• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of December 19, 2012

  • Print
  • Share
  • E-mail
-

Class I Food Event

Event ID57212
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Nov-10
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBaugher Enterprises, Incorporated
CityWestminster
StateMD
CountryUS
Distribution PatternThe product was sold to a distributor in MD and retailers in MD and the Gettysburg, PA area.
 

Associated Products

Product DescriptionBaugher's Apple Cider, one gallon and half gallon plastic jugs, with plastic caps labeled in part ***Fresh*** Preservatives added-keep under refrigeration***. Jugs are labeled in part ***FDA Required Warning: This product has not been pasteurized and therefore may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems***.
Code InfoThe products are not identified with lot numbers. The jugs are labeled with UPCs: 710372330024 710372330017
ClassificationClass I
Reason for RecallAn unpasteurized apple cider product is potentially linked to foodborne illnesses in cases confirmed with E. coli 0157:H7.
Product Quantity14200 gallons total
Recall NumberF-0820-2013

Class I Food Event

Event ID63472
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLin-Mar Partners Inc
CityAustin
StateTX
CountryUS
Distribution PatternTX only
 

Associated Products

Product DescriptionLonghorn Bar Roasted Peanut with Chocolate (1.23 oz), 144 units per case. The bars are in packaging labeled as Longhorn Bars and have a picture of roasted peanuts and chocolate.
Code InfoThe UPC code for the Roasted Peanut Energy Bar is 8-57087-00301-7 and best by date of 11/10/12. The lot Number is 111012. These codes are printed on the back of the products.
ClassificationClass I
Reason for RecallLIN-MAR PARTNERS, INC of Austin, Texas recalled two varieties of Longhorn Bars: Roasted Peanut with Chocolate Energy Bars and Peanut Butter Trail Mix Protein Bars, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. This recall was initiated because these products were made using peanuts from Sunland Inc. which has issued an expanded recall of the peanuts used in these products.
Product Quantity30,853 bars of the Roasted Peanut with Chocolate
Recall NumberF-0818-2013
Product DescriptionLonghorn Bar Peanut Butter Trail Mix (1.80 oz), 144 units per case. The bars are in packaging labeled as Longhorn Bars and have a picture of roasted peanuts and trail mix.
Code InfoThe UPC code for the Peanut Butter Trail Mix Protein Bar is 8-57087-00303-1 and best by date of 11/11/12. The lot Number is 111112. These codes are printed on the back of the products.
ClassificationClass I
Reason for RecallLIN-MAR PARTNERS, INC of Austin, Texas recalled two varieties of Longhorn Bars: Roasted Peanut with Chocolate Energy Bars and Peanut Butter Trail Mix Protein Bars, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. This recall was initiated because these products were made using peanuts from Sunland Inc. which has issued an expanded recall of the peanuts used in these products.
Product Quantity25,164 bars of the Peanut Butter Trail Mix
Recall NumberF-0819-2013

Class I Devices Event

Event ID63635
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmVerathon, Inc.
CityBothell
StateWA
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NM, NV, NJ, NY, OK, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and countries of: Argentina, Australia, Canada, China, France, Germany, Indonesia, Japan, The Netherlands, Pakistan, Panama, Peru, Philippines, Singapore, South Korea, Taiwan, Thailand, United Kingdom, and Venezuela.
 

Associated Products

Product DescriptionThe GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. The affected GVL and Part numbers are GVL 3  0574-0007, GVL 4  0574-0001, and GVL 5  0574-0030. The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures.
Code InfoSerial numbers range for GVL3: 0574-0007/ MD10500 to MD112387; Serial numbers range for GVL4: 0574-0001/ LG105000 to LG112758; Serial numbers range for GVL5: 0574-0030/ XL105000 to XL111798.
ClassificationClass I
Reason for RecallRe-usable video laryngoscope blades of the GlideScope GVL3, GVL4, and GVL5 were recalled due to potential cracking.
Product Quantitytotal 2710 units
Recall NumberZ-0478-2013

Class I Food Event

Event ID63693
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Nov-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmTurkana Food Inc.
CityKenilworth
StateNJ
CountryUS
Distribution PatternNortheast
 

Associated Products

Product DescriptionTurkana Valley Dried Apricot 250 g, UPC 8692594007804 and 500 g UPC 8692594007811 Tunas Gida, San Ve Tic. Ltd. Sti 2 Org. San. Bol. Celal Dogan Bulvari No.:3 Baspinar Gaziantep/ Turkey packaged in plastic container
Code Info250 g- Best Before 02/2013 Lot #11-4 500 g- Best Before 02/2013 Lot #11-3
ClassificationClass I
Reason for RecallTurkana Valley dried apricots contain undeclared sulfites which was discovered during NYSDAM sampling.
Product Quantity147 boxes (250g each); 194 boxes (500g each)
Recall NumberF-0807-2013

Class I Food Event

Event ID63696
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Nov-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmBerres Brothers, Inc.
CityWatertown
StateWI
CountryUS
Distribution PatternAL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, MD, MI, MN, MS,MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, SC,SD, TN, TX, VA, WA, AW, WI, WY. OUS: GU, AE, CA
 

Associated Products

Product DescriptionBerres Brothers Coffee Roasters Chocolate & Peanut Butter regular whole bean coffee packaged in the following sizes: 12 oz. (340g) UPC 746774-003594 and 5 LB bulk, UPC 746774-00499.
Code InfoJulian date codes 12001 - 12318 (January 1, 2012 thru November 13, 2012)
ClassificationClass I
Reason for RecallBerres Brothers Coffee Roasters is recalling 3 flavors of regular and decaffeinated, ground and whole bean coffees because they contain undeclared walnut. Chocolate & Peanut Butter, Monkey Mocha, and Lunch with Elvis
Product Quantity1729 packages
Recall NumberF-0808-2013
Product DescriptionBerres Brothers Coffee Roasters Chocolate & Peanut Butter Decaffeinated whole bean coffee packaged in 12 oz. (340g) bags with no UPC code.
Code InfoJulian date codes 12001 - 12318 (January 1, 2012 thru November 13, 2012)
ClassificationClass I
Reason for RecallBerres Brothers Coffee Roasters is recalling 3 flavors of regular and decaffeinated, ground and whole bean coffees because they contain undeclared walnut. Chocolate & Peanut Butter, Monkey Mocha, and Lunch with Elvis
Product Quantity73 packages
Recall NumberF-0809-2013
Product DescriptionBerres Brothers Coffee Roasters Chocolate & Peanut Butter regular ground coffee packaged in the following sizes: 1.5 oz. (42.5g) with UPC 746774-00042, 2.5 oz. with no UPC, and 12 oz. (340g) bags with UPC 746774-00359.
Code InfoJulian date codes 12001 - 12318 (January 1, 2012 thru November 13, 2012)
ClassificationClass I
Reason for RecallBerres Brothers Coffee Roasters is recalling 3 flavors of regular and decaffeinated, ground and whole bean coffees because they contain undeclared walnut. Chocolate & Peanut Butter, Monkey Mocha, and Lunch with Elvis
Product Quantity12327 packages
Recall NumberF-0810-2013
Product DescriptionBerres Brothers Coffee Roasters Chocolate & Peanut Butter Decaffeinated ground coffee packaged in 12 oz. (340g) bags with no UPC.
Code InfoJulian date codes 12001 - 12318 (January 1, 2012 thru November 13, 2012)
ClassificationClass I
Reason for RecallBerres Brothers Coffee Roasters is recalling 3 flavors of regular and decaffeinated, ground and whole bean coffees because they contain undeclared walnut. Chocolate & Peanut Butter, Monkey Mocha, and Lunch with Elvis
Product Quantity39 packages
Recall NumberF-0811-2013
Product DescriptionBerres Brothers Coffee Roasters Mocha Monkey regular whole bean coffee packaged in 5 lb bulk bags with UPC 746774-00509.
Code InfoJulian date codes 12271 - 12318 (September 27 1, 2012 thru November 13, 2012)
ClassificationClass I
Reason for RecallBerres Brothers Coffee Roasters is recalling 3 flavors of regular and decaffeinated, ground and whole bean coffees because they contain undeclared walnut. Chocolate & Peanut Butter, Monkey Mocha, and Lunch with Elvis
Product Quantity10 packages
Recall NumberF-0812-2013
Product DescriptionBerres Brothers Coffee Roasters Mocha Monkey regular ground coffee packaged in 1.5 oz. (42.5g) bags with UPC 746774-000425.
Code InfoJulian date codes 12271 - 12318 (September 27 1, 2012 thru November 13, 2012)
ClassificationClass I
Reason for RecallBerres Brothers Coffee Roasters is recalling 3 flavors of regular and decaffeinated, ground and whole bean coffees because they contain undeclared walnut. Chocolate & Peanut Butter, Monkey Mocha, and Lunch with Elvis
Product Quantity4209 packages
Recall NumberF-0813-2013
Product DescriptionBerres Brothers Coffee Roasters Lunch with Elvis regular whole bean coffee packaged in the following sizes: 12 oz. (340g) bags with no UPC, and 5 lb bulk bags with UPC 746774-5093
Code InfoJulian date codes 12091 - 12319 (April 1, 2012 thru November 15, 2012)
ClassificationClass I
Reason for RecallBerres Brothers Coffee Roasters is recalling 3 flavors of regular and decaffeinated, ground and whole bean coffees because they contain undeclared walnut. Chocolate & Peanut Butter, Monkey Mocha, and Lunch with Elvis
Product Quantity66 packages
Recall NumberF-0814-2013
Product DescriptionBerres Brothers Coffee Roasters Lunch with Elvis decaffeinated whole bean coffee packaged in 12 oz. (42.5g) bags with no UPC.
Code InfoJulian date codes 12091 - 12319 (April 1, 2012 thru November 15, 2012)
ClassificationClass I
Reason for RecallBerres Brothers Coffee Roasters is recalling 3 flavors of regular and decaffeinated, ground and whole bean coffees because they contain undeclared walnut. Chocolate & Peanut Butter, Monkey Mocha, and Lunch with Elvis
Product Quantity2 packages
Recall NumberF-0815-2013
Product DescriptionBerres Brothers Coffee Roasters Lunch with Elvis regular ground coffee packaged in the following sizes: 1.5 oz. (42.5g) with UPC 746774-000425, and 12 oz. (340g) bags with no UPC.
Code InfoJulian date codes 12091 - 12319 (April 1, 2012 thru November 15, 2012)
ClassificationClass I
Reason for RecallBerres Brothers Coffee Roasters is recalling 3 flavors of regular and decaffeinated, ground and whole bean coffees because they contain undeclared walnut. Chocolate & Peanut Butter, Monkey Mocha, and Lunch with Elvis
Product Quantity9998 packages
Recall NumberF-0816-2013
Product DescriptionBerres Brothers Coffee Roasters Lunch with Elvis decaffeinated ground coffee packaged in 12 oz. (340g) bags with no UPC.
Code InfoJulian date codes 12091 - 12319 (April 1, 2012 thru November 15, 2012)
ClassificationClass I
Reason for RecallBerres Brothers Coffee Roasters is recalling 3 flavors of regular and decaffeinated, ground and whole bean coffees because they contain undeclared walnut. Chocolate & Peanut Butter, Monkey Mocha, and Lunch with Elvis
Product Quantity10 packages
Recall NumberF-0817-2013

Class I Devices Event

Event ID63712
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMedtronic Neuromodulation
CityMinneapolis
StateMN
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and countries including: Canada and Mexico.
 

Associated Products

Product DescriptionSynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump is part of an implanted infusion system that consists of a SynchroMed EL pump and a catheter. The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The SynchroMed EL Infusion System with a 10 mL reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids referred to in this manual.
Code InfoAll SynchroMed EL and SynchroMed II pumps
ClassificationClass I
Reason for RecallMedtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of unapproved drugs with SynchroMed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion.
Product Quantity174,700 devices total
Recall NumberZ-0496-2013
Product DescriptionMedtronic SynchroMed II, Model 8637, (The SynchroMed® II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.
Code InfoAll SynchroMed EL and SynchroMed II pumps
ClassificationClass I
Reason for RecallMedtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of unapproved drugs with SynchroMed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion.
Product Quantity174,700 devices total
Recall NumberZ-0497-2013

Class II Biologics Event

Event ID39107
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Mar-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternMissouri; Pennsylvania
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoKN07221 Part A ;KN07221 Part B ;KN07221 Part C
ClassificationClass II
Reason for RecallBlood products, for which the quality control testing was incomplete or not performed , were distributed.
Product Quantity3 Units
Recall NumberB-0213-13

Class II Biologics Event

Event ID40495
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Jul-05
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services L.P.
CityLaramie
StateWY
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info05LWYC0246; 05LWYC0547; 05LWYC1310; 05LWYC1732; 05LWYC2154
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity5 units
Recall NumberB-0074-13

Class II Biologics Event

Event ID48840
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-May-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services L.P.
CityOgden
StateUT
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info08OUTB1976, 08OUTB1529, 08OUTB0961, 08OUTB0273, 08OUTBA9103, 08OUTA8564, 08OUTA7926, 08OUTA6759, 08OUTA6248, 08OUTA5650, 08OUTA5118, 08OUTA4464
ClassificationClass II
Reason for RecallBlood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity12
Recall NumberB-0071-13

Class II Biologics Event

Event ID49612
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jun-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services L.P.
CityOgden
StateUT
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info08OUTB2306
ClassificationClass II
Reason for RecallBlood product, for which the sterility may have been compromised during collection, was distributed.
Product Quantity1 unit
Recall NumberB-0073-13

Class II Biologics Event

Event ID50285
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Oct-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services L.P.
CityLayton
StateUT
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info08OUTD6551, 08OUTD4301, 08OUTD3924, 08OUTD1660, 08OUTD1174, 08OUTD0586, 08OUTC5971, 08OUTC5400, 08OUTC4692, 08OUTC4317, 08OUTC3409, 08OUTC2970, 08OUTC2325, 08OUTC1695, 08OUTC1093, 08OUTC0373, 08OUTB9920, 08OUTB9060, 08OUTD5251, 08OUTD5616, , 08OUTD7075, 08OUTD7926, 08OUTD8806, 08OUTD9079, 08OUTE3717, 08OUTE4270, 08OUTE6072, 08OUTE8200, 08OUTE7490, 08OUTE6713, 08OUTE5972, 08OUTE5530, 08OUTE8484, 08OUTE5464, 08OUTE4979, 08OUTE3618, 08OUTE2621, 08OUTE2221, 08OUTE1511, 08OUTE0774, 08OUTE0325, 07OUTE6189, 07OUTE5921, 07OUTE5428, 07OUTE4998, 07OUTE4173, 07OUTE3749, 07OUTE2920, 07OUTE2343, 07OUTE7637,
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity50 units
Recall NumberB-0078-13

Class II Biologics Event

Event ID51460
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Dec-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionSource Plasma
Code Info366094388, 366093087, 366092413, 366091596, 366084072, 366083393, 366082163, 366065026, 366060955, 366113926, 366110996, 366110471, 366109901, 366108842, 366107910, 366107049, 366106353, 366105442, 366105014, 366102656, 366101856, 366101112, 366100324, 366099605, 366098399, 366097660, 366096836, 366096068, 366095287, 366094510, 366093322, 366092563, 366091863, 366082317, 366081714, 366080489, 366079137, 366075995, 366093105, 366070315, 366069379, 366068747, 366068434, 366067647, 366067277, 366066211, 366065866, 366064670, 366064344, 366063599, 366063003, 366062329, 366062006, 366061427, 366060233, 366059691, 366059016, 366058504, 366057680, 366057519, 366057162, 366055848, 366055023, 366054676, 366054177, 366053775, 366051612, 366051576, 366097574, 366096482, 366095805, 366094802, 366094270, 366092806, 366092279, 366091395, 366090877, 366083360, 366079277, 366079221, 366025051, 366024547, 366014206, 366008260, 366001846, 366001406, 366000422, I52062987, I52059231, I52059104, 366083961, 366083552, 366081818, 366081027, 366113691, 366110621, 366110095, 366109268, 366108777, 366107493, 366107003, 366106181, 366105614, 366104722, 366104100, 366102624, 366102131, 366101123, 366100603, 366099449, 366099002, 366097498, 366096782, 366095968, 366095162, 366094434, 366092824, 366068531, 366066360, 366065971, 366064392, 366060781, 366060723, 366099802, 366096261, 366095773, 366094251, 366092789, 366092238, 366110712, 366110447, 366106307, 366102745, 366102241, 366101270, 366100805, 366099721, 366099273, 366096252, 366080277, 366078027, 366075276, 366074823, 366073845, 366073434, 366072216, 366071896, 366069729, 366069679, 366113651, 366099355, 366098374, 366086066, 366086016, 366087145, 366076082, 366075349, 366074365, 366074146, 366073056, 366072356, 366071278, 366070698, 366070234, 366068495, 366067952, 366066523, 366066157, 366064582, 366064264, 366063507, 366063202, 366060645, 366060618, 366111886, 366112656, 366114608, 366114949, 366116219 , 366117115, 366120130, 366120610, 366121123, 366122361, 366123396, 366089973, 366093538, 366123064, 366123164, 366121993, 366121619, 366120961, 366120578, 366117117, 366116201, 366115341, 366114910, 366114064, 366112611, 366111337, 366113228, 366086494, 366089533, 366114610, 366115171, 366120048, 366121148, 366122185, 366123463, 366114460, 366115298, 366116042, 366116443, 366121239, 366127033, 366114216, 366114537, 366115707, 366112884, 366121370, 366086401, 366086461,
ClassificationClass II
Reason for RecallBlood products, collected from a donor who did not have a complete physical examination, were distributed
Product Quantity222 units
Recall NumberB-0081-13

Class II Biologics Event

Event ID53202
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jul-09
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCSL Plasma, Inc.
CityAlbuquerque
StateNM
CountryUS
Distribution PatternIllinois, Indiana, Switzerland, Germany
 

Associated Products

Product DescriptionSource Plasma
Code Info0341007549 0341005122 0341004679 0341002609 0341002159 0341000629 0340999968 0340997686 0340996842 0340996406 0340995527 0340994628 0340994019 0340993267 0340992600 0340991873 0340990962 0340989961 0340989647 0340988469 0340987833 0340986753 0340983456 0340981203 0340978612 0340977603 0340976941 0340975620 0340975208 0340974094 0340973742 0340972294
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
Product Quantity32 units
Recall NumberB-0079-13

Class II Biologics Event

Event ID54050
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Sep-09
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc.
CityOmaha
StateNE
CountryUS
Distribution PatternIllinois; Germany; Switzerland
 

Associated Products

Product DescriptionSource Plasma
Code Info4210323584; 4210304150; 4210303303; 4210297992; 4210293731; 4210291514; 4210289430; 4210288836; 4210285683; 4210283789; 4210281923; 4210279978; 4210279178; 4210276807; 4210271979; 4210271352; 4210263791; 4210262764; 4210259138; 4210256999; 4210255306; 4210254855; 4210252067; 4210250138; 4210248709; 4210247652; 4210245956; 4210244829; 4210243609; 4210242768; 4210228374; 4210227747; 4210225801; 4210224285; 4210222290; 4210220217; 4210218485; 4210217989; 4210216569; 4210215918; 4210214293; 4210209079; 4210208585.
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose scheduled physical examination was incomplete, were distributed..
Product Quantity43 Units
Recall NumberB-0148-13

Class II Biologics Event

Event ID54210
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Nov-09
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc.
CityKansas City
StateMO
CountryUS
Distribution PatternIllinois
 

Associated Products

Product DescriptionSource Plasma
Code Info4100356139; 4100352050; 4100349660; 4100348615; 4100347189; 4100344881; 4100343098; 4100341929; 4100340798; 4100339619; 4100337254; 4100335779; 4100334476; 4100333203; 4100332004; 4100330362; 4100329365; 4100327908; 4100327047; 4100325518; 4100324794; 4100322468; 4100319907; 4100309110; 4100306283; 4100299035; 4100269941; 4100261168; 4100258592; 4100255865; 4100253193; 4100250678; 4100249217; 4100248010; 4100244455; 4100241666; 4100204861; 4100203016; 4100201527.
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
Product Quantity39 Units
Recall NumberB-0080-13

Class II Biologics Event

Event ID54962
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Feb-10
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCSL Plasma, Inc.
CityAlbuquerque
StateNM
CountryUS
Distribution PatternIllinois, North Carolina, Switzerland, Germany,
 

Associated Products

Product DescriptionSource Plasma
Code Info0340915828, 0340915071, 0340914770, 0340913746, 0340912654, 0340911284, 0340911018, 0340910027, 0340909550, 0340908516, 0340907958, 0340907400, 0340906861, 0340906361, 0340905737, 0340904779, 0340904365, 0340903388, 0340902528, 0340901517, 0340900743, 0340900331, 0340899543, 0340899046, 0340898242, 0340897871, 0340896285, 0340895930, 0340894987, 0340894700, 0340893917, 0340893580, 0340892772, 0340892465, 0340891581, 0340890613, 0340889733, 0340885348, 0340884896, 0340884156, 0340883695, 0340883041, 0340882530, 0340881146, 0340880335, 0340878822, 0340878425, 0340864900, 0340862634, 0340862269, 0340861260, 0340861014, 0340859405, 0340859105, 70959536, 70955262, 70950526, 70926934, 70918380, 70915082, 70898347, 70830835, 70824360, 70818703, 0340667648, 0340666613, 0340665953, 0340665304, 39 BNHCPR, 39 BNHCMS, 39 BNHBQH, 39 BNHBHM, 39 BNHBDQ, 39 BNGZXT, 39 BNGZVS, 39 BNGZNQ, 39 BNGZLP, 39 BNGKBP, 39 BNGJYS, 39 BNGGZH, 39 BNGGWK, 39 BNGGQZ, 39 BNGGNF, 39 BNGGFX, 39 BNGGCM, 39 BNGGBF, 39 BNGFWK, 39 BNGFTV, 39 BNGFPT, 39 BNGFNG, 39 BNGFJD, 39 BNGFGD, 39 BNGDZP, 39 BNGDYF, 39 BNGDFM, 39 BNGDBR, 39 BNGCSG, 39 BNGCPF, 39BNFNCP, 39BNFKYT, 39 BNFNGC, 39 BNFMRG, 39 BNFMKV, 39 BNFMHB, 39 BNFMBM, 39 BNFLXN, 39 BNFLRX, 39 BNFLPH, 39 BNFLHT, 70903768, 39 BNFLFX, 39 BNFKVX, 39BNFKNM, 39BNFKJY, 39BNFGRD
ClassificationClass II
Reason for RecallBlood products, collected from donors who were previously deferred, were distributed.
Product Quantity115 units
Recall NumberB-0150-13

Class II Biologics Event

Event ID54971
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Nov-09
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc.
CityKansas City
StateMO
CountryUS
Distribution PatternIllinois; Germany; Switzerland
 

Associated Products

Product DescriptionSource Plasma
Code Info4100277850; 4100276582; 4100275333; 4100274081; 4100272722; 4100271544; 4100269970; 4100268693; 4100267245; 4100265930; 4100264695; 4100263580; 4100262073; 4100260749; 4100259294; 4100258041; 4100256558; 4100254300; 4100253637; 4100243130; 4100241888; 4100240692; 4100239324; 4100238183; 4100236832; 4100235771; 4100234597; 4100232998; 4100232190; 4100230520; 4100229264; 4100228088; 4100226938; 4100225617; 4100224715; 4100223221; 4100221952; 4100221045; 4100219439; 4100215576; 4100214281; 4100213246; 4100211933; 4100211056; 4100209898; 4100208871; 4100207555; 4100206958; 4100205556; 4100204906.
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
Product Quantity50 Units
Recall NumberB-0149-13

Class II Biologics Event

Event ID56901
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Aug-10
Initial Firm Notification of Consignee or Public Other
Recalling FirmLifeShare Blood Centers
CityBeaumont
StateTX
CountryUS
Distribution PatternTexas
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036510090662
ClassificationClass II
Reason for RecallBlood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Product Quantity1
Recall NumberB-0249-13

Class II Biologics Event

Event ID57717
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Nov-10
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross (The)
CitySalt Lake City
StateUT
CountryUS
Distribution PatternCA, AZ, ID, TN, MI, UT
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info20KV51488, 020L53142, 20KK78860; 20X73265, 20FW41272; 20X72735, 20X72392; 20L51192; 20LW33694; 020x74860; 20FW48207; 20KK82966; 20KK82969; 20KV57460, 20LW41602; 20LW41776;20X81069, 20X81089, 20X74714; 20X77093; 20X77875; 020L53298; 20LW36510;20X76725;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Product Quantity24 units
Recall NumberB-0147-13

Class II Devices Event

Event ID61209
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Feb-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCovidien LLC dba Uni-Patch
CityWabasha
StateMN
CountryUS
Distribution PatternNationwide Distribution including CA, IL, MA, MN, and SD.
 

Associated Products

Product DescriptionReusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
Code InfoLots 202028 and 202722
ClassificationClass II
Reason for RecallCovidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut.
Product Quantity2,014 pouches
Recall NumberZ-0498-2013
Product DescriptionReusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.
Code InfoLots 202404, 202506, 203431,
ClassificationClass II
Reason for RecallCovidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut.
Product Quantity3594 pouches
Recall NumberZ-0499-2013
Product DescriptionPerforma reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.
Code InfoLot 202406
ClassificationClass II
Reason for RecallCovidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut.
Product Quantity3290
Recall NumberZ-0500-2013
Product DescriptionEmpi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.
Code InfoLots 200300 and 201203
ClassificationClass II
Reason for RecallCovidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut.
Product Quantity28,138 pouches
Recall NumberZ-0501-2013

Class II Biologics Event

Event ID63262
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Sep-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmONEBLOOD Inc DBA: Southeastern Comm. Blood Center
CityTallahassee
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW12701282750300;
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity1
Recall NumberB-0132-13

Class II Biologics Event

Event ID63280
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPuget Sound Blood Center and Program
CitySeattle
StateWA
CountryUS
Distribution PatternWashington
 

Associated Products

Product DescriptionRed Blood Cells Irradiated
Code InfoW141608132395;
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0141-13
Product DescriptionRed Blood Cells
Code InfoW141608134667; W141607089713;
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-0142-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW141609135513;
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-0143-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW141609135513;
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0144-13
Product DescriptionBlood Products - Other
Code InfoW141609135513;
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0145-13

Class II Biologics Event

Event ID63281
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Aug-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross The
CityPomona
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info06GL92017;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0135-13
Product DescriptionCryoprecipitated AHF
Code Info06GL92017;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0136-13

Class II Biologics Event

Event ID63294
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jun-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmDepartment Of The Army
CityTacoma
StateWA
CountryUS
Distribution PatternWashington; New York
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW010012200086; W010012200163;
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 Quantity2
Recall NumberB-0151-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW010011008546;
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
Recall NumberB-0152-13
Product DescriptionFresh Frozen Plasma
Code InfoW010012200086; W010012200125; W010012200163; W010012000827; W010012002215;
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 Quantity5
Recall NumberB-0153-13

Class II Devices Event

Event ID63312
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRoche Molecular Systems, Inc.
CityBranchburg
StateNJ
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionAMPLILINK software, For use with COBAS® AmpliPrep instrument, COBAS® TaqMan® analyzer, COBAS® TaqMan® 48 analyzer, COBAS® AMPLICOR® analyzer, and Cobas p 630 instrument AMPLILINK software is used to integrate all instruments and analyzers offering a single user interface for PCR testing.
Code InfoAMPLILINK version 3.3 and 3.2
ClassificationClass II
Reason for RecallSymantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which is a software product for accessing PCs remotely. The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on. The following Roche products are potentially affected by this issue: AMPLILINK Data Station, MagNA Pure LC, MagNA Pure 96 Instrument IVD, LightCycler 1.2 Instrument, LightCycler 2.0 Instrument, cobas 8000, Instrument Manager, DataCare GM, DataCare POC and COBAS INTEGRA 400/400+ .
Product Quantity884 units
Recall NumberZ-0484-2013
Product DescriptionRoche Applied Science MagNA Pure LC Version 3.0. The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials.
Code InfoMagNA Pure LC version 3.0
ClassificationClass II
Reason for RecallSymantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which is a software product for accessing PCs remotely. The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on. The following Roche products are potentially affected by this issue: AMPLILINK Data Station, MagNA Pure LC, MagNA Pure 96 Instrument IVD, LightCycler 1.2 Instrument, LightCycler 2.0 Instrument, cobas 8000, Instrument Manager, DataCare GM, DataCare POC and COBAS INTEGRA 400/400+ .
Product Quantity816 units
Recall NumberZ-0485-2013
Product DescriptionRoche MagNA Pure 96 System Version 1.0 (Software Version 2.0) for in vitro diagnostic use. The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instrument. There are no corresponding assays.
Code InfoRoche MagNA Pure 96 System Version 1.0 (Software Version 2.0)
ClassificationClass II
Reason for RecallSymantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which is a software product for accessing PCs remotely. The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on. The following Roche products are potentially affected by this issue: AMPLILINK Data Station, MagNA Pure LC, MagNA Pure 96 Instrument IVD, LightCycler 1.2 Instrument, LightCycler 2.0 Instrument, cobas 8000, Instrument Manager, DataCare GM, DataCare POC and COBAS INTEGRA 400/400+ .
Product Quantity13 units
Recall NumberZ-0486-2013
Product DescriptionRoche Molecular Biochemicals LightCycler 1.2 with software version 3.5. LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis
Code InfoRoche Molecular Biochemicals LightCycler 1.2 with software version 3.5.
ClassificationClass II
Reason for RecallSymantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which is a software product for accessing PCs remotely. The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on. The following Roche products are potentially affected by this issue: AMPLILINK Data Station, MagNA Pure LC, MagNA Pure 96 Instrument IVD, LightCycler 1.2 Instrument, LightCycler 2.0 Instrument, cobas 8000, Instrument Manager, DataCare GM, DataCare POC and COBAS INTEGRA 400/400+ .
Product Quantity3,772 units
Recall NumberZ-0487-2013
Product DescriptionRoche LightCycler 2.0 Instrument with software version 4.1. LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis.
Code InfoRoche LightCycler 2.0 Instrument with software version 4.1.
ClassificationClass II
Reason for RecallSymantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which is a software product for accessing PCs remotely. The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on. The following Roche products are potentially affected by this issue: AMPLILINK Data Station, MagNA Pure LC, MagNA Pure 96 Instrument IVD, LightCycler 1.2 Instrument, LightCycler 2.0 Instrument, cobas 8000, Instrument Manager, DataCare GM, DataCare POC and COBAS INTEGRA 400/400+ .
Product Quantity1,213 units
Recall NumberZ-0488-2013
Product Descriptioncobas® 8000 modular analyzer series The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests.
Code Infocobas® 8000 modular analyzer series
ClassificationClass II
Reason for RecallSymantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which is a software product for accessing PCs remotely. The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on. The following Roche products are potentially affected by this issue: AMPLILINK Data Station, MagNA Pure LC, MagNA Pure 96 Instrument IVD, LightCycler 1.2 Instrument, LightCycler 2.0 Instrument, cobas 8000, Instrument Manager, DataCare GM, DataCare POC and COBAS INTEGRA 400/400+ .
Product Quantity77 units
Recall NumberZ-0489-2013
Product Descriptioncobas® Integra 400/400 Plus (Software version 3.4) The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.
Code Infocobas® Integra 400/400 Plus (Software version 3.4)
ClassificationClass II
Reason for RecallSymantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which is a software product for accessing PCs remotely. The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on. The following Roche products are potentially affected by this issue: AMPLILINK Data Station, MagNA Pure LC, MagNA Pure 96 Instrument IVD, LightCycler 1.2 Instrument, LightCycler 2.0 Instrument, cobas 8000, Instrument Manager, DataCare GM, DataCare POC and COBAS INTEGRA 400/400+ .
Product Quantity855 units.
Recall NumberZ-0490-2013
Product DescriptionDataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.
Code InfoInstrument Manager version 8.04.
ClassificationClass II
Reason for RecallSymantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which is a software product for accessing PCs remotely. The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on. The following Roche products are potentially affected by this issue: AMPLILINK Data Station, MagNA Pure LC, MagNA Pure 96 Instrument IVD, LightCycler 1.2 Instrument, LightCycler 2.0 Instrument, cobas 8000, Instrument Manager, DataCare GM, DataCare POC and COBAS INTEGRA 400/400+ .
Product Quantity1,015 units
Recall NumberZ-0491-2013
Product DescriptionDataCare GM DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
Code InfoDataCare GM
ClassificationClass II
Reason for RecallSymantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which is a software product for accessing PCs remotely. The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on. The following Roche products are potentially affected by this issue: AMPLILINK Data Station, MagNA Pure LC, MagNA Pure 96 Instrument IVD, LightCycler 1.2 Instrument, LightCycler 2.0 Instrument, cobas 8000, Instrument Manager, DataCare GM, DataCare POC and COBAS INTEGRA 400/400+ .
Product Quantity479 units
Recall NumberZ-0492-2013
Product DescriptionDataCare POC  is an information management system that provides data management functionality for managing point-of -care testing data.
Code InfoDataCare POC
ClassificationClass II
Reason for RecallSymantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which is a software product for accessing PCs remotely. The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on. The following Roche products are potentially affected by this issue: AMPLILINK Data Station, MagNA Pure LC, MagNA Pure 96 Instrument IVD, LightCycler 1.2 Instrument, LightCycler 2.0 Instrument, cobas 8000, Instrument Manager, DataCare GM, DataCare POC and COBAS INTEGRA 400/400+ .
Product Quantity126 units
Recall NumberZ-0493-2013

Class II Biologics Event

Event ID63324
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPlatelets Pooled Leukocytes Reduced Irradiated
Code InfoW036810810072;
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-0138-13
Product DescriptionFresh Frozen Plasma
Code InfoW036810133837;
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-0139-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW036810133837;
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-0140-13

Class II Biologics Event

Event ID63325
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW036812378958;
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-0208-13
Product DescriptionFresh Frozen Plasma
Code InfoW036812378958;
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-0209-13

Class II Biologics Event

Event ID63376
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Aug-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBiomat USA, Inc.
CityEverett
StateWA
CountryUS
Distribution PatternSpain
 

Associated Products

Product DescriptionSource Plasma
Code Info0130197454; 0130197627; 0130198664; 0130199217; 0130200183; 0130200684; 0130201542; 0130202069; 0130202716; 0130203363; 0130203497; 0130204401; 0130204924; 0130205769; 0130206292; 0130207083; 0130207418; 0130208006; 0130208347; 0130209547; 0130210067; 0130210650; 0130211189; 0130211872; 0130212389;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity25
Recall NumberB-0210-13

Class II Biologics Event

Event ID63377
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBiomat USA, Inc.
CitySan Antonio
StateTX
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info0640291398;
ClassificationClass II
Reason for RecallBlood product, collected from a deferred donor due to risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Product Quantity1
Recall NumberB-0211-13

Class II Biologics Event

Event ID63399
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Aug-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers, Inc.
CityGainesville
StateFL
CountryUS
Distribution PatternAlabama
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW1151122564178;
ClassificationClass II
Reason for RecallBlood product, which did not meet acceptable product specifications, was distributed.
Product Quantity1
Recall NumberB-0212-13

Class II Devices Event

Event ID63496
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc
CityMalvern
StatePA
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionMAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light
Code InfoPart numbers 7721165, 4787714, 7559375, 10281150, 10281151, 10281152 and 10281183
ClassificationClass II
Reason for RecallA particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 systems.
Product Quantity1315
Recall NumberZ-0515-2013

Class II Devices Event

Event ID63518
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) including Puerto Rico, and the countries of Australia, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Denmark, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Lavenia, South Africa, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United Arab Emirates and Vietnam.
 

Associated Products

Product DescriptionPlum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking; Hospira, Inc., Lake Forest, IL 60045; pump list number 11971, module list numbers 12101, 12102 and 12393; pump list number 11973, module list number 12380; pump list number 12391, module list numbers 12097 and 12680 Product Usage: The Plum A+ Infusion System is a dual-line volumetric infusion pump that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care
Code Infopump list number 11971, module list numbers 12101, 12102 and 12393; pump list number 11973, module list number 12380; pump list number 12391, module list numbers 12097 and 12680; all serial numbers
ClassificationClass II
Reason for RecallThe volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.
Product Quantity
Recall NumberZ-0481-2013
Product DescriptionPlum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature; Hospira, Inc., Lake Forest, IL 60045; pump list number 11005, module list number 11006 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.
Code Infopump list number 11005 and module list number 11006; all serial numbers
ClassificationClass II
Reason for RecallThe volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.
Product Quantity
Recall NumberZ-0482-2013
Product DescriptionPlum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature; Hospira, Inc., Lake Forest, IL 60045; pump list #20679 and 20792, module list number 20677. The Plum A+ Infusion System with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature.
Code Infopump list numbers 20679 and 20792, and module list number 20677; all serial numbers
ClassificationClass II
Reason for RecallThe volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.
Product Quantity
Recall NumberZ-0483-2013

Class II Devices Event

Event ID63530
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmQuasar Bio-Tech, Inc. dba Silver Bay LLC
CitySarasota
StateFL
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) including states of: AZ, CA, CO, FL, GA, HI, ID, IL, KS, MD, MI, MN, MO, NC, NJ, NY, NV, OH, OR, TN, TX, UT, VA, and WA; and countries of: Aruba, Canada, Cayman Islands, China, Estonia, Ireland, Malaysia, New Zealand, Singapore, Sweden, Taiwan, and United Kingdom.
 

Associated Products

Product DescriptionBaby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are labeled in part: "***BABY QUASAR***FOR YOUTHFUL RADIANT SKIN***Skin Rejuvenating System with Sequepulse***Manufactured by: Silver Bay, LLC; Made in the USA, with highest quality components and durable aluminum. Five Year Warranty The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
Code InfoBaby Quasar- Model BQ-101, UPC Code 6 89076290272, Batch # 11253, 11523, 11658, 2382, 13009, 13177, 13186, 13243, 13270, 13306, 13327, 13342, 13459, 13528, 13529, 13635, 13730, 13767. Baby Quasar Pink- Model BQ-101-P, UPC 837654072172, Batch # 11927, 11945, 11989, 11990 12017,12073.
ClassificationClass II
Reason for RecallQuasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved.
Product Quantity7,734 devices total
Recall NumberZ-0517-2013
Product DescriptionQuasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD INCLUDES***QUASAR MD***USER MANUAL***12 VOLT POWER SUPPLY***1 OZ PURE SILK SERUM***Made in the USA.***Five year warranty***" The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
Code InfoQuasar MD- Model QMD-101 UPC Code 837654072196, Batch # 11652, 11727, 2441, 11870, 11884, 11955, 11969, 12005, 12006, 12029, 12057, 13008, 13193, 13199, 13221, 13242, 13271, 13288, 13325, 13514, 13521.
ClassificationClass II
Reason for RecallQuasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved.
Product Quantity7,734 devices total
Recall NumberZ-0518-2013
Product DescriptionQuasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is an infrared LED lamp. The Baby Blue uses blue LED light to be used in combination with the Baby Quasar to treat acne. The Quasar Power Pack is labeled in part: "***BABY QUASAR & BABY BLUE***QUASAR POWERPACK***FOR YOUTHFUL, RADIANT, CLEAR SKIN***SKIN REJUVENATING SYSTEM WITH SEQUEPULSE PLUS ADVANCED ACNE CLARIFYING SYSTEM***Manufactured by: Quasar Biotech, Inc., BPP101 LAB-003-E, ***Made in the USA with highest quality components and durable aluminum. Five Year Warranty.***"
Code InfoQuasar Power Pack- Model BPP-101 UPC Code 837654050170, Batch # 11253, 11523, 11658, 2382, 13009, 13177, 13186, 13243, 13270, 13306, 13327, 13342, 13459, 13528, 13529, 13635, 13730, 13767.
ClassificationClass II
Reason for RecallQuasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved.
Product Quantity7,734 devices total (included in batches identified for the Baby Quasar )
Recall NumberZ-0519-2013

Class II Food Event

Event ID63546
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmCostco Wholesale
CityIssaquah
StateWA
CountryUS
Distribution PatternProduct was distributed in Costco Warehouse stores throughout the United States
 

Associated Products

Product DescriptionCold-Smoked Atlantic Salmon in vacuum packed plastic, labeled in part: "FOPPEN NORWEGIAN SMOKED SALMON SLICES INCLUDES PACKET OF HONEY MUSTARD DILL SAUCE READY TO EAT PEPPERED TRADITIONAL DILL NET WT 12oz / 341g (291g Salmon + 50g Sauce 8 712224 129277***INGREDIENTS SALMON: Atlantic Salmon (Salmo salar), salt, pepper, dill, paprika, parsley, smoke, color added***Manufactured by: Foppen Salmon Daltonstraat 24, 3846 BX HARDERWIJK, The Netherlands***"
Code InfoExpiration dates between 10.1.12 - 10.27.12.
ClassificationClass II
Reason for RecallSalmon was produced in a plant in Greece, owned by Foppen of the Netherlands, where Salmonella was found on one of the lines.
Product Quantity41,601 - 12 ounce packages
Recall NumberF-0823-2013

Class II Devices Event

Event ID63614
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Aug-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMindray DS USA, Inc. d.b.a. Mindray North America
CityMahwah
StateNJ
CountryUS
Distribution PatternNationwide Distribution-USA (nationwide) including the states of WA, IL, FL, MN, SC, NV, MI, TN, PA, LA, NE, TX, and IA.
 

Associated Products

Product DescriptionDPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG),impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM).
Code InfoK092449 DPM 6- p/n 6802F-PA00001 DPM 7 - p/n 6800F-PA00001
ClassificationClass II
Reason for RecallThere is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailable : Full Disclosure, Drug, Hemodynamic Calculations, Renal Calculations, Oxygenation Calculations, and Ventilation Calculations.
Product Quantity124 units
Recall NumberZ-0513-2013

Class II Devices Event

Event ID63680
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRoche Diagnostics Operations, Inc.
CityIndianapolis
StateIN
CountryUS
Distribution PatternNationwide Distribution including NE and AZ.
 

Associated Products

Product DescriptionCobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Gluc, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHB, COHB, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory.
Code InfoPart number: 05169992001 cobas b 123 Fluid Pack COOX, 200 with Lot# 21426121 and Lot# 21426171.
ClassificationClass II
Reason for RecallIt has been determined that cobas b 123 Fluid Pack COOX cuvettes for lot numbers 21426121 and 21426171, exhibit a significant increase in the out-of-box failure rate caused by a change in the thickness in the cuvette layer. Internal investigations found the altered thickness of the cuvette was due to production equipment settings. Cuvettes were produced within specifications, but within the upper limit of the tolerance level which could lead to a significant increase in the out-of box failure rate.
Product Quantity23 units of Fluid Pack COOX, 200 were distributed
Recall NumberZ-0522-2013

Class II Devices Event

Event ID63682
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics, Inc
CityEast Walpole
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and Internationally to the following countries: Argentina Australia Austria Azerbaijan Belgium Bosnia Herzeg. Brazil Canada Chile COLOMBIA Croatia Czech Republic Denmark Egypt Estonia Finland France Germany Greece Hong Kong Hungary Iceland India Indonesia Iran Ireland Italy Japan Kazakhstan Latvia Lithuania Malaysia Mexico Netherlands New Caledonia Norway Oman P.R. China Philippines Poland Portugal Qatar Rep. of Yemen Republic Korea Reunion Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey U.A.E. United Kingdom Uruguay Vietnam
 

Associated Products

Product DescriptionSiemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 02816138 10309045, 10309044 028 Intended Use For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of heart failure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the likelihood of future heart failure.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallOperating range of the ADVIA Centaur systems is 18°C to 30°C (64.4°F to 86.0°F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.
Product Quantity100 test=24291 and 500 test= 9679
Recall NumberZ-0506-2013
Product DescriptionSiemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit 02419937 Ref Kit (US only) 10340081 Intended Use The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur and ADVIA Centaur XP systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage Ill breast cancer.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallOperating range of the ADVIA Centaur systems is 18°C to 30°C (64.4°F to 86.0°F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.
Product Quantity250 test =1678 and 50 test =2660 and Ref. 1196
Recall NumberZ-0507-2013
Product DescriptionSiemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use The ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallOperating range of the ADVIA Centaur systems is 18C to 30°C (64.4°F to 86.0°F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.
Product Quantity250 test=525 and 50 test=12243
Recall NumberZ-0508-2013
Product DescriptionSiemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) 50 Test 06489701 The ADVIA Centaur DHEAS assay is an in vitro diagnostic immunoassay for the quantitative determination of dehydroepiandrosterone sulfate (DHEAS) in human serum and plasma using the ADVIA Centaur and ADVIA Centaur XP systems
Code InfoAll lot codes
ClassificationClass II
Reason for RecallOperating range of the ADVIA Centaur systems is 18C to 30°C (64.4°F to 86.0°F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.
Product Quantity12976
Recall NumberZ-0509-2013
Product DescriptionSiemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended Use For in vitro diagnostic use in the quantitative determination of digitoxin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallOperating range of the ADVIA Centaur systems is 18°C to 30°C (64.4°F to 86.0°F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.
Product Quantity50 test=792 and 250 test=525
Recall NumberZ-0510-2013
Product DescriptionSiemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US only) 09132781 Ref Kit (US only) 00203473 Intended Use For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems.
Code InfoAl lot codes
ClassificationClass II
Reason for RecallOperating range of the ADVIA Centaur systems is 18C° to 30°C (64.4°F to 86.0°F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.
Product Quantity100 Test=27392; 500 test=21045 and Reference Kits=3773
Recall NumberZ-0511-2013
Product DescriptionSiemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test 08838753 50 Test 03009619 Intended Use For in vitro diagnostic use in the quantitative determination of theophylline in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallOperating range of the ADVIA Centaur systems is 18°C to 30°C (64.4°F to 86.0°F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.
Product Quantity50 test=2397 and 250 test= 594
Recall NumberZ-0512-2013

Class II Devices Event

Event ID63694
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLeica Microsystems, Inc.
CityBuffalo Grove
StateIL
CountryUS
Distribution PatternWorldwide Distribution -- USA including Arkansas, California, Florida, Illinois, Maryland, Michigan, Minnesota, Missouri, North Carolina, Oregon, Rhode Island, Tennessee, Texas and Wisconsin, and the country of Canada.
 

Associated Products

Product DescriptionNovocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro staining reagent for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections; Catalog No. RTU-TdT-339; packaged in 7 mL vials; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. RTU-TdT-339 is intended for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
Code InfoCatalog No. RTU-TdT-339, lot numbers 6001845, expiry 2012-11 and 6009645, expiry 2014-04 The recall also included the folowing expired lots: 804804, 804805, 804806, 804809, 804810, 804812
ClassificationClass II
Reason for RecallRTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining intensity.
Product Quantity322 vials
Recall NumberZ-0521-2013

Class II Devices Event

Event ID63709
StatusOngoing
Product TypeDevices
Voluntary/Mandated
Recall Initiation Date09-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Healthcare Inc.
CityAndover
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and Canada.
 

Associated Products

Product DescriptionPhilips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.
Code InfoPIIC 865435 M3140 Information Center Low Acuity 865436 M3150 Information Center Local DB 865417 M3145 Information Center Small NW DB 865418 M3155 Information Center NW DB 865415 M3151 Information Center Client 865421  M3170 Patient Link 865416  M3177 Trend Display 865422  M3140 Upgrade 865423  M3150 Upgrade 865426  M3145 Upgrade 865427  M3155 Upgrade 865424  M3151 Upgrade 865266 - M3140 Information Center Low Acuity 865267  M3150 Information Center Local DB 865269  M3145 Information Center Small NW DB 865268  M3155 Information Center NW DB 865270  M3151 Information Center Client 865274  M3170 Patient Link 865271  M3177 Trend Display 865277  M3140 Upgrade 865278  M3150 Upgrade 865281  M3145 Upgrade 865282  M3155 Upgrade 865279  M3151 Upgrade PIIC iX 866023  IntelliVue Info Center iX 866117  PIIC Classic Upgrade 866027  PIIC iX HW Upgrade
ClassificationClass II
Reason for RecallInternal audio cable may have diminished retention force due to damaged contacts, which could lead to intermittent or loss of audible alarms.
Product Quantity3165
Recall NumberZ-0495-2013

Class II Devices Event

Event ID63723
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBecton Dickinson & Co.
CitySparks
StateMD
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) to international customers in Belgium, India, Japan, South Korea, Thailand and Mexico
 

Associated Products

Product DescriptionBD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds***
Code InfoLot number 2089253
ClassificationClass II
Reason for RecallIn vitro diagnostic test kit was not manufactured according to specifications and may cause false negatives or misidentification of Hemophilus species present in patient specimens.
Product Quantity650 vials
Recall NumberZ-0523-2013

Class II Devices Event

Event ID63728
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmConMed Corporation
CityUtica
StateNY
CountryUS
Distribution PatternWorldwide Distribution - USA including CA , FL, IA, IN, MA, MD, ME, MO, MS, NC, NM, OH, PA, TX. Foreign distribution to Spain, Portugal, Japan and Hungary.
 

Associated Products

Product DescriptionWANG Transbronchial Aspiration Needles Cat. No. MW-222, WANG Cytology Needles, Central or Peripheral Regions, 22 g x 13 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. These are disposable sterile, single-use devices.
Code InfoBegining Lot 1207251, Ending Lot Code 1207251; Beginning Lot Code 1209171, Ending Lot Code 1210151. Lot codes on boxes and packaging contain a lot code in the following form 12 09 17 1 where 12 represents the year (2012), 09 represents the month (September), 17 is the day of the month, and 1 is the Manufacturing Shift Code (1, 2, 3, 4, 5, 6 or 9).
ClassificationClass II
Reason for RecallConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the device will not fit through the instrument channel of a 2.0 mm bronchoscope, it must be replaced with an alternate device and could result in minor inconvenience to the user.
Product QuantityTotal 452
Recall NumberZ-0502-2013
Product DescriptionWANG Transbronchial Aspiration Needles Cat. No. MW-322, WANG Cytology Needles, Central, Mediastinal and Hilar Regions, 22 g x 13 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. These are disposable sterile, single-use devices.
Code InfoBeginning Lot Code 1209171, Ending Lot Code 1210101. Lot codes on boxes and packaging contain a lot code in the following form 12 09 17 1 where 12 represents the year (2012), 09 represents the month (September), 17 is the day of the month, and 1 is the Manufacturing Shift Code (1, 2, 3, 4, 5, 6 or 9).
ClassificationClass II
Reason for RecallConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the device will not fit through the instrument channel of a 2.0 mm bronchoscope, it must be replaced with an alternate device and could result in minor inconvenience to the user.
Product QuantityTotal 452
Recall NumberZ-0503-2013
Product DescriptionWANG Transbronchial Aspiration Needles Cat. No. SW-121, WANG Cytology Needles, Central, Carinal and Mediastinal Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. These are disposable sterile, single-use devices.
Code InfoBegining Lot 11207241, Ending Lot Code 1207251; Beginning Lot Code 1209171, Ending Lot Code 1210081. Lot codes on boxes and packaging contain a lot code in the following form 12 09 17 1 where 12 represents the year (2012), 09 represents the month (September), 17 is the day of the month, and 1 is the Manufacturing Shift Code (1, 2, 3, 4, 5, 6 or 9).
ClassificationClass II
Reason for RecallConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the device will not fit through the instrument channel of a 2.0 mm bronchoscope, it must be replaced with an alternate device and could result in minor inconvenience to the user.
Product QuantityTotal 452
Recall NumberZ-0504-2013
Product DescriptionWANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needles, Central or Peripheral Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. These are disposable sterile, single-use devices.
Code InfoBeginning Lot Code 1209171, Ending Lot Code 1209201. Lot codes on boxes and packaging contain a lot code in the following form 12 09 17 1 where 12 represents the year (2012), 09 represents the month (September), 17 is the day of the month, and 1 is the Manufacturing Shift Code (1, 2, 3, 4, 5, 6 or 9).
ClassificationClass II
Reason for RecallConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the device will not fit through the instrument channel of a 2.0 mm bronchoscope, it must be replaced with an alternate device and could result in minor inconvenience to the user.
Product QuantityTotal 452
Recall NumberZ-0505-2013

Class II Devices Event

Event ID63758
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAdvanced Sterilization Products
CityIrvine
StateCA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of AR, AU, BE, BR, CA, CL, CN, CO, EC, GT, HK, ID, IN, JP, KR, MX, MY, PA, PE, PH, SG, TH, VE, and RU.
 

Associated Products

Product DescriptionSTERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad 100NX Express Cycle Upgrade Kit. 10137 Sterrad 100NX Duo Cycle Upgrade kit. 14325 Cyclesure Challenge Pack Kit. 20103 Sterrad 100NX Test Pack Kit. 20228 Sterrad 100NX Intl Validation Kit. 20229 Sterrad 100NX Validation Kit, USA. 20232 Sterrad 50/100S Validation Kit. 20236 Sterrad 50/100S Validation Kit. 20248 Sterrad 100NX Express Validation Kit. 20253 Sterrad NX Validation Kit. 20254 Sterrad NX Validation Kit Domestic, US. The Sterrad Cyclesure 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilization System cycles.
Code InfoLot: 225117 337117 295117 334117 227117 338117 296117 326117 227118 264117 300117 327117 230117 265117 301117 330117 233117 266117 302117 331117 235117 267117 310117 331118 235118 268117 311117 332117 237117 269117 312117 335117 239117 270117 313117 341111 241117 273117 314117 343111 242117 275117 315117 348111 243117 277117 316117 350111 244117 278117 317117 245117 280117 318117 246117 281117 319117 249117 282117 321111 253117 283117 321117 255117 284117 322111 257117 285117 322117 259117 287117 323111 261117 289117 323117 263117 291117 324117 333117 292117 325111 334111 294117 325117 336111 357111 333111 04581Z 07781Z 10081Z 14881Z 04681Z 07482Z 10082Z 14981Z 04781Z 07981Z 10381Z 15081Z 04981Z 07881Z 10981Z 15281Z 05081Z 07581Z 10881A 15681Z 05281Z 08181Z 10581Z 15781Z 05181Z 07381Z 10681A 15881Z 05681Z 08481Z 10181Z 15981A 05781Z 08081Z 10281Z 15481Z 05981Z 08281Z 10282A 16381Z 05782Z 08482Z 11281Z 16481Z 06081Z 08581Z 10882Z 16881Z 06181Z 08582Z 11381Z 16181A 06182Z 08681Z 11081A 16581Z 05381Z 08682Z 11082Z 16981Z 05881Z 08781Z 11481Z 17081Z 05982Z 08881A 11681Z 17281A 06381Z 08981Z 12081Z 17581Z 06481Z 07782Z 12181Z 17781A 06482Z 09181Z 12381Z 17981A 06581Z 09281Z 12881Z 17681Z 06681Z 09282Z 13081Z 18281A 06682Z 08782A 13381Z 18581Z 06882Z 09481Z 13581Z 18981Z 06781Z 09381Z 12781Z 19081Z 06881Z 09482Z 13681Z 19181A 07081Z 09581Z 13881Z 19381A 07181Z 09881Z 14081Z 18381Z 07182Z 09981Z 14281Z 19681Z 07481Z 09982Z 14381Z 19781A 19881Z 26081Z 31581Z 02891Z 19981A 26381Z 31681Z 03091Z 20381A 26781Z 31881Z 03491Z 20481A 26881Z 31981Z 03591A 20581A 27081Z 32281Z 03791Z 21381Z 27381Z 32381Z 04091Z 21481A 27481Z 32581Z 04191Z 21881A 27581Z 32981Z 04391Z 21081A 27781Z 33081Z 04491Z 21281A 28181Z 33681Z 04991Z 22081A 28281Z 33781Z 05091Z 20681A 28381Z 33981Z 05191A 22181Z 28481Z 34081Z 05591Z 22481Z 28781A 34381Z 05691Z 22581A 28981Z 35081Z 05891Z 22781Z 29081Z 35181Z 06191Z 22881A 29181Z 35381Z 06291Z 23181A 29481Z 35481Z 06491Z 23381Z 29581Z 35581Z 06891Z 23481Z 29681Z 35781Z 06591Z 23581Z 29781Z 00591Z 06991Z 23981Z 30181Z 00691Z 07191Z 24081A 30281A 00891Z 07291A 24781Z 29881Z 00991Z 07591A 24981Z 30381Z 01219Z 07791A 25281Z 30481Z 01419Z 07891Z 25481Z 30881Z 01691Z 07991Z 25581Z 30981A 01991Z 08391A 25981Z 31081Z 02691Z 08491A 26281Z 31281Z 02791Z 08591A 08991Z 14691Z 26691Z 32091Z 09091A 14791Z 19491Z 32191Z 09291Z 14991A 19891Z 32291Z 09391Z 15291A 26791Z 32391Z 09691A 15491A 19191Z 32491Z 09891A 15591A 19691A 32791A 09991A 15991Z 27191Z 32891Z 10491A 16191Z 27291Z 32991A 10091A 16391Z 27591Z 33491Z 10791Z 16791Z 27891Z 33591Z 11091Z 16891Z 28091Z 33791Z 11191Z 17091Z 28191Z 341091 11391A 17491A 28591Z 342091 11791Z 17691Z 28791Z 343091 11491Z 17791Z 28891Z 344091 11991Z 18191A 29391Z 345091 10591Z 18391A 29491Z 348091 12091A 18791Z 29691A 349091 12191A 18991Z 29991Z 351091 12491A 23191A 30191A 352091 12691Z 23291A 30391Z 355091 12791Z 23391Z 30691Z 356091 12891Z 23691A 30791Z 004101 13191A 23791Z 30891Z 005101 13192A 23891Z 30991Z 007101 13491Z 25491Z 31391Z 008101 13591A 24791Z 31491Z 011101 13991Z 25791Z 31191Z 012101 14091Z 25991Z 31591Z 013101 14291Z 26491Z 31691Z 014101 015101 048101 069102 140107 015107 048107 069107 144107 018101 049101 070101 145107 019101 049102 071101 147107 020117 050101 071102 153107 021101 053101 074101 156107 021107 054101 074102 158107 022101 055101 075101 166107 023101 055102 076101 168107 025107 055107 076107 169107 026101 056101 077101 173107 027101 057101 078101 175107 028101 057102 078102 176107 028107 057107 081101 177107 029101 058101 082101 179107 032101 060101 082102 180107 032107 060102 083101 181107 034101 061101 084101 187107 034107 061117 088101 195107 035101 062102 092107 196107 035117 063101 097107 198107 037101 063107 102107 199107 039101 064101 106107 201107 040101 064102 110107 202107 041101 066117 113107 207107 041102 067101 117107 208107 042101 067107 127107 209107 042107 068101 131107 210107 043101 068102 136107 211107 047101 069101 137107 214107 215107 264107 273107 314107 216107 265107 277107 315107 217107 263107 278107 309107 221108 266107 279107 316107 223107 267107 280107 318107 224107 270107 281107 320107 225107 272107 285107 321107 228107 273107 286107 181107 229107 277107 168107 322107 230107 278107 287107 335107 231107 279107 288107 340107 232107 280107 166107 341107 235107 281107 291107 342107 236107 285107 169107 343107 236117 286107 173107 343108 237107 287107 175107 337107 238107 288107 176107 345107 242107 291107 177107 349107 244107 295107 179107 349108 245107 300107 295107 350107 250107 301107 300107 347108 244108 302107 301107 351107 250108 303107 303107 354107 251107 305107 302107 347107 252107 306107 305107 352107 254107 307107 306107 361107 257107 308107 307107 362107 253107 312107 308107 364107 255107 313107 312107 003117 257108 314107 313107 004117 005118 053117 089117 131117 214117 006117 055117 090117 132117 216117 010117 045117 094117 133117 217117 011117 058117 091117 136117 218117 012117 050117 092117 137117 220117 013117 054117 095117 138117 221117 014117 059117 096117 139117 222117 016117 356107 097117 140117 223117 187107 060117 098117 141117 224117 020118 061117 099117 143117 228117 021117 062117 101117 134117 024117 063117 102117 144117 025117 065117 103117 145117 027117 069117 104117 146117 026117 069118 105117 147117 031117 070117 106117 151117 032117 076117 108117 152117 034117 074117 109117 153117 036117 075117 110117 154117 038117 077117 112117 156117 035118 078117 115117 157117 039117 080117 116117 159117 040117 081117 117117 160117 042117 081118 118117 161117 041117 082117 123117 172117 020117 083117 125117 173117 043117 085117 126117 177117 047117 084117 121117 175117 048117 087117 124117 179117 049117 088117 129117 181117
ClassificationClass II
Reason for RecallAdvanced Sterilization Products (ASP) is recalling all lots of Sterrad Cyclesure 24 Biological Indicator (BI) manufactured between February 2008 and December 2011 because it may not have adequate data to support the entire duration of the labeled shelf-life.
Product Quantity38,532 units
Recall NumberZ-0520-2013

Class III Veterinary Event

Event ID62800
StatusCompleted
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Aug-12
Initial Firm Notification of Consignee or Public Visit
Recalling FirmPECO Foods Inc.
CityNewark
StateAR
CountryUS
Distribution PatternArkansas
 

Associated Products

Product DescriptionBulk Broiler Feed labeled as WD-2
Code InfoAll feed distributed from source bin 860 on 08/02/12.
ClassificationClass III
Reason for RecallThe feed contains undeclared Larvadex.
Product Quantity242,420 pounds
Recall NumberV-118-2013

Class III Drugs Event

Event ID62924
StatusCompleted
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Apr-11
Initial Firm Notification of Consignee or Public FAX
Recalling FirmPhysicians Total Care, Inc.
CityTulsa
StateOK
CountryUS
Distribution PatternVA
 

Associated Products

Product DescriptionEnjuvia (synthetic conjugated estrogens, B) tablets, 0.3mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6164-1.
Code Info62QJ, Exp 12/11
ClassificationClass III
Reason for RecallSubpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
Product Quantity5 bottles
Recall NumberD-090-2013
Product DescriptionEnjuvia (synthetic conjugated estrogens, B) tablets, 0.625 mg, 30-count tablets per bottle, Rx only, Mfg. By: Teva Pharmaceuticals USA, Sellersville PA 18960; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6163-1.
Code InfoLot #: 62QI, Exp 01/12; 6DYQ, Exp 08/12
ClassificationClass III
Reason for RecallSubpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
Product Quantity9 bottles
Recall NumberD-091-2013
Product DescriptionEnjuvia (synthetic conjugated estrogens, B) tablets, 0.9mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6165-1.
Code InfoLot # 62QH, Exp 4/12
ClassificationClass III
Reason for RecallSubpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
Product Quantity5 Bottles
Recall NumberD-092-2013

Class III Biologics Event

Event ID63323
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Aug-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross, The
CityTucson
StateAZ
CountryUS
Distribution PatternWest Virginia
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info007GG29014 Part A ; 007GG29014 Partt B;
ClassificationClass III
Reason for RecallBlood products , in which extra amount of red cell preservative solution was added, were distributed.
Product Quantity2
Recall NumberB-0137-13

Class III Food Event

Event ID63620
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmElla's Kitchen
CityMontclair
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionElla's Kitchen yum yummy milk + vanilla baby cookies Net Wt. 3.8 oz (108 g) Ella's Daddy's Company Ella's Kitchen Inc. Montclair, NJ 07042 UPC 845901000526 packaged in a chipboard carton with 12 cookies per box
Code InfoBest By 5/07/2013 and 5/16/2013
ClassificationClass III
Reason for RecallCookies may contain mold.
Product Quantity26,400 retail units
Recall NumberF-0821-2013
Product DescriptionElla's Kitchen yum yummy apple + ginger baby cookies Net Wt. 3.8 oz (108 g) Ella's Daddy's Company Ella's Kitchen Inc. Montclair, NJ 07042 UPC 845901000533 packaged in a chipboard carton with 12 cookies per box
Code InfoBest By 5/16/2013
ClassificationClass III
Reason for RecallCookies may contain mold.
Product Quantity10,700 units
Recall NumberF0822-2013

Class III Food Event

Event ID63844
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmUnified Grocers Inc.
CityCity Of Commerce
StateCA
CountryUS
Distribution PatternNationwide in the US: CA, AK, WA, and OR.
 

Associated Products

Product DescriptionPure Apricot Pecan Flats, 10 units/case, 6oz. UPC 8 73376 00303.
Code InfoAll lot codes
ClassificationClass III
Reason for RecallUnified Grocers is recalling Pure Apricot Pecan Flats because it may contain undeclared sulfites.
Product Quantity2120 units
Recall NumberF-0806-2013

Mixed Classification Biologics Event

Event ID49613
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Jul-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityLittle Rock
StateAR
CountryUS
Distribution PatternAR, CA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info55F16132
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed
Product Quantity1 component
Recall NumberB-0075-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info55F16132
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed
Product Quantity1 component
Recall NumberB-0076-13

Mixed Classification Biologics Event

Event ID63263
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross, Penn-Jersey Region
CityPhiladelphia
StatePA
CountryUS
Distribution PatternPennsylvania; California
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info22FX86182;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0133-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info22FX86182;
ClassificationClass III
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0134-13
-
-