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U.S. Department of Health and Human Services

Enforcement Report - Week of September 12, 2012

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Class I Veterinary Event

Event ID61581
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Apr-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmDiamond Pet Foods
CityMeta
StateMO
CountryUS
Distribution PatternAL, FL, GA, IA, KY, MD, MI, NY, NC, OH, PA, SC, TN, VA, Canada, Colombia, Japan and the Russian Federation.
 

Associated Products

Product DescriptionDiamond Pet Foods, Naturals Lamb Meal & Rice Formula for Adult Dogs, Packed in 6 lb (UPC: 0 7419860995 6), 20 lb (UPC 0 7419860816 4), and 40 lb (UPC 0 7419860817 1) bags, Proudly made by Diamond Pet Food, Meta, Missouri.
Code InfoProduct Code: DLR0101D3XALW, Best Before 04 Jan 2013 (6 lb bag); DLR0101C31XMF, Best Before 03 Jan 2013 (20 lb bag); DLR0101C31XMF, Best Before 03 Jan 3013; DLR0101C31XAG, Best Before 03 Jan 2013 and DLR0101D32XMS, Best Before 04 Jan 2013 (40 lb bags).
ClassificationClass I
Reason for RecallSalmonella contamination.
Product Quantity7240 total units
Recall NumberV-205-2012
Product DescriptionChicken Soup for the Dog Lovers Soul, Adult Dog Light Formula, Brand Dog Food, Net Wt 6 lb (UPC Code: 0 7419860795 2) and 35 lbs (15.87kg) bags (UPC Code: 0 7419860981 0), Proudly made by Diamond Pet Food, Meta, Missouri.
Code InfoCode: Production Code: CLF0102B31XCW, Best By Date: 27/JAN/2013, CLF0102B31XCW, Best By Date: 28/JAN/2013 and CLF0102B32XWR, Best By Date: 28/JAN/2013 (35 lb bags). Product Code: CLF0102B3XALW, Best by Date: 28/JAN/2013 (6 lb bags).
ClassificationClass I
Reason for RecallSalmonella contamination.
Product Quantity2,444/35 lb bags and 251 6/6 lb bags and 49 6/8 lb bags
Recall NumberV-206-2012
Product DescriptionDiamond Pet Foods, Puppy, Net Wt 6 oz samples (UPC Code: 0 7419800200 9), 8 lb (UPC Code: 0 7419800208 5), 20 lb (UPC Code: 0 7419800220 7) and 40 lb bags (UPC Code: 0 7419800240 5), Proudly made by Diamond Pet Food, Meta, Missouri.
Code InfoCode: Production Code: DPP0401 (6 oz samples); DPP0401B2XALW, Best By Date: 7Apr/2013 (8 lb bags); DPP0101C31XRB, Best By Date: 11/Jan/2013, DPP0101C31XME, Best By Date: 11/Jan/2013, DPP0401B22XJW, Best By Date: 6/Aprl/2013 (20 lb bags) and DPP040B2XDJ, Best By Date: 7/Apr/2013, DPP0101C31XME, Best By Date: 11/Jan/2013, DPP0401A21XAW, Best By Date: 6/Apr/2013 and DPP0401B22XJW, Best By Date: 6/Apr/2013.
ClassificationClass I
Reason for RecallSalmonella contamination.
Product Quantity49-6/8 lb bags, 3350-20 lb bags and 4968-40 lb bags.
Recall NumberV-207-2012

Class I Veterinary Event

Event ID61845
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-May-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmNestle Purina PetCare Co
CitySaint Louis
StateMO
CountryUS
Distribution PatternDistribution was made to IL, CO, TX, PA, FL, and NV. Foreign distribution was made to Canada.
 

Associated Products

Product DescriptionPurina Veterinary Diets OM Overweight Management Feline Formula, packaged in 5.5-oz. cans, UPC 38100-13810, for prescription and sale only by veterinarians. The firm name on the label is Nestle Purina Petcare Co., St. Louis, MO.
Code InfoBest By Jun 2013 11721159
ClassificationClass I
Reason for RecallThe product is deficient in thiamine (Vitamin B1)
Product Quantity20,356/24/5.5-oz. can cases
Recall NumberV-204-2012

Class I Food Event

Event ID62282
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jun-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmVauxner-USA, LLC
CityBow
StateWA
CountryUS
Distribution PatternFarmers markets in Washington State and retailers in Washington and Oregon.
 

Associated Products

Product DescriptionFlavored cheddar cheese, vacuum packed in weights ranging from 0.25-0.50 pounds, labeled and batch coded by firm. Cheese labeled in part: "Medium Cheddar Red Pepper with Onion & Garlic Pasteurized whole milk, salt, culture, vegetable rennet, spices. r-BST free.***GOLDEN GLEN CREAMERY 15098 Field Road Bow, WA 98232***887"
Code Info"887" on primary label
ClassificationClass I
Reason for RecallProduct may be contaminated with Listeria monocytogenes.
Product Quantity99 lbs
Recall NumberF-2113-2012

Class I Food Event

Event ID62689
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jul-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSimmering Soups Inc.
CityCumberland
StateRI
CountryUS
Distribution PatternFL, GA, NC, SC, TN and VA.
 

Associated Products

Product DescriptionTrader Jose's, Mild Salsa, 16 ounce (1 lb) 454g), in clear rigid plastic containers with snap on lids.
Code InfoSKU# 082584, UPC #00285841
ClassificationClass I
Reason for RecallProducts contain an ingredient (onions) that were found to be contaminated with Listeria monocytogenes.
Product Quantity168/16oz. containers
Recall NumberF-2116-2012
Product DescriptionTrader Joe's, Balela (A savory Middle Eastern salad with chickpeas, black beans and tomatoes). 8 ounces (227g). in clear rigid plastic containers with snap on lids.
Code InfoSKU #068306, UPC #00683067
ClassificationClass I
Reason for RecallProducts contain an ingredient (onions) that were found to be contaminated with Listeria monocytogenes.
Product Quantity204/8oz. containers
Recall NumberF-2117-2012

Class I Devices Event

Event ID62848
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRespironics California Inc
CityCarlsbad
StateCA
CountryUS
Distribution PatternWorldwide Distribution - US (Nationwide) and the countries of: Australia, Belgium, Canada, China, Germany, Italy, Japan, Kuwait, Netherlands, Norway. Qatar, Saudi Arabia, Turkey, and United Kingdom.
 

Associated Products

Product DescriptionV60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 Ibs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.
Code InfoSeria Numbers: 100026615 100029321 100029838 100030462 100030832 100026808 100029324 100029841 100030463 100030833 100026826 100029325 100029843 100030464 100030834 100027107 100029327 100029845 100030466 100030836 100027181 100029328 100029847 100030468 100030838 100027189 100029330 100030043 100030469 100030840 100027544 100029334 100030106 100030471 100030843 100027660 100029337 100030107 100030472 100030844 100027751 100029455 100030111 100030473 100030845 100027870 100029456 100030112 100030474 100030847 100027872 100029459 100030113 100030475 100030850 100027875 100029462 100030115 100030481 100030977 100028047 100029473 100030117 100030482 100030979 100028053 100029474 100030118 100030485 100030980 100028069 100029500 100030119 100030591 100030983 100028249 100029504 100030120 100030593 100030985 100028324 100029505 100030121 100030594 100030986 100028328 100029507 100030133 100030595 100030987 100028334 100029508 100030204 100030596 100030989 100028339 100029512 100030212 100030608 100030990 100028570 100029514 100030215 100030609 100030991 100028665 100029515 100030216 100030612 100030992 100028666 100029516 100030217 100030618 100030994 100028673 100029518 100030220 100030620 100030995 100029074 100029520 100030223 100030762 100030996 100029116 100029524 100030224 100030766 100030997 100029119 100029525 100030226 100030767 100030998 100029215 100029672 100030229 100030768 100031004 100029217 100029679 100030337 100030769 100031071 100029220 100029684 100030342 100030771 100031072 100029223 100029685 100030343 100030773 100031084 100029224 100029690 100030344 100030778 100031085 100029241 100029691 100030345 100030779 100031089 100029242 100029692 100030349 100030780 100031143 100029243 100029698 100030355 100030781 100031144 100029313 100029832 100030359 100030782 100031147 100029316 100029833 100030456 100030823 201002392 100029318 100029835 100030457 100030825 100029319 100029836 100030458 100030827 100029320 100029837 100030459 100030829
ClassificationClass I
Reason for RecallRespironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet specifications. Specifically, the impeller may not be properly seated on the blower motor shaft. This could subsequently cause the blower to cease functioning which would result in the failure of the V60 ventilator to deliver therapy to the patient due to the loss of ventilation.
Product Quantity197 units total (116 in the US)
Recall NumberZ-2260-2012

Class I Devices Event

Event ID62856
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNewport Medical Instruments Inc
CityCosta Mesa
StateCA
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and countries of: Brazil, Chile, Egypt, France, Hong Kong, India, Japan, Norway, Philippines and South Africa.
 

Associated Products

Product DescriptionNewport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT70 ventilator system is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs.). The HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
Code InfoModel Number: HT70 and HT70 Plus. Serial numbers: N12HT700514226 to N12HT700514231, N12HT700514233 to N12HT700514236, N12HT700514238 to N12HT700614280, N12HT700614282 to N12HT700614299, N12HT700614301 to N12HT700614309, N12HT720410266 to N12HT720410268, N12HT720410271, N12HT720410273, N12HT720410282, N12HT720410283, N12HT720410286, N12HT720410288, N12HT720410289, N12HT720410290, N12HT720410294 to N12HT720510300, N12HT720510302, N12HT720510322 to N12HT720510330, N12HT720510332 to N12HT720510344,
ClassificationClass I
Reason for RecallMay emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure on the control board.
Product Quantity72
Recall NumberZ-2250-2012

Class I Food Event

Event ID62994
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmUnited Salad Company
CityPortland
StateOR
CountryUS
Distribution PatternProduct was distributed in Idaho, Oregon, Washington,
 

Associated Products

Product DescriptionDole Mushroom, packaged in a retail package, net wt. 8 oz. The UPC is 0 33383 67600 5.
Code InfoCode 336. Packed on Date is 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 RecallDole 8 oz Sliced Mushrooms, product of Canada, are recalled due to potential contamination of Listeria monocytogenes.
Product Quantity60 cases/12 packages/8 oz
Recall NumberF-2115-2012

Class I Food Event

Event ID62995
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSafeway Inc
CityPleasanton
StateCA
CountryUS
Distribution PatternAuburn, WA DC and Spokane, WA DC - distributes to retail stores in OR, WA, ID and MT.
 

Associated Products

Product Description"SAFEWAY farms White Sliced Mushrooms***DISTRIBUTED BY SAFEWAY INC.***PLEASATON, CA***PRODUCT OF CANADA***NET WT 8 OZ (227g)" UPC 0 21130 28443 6
Code InfoLot number 224S4189, UPC 0 21130 28443 6
ClassificationClass I
Reason for RecallChamps 8 oz Sliced White Mushrooms are recalled due to potential contamination of Listeria monocytogenes
Product Quantity230 cases from Auburn, WA DC; 50 cases from Spokane, WA DC
Recall NumberF-2114-2012

Class I Food Event

Event ID63003
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Aug-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmFresh Express Incorporated
CitySalinas
StateCA
CountryUS
Distribution PatternAL, AR, FL, GA, IL, IN, KY, LA, MD, MO, MS, NC, OH, PA, SC, TN, TX, VA, WV.
 

Associated Products

Product DescriptionFresh Express Hearts of Romaine Crunchy and Sweet 100% Hearts of Romaine Lettuce. 10 oz. plastic bag UPC 71279 26102. Fresh Express, Salinas, CA.
Code InfoG222B3A; Use by August 23.
ClassificationClass I
Reason for RecallFDA IEH sample of Fresh Express Hearts of Romaine was found positive for Listeria Monocytogenes.
Product Quantityunknown at this time
Recall NumberF-2131-2012

Class II Biologics Event

Event ID43045
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Oct-06
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma Inc
CityBoca Raton
StateFL
CountryUS
Distribution PatternSwitzerland, Germany, IL
 

Associated Products

Product DescriptionSource Plasma
Code Info4210100174; 4210099656;4210098041;4210096392 4210094813;4210093350;4210091935;4210090417 4210088901;4210087397;4210085959;4210084393 4210076890;4210075903;4210075465;4210074628 4210074229;4210073382;4210072979
ClassificationClass II
Reason for RecallBlood products, collected from a donor who did not have a complete physical examination, were distributed
Product Quantity19 units
Recall NumberB-1285-12

Class II Biologics Event

Event ID45121
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Aug-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CityWichita
StateKS
CountryUS
Distribution PatternTX
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info02LC88260
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-2223-12

Class II Biologics Event

Event ID45720
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Sep-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CityWichita
StateKS
CountryUS
Distribution PatternKS
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info02KH21573
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-2222-12

Class II Biologics Event

Event ID45792
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Sep-07
Initial Firm Notification of Consignee or Public Other
Recalling FirmCsl Bioplasma Inc
CityBoca Raton
StateFL
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info0190528263; 0190526052; 0190512784
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor with a history of high risk behaviors, were distributed.
Product Quantity3 units
Recall NumberB-2183-12

Class II Biologics Event

Event ID46069
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Oct-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityOakland
StateCA
CountryUS
Distribution PatternCA.
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info84LJ01588 Part 1; 84LJ01588 Part 2
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-1804-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info84J09758
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1805-12

Class II Biologics Event

Event ID47936
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Mar-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityLouisville
StateKY
CountryUS
Distribution PatternKY, IN
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info24fp10765, 24fp10775, 24fp10784, 24fp10801, 24fz07992, 24fp10935, 24fp10827 Part 1, 24fp10749 Part1, 24fp10745 Part1, 24fp10766 Part1, 24fp10773 Part1, 24fp10884, 24fr10880, 24fp10879, 24fz07990 Part1, 24fp10923 Part1, 24fp10926 Part1, 24ff07183 Part1, 24fr02802 Part1, 24fz07987 Part1, 24fz07988 Part1, 24fp10852 Part1, 24fp10842 Part1, 24fp10845 Part1, 24fp10848 Part1, 24fp10828 Part1, 24fp10825 Part1, 24fw44511, 24fp10884, 24fp10880, 24fp10879, 24fp10765, 24fp10775, 24fp10784, 24fp10801, 24fp10827Part2, 24fp10749 Part2, 24fp10745 Part2, 24fp10766 Part2, 24fp10773 Part2, 24fz07990 Part2, 24fp10923 Part2, 24fp10926 Part2, 24ff07183 Part2, 24fr02801, 24fr02802 Part2, 24fz07987 Part2, 24fz07988 Part2, 24fp10852 Part2, 24fp10842 Part2, 24fp10845 Part2, 24fp10848 Part2, 24fp10828 Part2, 24fp10825 Part2,
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity54
Recall NumberB-2364-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info24kq88216, 24fl12269, 24fl12299, 24fq09131, 24kj01253, 24ky06776, 24kw64079, 24ks88434, 24kj01618, 24fq09123, 24kj01229, 24kg83549, 24ks88433, 24ke74629, 24fw46054, 24fw46053, 24kw64218, 24kj01615, 24kj01626, 24kj01623, 24kj01628, 24kj01619, 24kc53680, 24kj02246, 24kj02261, 24fs26136, 24kh00054, 24kj02257, 24kj02247, 24kj02258, 24kv27510, 24kw64211, 24kh00065, 24kw64079, 24kj01246, 24fw45965, 24fw45968, 24fw45978, 24fw45969, 24ks89235, 24Ks89249, 24Kr48076, 24Kq87775, 24fw44511, 24kq87776, 24kj01248, 24kg83511, 24y06759, 24kq87777, 24kg83586, 24kq87636, 24kq88224, 24kv27473, 24kw64144, 24kv27471, 24kj02226, 24kh00043, 24kc53663, 24kq87773, 24fw45987, 24yo6773, 24ks88087, 24kc53664, 24fq09047, 24fl12285, 24kh00043, 24kj02251, 24fw46056, 24kg83995, 24kg83992, 24fw46040, 24ks89259, 24ks89262, 24kj01244, 24fw45893, 24kj01231, 24fw45979, 24kj02067, 24kv27469, 24fs26245, 24kw64220, 24kv27472, 24kq88222, 24kc53656, 24fl12273, 24fl12272, 24fl12295, 24fj13592, 24fc59547, 24fq09128, 24fq09126, 24kj01622, 24kq88229, 24kj02069, 24ks89278, 24kg83515, 24fj13594, 24fw45979, 24kj02067, 24kv27469, 24fs26245, 24kw64220, 24kv27472, 24kq88222, 24kc53656, 24kj01598, 24ks89282, 24kh00059, 24kh00050, 24kh00046, 24kw64143, 24kh00067, 24fw45969, 24fq09134, 24fq09122, 24kg83505, 24ky06765, 24fw45882, 24fw45884, 24fw45890, 24kj01227, 24fq09189, 24kj01603, 24kg8399, 24kg83991, 24kq87641, 24fj13600, 24kw64067, 24fw46061, 24ks89281, 24ks89265, 24kj02264, 24kv27502, 24fw46042, 24fl12288, 24fl12283, 24kv27503, 24kq87781, 24fq09129, 24kg83585, 24kj02254, 24kj02245, 24kh00042, 24kj02243,
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity144
Recall NumberB-2365-12
Product DescriptionCryoprecipitated AHF
Code Info24kv27472, 24kv27472, 24fs26136, 24kv27471, 24Kq87775, 24kq87781, 24ks89265, 24kc53652, 24kq87636, 24kq87773, 24kq87627, 24kg83999, 24kj01227, 24kj01229, 24fs26134, 24Kq87641, 24kj01246, 24kv27516, 24kc53663
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity19
Recall NumberB-2366-12
Product DescriptionPlasma Frozen Cryoprecipitated Reduced
Code Info24KV27516
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity1
Recall NumberB-2367-12
Product DescriptionPlasma Frozen
Code Info24kh00042, 24kj02064, 24kv27498, 24Kv27516
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity4
Recall NumberB-2368-12
Product DescriptionFresh Frozen Plasma
Code Info24y06765, 24kj02110, 24fq09047, 24kq88222, 24kg83586, 24kv27503. 24fw45884, 24fw45890, 24fw46040, 24fw45893, 24fq09123, 24kj02112, 24kh00060, 24kh00056, 24kh00054, 24kq88216, 24kj02103, 24ks89254, 24fq09189,
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity19
Recall NumberB-2369-12

Class II Biologics Event

Event ID47991
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Mar-08
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmAmerican Red Cross Blood Services
CityWichita
StateKS
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info02KH08386
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-2371-12

Class II Biologics Event

Event ID48859
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-May-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CityWichita
StateKS
CountryUS
Distribution PatternKS
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info02GJ12175; 02KH29581
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity2 units
Recall NumberB-2372-12

Class II Biologics Event

Event ID48916
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jun-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center of the Ozarks
CitySpringfield
StateMO
CountryUS
Distribution PatternMO
 

Associated Products

Product DescriptionRed Blood Cells
Code Info6880697
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-2361-12

Class II Biologics Event

Event ID49249
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jun-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Centers of the Pacific
CitySan Francisco
StateCA
CountryUS
Distribution PatternCA.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW117008201670
ClassificationClass II
Reason for RecallBlood product, collected from a donor who received a mumps, measles , rubella (MMR) vaccination, was distributed.
Product Quantity1
Recall NumberB-1774-12

Class II Biologics Event

Event ID50261
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Sep-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican Red Cross Blood Services Carolinas Region
CityWinston Salem
StateNC
CountryUS
Distribution PatternAL, GA, KY, NJ, NY, NC, PA, SC, TN
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info12KJ48233, 12KJ48243, 12KJ48251, 12KJ48263, 12KJ48278, 12KJ48287, 12KJ48297, 12KJ48305, 12KJ48315, 12KJ48327, 12KJ48338, 12KJ48346, 12KJ48360, 12KJ48388, 12KJ48423, 12KJ48433, 12KJ48443, 12KJ48454, 12KJ48467, 12KJ48479, 12KJ48484, 12KJ48497, 12KJ48509, 12KJ48524, 12KJ48555, 12KJ48575, 12KJ48588, 12KJ48606, 12KJ48614, 12KJ48626, 12KJ48639, 12KJ48648, 12KJ48656, 12KJ48678, 12KJ48702, 12KJ48721, 12KJ48740, 12KJ48746, 12KJ48756, 12KJ48768, 12KJ48787, 12KJ48791, 12KJ48801, 12KJ48816, 12KJ48827, 12KJ48848, 12KJ48862, 12KJ48879, 12KJ48892, 12KJ48901, 12KJ48923, 12KJ48930, 12KJ48946, 12KJ48955, 12KJ48966, 12KJ48978, 12KJ48994, 12KJ49002, 12KJ49011, 12KJ49020, 12KJ49042, 12KJ49049, 12KJ49072, 12KJ49085, 12KJ49096, 12KJ49107, 12KJ49144, 12KJ49157, 12KJ49183, 12KJ49206, 12KJ49226, 12KJ49257, 12KJ49265, 12KJ49279, 12KJ49296, 12KJ49309, 12KJ49326, 12KJ49369, 12KJ49384, 12KJ49412, 12KJ49422, 12KJ49433, 12KJ49454
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity83 units
Recall NumberB-2186-12
Product DescriptionFresh Frozen Plasma (Apheresis)
Code Info12KJ48315
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity1
Recall NumberB-2187-12
Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code Info12KJ48454, 12KJ48656, 12KJ48801, 12KJ48901, 12KJ48978, 12KJ49011
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity6
Recall NumberB-2188-12

Class II Biologics Event

Event ID56477
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Mar-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTalecris Plasma Resources, Inc.
CityN Las Vegas
StateNV
CountryUS
Distribution PatternNC.
 

Associated Products

Product DescriptionSource Plasma
Code Info3910085746,3910089389,3910081796,3910082510, 3910084270,3910084649,3910084957,3910085501, 3910085909,3910086413,3910082256,3910083028, 3910083163,3910086705,3910087030,3910088404, 3910088670,3910089156
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
Product Quantity18
Recall NumberB-1163-12

Class II Biologics Event

Event ID56478
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Mar-10
Initial Firm Notification of Consignee or Public
Recalling FirmTalecris Plasma Resources, Inc.
CityN Las Vegas
StateNV
CountryUS
Distribution PatternNC.
 

Associated Products

Product DescriptionSource Plasma
Code Info3910081503, 3910081868, 3910082275, 3910082774,3910083156,3910083903,3910084951, 3910085815,3910086223,3910081900,3910082232, 3910082762,3910083137,3910083887,3910084221, 3910084617,3910084939,3910085447,3910085791, 3910086679,3910080955,3910081305,3910081712, 3910082101,3910082598,3910082906,3910085911, 3910086807,3910084747,3910085517,3910081864, 3910086960,3910082356,3910082867,3910083346, 3910083932,3910084404,3910085174,3910085487, 3910086069,3910082792,3910083133,3910084807, 3910085102,3910082281,3910083178,3910083688, 3910085520,3910085810,3910083571,3910086348, 3910080712,3910081330,3910081273,3910082149, 3910082726,3910083078,3910083587,3910083836, 3910084337,3910084447,3910085080,3910084280, 3910086049,3910078976,3910081574,3910082789, 3910083356,3910080630,3910081032,3910081705, 3910082025,3910082629,3910083021,3910084399, 3910079869,3910080355,3910080904,3910081365, 3910081708,3910082186,3910083124,3910083591, 3910083876,3910084279,3910086022,3910086341, 3910086999,3910088048,3910088078,3910088978, 3910082650,3910083064,3910083586,3910084339, 3910085083,3910083942,3910084381,3910080308, 3910080765,3910081042,3910081547,3910081879, 3910082682,3910083362,3910083708,3910084274, 3910084484,3910084967,3910085271,3910085858, 3910086140,3910082818,3910084114,3910086472, 3910085544,3910085798,3910084003,3910084266, 3910084879,3910085422,3910085762,3910086283, 3910080445,3910082380,3910081535,3910082301, 3910083062,3910083519,3910084000,3910084304, 3910084745,3910084997,3910085560,3910085886, 3910086500,3910086729,3910085208,3910085790, 3910084145,3910084571,3910085459,3910081886, 3910083546,3910084704,3910084970,3910086290, 3910084982,3910085671,3910083670,3910083913, 3910086045,3910086355,3910080168,3910080678, 3910081229,3910081480,3910082038,3910082319, 3910083132,3910083218,3910083843,3910083988, 3910084472,3910085524,3910085874,3910085359, 3910084124,3910084521,3910084834,3910079763, 3910080016,3910080417,3910081086,3910081508, 3910081999,3910082487,3910083052,3910083458, 3910083826,3910084203,3910084842,3910083262, 3910083848,3910084147,3910086494,3910084025, 3910084405,3910083981,3910084303,3910079470, 3910079842,3910083375,3910083781,3910082376, 3910083197,3910083998,3910084334,3910084830, 3910086743,3910082741,3910082907,3910083529, 3910083634,3910085393,3910086753,3910079092, 3910079828,3910081076,3910081426,3910082271, 3910082973,3910083230,3910083706,3910083945, 3910085269,3910083281,3910083917,3910085167, 3910084868,3910085216,3910085654,3910083029, 3910084824,3910081742,3910082026,3910082614, 3910082969,3910083525,3910083655,3910084281, 3910084839,3910085091,3910085670,3910085973, 3910079679,3910080273,3910080965,3910081287, 3910082042,3910082365,3910083002,3910083181, 3910083728,3910084039,3910084514,3910084773, 3910085248,3910085602,3910082954,3910083167, 3910085746,3910089389,3910081796,3910082510, 3910084270,3910084649,3910084957,3910085501, 3910085909,3910086413,3910082256,3910083028, 3910083163,3910086705,3910087030,3910088404, 3910088670,3910089156
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
Product Quantity269 units
Recall NumberB-2323-12

Class II Devices Event

Event ID58247
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Aug-10
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBreg Inc, An Orthofix Company
CityVista
StateCA
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and country of: Nova Scotia.
 

Associated Products

Product DescriptionPolar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation barrier between the pad and patient's skin.
Code InfoLot # D101564
ClassificationClass II
Reason for RecallThis recall has been initiated due to confirmation that the Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg does not meet the required thickness as specified. The dressing in the sterile pouch measures a thickness of 0.010" instead of 0.020". This change in thickness makes the dressing thinner, less durable and subject to tearing. The product is mislabeled.
Product Quantity502 units
Recall NumberZ-2326-2012

Class II Food Event

Event ID61120
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jan-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmDr Pepper/ Seven Up, Inc
CityPlano
StateTX
CountryUS
Distribution PatternProduct was distributed within the US to IL, NJ, and NY.
 

Associated Products

Product DescriptionStewart's Diet Orange N' Cream Soda, 12oz glass bottles
Code InfoBottle Code CT101528K
ClassificationClass II
Reason for RecallIncorrectly placed ingredient label for non-diet beverage on bottles of diet beverage. The ingredient label incorrectly provided the ingredients for regular Stewart's Orange N' Cream Soda. The front label on the glass bottles and the 4 carrier secondary package correctly identified the product as Stewart's Diet Orange N' Cream Soda.
Product Quantity710 cases
Recall NumberF-2127-2012

Class II Devices Event

Event ID61451
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jan-12
Initial Firm Notification of Consignee or Public Other
Recalling FirmCook Ireland Ltd.
CityLimerick, Peroc
State
CountryIE
Distribution PatternWorldwide distribution: USA (nationwide) and country of: Japan.
 

Associated Products

Product DescriptionZilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.
Code InfoPart order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014
ClassificationClass II
Reason for RecallCook Ireland received a product complaint from Japan on December 22nd, 2011. The complainant reported that a 5 French Zilver Vascular Stent (part number ZIV5-18-125-8-80 from Lot# CF694429) was inserted into a sheath over a wire guide where it became lodged in the sheath hub. After further examination, the user determined that the product was a 6 French Zilver Vascular Stent (part number ZIV6-35-80-10-30) rather than a 5 French size.
Product Quantity15 units of ZIV5-18-125-8-80 LOT# CF694429
Recall NumberZ-2309-2012

Class II Biologics Event

Event ID61566
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Feb-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBanco de Sangre Servicios Mutuos, Inc.
CityHato Rey
StatePR
CountryUS
Distribution PatternPR
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW363711008736
ClassificationClass II
Reason for RecallBlood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-2322-12

Class II Devices Event

Event ID61984
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Aug-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmExactech, Inc.
CityGainesville
StateFL
CountryUS
Distribution PatternUSA ( nationwide) WA, OH, OK, TX, NC, NY, CO, VA, MA, IL, TN, MN, NJ and FL.
 

Associated Products

Product DescriptionOPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. There are three product sizes being recalled, 11mm, 13mm, 15mm. All other information is the same. The Optetrak Logic Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
Code InfoCatalog numbers 02-012-35-6011, 02-012-35-6013, 02-012-35-6015 All lots.
ClassificationClass II
Reason for RecallExactech, Inc. of Gainesville, FL is recalling their Optetrak Logic Posterior Stabilized Tibial Insert, Size 6 after the device was determined to be out of dimensional specification.
Product Quantity193
Recall NumberZ-2310-2012

Class II Cosmetics Event

Event ID62129
StatusOngoing
Product TypeCosmetics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Nov-11
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmKingpin Tattoo Supply, Inc.
CitySt Petersburg
StateFL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product Description4 oz translucent plastic bottle of - One Black Tattoo Ink. Primary Display Panel - front of squeeze bottle is labeled as follows: "***one***Ingredients: C.I.77226; C.I.74160;***proprietary; glycerin; distilled water; alcohol Net 4 fl oz. (118.4)***Warning: This product is pure pigment. application on certain individuals may cause allergic reaction, we disclaim any responsibility for allergic reactions of certain individuals to who this pigment is applied. Spot testing or consultation with a dermatologist prior to application is urged.***Keep in Cool Dry Place Away from Extreme Heat.***Do Not Freeze- Non Toxic - Non Flammable***Keep out of the reach of childern***Dispose of in accordance to Federal, State and Local Laws***" The Secondary Display Panel - back of squeeze bottle is labeled as follows: "***Lot#***EXP***" or with "***Lot#***EXP*** Warning: This product is pure pigment. application on certain individuals may cause allergic reaction, we disclaim any responsibility for allergic reactions of certain individuals to who this pigment is applied. Spot testing or consultation with a dermatologist prior to application is urged.***Keep in Cool Dry Place Away from Extreme Heat.***Do Not Freeze- Non Toxic - Non Flammable***Keep out of the reach of childern***Dispose of in accordance to Federal, State and Local Laws***"
Code InfoOne Black Tattoo Ink 4oz. translucent plastic bottle. Lot #'s 20110621, 20110901, 20111014, 21120104, and 20120223.
ClassificationClass II
Reason for RecallOn 11/15/2011, Kingpin Tattoo Supply, Inc. initiated a recall for the product ONE Black Tattoo Ink (4 oz. bottle) due to lab test results finding traces of a soil based bacillus type bacteria in the ink.
Product Quantity4904 bottles
Recall NumberF-2112-2012

Class II Drugs Event

Event ID62402
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMedtech Products, Inc.
CityIrvington
StateNY
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionLittle Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (30 mL), Dist. by Medtech Products Inc., Irvington, NY 10533, UPC 7 56184 12071 2.
Code InfoLot # 11338, Exp 04/13
ClassificationClass II
Reason for RecallSubpotent (Single Ingredient) Drug: This product is being recalled because of sub-potency of the sennosides.
Product Quantity12,720 bottles
Recall NumberD-1673-2012

Class II Devices Event

Event ID62505
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBecton Dickinson & Co.
CitySparks
StateMD
CountryUS
Distribution PatternNationwide Distribution including CA, DE, FL, GA, IL, IN, KS, KY, ME, MT, NC, NJ, NM, NY, OH, OK, PA, SC, TX, VA, WA, WI, and WV.
 

Associated Products

Product DescriptionBD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. Test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections.
Code InfoLot/Exp date: 03T11346Z 2012-06-11, 03T12034 2012-07-31
ClassificationClass II
Reason for RecallLeakage in Cepheid SmartCycler reaction tubes.
Product Quantity38 kits
Recall NumberZ-2316-2012
Product DescriptionBD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***GeneOhm Sciences Canada, Inc. 2555 Boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. Test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. .
Code InfoLot/ Exp. 03T11345ZU 2012-07-09
ClassificationClass II
Reason for RecallLeakage in Cepheid SmartCycler reaction tubes.
Product Quantity68 kits
Recall NumberZ-2317-2012
Product DescriptionBD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (tcdB) in human liquid or soft stool specimens fr.om patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.
Code InfoLot/ Exp. 08T11248 2012-06-22, 08T11251 2012-06-26
ClassificationClass II
Reason for RecallLeakage in Cepheid SmartCycler reaction tubes.
Product Quantity57 kits
Recall NumberZ-2318-2012
Product DescriptionBD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.
Code InfoLot/ Exp. 08T11250 2012-07-06
ClassificationClass II
Reason for RecallLeakage in Cepheid SmartCycler reaction tubes.
Product Quantity32 kits
Recall NumberZ-2319-2012
Product DescriptionBD GeneOhm VanR Assay , Catalog # 441250, 5 box tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***. The BD GeneOhm VanR Assay is a qualitative in vitro test for the rapid detection of vancomycin-resistance (vanA and vanB) genes directly from perianal or rectal swabs. The BD GeneOhm VanR Assay detects the presence of the vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE). The assay is performed on an automated real-time PCR instrument with perianal or rectal swabs from individuals at risk for VRE colonization. The BD GeneOhm VanR Assay can be used as an aid to identify, prevent and control vancomycin-resistant colonization in healthcare settings. The BD GeneOhm VanR Assay is not intended to diagnose VRE infections nor to guide or monitor treatment for VRE infections. Concomitant cultures are necessary to recover organisms for epidemiological typing, susceptibility testing and for further confirmatory identification.
Code InfoLot/ Exp. 05T11042 2012-04-30 (ONLY SOLD IN EUROPE)
ClassificationClass II
Reason for RecallLeakage in Cepheid SmartCycler reaction tubes.
Product Quantity5 kits
Recall NumberZ-2320-2012

Class II Devices Event

Event ID62537
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Mar-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPrinceton Biomeditech Corp
CityMonmouth Junction
StateNJ
CountryUS
Distribution PatternNationwide Distribution-including the states of NJ, NY, and PA.
 

Associated Products

Product DescriptionOrasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
Code Info510 k K083746 Catalog Number 1001-0320 - 22 test kits Catalog 1001-0322 - 12 test kits
ClassificationClass II
Reason for RecallThere have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Product Quantity370 (12 tests per kit) ;2800 kits (22 tests per kit)
Recall NumberZ-2306-2012
Product DescriptionPoly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-739-5400 Fax 914-739-5890. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
Code Info510 k K083746 Catalog Number FLU22 Lot numbers 441A11, 441C11
ClassificationClass II
Reason for RecallThere have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Product Quantity103 kits (22 tests per kit)
Recall NumberZ-2307-2012
Product DescriptionStatus Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 08852 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
Code Info510 k K083746 Catalog Number 36022 Lot numbers 441H11 90 kits (22 tests per kit)
ClassificationClass II
Reason for RecallThere have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Product Quantity90 kits (22 tests per kit)
Recall NumberZ-2308-2012

Class II Devices Event

Event ID62593
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTrumpf Medical Systems, Inc.
CityCharleston
StateSC
CountryUS
Distribution PatternWorldwide Distribution - USA including CA, OH, OK, NY, PA, TX, WY and the country of Canada
 

Associated Products

Product DescriptionAcrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
Code InfoI.D. on nameplate: FA AC3 or FA AC3000; Material #1920632, Serial #011201602557 to 011201602588; Serial #011203602617 to 011202602621; Serial #011203602676 to 011203602695; Serial #011203602756 to 011203602775; Serial #011203602776 to 011203602795; Serial #011204602798 to 011204602817; Serial #011204602861 to 011204602880; Serial #011204602970 to 011204602989; Serial #011205603032 to 011205603081; Serial #011206603118 to 011206603167; Serial #011206603168 to 011206603217; Serial #011207603303 to 011207603314; Serial #011208603316 to 011205603333; Serial #011208603361 - Serial #011209603431 to 011209603462; Serial #011210603572 to 011210603597 and Material #1851710, Serial #3705776 to 3705777 and Serial #4105778 to 4105781.
ClassificationClass II
Reason for RecallCracks can arise on the welded seam on the rear joint.
Product Quantity402 units
Recall NumberZ-2311-2012

Class II Devices Event

Event ID62702
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics, Inc
CityEast Walpole
StateMA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of Canada, Argentina, Australia, Brazil, Chile, China, Croatia, Denmark, Ecuduar, Egypt,Guatemala, Hong Kong,India,Ireland, Israel,India, Japan,Korea, Mexico, Malyasia, Peru, Pakistan, Saudi Arabia,Singapore, Thailand,Uruguay, Viet Nam, and South Africa.
 

Associated Products

Product DescriptionSiemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems. Catalog Numbers: 2 Pack REF 07907174 (110312) 6 Pack REF 07293184 (110313). Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems.
Code Info Lot # Expiry Date 2 Pack 76129 22 JUN 2012 77542 22 JUN 2012 78696 22 JUN 2012 80828 26 SEP 2012 80857 26 SEP 2012 81441 26 SEP 2012 82189 26 SEP 2012 83647 26 SEP 2012 84772 26 SEP 2012 86037 13 JAN 2013 86783 13 JAN 2013 88712 13 JAN 2013 90056 13 JAN 2013 91002 13 JAN 2013 93126 13 JAN 2013 6 Pack 76102 22 JUN 2012 76432 22 JUN 2012 77075 22 JUN 2012 78264 22 JUN 2012 79037 22 JUN 2012 81006 26 SEP 2012 82539 26 SEP 2012 83321 26 SEP 2012 84123 26 SEP 2012 85795 13 JAN 2013 86698 13 JAN 2013 88318 13 JAN 2013 89286 13 JAN 2013 90490 13 JAN 2013 91672 13 JAN 2013 93129 13 JAN 2013
ClassificationClass II
Reason for RecallDecrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems for for BNP and TSH3 Ultra assays
Product Quantity2 Packs = 15879 and 6 Packs = 7414
Recall NumberZ-2313-2012

Class II Devices Event

Event ID62709
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics, Inc.
CityNewark
StateDE
CountryUS
Distribution PatternUSA ( nationwide ) including the states of AZ, CA, FL, IL, KY, MD, MA, MN, MS, MO, NE, NH, NJ, NY, NC, OH, PA, TX, VA and WV.
 

Associated Products

Product Descriptionsyngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments.
Code InfoVersion VA11B and all previously released versions.
ClassificationClass II
Reason for RecallWhen using the syngo Quality Control package the system may not perform as intended for Multi-Rule QC violation [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions on page 2 of the recall notification. QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the patient results will not be held as expected. The problem is encountered under the following conditions: 1 - The QC package within the syngo(R) system is being used to evaluate QC; 2 - The syngo(R) system is configured with Multi-Rule QC, and the Multi-level option is selected without following the instructions on page 2 of the recall letter.
Product Quantity44
Recall NumberZ-2305-2012

Class II Food Event

Event ID62754
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmKarl Bissinger Inc
CitySaint Louis
StateMO
CountryUS
Distribution PatternDistribution was made to CA, CO, DE, FL, ID, IL, MD, MO, NJ, NM, NY, OH, OR, TX, VA, and WA.
 

Associated Products

Product DescriptionBissinger's Campfire S'Mores Salt Caramels, packaged in 1.8-oz. boxes, 5 pieces per box, 12 boxes per display case, UPC 846107012788. The firm name on the label is Bissinger's Handcrafted Chocolatier, St. Louis, MO.
Code InfoLots 000159049, 0001159168, and 0001159302.
ClassificationClass II
Reason for RecallThe product is labeled as gluten free but contains wheat, which is listed in the ingredient statement
Product Quantity80/12-box display cases
Recall NumberF-2118-2012

Class II Food Event

Event ID62829
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmJaffe Brothers
CityValley Center
StateCA
CountryUS
Distribution PatternUS States nationwide.
 

Associated Products

Product DescriptionPine nuts, raw and shelled. Packaged in plastic bag. Labeling reads in part:"Jaffe Bros.***Organically Grown Raw, Shelled Pine Nuts This product was packaged on shared equipment that also processes Peanuts***Distributed by Jaffe Bros., Inc. P.O.Box 636 Valley Center, CA 92082***".
Code InfoLot number 97638
ClassificationClass II
Reason for RecallRecall was initiated after firm was informed by their supplier Specialty Commodities that a recall was initiated due to peanuts found in pine nuts.
Product Quantity
Recall NumberF-2125-2012

Class II Food Event

Event ID62843
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmApio, Inc. DBA Apio Fresh LLC
CityGuadalupe
StateCA
CountryUS
Distribution PatternNationwide in the US and worldwide to Mexico, Canada.
 

Associated Products

Product DescriptionFresh Select Brussels Sprouts, 6x8oz, 9x12oz. Item # 22986, 22707, UPC 0 11110 91610 5, 7 09351 32222 8.
Code InfoCode dates: A07208, A08208, Lot# 5873989, 5873990
ClassificationClass II
Reason for RecallApio Inc. is recalling brussel sprouts, broccoli-cauliflower, and snap peas because they may contain foreign material contamination of small plastic shavings from a single production line.
Product Quantity236 units
Recall NumberF-2121-2012
Product DescriptionEat Smart Snap Peas, 14x2lbs, 6x8oz , 12x8oz. Item # 18786, 22216, 10094, UPC 7 09351 00035 5, 7 09351 00901 3
Code InfoCode Dates: A07207, A08207, A07208, A08208, Lot # 5873907, 5873905, 5873906, 5874020, 5874019, 5874021.
ClassificationClass II
Reason for RecallApio Inc. is recalling brussel sprouts, broccoli-cauliflower, and snap peas because they may contain foreign material contamination of small plastic shavings from a single production line.
Product Quantity1,618 units
Recall NumberF-2122-2012
Product DescriptionEat Smart Broccoli & Cauliflower, 9x12oz. Item # 10068. Code Dates: B07208, B08208.
Code InfoUPC 7 09351 00026 3. Lot # 5873991.
ClassificationClass II
Reason for RecallApio Inc. is recalling brussel sprouts, broccoli-cauliflower, and snap peas because they may contain foreign material contamination of small plastic shavings from a single production line.
Product Quantity22 units
Recall NumberF-2123-2012

Class II Food Event

Event ID62847
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Aug-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmClif Bar And Company
CityEmeryville
StateCA
CountryUS
Distribution PatternThe distributors in MA and WI.
 

Associated Products

Product DescriptionBlueberry Crisp CLIF Bars, 12 pack boxes, UPC: 7-22252-30260-1
Code InfoBest By date 17MAR13G3
ClassificationClass II
Reason for RecallA small amount of Blueberry Crisp CLIF bars were inadvertently placed in Chocolate Chip CLIF bar wrappers and placed inside correctly labeled Blueberry Crisp CLIF bar 12-pack boxes. Retailers sell to consumers in 12-pack boxes, and sometimes as individual bars.
Product Quantity384 Boxes
Recall NumberF-2129-2012
Product DescriptionChocolate Chip CLIF Bars, 2.4-oz (68g), individually wrapped, UPC: 7-22252-10090
Code InfoBest By date 17MAR13G3
ClassificationClass II
Reason for RecallA small amount of Blueberry Crisp CLIF bars were inadvertently placed in Chocolate Chip CLIF bar wrappers and placed inside correctly labeled Blueberry Crisp CLIF bar 12-pack boxes. Retailers sell to consumers in 12-pack boxes, and sometimes as individual bars.
Product Quantity4608 Bars
Recall NumberF-2130-2012

Class II Food Event

Event ID62855
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Importing Co, Inc
CityMinneapolis
StateMN
CountryUS
Distribution PatternAL, AZ, ALR, CA, FL, GA, IL, IN, KS, KY, ME, MS, MO, NE, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WY.
 

Associated Products

Product DescriptionNature's Harvest, pine nuts, Net WT 3 oz (85 g), Distributed by Amport Foods, 550 Kasota Ave, SE., Minneapolis, MN 55414, 3 00 71725 72753 4. Case Label Stock No. 5640 8/3 oz Nature's Harvest, Pine Nuts Best by: 12-28-12 363x1E1, 3 00 71725 72753 5. Amport Foods Bags: Amport Foods, Pine Nuts, Net WT 4 0 z (113 g), 0 71725 70172 5, American Importing Co. Inc, Minneapolis, MN 5514. Case label: Stock No 50578 12/4 oz, Amport, Pine Nuts Best by: 03-28-13 3621F1, 1 00 71725 70172 2. Amport Foods Tubs: Pine Nuts, Net WT 4 0 z (113 g), 0 71725 71180 9, Best BY: 01-10-13 0102 MM1, Distributed by American Importing Co, INC, Minneapolis, MN 55414. Tub Case Label: Item #41130 12/4 oz, Amport Foods, Pine Nuts, Best by: 01-10-13 0102MM1, 1 00 71725 71180 6.
Code InfoBest By 12-28-12, 363X1E1, 08:30 (Nature's Harvest) Best By 03-28-13, 3621F1, 08:30 (Amport bags) Best By 01-10-13, 0102MM (Amport tubs)
ClassificationClass II
Reason for RecallAmport Foods is recalling one lot of pine nuts because there may be undeclared Peanuts present in the product.
Product Quantity5,441 cases or 50,100 individual packages
Recall NumberF-2124-2012

Class II Food Event

Event ID62872
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDrucker Labs LP
CityPlano
StateTX
CountryUS
Distribution PatternNationwide and to Canada
 

Associated Products

Product DescriptionintraKID Lot 658 with a Best By date of 12/12, 33 oz and 2 oz bottles
Code InfoLot 658 with a Best By date of 12/12
ClassificationClass II
Reason for RecallAfter extensive testing and investigation, Drucker Labs has determined that an incorrect form of Vitamin B3, Nicotinic Acid, was used in the manufacturing of intraKID Lot 658. This nutrient may cause a temporary symptom in a small number of consumers. This symptom, commonly known as Niacin Flush, may include itching, redness, or warmth of the skin. This typically subsides within 15  20 minutes and has no long-term side effects.
Product Quantity2026 bottles
Recall NumberF-2126-2012

Class II Food Event

Event ID62888
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAtlantic Fisheries
CityMiami
StateFL
CountryUS
Distribution PatternProduct was distributed to Winn Dixie Distribution Centers in FL, AL, and LA.
 

Associated Products

Product DescriptionFresh Mahi Mahi Fillets,10 lb Styrofoam case, labeled in part: "***Mahi Fillets S/ON Costa Rica Wild****KEEP AT 38 OR BELOW Keep refrigerated***ATLANTIC FISHERIES 8195 NW 67TH ST MIAMI FLORIDA 33166***TEL***FAX 305-594-4301***PACK U.S.A.
Code InfoSell by dates of 8/11/12, 8/13/12, and 8/14/12.
ClassificationClass II
Reason for RecallAtlantic Fisheries recalled 580 lbs of Mahi Mahi Fillets due to histamine levels over 50 ppm.
Product Quantity580 lbs
Recall NumberF-2128-2012

Class II Devices Event

Event ID62891
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmeriWater Inc
CityDayton
StateOH
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) including states of: AL, AR, CO, CT, FL, GA, IL, IN, KS, MA, MD, MO, MS, NC, NY, OH, OK, SC, TN, TX and VA; and country of: Canada.
 

Associated Products

Product DescriptionAmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com. The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater Portable MROS model is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The AmeriWater Portable MRO1 model is for treatment of up to two patients in a hospital, clinic, or dialysis centers.
Code InfoModel Number MROS, Catalog #00MROS20, 00MROS21 & Model Number MRO1, Catalog #00MRO120, and 00MRO121; Model Number(s): MROS and MRO1; Serial #'s 31000 to 31079.
ClassificationClass II
Reason for RecallThe firm was notified that a malfunction of the device was caused by an incorrect fuse 32 volt 15 amp fuses instead of 250 volt 15 amp fuses, that was installed in the water system. The incorrect fuse may result in excessive heat in the fuse holder eventually resulting in failure of the device to operate.
Product Quantity80 Units
Recall NumberZ-2321-2012

Class II Devices Event

Event ID62928
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Feb-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmToshiba American Medical Systems Inc
CityTustin
StateCA
CountryUS
Distribution PatternUS (nationwide) distribution including the states of Ohio and Texas.
 

Associated Products

Product DescriptionToshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging.
Code InfoMRT-1503/P5-Vantage MRI System. Serial Codes: P5A0632002, P5B06Y2005, P5B0712006, P3F11Z2143.
ClassificationClass II
Reason for RecallThe firm recalled due to a potentail problem with the position of the hold in the lug teminals on the power cables connected to the terminal blocks on the gradient coil.
Product Quantity3 units
Recall NumberZ-2315-2012

Class II Devices Event

Event ID62949
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jul-12
Initial Firm Notification of Consignee or Public Other
Recalling FirmQuality Electrodynamics LLC
CityMayfield Village
StateOH
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide): Tennessee only and country of: Germany
 

Associated Products

Product DescriptionTxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpreted by a trained physician.
Code InfoQED part numbers: Q7000057/QED000057/QSV000057 Siemens part numbers: 10606829 / 10606614 Serial #s: 1002-1012, 1016-1020, and 1022.
ClassificationClass II
Reason for RecallOn July 27, 2012, it was reported to the firm that the Siemens 3T 15ch Knee Coil was not functional because the coil identification code for the device was incorrect.
Product Quantity17 units
Recall NumberZ-2314-2012

Class II Food Event

Event ID62961
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmThe Humphrey Popcorn Co
CityWarrensville Heights
StateOH
CountryUS
Distribution PatternProduct was distributed to the states of Ohio, Pennsylvania, New York, Florida. There were no US governernment consignees or foreign consignees.
 

Associated Products

Product DescriptionHumphrey Candy Kisses, 4 oz. individually wrapped and contained in a clear plastic bag, UPC Code 81084 00002. Bags are packed 40 to a case.
Code InfoDated 2-23-12 to 5-23-12
ClassificationClass II
Reason for RecallOn 6/5/2012 the firm voluntarily recalled their Candy Kisses due to undeclared milk on the label.
Product Quantity145.5 cases
Recall NumberF-2132-2012
Product DescriptionHumphrey Chocolate Drizzle, 5 oz. in a clear plastic bag, UPC Code 8108400009. Bags are packed 12 to a case.
Code InfoDated 2-23-12 to 5-23-12
ClassificationClass II
Reason for RecallOn 6/5/2012 the firm voluntarily recalled their Chocolate Drizzle Popcorn due to undeclared soy lecithin on the label.
Product Quantity415.4 cases
Recall NumberF-2133-2012

Class II Devices Event

Event ID62967
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRAYSEARCH LABORATORIES AB
CityStockholm
State
CountrySE
Distribution PatternWorldwide distribution: USA (nationwide) including states of: FL, MA, NJ, and NY; and countries of: Canada Germany, Netherlands and Switzerland.
 

Associated Products

Product DescriptionBrand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
Code InfoSoftware version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years.
ClassificationClass II
Reason for RecallThe firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, Raystation 2.5.1. The problem has not caused any patient mistreatment or other incidents. However, the user must be aware of this information to avoid incorrect dose calculations during treatment planning. The dose calculation is not correctly normalized in the unusual case of preventing the optimization of segment shapes and allowing for optimization of segment Monitor Units. As a result, the dose calculation may be incorrect by a factor of 3-6. The result is always an underestimation of the dose, potentially leading to over-dosage of the patient as MU values are increased to compensate.
Product Quantity19 units
Recall NumberZ-2324-2012

Class II Devices Event

Event ID62982
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCapintec Inc
CityPittsburgh
StatePA
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and countries of: Argentina, Belgium, Brazil, Canada, China, Greece, Hong Kong, India, Israel, Malaysia, Philippines, Spain, South Korea, Thailand, and Turkey.
 

Associated Products

Product DescriptionCapintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement of organ uptake and circulating radioactivity.
Code InfoCatalog numbers for new systems: 5430-0076, 5430-0077, 5430-0103, and 5430-0087. Catalog numbers for conversion systems: 5430-0118 and 5430-0119. Serial numbers for new systems: 901006 through 901394, inclusive. Serial numbers for conversion systems: CNV 674 through CNV 730, inclusive. Also affected are devices which were serviced and devices for which customers received software upgrades between January 20, 2011 and June 30, 2012 with Revision 1.22, 1.23, 1.24, 1.25, or 1.26. (NOTE: Item number 5430-0075, Captus 3000 well counter system, is excluded. This system does not have the ability to perform thyroid uptake procedures.)
ClassificationClass II
Reason for RecallCustomers who received a Capintec Captus 3000 Thyroid Uptake System with Software Revisions 1.22, 1.23, 1.24, 1.25, and 1.26 may encounter an error while using the thyroid uptake protocol ?Measure Liquid and Subtract Residual." This protocol was a new feature added to Software Revision 1.22 in January 2011. The error occurs only if the user does NOT measure the residual dose immediately after measuring and administering the does.
Product Quantity256
Recall NumberZ-2312-2012

Class II Devices Event

Event ID63042
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc
CityMalvern
StatePA
CountryUS
Distribution PatternNationwide Distribution- including the states of GA, ID, IL, IA, KS, NC, OH, SD, TX, and WI.
 

Associated Products

Product DescriptionSiemens Mobilett Mira. Mobile X-Ray System.
Code InfoModel number 10273100 -- serial numbers 1034, 1038, 1041, 1042, 1043, 1053, 1057, 1070, 1079, 1081, 1088, 1098, 1099, 1102, 1103, 1105, 1106, 1107, 1108, and 1112.
ClassificationClass II
Reason for RecallDuring regular product monitoring, Siemens has become aware of a potential issue with the Mobilett Mira system. During normal clinical operation the switch on the motor drive handle of the unit may become loose and slide horizontally to the right and become trapped under the cover. This may cause the system to continuously move. In response, Siemens has issued Update Instruction XP038/12/S to replace motor drive handles and circuit board connection cables on all affected Mobilett Mira systems.
Product Quantity20
Recall NumberZ-2322-2012

Class III Biologics Event

Event ID39540
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Dec-04
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)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info01Y57775 ; 01Y57776; 01Y57777; 01Y57778; 01Y57780; 01Y57781; 01Y57782; 01Y57783; 01Y57784
ClassificationClass III
Reason for RecallBlood products, collected using expired blood collection sets, were distributed.
Product Quantity9
Recall NumberB-2174-12
Product DescriptionPlatelets
Code Info01Y57775 ; 01Y57776; 01Y57780; 01Y57781; 01Y57783
ClassificationClass III
Reason for RecallBlood Products, which were collected in an expired collection bag, were distributed.
Product Quantity5
Recall NumberB-2175-12
Product DescriptionPlasma Frozen within 24 hrs After Phlebotomy
Code Info01Y57775; 01Y57778; 01Y57781; 01Y57783
ClassificationClass III
Reason for RecallBlood products, collected using expired blood collection sets, were distributed.
Product Quantity4
Recall NumberB-2176-12

Class III Biologics Event

Event ID39858
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Mar-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomat USA, Inc.
CityLos Angeles
StateCA
CountryUS
Distribution Patternall units were shipped to Spain
 

Associated Products

Product DescriptionSource Plasma
Code Info380001943, 380002525, 380004157, 380005454, 380006271, 380007553, 380007713, 380002110. 380001521, 380003365, 380003625, 380005713, 380006093, 380008037, 380008629, 380008896, 380009446, 380009942, 380010141, 380010432, 380010668, 380011122, 380011476, 380012030, 380012185, 380012470, 380012689, 380013021, 380013200, 380013643, 380013915, 380014838, 380015927, 380016011, 380016486.
ClassificationClass III
Reason for RecallBlood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed
Product Quantity35 units
Recall NumberB-2370-12

Class III Biologics Event

Event ID41332
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Nov-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityPomona
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionWhole Blood
Code Info06FS97949, 06FS97950,06FS97952
ClassificationClass III
Reason for RecallBlood products, collected using expired blood collection sets, were distributed.
Product Quantity3
Recall NumberB-2189-12

Class III Biologics Event

Event ID41411
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jan-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityPomona
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info06GY30608, 06GY30609, 06GY306011
ClassificationClass III
Reason for RecallBlood products, collected using expired blood collection sets, were distributed.
Product Quantity3
Recall NumberB-2190-12
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info06GY306014
ClassificationClass III
Reason for RecallBlood products, collected using expired blood collection sets, were distributed.
Product Quantity1
Recall NumberB-2191-12

Class III Biologics Event

Event ID53629
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Jul-09
Initial Firm Notification of Consignee or Public Other
Recalling FirmCsl Plasma Inc
CityBoca Raton
StateFL
CountryUS
Distribution PatternIllinois, Switzerland, Germany
 

Associated Products

Product DescriptionSource Plasma
Code Info4150297715; 4150294349; 4150293435; 4150292493; 4150288630; 4150287719; 4150286846; 4150286095; 4150284457; 4150283934 4150282834; 4150281920; 4150280786; 4150278941; 4150277345; 4150276981; 4150275679; 4150274422; 4150274155; 4150269751 4150268915; 4150267926; 4150267061; 4150265978; 4150265356 4150264180; 4150263579; 4150262513; 4150261396; 4150259690 4150258205; 4150256705; 4150256144; 4150254565; 4150252995 4150251796; 4150251162; 4150250065; 4150248969; 4150248434 4150247203; 4150246138; 4150245557; 4150244387; 4150243771 4150242893; 4150242294; 4150240661; 4150238481; 4150237503 4150236648; 4150235331; 4150234650; 4150233857; 4150233129 4150231965; 4150223312; 4150222670; 4150221568; 4150220888 4150219778; 4150219281; 4150217819; 4150217210
ClassificationClass III
Reason for RecallDonor Screening/Donor did not meet acceptance criteria
Product Quantity65 Units
Recall NumberB-2362-12

Class III Biologics Event

Event ID53630
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Aug-09
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc.
CityBoca Raton
StateFL
CountryUS
Distribution PatternIllinois
 

Associated Products

Product DescriptionSource Plasma
Code Info4100357245;4100353872;4100352989;4100349565; 4100342044;4100339263;4100337890;4100335910; 4100333175;4100332154;4100330801;4100329645; 4100327628;4100326150;4100325573;4100323863; 4100323233;4100320460;4100319487;4100318146 4100317254;4100315413;4100314701;4100312805; 4100310298;4100307910;4100306851;4100305683; 4100304613;4100303660;4100302605;4100301245; 4100300337;4100295622;4100294702;4100293336; 4100292077
ClassificationClass III
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity37 Units
Recall NumberB-2363-12

Class III Biologics Event

Event ID55592
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Mar-10
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityLouisville
StateKY
CountryUS
Distribution PatternKentucky, Indiana, and Illinois.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info024FJ24130; 024FJ24132; 024FJ24133; 024FJ24134; 024FJ24139; 024FJ24144; 024GL69697; 024GL69704; 024KC60837; 024KG92957; 024KG92963;024KG92978; 024KG92981; 024KG92983; 024KQ99617;024KQ99618; 024KQ99620, 024KG92580, 024KS00234, 024FL27016, 024FT14085, 024GL69657, 024GY45090, 024GY45096, 024GY45100, 024KY02545, 024KY02577, 024FJ24139, 024GK72339, 024KE82978, 024KG92974, 024KG92963, 024KP1666, 024KQ99618, 024KY02731, 024KY02732, 024KY02739, 024GP05065, 024GP05067, 024KJ12425, 024KZ65305.
ClassificationClass III
Reason for RecallBlood products, which may have reached an unacceptable temperature during storage, were distributed.
Product Quantity41 units
Recall NumberB-2192-12

Class III Biologics Event

Event ID62429
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (the)
CityCharlotte
StateNC
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info12FR27060;
ClassificationClass III
Reason for RecallBlood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-2072-12

Class III Food Event

Event ID62695
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Jul-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmClif Bar And Company
CityEmeryville
StateCA
CountryUS
Distribution PatternDistributed to Targets and Walmarts in 25 states.
 

Associated Products

Product DescriptionCLIF Bar Brand Coconut Chocolate Chip CLIF Bars, 6-pack boxes, UPC: 7-22252-66030-5 Product is manufactured by Harlan Bakeries in Indianapolis, IN.
Code InfoBest By date: 16MAY13G1 on both carton and individual bars contained within.
ClassificationClass III
Reason for RecallThe product contains undeclared Coconut in the ingredient statement. The Coconut Chocolate Chip bars were inadvertently placed in White Chocolate Macadamia CLIF Bar wrappers and these mislabeled bars were placed inside correctly labeled Coconut Chocolate Chip CLIF Bar boxes.
Product Quantity53,453 boxes. Each box contains 6 bars
Recall NumberF-2119-2012
Product DescriptionCLIF Bar Brand White Chocolate Macadamia CLIF Bar, 2.4 oz (68g), Individually wrapped bars Product is manufactured by Harlan Bakeries in Indianapolis, IN.
Code InfoBest By date: 16MAY13G1
ClassificationClass III
Reason for RecallThe product contains undeclared Coconut in the ingredient statement. The Coconut Chocolate Chip bars were inadvertently placed in White Chocolate Macadamia CLIF Bar wrappers and these mislabeled bars were placed inside correctly labeled Coconut Chocolate Chip CLIF Bar boxes.
Product Quantity53,453 boxes. Each box contains 6 bars
Recall NumberF-2120-2012

Class III Devices Event

Event ID62757
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTrek Diagnostic Systems
CityCleveland
StateOH
CountryUS
Distribution PatternWorldwide Distribution - USA including AL, AR, AZ, CA, CO , CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SD, TN, TX, VA, VT, WA, WI, WV, and WY. Internationally to the countries of Bahamas, Bangladesh, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, India, Ireland, Italy, Japan, Jordan, Kenya, Kuwait, Malaysia, Mexico, Pakistan, Peru, Philippines, Portugal, Puerto Rico, Russian Federation, South Africa, Spain, Thailand, Turkey, and United Kingdom
 

Associated Products

Product DescriptionVersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile body fluids.
Code InfoSoftware: Cat. 6133-30-3, Version 5.4.3.
ClassificationClass III
Reason for RecallReview of instrument software databases and investigation of two customer reports determined that on rare occasions (less than 0.3%), following the removal of a positive signaling bottle from the VersaTREK instrument, the positive test result inadvertently reverted to a negative result in the instrument database.
Product Quantity333 units
Recall NumberZ-2323-2012

Class III Devices Event

Event ID62852
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSteris Corporation
CityMentor
StateOH
CountryUS
Distribution PatternWorldwide Distribution--USA (nationwide) including the states of AL, AZ, CA, FL, IL, IN, KY, LA, MO, MS, NJ, OH, PA, SD, TX, and VA., and the countries of Japan, Peru, and Suriname.
 

Associated Products

Product Description100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.
Code InfoProduct code KCT; Lot number: 60263
ClassificationClass III
Reason for RecallOn 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected by Steris due to failing process indicators.
Product Quantity77 packs
Recall NumberZ-2325-2012

Mixed Classification Biologics Event

Event ID40074
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Apr-05
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmAmerican National Red Cross (The)
CitySaint Louis
StateMO
CountryUS
Distribution PatternMO, IL, TN, AR, AL, PR, SC
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced.
Code Info 011FL31359, 011FL31370, 011FL31413, 011FL31424, 011FS36104, 011FS35106, 011FS36117, 011FS35118, 011FS36121, 011GG39706, 011GG39708, 011GJ65355, 011GK83746, 011GH83753, 011GK83767, 011GK83774, 011GK83775, 011GK83779, 011GM89817, 011GM89820, 011GM89821, 011GM89825, 011GM89826, 011GM89839, 011GM89842, 011GM89851, 011GN80908, 011GN80912, 011GN80914, 011GN80916, 011GN80919, 011GN80937, 011GN80938, 011GN80941, 011GN80949, 011GQ72541, 011GQ72543, 011GQ72545, 011GQ72547, 011GQ72548, 011GR66347, 011GR66349, 011GR66353, 011GR66357, 011GR66359, 011GR66361, 011GR66362, 011GR66363, 011GR66380, 011GR66387
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity50 UNITS
Recall NumberB-2437-12
Product DescriptionCryoprecipitated AHF. .
Code Info 011FL31370, 011FL31376, 011FL31413, 011FS35106, 011FS36117, 011FS35118, 011GG39706, 011GG39708, 011GN80937, 011GN80938, 011GN80941, 011GN80946, 011GN80949, 011GQ72533, 011GQ72541, 011GQ72543, 011GQ72545, 011GQ72547, 011GQ72548
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity19 UNITS
Recall NumberB-2438-12
Product DescriptionFresh Frozen Plasma.
Code Info 011GJ65355, 011GK83777, 011GM89839, 011GM89842, 011GM89844, 011GM89849, 011GR66380
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity7 units
Recall NumberB-2439-12
Product DescriptionRecovered Plasma
Code Info 011FL31346, 011FL31353, 011FL31376, 011GG39708, 011GK83777, 011GN80908, 011GN80912, 011GN80914, 011GN80919, 011GN80937, 011GN80938, 011GN80941, 011GN80946, 011GN80949, 011GQ72540, 011GQ72541, 011GQ72545, 011GQ72547, 011GQ72548, 011GR66347, 011GR66349, 011GR66353, 011GR66357, 011GR66359, 011GR66361, 011GR66362, 011GR66363, 011GR66387
ClassificationClass III
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity28 units
Recall NumberB-2440-12
Product DescriptionRed Blood Cells. .
Code Info 011GQ72533
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 UNIT
Recall NumberB-2441-12
Product DescriptionPlasma Frozen .
Code Info 011GK83748
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2442-12

Mixed Classification Biologics Event

Event ID44691
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Mar-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CityWichita
StateKS
CountryUS
Distribution PatternOK, CA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info02LJ81794
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2184-12
Product DescriptionBlood and Blood Products for Reprocessing
Code Info02LJ81794
ClassificationClass III
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2185-12

Mixed Classification Biologics Event

Event ID44996
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Sep-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmThe American National Red Cross - Southern Region
CityDouglasville
StateGA
CountryUS
Distribution PatternAL, GA & SC
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code Info003KT21845, 003KT22093, 003KT21844, 003KT21846, 003KP40859, 003KT22248, 003KF32591, 003KT23823, 003KF30043, 003KJ21806, 003KJ21790, 003KP40848, 003KP40870, 003KF30502, 003KJ21312, 003KJ21314, 003KT23926, 003KJ21345, 003KJ21727, 003KJ21729, 003KT21947, 003KT21814, 003KP40853, 003KJ21368, 003KJ21372, 003KT23988, 003KT24059, 003KT24152, 003KT24159, 003KP47200, 003KT24275, 003KT24288, 003KT24318, 003KJ21821, 003KP40829, 003KP40832, 003KP40858, 003KT24112, 003KT21927, 003KT23932, 003KT23928, 003KT23941, 003KT24281, 003KT21808, 003KT21831, 003KT21931, 003KP40866, 003KP40872, 003KF30085, 003KT22261, 003KT22262, 003KF32600, 003KQ40068, 003KT23894, 003KT23897, 003KT23940, 003KT23945, 003KP46744, 003KP46750, 003KJ21375, 003KJ21395, 003KJ21435, 003KQ40330, 003KT24018, 003KT24021, 003KT24114, 003KT24116, 003KT24145, 003KT24269, 003KT24286, 003KT24302, 003KF30497, 003KF30500, 003KF30530, 003KT22122, 003KT22128, 003KT22135, 003KT24171, 003KT24247, 003KT21200, 003KT21201, 003KT21204, 003KT24291, 003KT21821, 003KT21843, 003KP40837, 003KP40862, 003KP40871, 003KF3000, 003KF30139, 003KT22110, 003KF30504, 003KT22132, 003KT22133, 003KT22136, 003KT23831, 003KJ21351, 003KJ21392, 003KJ21427, 003KJ21436, 003KT23991, 003KT24051, 003KJ21699, 003KT24283, 003KT24301, 003KT24311, 003KT24315, 003KJ21804, 003KJ21850, 003KT21836, 003KT21842, 003KP40840, 003KT21981, 003KF30007, 003KF30073, 003KF30197, 003KT22131, 003KT22134, 003KT24118, 003KT21938, 003KJ21782, 003KT21849, 003KQ40059, 003KT21834, 003KQ40067, 003KJ21616, 003KJ21859, 003KJ21861, 003KT24014, 003KT21820, 003KT21824, 003KT21825, 003KT21827, 003KT21830, 003KT21837, 003KT21840, 003KP40838, 003KP40839, 003KF30037, 003KT21839, 003KF30040, 003KF30048, 003KF30056, 003KT22079, 003KT22082, 003KF30517, 003KT22259, 003KQ40066, 003KT23929, 003KT23933, 003KT23949, 003KT23954, 003KT23955, 003KJ21361, 003KJ21362, 003KJ21394, 003KJ21397, 003KT23970, 003KT24007, 003KT24199, 003KJ21774, 003KJ21784, 003KJ21785, 003KT24274, 003KT24330, 003KJ21839, 003KJ21852, 003KF30512, 003KT24327, 003KP40863, 003KF30057, 003KT22080, 003KT22081, 003KT22084, 003KT22255, 003KJ21305, 003KT24015, 003KT24300, 003KT22292, 003KT23636, 003KT23757, 003KT24011, 003KT22083, 003KT21810, 003KT24148, 003KJ21843, 003KJ21846, 003KT21203, 003KT21209, 003KT21813, 003KP40857, 003KF30097, 003KT22111, 003KF30507, 003KF30515, 003KT22119, 003KT23925, 003KJ21428, 003KT24077, 003KT24113, 003KJ21717, 003KJ21730, 003KP47192, 003KP47196, 003KP47197, 003KP47199, 003KJ21796, 003KJ21880, 003KT24047, 003KT21206, 003KT21848, 003KP40827, 003KP40835, 003KP40852, 003KP40855, 003KF30011, 003KF30016, 003KF30025, 003KF30091, 003KF32594, 003KF32604, 003KF32615, 003KQ40062, 003KT23836, 003KT24047, 003KJ21863, 003KT21816, 003KT21818, 003KT23805, 003KT23819, 003KJ21348, 003KT24246, 003KT23811, 003KT24312, 003KJ21313, 003KT21972, 003KT22093, 003KJ21449, 003KT21940, 003KT21970, 003KJ21308, 003KJ21697, 003KP46746, 003KT23636, 003KT23816, 003KT24251, 003KF30027, 003KF30090, 003KT21847, 003KP40868, 003KF30046, 003KT22123, 003KF30513, 003KT24255, 003KP47191, 003KP47193, 003KF30020, 003KT22197, 003KT22239, 003KT24057, 003KT24065, 003KP47188, 003KP47203, 003KT22253, 003KT24074, 003KT24074, 003KT22243, 003KT24063, 003KT23838, 003KT24048, 003KT24266, 003KJ21878, 003KF30104, 003KJ21315, 003KT22249
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity275 units
Recall NumberB-2177-12
Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info003KJ21504, 003KJ21506, 003KT24309, 003KF30063, 003KJ21466, 003KT23946, 003KF30506, 003KF30523, 003KJ21504, 003KJ21299, 003KT23611, 003KT23824, 003KT21985, 003KT23919, 003KT24309, 003KF32619, 003KF32625, 003KT23915, 003KT23919, 003KF30506, 003KT23946, 003KT23952, 003KT23694, 003KT23694, 003KT23952, 003KT24164, 003KJ21506, 003KJ21299, 003KT23653, 003KT24257, 003KF30063, 003KJ21244, 003KT23610, 003KT23611, 003KT23653, 003KT24257, 003KQ40055, 003KT23830, 003KJ21466, 003KT23915, 003KF32619, 003KF32625, 003KJ21244, 003KT23610
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity44 units
Recall NumberB-2178-12
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info003KT21971, 003KF30025, 003KT21764, 003KT34048, 003KT24315, 003KQ40318, 003KQ40327, 003KT22197, 003KT24014, 003KT24104, 003KJ21494, 003KT24311, 003KJ21691, 003KT24305, 003KJ21229, 003KJ21246, 003KT24051, 003KJ21774, 003KT24314, 003KT24320, 003KJ21224, 03KQ40325, 003KT23980, 003KT24038, 003S42158, 003KT21983, 003KT24047, 003KT24103, 003KJ21294, 003KT21229, 003KT23982, 003KJ21578, 003KT24199, 003KT23808, 003KT23816, 003KT23821, 003KT23926
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity37 units
Recall NumberB-2179-12
Product DescriptionRed Blood Cells Leukocytes Reduced Washed
Code Info003KJ21693
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product QuantityOne unit
Recall NumberB-2180-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info003KJ21586, 003KT23643, 003V47039, 003KP40835, 003KT21821, 003KT22063, 003KT22054, 003KT21840, 003KT23957, 003KT23960, 003KT23964, 003KT23972, 003V47019, 003V47022, 003KT24291, 003V47045, 003KT23619, 003KF30512, 003KF30513, 003KT22239, 003KT22255, 003KT24053, 003KT21818, 003KF30034, 003KF30166, 003KJ21302, 003KJ21397, 003KJ21402, 003KJ21403, 003KJ21450, 003KJ21454, 003KJ21467, 003KJ21579, 003KJ21580, 003KT21781, 003KT21981, 003KT22240, 003KT23608, 003KT23617, 003KT23759, 003KT23929, 003KT23941, 003KT23949, 003KT24011, 003KT24265, 003V47015, 003V47034, 003V47046, 003KT24328, 003KP47196, 003KJ21696, 003KJ21434, 003KT21212, 003KT21233, 003KT23633, 003KT23651, 003KT23658, 003KT23990, 003KT24315, 003V47161, 003KF30139, 003KF30502, 003KF30507, 003KF30509, 003KF30515, 003KJ21353, 003KJ21811, 003KT21810, 003KT21825, 003KT21849, 003KT21927, 003KT21933, 003KT21986, 003KT22044, 003KT22046, 003KT22048, 003KT22070, 003KT22131, 003KT22134, 003KT22137, 003KT22200, 003KT22206, 003KT22262, 003KT23625, 003KT23681, 003KT24068, 003KT24108, 003KT24306, 003KJ21490, 003KJ21811, 003KT22194, 003KT22093, 003KJ21428, 003KJ21461, 003KT22208, 003KT23814, 003KT23940, 003KT23950, 003KJ21338, 003KT23916, 003KJ21340, 003KJ21436, 003KJ21796, 003KP47186, 003KT21236, 003KT21812, 003KT21813, 003KT21814, 003KT21847, 003KT22049, 003KT22122, 003KT22128, 003KT22129, 003KT22132, 003KT22135, 003KT22253, 003KT23626, 003KT23663, 003KT23830, 003KT24154, 003KJ21936, 003KT22042, 003KT22243, 003KJ21393, 003KF30197, 003KJ21730, 003KP40836, 003KT21945, 003KT23894, 003KT21200, 003KJ21804, 003KJ21346, 003KJ21782, 003KJ21784, 003KT22305, 003KT24057, 003KJ21503, 003KJ21348, 003KF30000, 003KF32591, 003KJ21251, 003KJ21312, 003KJ21584, 003KJ21695, 003KT22081, 003KF30132, 003KT21757, 003KT21934, 003KT21938, 003KT21940, 003KT21970, 003KT22061, 003KJ21814, 003KP47197, 003KJ21313, 003KT23624, 003KT24157, 003KP47203, 003KJ21777, 003KT24271, 003KJ21356, 003KF30057, 003KF30073, 003KF32615, 003KJ21245, 003KJ21304, 003KJ21308, 003KJ21396, 003KJ21439, 003KJ21361, 003KJ21508, 003KJ21585, 003KP40871, 003KT21830, 003KT21930, 003KT21943, 003KT21947, 003KT22066, 003KT22186, 003KT22187, 003KT22192, 003KT23616, 003KT23648, 003KT23654, 003KT23918, 003KT23943, 003V47028, 003V47158, 003KF30517, 003KT21748, 003KT21750, 003KT21760, 003KT21770, 003KT21774, 003KT22062, 003KT22119, 003KT22051, 003KT24168, 003KT24249, 003KT24333, 003KJ21818, 003KJ21830, 003KJ21878, 003KF32594, 003KT21834, 003KT21976, 003KT22307, 003KJ21500, 003KF30097, 003KJ21463, 003KJ21502, 003KJ21583, 003KP46747, 003KT21978, 003KT22069, 003KT22248, 003KT22298, 003KT23991, 003KJ21342, 003KJ21359, 003KP40829, 003KF30114, 003KJ21290, 003KJ21293, 003KJ21426, 003KP46746, 003KT21844, 003KT21985, 003KT22108, 003KT22252, 003KT22280, 003KT22287, 003KT23661, 003KT23680, 003KT23819, 003KT23824, 003KT23826, 003KT23958, 003KT23962, 003KT24019, 003KT24066, 003KT24114, 003KT24149, 003KJ21725, 003KP47188, 003KP47192, 003KT24334, 003KJ21362, 003KT24286, 003KT24308, 003KT22057, 003KT22083, 003KT22299, 003KT22306, 003KT22308, 003KT22310, 003KT23994, 003KF30010, 003KF30016, 003KJ21575, 003KT23613, 003KT23642, 003KT24049, 003KT24074, 003KT24246, 003KJ21848, 003KF30504, 003KJ21859, 003KJ21398, 003KQ40057, 003KQ40066, 003KT21209, 003KT24145, 003KT24148, 003KT24162, 003V47041, 003V47155, 003KT21816, 003KT24023, 003KJ21839, 003KJ21307, 003KJ21399, 003KJ21247, 003KF30530, 003KQ40054, 003KQ40065, 003KQ40068, 003KT22210, 003KT24318, 003KT21234, 003KT24040, 003KT24063, 003V47026, 003V47040, 003KJ21427, 003KJ21616, 003KP40866, 003KP46748, 003KQ40055, 003KT21231, 003KT21838, 003KT24302, 003KT22079, 003KT24301, 003KJ21850, 003KJ21827, 003KJ21351, 003KT21842, 003KT21846, 003KT21972, 003KT22105, 003KT22106, 003KT22110, 003KT22111, 003V47025, 003KT24021, 003KF32604, 003KP40868, 003KF30164, 003KJ21314, 003KJ21492, 003KJ21779, 003KJ21846, 003KT24255, 003KJ21699, 003KP40838, 003KT21931, 003KT21949, 003KT22123, 003KT22136, 003KT23812, 003KF30104, 003KJ21238, 003KJ21377, 003KT22082, 003KT22184, 003KP40837, 003KT21843, 003KT21848, 003KJ21775, 003KJ21780, 003KJ21790, 003KJ21845, 003KJ21855, 003KF30091, 003KF30121, 003KJ21315, 003KP40860, 003KP40862, 003KT21207, 003KT21837, 003KT23602, 003KJ21391, 003KT22183, 003KT22189, 003KT22209, 003KT23635, 003KJ21843, 003KF32618, 003KT22060, 003KT24147, 003KJ21364, 003KT21216, 003V47159, 003V47162, 003KJ21686, 003KY24153, 003KT24274, 003KJ21857, 003KT22268, 003KT22278, 003KT24105, 003KT24264, 003KT24262, 003KT24266, 003KF30011, 003KF30037, 003KF30046, 003KJ21394, 003KJ21433, 003KJ21452, 003KJ21459, 003KJ21465, 003KJ21577, 003KP40839, 003KP40848, 003KP40863, 003KP46744, 003KT21206, 003KT21768, 003KT21975, 003KT21977, 003KT22117, 003KT22203, 003KT22259, 003KT22269, 003KT23678, 003KT23679, 003KT23831, 003KT23954, 003KT23955, 003KT23970, 003KT23975, 003KT24262, 003KT24266, 003KJ21216, 003KJ21333, 003KJ21335, 003KJ21345, 003KJ21372, 003KJ21449, 003KT21203, 003KT22272, 003KT23607, 003KT23627, 003KT23629, 003KT23631, 003KT23838, 003KT24009, 003KJ21727, 003KJ21729, 003KT24169, 003KP47191, 003KP47200, 003KT24161, 003KJ21368, 003KJ21834, 003KT24018, 003KT24152, 003KT24275, 003KJ21837, 003KF30007, 003KF30056, 003KF30082, 003KF30497, 003KJ21499, 003KJ21507, 003KJ21581, 003KJ21785, 003KT24247, 003KF30048, 003KT21755, 003KT21766, 003KT21973, 003KT21979, 003KT23614, 003KT23656, 003KT24059, 003S42155, 003KP40827, 003KP40861, 003KQ40330, 003KT23897, 003V47160, 003KT21747, 003KT21753, 003KJ21371, 003KP40870, 003V47035, 003KJ21880, 003KF30085, 003KF30027, 003KF30040, 003KF30090, 003KJ21305, 003KJ21424, 003KP40831, 003KP40853, 003KT21235, 003KT22267, 003KT22296, 003KT22303, 003KT23811, 003KT23836, 003KT23925, 003KT23945, 003KP40855, 003KT21759, 003KT22056, 003KT22133, 003KT23665, 003KJ21821, 003KT23665, 003KT24312, 003KF30043, 003KF30500, 003KQ40324, 003KT21831, 003KT22080, 003KT22084, 003KT22107, 003KT23618, 003KT23921, 003KT23985, 003KT23996, 003KT24077, 003KT24312, 003V47023, 003KF32616, 003KT21777, 003KT21778, 003KT23647, 003KT23660, 003KT23823, 003KT23988, 003KJ21806, 003KF30020, 003KT21850, 003KJ21392, 003KJ21614, 003KT21820, 003KT21827, 003KT21836, 003KP40832, 003KT22293, 003KT24171, 003KP47199, 003KT24281, 003KJ21306, 003KJ21437, 003KJ21486, 003KJ21588, 003KQ40052, 003KQ40058, 003KQ40059, 003KT22274, 003KT23606, 003KT24039, 003KT24045, 003KT24065, 003V47027, 003KP46750, 003KP48057, 003KT21218, 003KT21219, 003KT22052, 003KT22249, 003KT21204, 003V47153, 003KF32610, 003KT21841, 003KT23639, 003V47152, 003KJ21717, 003KT24288, 003KJ21435, 003KJ21697, 003KT23603, 003V47033, 003KT24159, 003KQ40067, 003KF30060, 003KJ21292, 003KJ21295, 003KJ21430, 003KJ21432, 003KJ21448, 003KJ21457, 003KP40872, 003KT21201, 003KT21213, 003KT22196, 003KT23928, 003KT23932, 003KT23933, 003KT22291, 003KT22304, 003KJ21365, 003KT24269, 003KJ21223, 003KT21773, 003KJ21509, 003KP40840, 003KP40852, 003KP40858, 003KP40859, 003KT22301, 003KT24327, 003KT24330, 003KT21808, 003KJ21310, 003KT22072, 003KJ21446, 003KT24118, 003KT24144, 003KF32600, 003KF32606, 003KJ21496, 003KJ21498, 003KQ40061, 003KQ40062, 003KT21752, 003KT21845, 003KT23922, 003KT21824, 003KT22109, 003KT21237, 003KJ21863, 003S42153, 003S42156, 003KJ21375, 003KJ21376, 003KJ21395, 003KJ21401
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity612 units
Recall NumberB-2181-12
Product DescriptionBlood and Blood Products for Reprocessing
Code Info003KJ21463, 003KT23606, 993KF30121, 003KF30164, 003KF30166, 003KF30180, 003KF30509, 003KF32606, 003KF32616, 003KJ21212, 003KJ21216, 003KJ21223, 003KJ21224, 003KJ21229, 003KJ21238, 003KJ21241, 003KJ21245, 003KJ21246, 003KJ21247, 003KJ21251, 003KJ21290, 003KJ21292, 003KJ21293, 003KJ21294, 003KJ21295, 003KJ21304, 003KJ21306, 003KJ21310, 003KJ21311, 003KJ21333, 003KJ21335, 003KJ21338, 003KJ21340, 003KJ21342, 003KJ21346, 003KJ21353, 003KJ21359, 003KJ21364, 003KJ21365, 003KJ21371, 003KJ21376, 003KJ21377, 003KJ21391, 003KJ21396, 003KJ21398, 003KJ21401, 003KJ21402, 003KJ21403, 003KJ21424, 003KJ21426, 003KJ21430, 003KJ21432, 003KJ21437, 003KJ21439, 003KJ21446, 003KJ21448, 003KJ21450, 003KJ21452, 003KJ21454, 003KJ21457, 003KJ21459, 003KJ21461, 003KJ21465, 003KJ21467, 003KJ21486, 003KJ21488, 003KJ21490, 003KJ21492, 003KJ21494, 003KJ21496, 003KJ21498, 003KJ21499, 003KJ21500, 003KJ21502, 003KJ21503, 003KJ21507, 003KJ21508, 003KJ21509, 003KJ21575, 003KJ21578, 003KJ21579, 003KJ21580, 003KJ21581, 003KJ21583, 003KJ21584, 003KJ21585, 003KJ21586, 003KJ21588, 003KJ21686, 003KJ21691, 003KJ21693, 003KJ21695, 003KJ21696, 003KJ21725, 003KJ21811, 003KJ21814, 003KJ21816, 003KJ21818, 003KJ21827, 003KJ21830, 003KJ21834, 003KJ21848, 003KP40831, 003KP40836, 003KP40850, 003KP40860, 003KP40861, 003KP40865, 003KP46747, 003KP46748, 003KP47186, 003KQ40052, 003KQ40054, 003KQ40057, 003KQ40058, 003KQ40061, 003KQ40065, 003KQ40318, 003KQ40324, 003KQ40325, 003KQ40327, 003KT21207, 003KT21212, 003KT21213, 003KT21216, 003KT21219, 003KT21229, 003KT21231, 003KT21233, 003KT21234, 003KT21235, 003KT21236, 003KT21237, 003KT21747, 003KT21748, 003KT21752, 003KT21753, 003KT21755, 003KT21757, 003KT21759, 003KT21763, 003KT21764, 003KT21766, 003KT21768, 003KT21772, 003KT21773, 003KT21774, 003KT21777, 003KT21778, 003KT21781, 003KT21782, 003KT21812, 003KT21841, 003KT21850, 003KT21971, 003KT21973, 003KT21975, 003KT21976, 003KT21977, 003KT21978, 003KT21979, 003KT21986, 003KT22042, 003KT22046, 003KT22048, 003KT22049, 003KT22051, 003KT22052, 003KT 22054, 003KT22056, 003KT22057, 003KT22060, 003KT22061, 003KT22062, 003KT22063, 003KT22066, 003KT22069, 003KT22070, 003KT22072, 003KT22105, 003KT22106, 003KT22107, 003KT22108, 003KT22109, 003KT22117, 003KT22137, 003KT22183, 003KT22184, 003KT22186, 003KT22187, 003KT22189, 003KT22192, 003KT22194, 003KT22196, 003KT22200, 003KT22203, 003KT22206, 003KT22208, 003KT22209, 003KT22210, 003KT22240, 003KT22245, 003KT22252, 003KT22267, 003KT22268, 003KT22269, 003KT22272, 003KT22274, 003KT22278, 003KT22280, 003KT22287, 003KT22291, 003KT22292, 003KT22293, 003KT22296, 003KT22298, 003KT22299, 003KT22301, 003KT22304, 003KT22305, 003KT22306, 003KT22307, 003KT22310, 003KT23602, 003KT23603, 003KT23607, 003KT23608, 003KT23613, 003KT23614, 003KT23616, 003KT23617, 003KT23618, 003KT23619, 003KT23624, 003KT23625, 003KT23626, 003KT23627, 003KT23629, 003KT23631, 003KT23633, 003KT23635, 003KT23639, 003KT23642, 003KT23643, 003KT23647, 003KT23648, 003KT23651, 003KT23654, 003KT23660, 003KT23663, 003KT23665, 003KT23678, 003KT23679, 003KT23680, 003KT23681, 003KT23757, 003KT23759, 003KT23808, 003KT23812, 003KT23814, 003KT23821, 003KT23834, 003KT23839, 003KT23916, 003KT23918, 003KT23921, 003KT23922, 003KT23935, 003KT23943, 003KT23950, 003KT23957, 003KT23958, 003KT23960, 003KT23962, 003KT23964, 003KT23965, 003KT23972, 003KT23975, 003KT23985, 003KT23990, 003KT23996, 003KT24009, 003KT24019, 003KT24023, 003KT24038, 003KT24039, 003KT24040, 003KT24045, 003KT24049, 003KT24055, 003KT24066, 003KT24068, 003KT24103, 003KT24104, 003KT24105, 003KT24108, 003KT24144, 003KT24147, 003KT24149, 003KT24154, 003KT24157, 003KT24161, 003KT24162, 003KT64164, 003KT24166, 003KT24168, 003KT24169, 003KT24262, 003KT24264, 003KT24271, 003KT24293, 003KT24305, 003KT24306, 003KT24314, 003S42153, 003S42155, 003S42156, 003S42158, 003V47015, 003V47016, 003V47019, 003V47022, 003V47023, 003V47025, 003V47026, 003V47027, 003V47028, 003V47033, 003V47034, 003V47035, 003V47039, 003V47040, 003V47041, 003V47045, 003V47046, 003V47152, 003V47153, 003V47155, 003V47158, 003V47159, 003V47160, 003V47161, 003V47162, 003KJ21356, 003KJ21393, 003KT21218, 003KT21770, 003KT21983, 003KT23656, 003KT21930, 003KT21934, 003KT21943, 003KT21945, 003KT21949, 003KT22044
ClassificationClass III
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity355 units
Recall NumberB-2182-12

Mixed Classification Biologics Event

Event ID46549
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Nov-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CityWichita
StateKS
CountryUS
Distribution PatternKS, CA
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info02FV16140; 02FV14910
ClassificationClass III
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-2172-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info02FV14910
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2173-12

Mixed Classification Biologics Event

Event ID48593
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-May-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityWichita
StateKS
CountryUS
Distribution PatternKansas and California
 

Associated Products

Product DescriptionRecovered Plasma
Code Info02KH05241
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2433-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info02KH05241
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2434-12

Mixed Classification Biologics Event

Event ID48861
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jun-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Red Cross Blood Services
CityWichita
StateKS
CountryUS
Distribution PatternKS, CA
 

Associated Products

Product DescriptionRecovered Plasma
Code Info02GG58419
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2435-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info02GG58419
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2436-12
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