional 26mm +7 00789502605 VerSys Femoral Head Provisional 26mm +10.5 12/14 Neck Taper The provisional heads replicate final femoral implant geometry y and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Code InfoAll lots distributed from lot 69998600 (2/20/1996) to present
ClassificationClass II
Reason for RecallComplaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (i.e. stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. Fourteen (14) of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. Provisional head dislodging may result from a number of combined factors, including patient BMI, patient soft tissue tension, incision size, and mating taper fit of the provisional.
Product Quantity231, 641 all lots
Recall NumberZ-2474-2012
Product Description12/14 Neck Taper 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0 00789502803 VerSys Femoral Head Provisional 28mm +3.5 00789502804 VerSys Femoral Head Provisional 28mm +7 00789502805 VerSys Femoral Head Provisional 28mm +10.5 12/14 Neck Taper The provisional heads replicate final femoral implant geometery and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Code InfoAll lots distributed from lot 69998600 (2/20/1996) to present
ClassificationClass II
Reason for RecallComplaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. 13 of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. An April 2001 letter was sent to all distributors and operation managers in the US explaining the events. A June 2011 letter was sent to distributors in Canada.
Product Quantity231,641 all lots, all sizes
Recall NumberZ-2475-2012
Product Description12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerSys Femoral Head Provisional 32mm +3.5 00789503204 VerSys Femoral Head Provisional 32mm +7 00789503205 VerSys Femoral Head Provisional 32mm +10.5 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Code InfoAll lots distributed from lot 69998600 (2/20/1996) to present
ClassificationClass II
Reason for RecallComplaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. 13 of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. An April 2001 letter was sent to all distributors and operation managers in the US explaining the events. A June 2011 letter was sent to distributors in Canada.
Product Quantity231,641 all lots, all sizes
Recall NumberZ-2476-2012
Product Description12/14 Neck Taper 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0 00789503603 VerSys Femoral Head Provisional 36mm +3.5 00789503604 VerSys Femoral Head Provisional 36mm +7 00789503605 VerSys Femoral Head Provisional 36mm +10.5 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Code InfoAll lots distributed from lot 69998600 (2/20/1996) to present
ClassificationClass II
Reason for RecallComplaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. 13 of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. An April 2001 letter was sent to all distributors and operation managers in the US explaining the events. A June 2011 letter was sent to distributors in Canada.
Product Quantity231,641
Recall NumberZ-2477-2012
Product Description12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head Provisional 40mm +3.5 00789504004 VerSys Femoral Head Provisional 40mm +7 00789504005 VerSys Femoral Head Provisional 40mm +10.5 MIS Femoral The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Code InfoAll lots distributed from lot 69998600 (2/20/1996) to present
ClassificationClass II
Reason for RecallComplaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. 13 of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. An April 2001 letter was sent to all distributors and operation managers in the US explaining the events. A June 2011 letter was sent to distributors in Canada.
Product Quantity231,641
Recall NumberZ-2478-2012
Product Description00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Code InfoAll lots including lot 78939000 (1/7/2002) to present
ClassificationClass II
Reason for RecallComplaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. 13 of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. An April 2001 letter was sent to all distributors and operation managers in the US explaining the events. A June 2011 letter was sent to distributors in Canada.
Product Quantity231, 641 all lots
Recall NumberZ-2479-2012
Product Description00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26 00780302604 MIS 12/14 Slotted Femoral Head Provisional +7X26 00780302605 MIS 12/14 Slotted Femoral Head Provisional +10.5X26 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Code InfoAll lots including lot 78939000 (1/7/2002) to present
ClassificationClass II
Reason for RecallComplaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. 13 of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. An April 2001 letter was sent to all distributors and operation managers in the US explaining the events. A June 2011 letter was sent to distributors in Canada.
Product Quantity231,641
Recall NumberZ-2480-2012
Product Description00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X28 00780302804 MIS 12/14 Slotted Femoral Head Provisional +7X28 00780302805 MIS 12/14 Slotted Femoral Head Provisional +10.5X28 00780302814 MIS 12/14 Slotted Femoral Head Provisional +7X28 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Code InfoAll lots including lot 78939000 (1/7/2002) to present
ClassificationClass II
Reason for RecallComplaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. 13 of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. An April 2001 letter was sent to all distributors and operation managers in the US explaining the events. A June 2011 letter was sent to distributors in Canada.
Product Quantity231,641 all lots, all sizes
Recall NumberZ-2481-2012
Product Description00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32 00780303204 MIS 12/14 Slotted Femoral Head Provisional +7X32 00780303205 MIS 12/14 Slotted Femoral Head Provisional +10.5X32 00780303214 MIS 12/14 Slotted Femoral Head Provisional +7X32 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Code InfoAll lots including lot 78939000 (1/7/2002) to present
ClassificationClass II
Reason for RecallComplaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. 13 of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. An April 2001 letter was sent to all distributors and operation managers in the US explaining the events. A June 2011 letter was sent to distributors in Canada.
Product Quantity231,641
Recall NumberZ-2482-2012
Product Description00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780303604 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780303605 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780304005 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Code InfoAll lots including lot 78939000 (1/7/2002) to present
ClassificationClass II
Reason for RecallComplaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. 13 of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. An April 2001 letter was sent to all distributors and operation managers in the US explaining the events. A June 2011 letter was sent to distributors in Canada.
Product Quantity231,641 all lots, all sizes
Recall NumberZ-2483-2012
Product Description00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780303604 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780303605 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780304005 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Code InfoAll lots including lot 78939000 (1/7/2002) to present
ClassificationClass II
Reason for RecallComplaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. 13 of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. An April 2001 letter was sent to all distributors and operation managers in the US explaining the events. A June 2011 letter was sent to distributors in Canada.
Product Quantity231,641 all lots, all sizes
Recall NumberZ-2484-2012

Class II Food Event

Event ID62554
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBliss Unlimited
CityEugene
StateOR
CountryUS
Distribution PatternCanada
 

Associated Products

Product DescriptionLuna & Larry's Coconut Bliss Mocha Maca Crunch; UPC 8 96767 00143 1
Code InfoMay 2, 2014 and May 3, 2014 (Best if used by) 41-61 (manufacturing facility federal number)
ClassificationClass II
Reason for RecallRecent tests show that one lot of the raw material, Casa de Mesquite brand Mesquite Bean flour, has the potential to be contaminated with Bacillus cereus, a spoilage organism which can cause diarrhea, nausea and other symptoms
Product Quantity1080 pints
Recall NumberF-0001-2013

Class II Devices Event

Event ID62594
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Apr-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Howmedica Osteonics Corp.
CityMahwah
StateNJ
CountryUS
Distribution PatternNationwide distribution
 

Associated Products

Product DescriptionStryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland. The Cone Body Trials simulate the respective Cone Body implants and mate with the stem trials to assist the surgeon in assessing the fit of the proposed Implants. The cone body trials is an assembly of the Body and 8 mm Hex Locking Bolt. The trial stem is attached to the trial Cone body via the distal thread of the Locking bolt.
Code InfoCatalog No. 6278-1-019 Mod Rev 19 mm std cone trial 6278-1-021 Mod Rev 21 mm std cone trial 6278-1-023 Mod Rev 23 mm std cone trial 6278-1-025 Mod Rev 25 mm std cone trial 6278-1-027 Mod Rev 27 mm std cone trial 6278-1-029 Mod Rev 29 mm std cone trial 6278-1-031 Mod Rev 31 mm std cone trial 6278-1-119 Mod Rev 19 mm + 10 mm cone trial 6278-1-121 Mod Rev 21mm + 10 mm cone trial 6278-1-123 Mod Rev 23mm + 10 mm cone trial 6278-1 -125 Mod Rev 25 mm + 10 mm cone trial 6278-1-127 Mod Rev 27mm + 10 mm cone trial 6278-1-129 Mod Rev 29mm + 10mm cone trial 6278-1-131 Mod Rev 31mm + 10 mm cone trial 6278 -1-219 Mod Rev 19mm + 20 mm cone trial 6278-1-221 Mod Rev 21mm +20 mm cone trial 6278-1-223 Mod Rev 23mm + 20 mm cone trial 6278-1-225 Mod Rev 25mm + 20 mm cone trial 6278-1-227 Mod Rev 27mm + 20 mm cone trial 6278-1-229 Mod Rev 29mm + 20 mm cone trial 6278-1-231 Mod Rev 31mm + 20 mm cone trial 6278-1-319 Mod Rev 19mm + 30 mm cone trial 6278-1-321 Mod Rev 21mm +30 mm cone trial 6278-1-323 Mod Rev 23mm + 30 mm cone trial 6278-1-325 Mod Rev 25mm + 30 mm cone trial 6278-1-327 Mod Rev 27mm + 30 mm cone trial 6278-1-329 Mod rev 29mm +30 mm cone trial 6278-1-331 Mod Rev 31mm + 30 mm cone trial 1 single unit to each non-sterile package Numerous lots numbers please see attachment.
ClassificationClass II
Reason for RecallStryker Orthopaedics has become aware of a burr, or a metal shaving, observed in the internal threaded portion of the Cone Body Trial. The typical size of the shaving observed was 1-2 mm in length and 0.037 mm squared in cross section.
Product Quantity10, 983 units
Recall NumberZ-2487-2012

Class II Devices Event

Event ID62621
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmEos Imaging Inc
CityCambridge
StateMA
CountryUS
Distribution PatternNationwide distribution
 

Associated Products

Product DescriptionEOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.
Code InfoAll associated Serial Numbers
ClassificationClass II
Reason for RecallIt was discovered of several generator failures of the EOS System due to failure of its anode controller board that drives the rotation of the X-ray tube anode.
Product Quantity12 EOS Systems installed in the US
Recall NumberZ-2072-2012

Class II Devices Event

Event ID62773
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSynthes USA HQ, Inc.
CityWest Chester
StatePA
CountryUS
Distribution PatternNationwide Distribution including CA, FL, ID, IN, MD, MI, MT, LA, NY, OH, PA, TX, VA and WA.
 

Associated Products

Product DescriptionMIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Code InfoMinimally Invasive Redution Screw System (MIRS) - Labeling number J11031-A
ClassificationClass II
Reason for RecallSynthes is initiating a Medical Device Labeling Correction following a detailed review of the current labeling in response to reported complaints. Synthes has identified technique measures and has updated the labeling associated with this system. The labeling reflects updated technique recommendations and emphasizes the importance of avoiding rod mis-alignment.
Product Quantity1602
Recall NumberZ-0001-2013

Class II Drugs Event

Event ID62900
StatusCompleted
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Apr-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCarefusion 213, Llc
CityEl Paso
StateTX
CountryUS
Distribution PatternIL, MO, and NJ
 

Associated Products

Product Description ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01.
Code InfoLot 52894, Product Code: 260400
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
Product Quantity576 Cartons
Recall NumberD-004-2013

Class II Devices Event

Event ID62966
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmInvuity, Inc.
CitySan Francisco
StateCA
CountryUS
Distribution PatternNationwide Distribution including AR, GA, SC, CA, OR, UT, and WA.
 

Associated Products

Product DescriptionBriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
Code InfoCatalog numbers: 1810000, 1811273, 1811873, 1810873, 18111073 All possible lot numbers: 8Fr: 09061802, 09070201, 09070201, 09101602, 09120701, 10022602, 10030801, 10060102; 10Fr: 09061801, 09070202, 09120702, 09101603, 10022603, 10030802, 10060905, 10060904, 10060103; 12Fr: 09052901, 09061201, 09120703, 09101604, 10022604, 10030803, 10060104.
ClassificationClass II
Reason for RecallInvuity is notifying customers to return all obsolete BriteField Illuminated Suction Devices from the field. It has not been distributed since March 2011 as the next generation product was introduced at that time.
Product Quantity197 devices
Recall NumberZ-0007-2013

Class II Food Event

Event ID63018
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Jun-11
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmOcho Rios-Miami, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternFL, GA, IL, MO, MD
 

Associated Products

Product DescriptionLabel reads in part "***OCHO RIOS***Jamaican***Curry***Seasoning***Net Wt. 4 & 8 oz (227 g)***Gold Series***Low Sodium***Extra delicious!***Distributed by :***Ocho Rios International***Miami, Florida 33142***Ingredients: Turmeric,***Fenugreek, Coriander, Cumin***Salt, Anise, Pimento, Garlic***""
Code InfoJamaican Curry Seasoning 4 oz: B/B # D2215 (Exp. 4/22/15)
ClassificationClass II
Reason for RecallWhole wheat not declared on label.
Product Quantity1,100 bottles
Recall NumberF-0002-2013
Product DescriptionLabel reads in part "***OCHO RIOS***Hot***Jamaican***Curry***Gold Series***Extra delicious!***Distributed by :***Ocho Rios International***Miami, Florida 33142***Ingredients: Turmeric,***Fenugreek, Coriander, Cumin, Salt,*** Anise, Pepper, Pimento, Garlic***Degree of "Heat" 4-Hot***"
Code InfoHot Jamaican Curry 4 oz: B/B # A1414 (Exp. 01/14/14) Hot Jamaican Curry 4 oz: B/B # K1713 (Exp. 11/17/13) Hot Jamaican Curry 8 oz: B/B # E2015 (Exp. 05/20/15)
ClassificationClass II
Reason for RecallWhole wheat not declared on label.
Product Quantity
Recall NumberF-0003-2013
Product DescriptionLabel reads in part "***OCHO RIOS***Spicy***Jerk***Curry***Distributed by :***Ocho Rios International***Miami, Florida 33142***Ingredients: Turmeric,***Fenugreek, Coriander, Cumin***Salt,*** Anise, Pepper, Pimento, Garlic***Degree of "Heat" 4-Hot***"
Code InfoSpicy Jerk Curry 4 oz: B/B # K1713 (Exp. 11/17/15) Spicy Jerk Curry 4 oz: B/B # E2015 (Exp. 05/20/15)
ClassificationClass II
Reason for RecallWhole wheat not declared on label.
Product Quantity
Recall NumberF-0004-2013
Product DescriptionLabel reads in part "***OCHO RIOS***Mild***Jerk***Curry***Seasoning***Extra delicious!***Distributed by :***Ocho Rios International***Miami, Florida 33142***Ingredients: Turmeric,Allspice***Coriander, Fenugreek, Salt, Pepper,***Cumin, Garlic, Onion, Nutmeg,***Cinnamon, Thyme and spices***Degree of "Heat" 2 Mild"***"
Code InfoMild Jerk Curry Seasoning 4 oz: B/B E1413 (Exp. 5/14/13)
ClassificationClass II
Reason for RecallWhole wheat not declared on label.
Product Quantity
Recall NumberF-0005-2013

Class II Drugs Event

Event ID63031
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSun Pharmaceutical Industries Inc.
CityCranbury
StateNJ
CountryUS
Distribution PatternOne direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts
 

Associated Products

Product DescriptionNimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Affiliate of Sun Pharmaceutical Industries, Inc.
Code InfoLot: a) 3305.039B, Exp 07/13; b) 3305.039A, Exp 07/13
ClassificationClass II
Reason for RecallCrystallization: Presence of crystals of Nimodipine within the capsule solution.
Product Quantitya) 2424 Cartons b) 2675 Cartons
Recall NumberD-003-2013

Class II Devices Event

Event ID63064
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAccuro Medical Product LLC
CityDowners Grove
StateIL
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and country of: Canada.
 

Associated Products

Product DescriptionWound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Code Infopart number 84635400182, serial numbers E000146 through E002039, (all serial numbers)
ClassificationClass II
Reason for RecallAccuro has received reports of some Apex Pumps either failing to operate or malfunctioning, at times without notifying the user of such failure or malfunction on the unit's display screen.
Product Quantity919 units
Recall NumberZ-0009-2013

Class II Devices Event

Event ID63073
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomet, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including the states of AL, GA, MT, TA, AZ, WA, CA, TA, IN, NY, NJ, VA, MA, MI, MD, PA, KY, NC, UT, NH, FL, OK, CO, LA, OH, MO and SD, and the countries of Japan, Netherlands, Australia, and Costa Rica.
 

Associated Products

Product DescriptionOptilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone. The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone. The OptiLock VL Distal Radius Plating System is intended for use in distal radius and ulna (and other small bones), including use in osteopenic bone.
Code InfoCatalog number: 14-400795; and lot numbers: 133420, 409460, 469960, 487650, 487660, 627940, 627950, 797190, and 797200.
ClassificationClass II
Reason for RecallField complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properly mate ("lock") into some of the specified screw heads. Drivers near MMC (Maximum Material Condition) or that are misshapen may not properly mate with screws at MMC. Design dimensions and tolerances of the drivers are not properly specified to prevent an incorrect fit between the drivers and the screws in all material conditions. The supplier did not manufacture the instruments to the same degree of geometrical accuracy as prior supplier. It was found that both the supplier and Biomet were not correctly using the "No-Stick" gauge.
Product Quantity268 units total
Recall NumberZ-2485-2012
Product DescriptionOptilock T15 AO Driver (3.5mm). Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone. The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone. The OptiLock VL Distal Radius Plating System is intended for use in distal radius and ulna (and other small bones), including use in osteopenic bone.
Code InfoCatalog number: 36505; and lot numbers: 069540, 179190, 201610, 385380, 419940, 427530, 440360, 440370, 555370, 638560, 645820, and 956960.
ClassificationClass II
Reason for RecallField complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properly mate ("lock") into some of the specified screw heads. Drivers near MMC (Maximum Material Condition) or that are misshapen may not properly mate with screws at MMC. Design dimensions and tolerances of the drivers are not properly specified to prevent an incorrect fit between the drivers and the screws in all material conditions. The supplier did not manufacture the instruments to the same degree of geometrical accuracy as prior supplier. It was found that both the supplier and Biomet were not correctly using the "No-Stick" gauge.
Product Quantity363 units
Recall NumberZ-2486-2012

Class II Devices Event

Event ID63116
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Healthcare Inc.
CityAndover
StateMA
CountryUS
Distribution PatternWorldwide distribution: USA (Nationwide) and countries of: AUSTRALIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, REPUBLIC OF KUWAIT LEBANON, MACAU, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, ROMANIA RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and VIET NAM.
 

Associated Products

Product DescriptionPhilips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.
Code InfoHeartStart XL battery M3516A labeled with Made in Taiwan and an R-2011-12 Date of Manufacture
ClassificationClass II
Reason for RecallHeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone.
Product Quantity2500 units
Recall NumberZ-0011-2013

Class II Devices Event

Event ID63125
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmZimmer, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternWorldwide Distribution - US Nationwide including the states of: AZ, CA, CO,FL, MN, IL, NJ, NY, OH, OR and the countries of Austrailia, Utd. Arab Emir., France, Germany, India, and Italy.
 

Associated Products

Product DescriptionCemented Tibial Drill Product Usage: The cemented tibial drill is used to prepare the tibial bone prior to the impaction of the applicable stemmed tibial broach. The cemented tibial drill has engraved lines that are size specific to guide the user as to the depth to insert the drill into the tibial bone.
Code InfoPart 42-5399-018-00, Lots 62034571, 62089766
ClassificationClass II
Reason for RecallZimmer is initiating a recall of the Cemented Tibial Drill for the Zimmer Persona Personalized Knee System due to three reports being received as of August 29. 2012 for tibial cortex perforation during preparation of the tibial bone. The investigation into the reports that have been received found that the perforations are occurring while using the Cemented Tibial Drill. The perforations have occurred in the anterior medial tibial cortex, particularly when preparing for a size E tibial plate. As a result of this investigation, Zimmer is detailing below some important aspects within the surgical technique that mitigate the potential of perforating the tibial cortex. In addition, Zimmer is replacing the current Cemented Tibial Drill with a modified version that has relocated the depth indicators for determining how deep to drill for the different sizes of tibial plates. Concurrent with delivery of this notification, your sales representative is replacing your Cemented Tibial Drill.
Product Quantity60
Recall NumberZ-2493-2012

Class II Devices Event

Event ID63134
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jan-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBeckman Coulter Inc.
CityBrea
StateCA
CountryUS
Distribution PatternWorldwide Distribution - US Nationwide and the countries of: Australia, Botswana, Canada, France, Germany, Japan, Malawi and Sweden.
 

Associated Products

Product DescriptionCOULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Code InfoAll Serial Numbers
ClassificationClass II
Reason for RecallThe recall was initiated because Beckman Coulter has confirmed that the Coulter PrepPlus may experience intermittant reagent level sense failures where the instrument may not produce a warning that a reagent vial is low or out of reagent.
Product Quantity36 units total (15 units in the US)
Recall NumberZ-0002-2013

Class II Devices Event

Event ID63136
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmC.R. Bard, Inc., Urological Division
CityCovington
StateGA
CountryUS
Distribution PatternNationwide distribution: USA and Puerto Rico
 

Associated Products

Product Description8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
Code InfoCatalog # 165808, Lot # NGWA1111
ClassificationClass II
Reason for RecallThe 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an incorrect inflation volume (10 ml instead of 5 ml) printed on the valve cap.
Product Quantity4,032 units
Recall NumberZ-0010-2013

Class II Devices Event

Event ID63152
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jan-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBeckman Coulter Inc.
CityBrea
StateCA
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and country of: Canada.
 

Associated Products

Product DescriptionIMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.
Code InfoLot# M012376 and M101865
ClassificationClass II
Reason for RecallThe recall was initiated because Beckman Coulter has confirmed customer reports of QC shifts, lot-to-lot variation, and an increase in the percent of patient samples recovering >20 IU/mL using the Lots# M012376 and M101865 of IMMAGE RF reagent. The lots identified for the RF reagent might produce false abnormal results.
Product Quantity925 units
Recall NumberZ-0003-2013

Class II Food Event

Event ID63163
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHenderson's Best Fresh-Cuts, LLC
CityHendersonville
StateNC
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionFresh Cuts, Pineapple Dices, 2 oz, Best By: SEP/15/12, Lot Number: 243 and 245.
Code InfoLot numbers: 243 and 245.
ClassificationClass II
Reason for RecallPossible fermentation.
Product Quantity48 cases - 75/2 oz containers per case
Recall NumberF-0023-2013

Class II Devices Event

Event ID63165
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Healthcare Inc.
CityAndover
StateMA
CountryUS
Distribution PatternWorldwide Distribution - US Nationwide and the countries of :Australia, Austria, Bahrain, Belgium, Canada, Chile, China, Czech Republic, Denmark, Finland, , France, Germany, Ireland, Italy, Japan, Netherlands, New Zealand, Norway, Poland, Qatar, Romania, Russia, Saudi Arabia, Sweden, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan. Thailand, Turkey,United Arab Emirates and United Kingdom.
 

Associated Products

Product DescriptionPhilips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 00 to 09 000 543. Product Usage: Stationary radiographic System
Code InfoSerial number range (patient carriage) from: 00 000 00 to 09 000 543.
ClassificationClass II
Reason for RecallHook does not securely hold the footplate in vertical position, causing the footplate to disengage and may fall on patient or operator
Product Quantity536 units
Recall NumberZ-2494-2012

Class II Food Event

Event ID63177
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmBoyd Coffee Co
CityPortland
StateOR
CountryUS
Distribution PatternProduct distributed in Washington
 

Associated Products

Product DescriptionE-3 Seasoning/Spice, Part #1690. Product is packaged in a white bucket. Net weight 35 lbs. The product is labeled in parts: "***E-3 SEASONING***NET WT 35 LB***Distributed by Boyd Coffee Company, Portland, OR 97230***
Code InfoPart # - 1690. Lot # - 94675, 95467, 98145, 98764, 101858, 102489, 106319, 107267, 109189, 109281, 114634, and 116602.
ClassificationClass II
Reason for Recallsub-ingredients hydrolyzed soy protein and hydrogenated soybean oil were not declared on the finished product label of E-3 Seasoning.
Product Quantitywill be provided
Recall NumberF-0006-2013

Class II Veterinary Event

Event ID63185
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmKelly Foods Corporation
CityBerlin
StateMD
CountryUS
Distribution PatternProduct distributed to AR, DC, DE, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, ND, NE, NH, NJ, NY, OH, OK, PA, RI, SD, TX, VA, WI, WV.
 

Associated Products

Product DescriptionBil-Jac brand Adult Select Formula Dog Food, 6 lb bags, 4bags/case, bags labled in part ***Manufactured by Kelly Foods Corp, Berlin, MD 21811***UPC 731794001095***
Code Info1792-02 (exp 27 Dec 2013)
ClassificationClass II
Reason for RecallDry dog food may contain mold.
Product Quantity1024 bags
Recall NumberV-001-2013

Class II Devices Event

Event ID63196
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Nov-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmUS Endoscopy Group Inc
CityMentor
StateOH
CountryUS
Distribution PatternWorldwide Distribution -- USA (nationwide) including the states of AL, AR, AZ, CA, FL, GA, HI, IA, IL, KY, LA, MD, ME, MI, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI; and to the following countries: Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Caribbean, Chile, Columbia, Croatia, Czech Republic, Denmark, Ecuador, El Salvador, Estonia, Finland, France, Germany, Great Britain, Greece, India, Ireland, Israel, Italy, Jordan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, and United Arab Emirates.
 

Associated Products

Product DescriptionEndoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.
Code InfoModel #00711177; S/N: 52979, 52981, 52982, 53643, 53644, 53891, 53892, 54238
ClassificationClass II
Reason for RecallWhen the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the patient, and excessive force is applied to the handle, the jaws may become inoperable and may become stuck in the open condition.
Product Quantity1153
Recall NumberZ-0006-2013

Class II Devices Event

Event ID63241
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCure Medical LLC
CityNewport Beach
StateCA
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionMale, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coudé-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.
Code InfoTotal affected product: M16, Lot 120425: 420 cases = 4,200 boxes = 126,000 each. 2017.03 is shown on the product labeling as the expiry date for the product, 4 years and 11 months from the date of packaging. The product, M16, is identified with the following UPC Codes for the individual pouches, intermediate boxes and case labels: ª Pouch Label UPC (M16) = *+M405M16 ª Box Label UPC (M16) = *+M405M163I* " Case Label UPC (M16) = *+M405M165K* Explanation of Lot Number: The lot number represents a planned packaging date of a set of work orders for various products, in the format YYMMDD at the contract manufacturers facility. At the order planning stage, the packaging date is estimated (based on production cycle time and pre-printed box delivery) and assigned to each work order The lot number represents a planned packaging date of a set of work orders for various products, in the format YYMMDD at the contract manufacturers facility. At the order planning stage, the packaging date is estimated (based on production cycle time and pre-printed box delivery) and assigned to each work order scheduled for packaging on this estimated date. Therefore, one lot number may be assigned to multiple catalog numbers. The lot number 120425 was assigned to both M16 and M16C products by the scheduling department Actual packaging of the M16 occurred from 23 May 2012 through 25 May 2012. Actual packaging of the M16C occurred from 19 May through 21 May 2012.
ClassificationClass II
Reason for RecallThe firm initiated the product recall because labeling on some of the intermediate boxes of catheters identify the contents to be M16C, a coudé-tip catheters while the actual contents are M16Fr male, 16Fr, straight-tip catheters with the pouch and the case box labeled as M16Fr male, 16Fr, straight-tip catheters.
Product Quantity420cases (= 4,200 boxes)
Recall NumberZ-0004-2013

Class III Biologics Event

Event ID39115
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jul-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoLW01187
ClassificationClass III
Reason for RecallBlood Products, collected from a donor who received varicella zoster vaccine less than 28 days before donating, were distributed.
Product Quantity1 Unit
Recall NumberB-2335-12

Class III Biologics Event

Event ID39625
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Feb-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center of Greater Kansas City
CityKansas City
StateMO
CountryUS
Distribution PatternKansas City, MO; Liberty, MO
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW045003903458; W045003906734; W045003901056; 9065994; 9081220; 9087572; 9088116; 9093337; 9084560; 9083132; 9091354; 9086849; 9072426; 9095890; 9090624; 9069089; 9072517
ClassificationClass III
Reason for RecallBlood products, stored under improper conditions, were distributed.
Product Quantity17
Recall NumberB-2002-12

Class III Biologics Event

Event ID39908
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Mar-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternKansas, Missouri
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW045005003086; I3920886; W045005006455; W045005006445; W045005003529; W045005003115; W045005003356; W045005006056; W045005006063; W045005005702; W045005006059; W045005005707; W045005010376; IFG21596; IFG21843; IFG21844; W045005901830; W045005901828; W045005005762; W045005010966
ClassificationClass III
Reason for RecallBlood products, stored at unacceptable temperatures, were distributed.
Product Quantity20 units
Recall NumberB-2001-12

Class III Biologics Event

Event ID40066
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Apr-05
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
Code InfoW045005023283
ClassificationClass III
Reason for RecallBlood product, stored at unacceptable temperatures, was distributed.
Product Quantity1 unit
Recall NumberB-1949-12

Class III Biologics Event

Event ID40097
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-May-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center of Greater Kansas City
CityKansas City
StateMO
CountryUS
Distribution PatternMO, KS
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045005018374; W045005011570
ClassificationClass III
Reason for RecallBlood Products, possible exposed to unacceptable temperatures, were distributed.
Product Quantity2 units
Recall NumberB-1978-12

Class III Biologics Event

Event ID47112
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Dec-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternPennsylvania
 

Associated Products

Product DescriptionPlatelets
Code InfoLM53631
ClassificationClass III
Reason for RecallBlood product, collected from a donor with a reactive syphilis screening test (RPR), was distributed.
Product Quantity1 Unit
Recall NumberB-2309-12

Class III Drugs Event

Event ID62911
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMylan Pharmaceuticals Inc.
CityMorgantown
StateWV
CountryUS
Distribution PatternNationwide and PR
 

Associated Products

Product DescriptionFamotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01
Code InfoLot: 3018952, Exp 08/12
ClassificationClass III
Reason for RecallImpurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.
Product Quantity31,867 Bottles
Recall NumberD-1703-2012

Class III Drugs Event

Event ID63127
StatusCompleted
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Mar-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMcKesson Packaging Services
CityConcord
StateNC
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionbuPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 449 10 7, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-449-10, carton barcode 6373944910.
Code InfoLot #: 0074583, Exp. Date 03/12
ClassificationClass III
Reason for RecallFailed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Product Quantity187 cartons
Recall NumberD-001-2013
Product DescriptionbuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 450 10 3, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-450-10, carton barcode 6373945010.
Code InfoLot #: 0075375, 0074584, Exp 08/12
ClassificationClass III
Reason for RecallFailed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Product Quantity674 cartons
Recall NumberD-002-2013

Class III Devices Event

Event ID63253
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmGynex Corporation
CityRedmond
StateWA
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionSterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***" Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece) It connects the electrode to the food activated electric generator. Electrodes are used in gynecological procedures, in a physician's office, for cutting to remove tissue and coagulation to control bleeding by the use of high frequency current.
Code InfoManufacturer's lot number: 54-12-2-21-12.
ClassificationClass III
Reason for RecallThe wrong electrical connector pin was attached to the cord during assembly by the manufacturer. this electrical connector is too big to fit into the port on the foot activated generator. this makes the device unusable.
Product Quantity19 boxes (containing 12 electorde hand pieces each)
Recall NumberZ-0008-2013

Mixed Classification Food Event

Event ID63055
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSadie's Salads
CityGordonville
StatePA
CountryUS
Distribution PatternDistribution within the US to PA.
 

Associated Products

Product DescriptionSadie's Salads Egg Salad, 5 lb, 10 lb plastic tubs
Code InfoAll product with use by date up to and including September 13, 2012
ClassificationClass II
Reason for RecallProduct labeling fails to declare allergens (soybean oil) contained in mayonnaise used as a sub-ingredient
Product QuantityUnknown
Recall NumberF-1070-2012
Product DescriptionSadie's Salads Egg-N-Olive Salad, 5 lb, 10 lb plastic tubs
Code InfoAll product with use by date up to and including September 13, 2012
ClassificationClass II
Reason for RecallProduct labeling fails to declare allergen (soybean oil) contained in salad dressing used as a sub-ingredient
Product QuantityUnknown
Recall NumberF-1071-2012
Product DescriptionSadie's Salads Broccoli Salad, 8 lb and 25 lb plastic tubs
Code InfoAll product with use by date up to and including September 13, 2012
ClassificationClass I
Reason for RecallProduct labeling fails to declare allergens (egg, milk, soybean oil) contained in mayonnaise and yellow american cheese used as sub-ingredients (no label)
Product QuantityUnknown
Recall NumberF-1072-2012
Product DescriptionSadie's Salads Old Fashioned Cream Slaw, 5 lb, 10 lb and 30 lb plastic tubs
Code InfoAll product with use by date up to and including September 13, 2012
ClassificationClass I
Reason for RecallProduct labeling fails to declare allergens (egg, soybean oil) contained in mayonnaise used as ingredients
Product QuantityUnknown
Recall NumberF-1073-2012
Product DescriptionSadie's Salads Cole Slaw, 5 lb, 10 lb and 30 lb plastic tubs
Code InfoAll product with use by date up to and including September 13, 2012
ClassificationClass I
Reason for RecallProduct labeling fails to declare allergens (egg, soybean oil) contained in mayonnaise used as ingredients
Product QuantityUnknown
Recall NumberF-1074-2012
Product DescriptionSadie's Salads Red Skin Potato Salad, 5 lb, 10 lb and 30 lb plastic tubs
Code InfoAll product with use by date up to and including September 13, 2012
ClassificationClass I
Reason for RecallProduct labeling fails to declare allergens (eggs, milk, soybean oil) contained in mayonnaise and sour cream used as sub-ingredients
Product QuantityUnknown
Recall NumberF-2440-2012
Product DescriptionSadie's Salads Potato Salad, 5 lb, 10 lb and 30 lb plastic tubs
Code InfoAll product with use by date up to and including September 13, 2012
ClassificationClass II
Reason for RecallProduct labeling fails to declare allergens (soybean oil) contained in salad dressing used as a sub-ingredient
Product QuantityUnknown
Recall NumberF-2445-2012
Product DescriptionSadie's Salads Macaroni Salad, 5 lb, 10 lb and 30 lb plastic tubs
Code InfoAll product with use by date up to and including September 13, 2012
ClassificationClass II
Reason for RecallProduct labeling fails to declare allergens (wheat, soybean oil, FD&C Yellow #5) contained in the macaroni, salad dressing and pickle relish used as sub-ingredients
Product QuantityUnknown
Recall NumberF-2446-2012
Product DescriptionSadie's Salads Macaroni and Cheese, 5 lb and 10 lb plastic tubs
Code InfoAll product with use by date up to and including September 13, 2012
ClassificationClass II
Reason for RecallProduct labeling fails to declare allergens (wheat and milk) contained in the macaroni and cheese used as sub-ingredients
Product QuantityUnknown
Recall NumberF-2447-2012
Product DescriptionSadie's Salads No Sugar Vegetable Pasta Salad, 4 lb and 8 lb plastic tubs
Code InfoAll product with use by date up to and including September 13, 2012
ClassificationClass II
Reason for RecallProduct labeling fails to declare allergen (wheat) contained in the rotini used as a sub-ingredient
Product QuantityUnknown
Recall NumberF-2448-2012

Mixed Classification Biologics Event

Event ID40082
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Jun-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityPomona
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info06GX46159
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred after testing HIV-1/2 repeat reactive, were distributed.
Product Quantity1
Recall NumberB-1999-12
Product DescriptionBlood and Blood Products for Reprocessing
Code Info06GX46159
ClassificationClass III
Reason for RecallBlood products, collected from a donor who was previously deferred after testing HIV-1/2 repeat reactive, were distributed.
Product Quantity1
Recall NumberB-2000-12
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