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U.S. Department of Health and Human Services

Enforcement Report - Week of January 9, 2013

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Class I Food Event

Event ID63657
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Nov-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmFresh Express Incorporated
CitySalinas
StateCA
CountryUS
Distribution PatternAZ, CA, CO, HI, ID, KS, MO, MT, NE, NV, NM, OK, OR, SD, TX, UT, WA and WY.
 

Associated Products

Product DescriptionFresh Express brand, Fresh Spinach, 9 oz.
Code InfoLot #S299B25
ClassificationClass I
Reason for RecallProduct tested positive for Salmonella
Product Quantity6610 units
Recall NumberF-0859-2013

Class I Devices Event

Event ID63794
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Nov-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmFisher & Paykel Healthcare, Ltd.
CityNorth Shore City
State
CountryNZ
Distribution PatternWorldwide Distribution - USA including IL, IN, AR and GA.
 

Associated Products

Product DescriptionFisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
Code InfoLots 110810 and 111020
ClassificationClass I
Reason for RecallFPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the intended ventilation therapy.
Product Quantity200 units total, 26 units US
Recall NumberZ-0621-2013

Class I Food Event

Event ID63816
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Aug-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmGourmet Cuisine, Inc.
CityMesquite
StateTX
CountryUS
Distribution PatternTX only
 

Associated Products

Product DescriptionLa Madeleine Potato Soup, 5 lb clear Cryovac pouches, 4 pouches per case.
Code InfoAll potato soup manufactured 08/09&10/2012. Expiration dates Aug 21 - Oct 21, 2012
ClassificationClass I
Reason for RecallThe potato in the potato soup is treated with sulfites. Sulfites were not declared on the firm's product label.
Product Quantity127 crates
Recall NumberF-0857-2013

Class II Biologics Event

Event ID39106
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Apr-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternIowa; Illinois
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoK42637
ClassificationClass II
Reason for RecallBlood products, for which the quality control testing was incomplete, were distributed.
Product Quantity1 Unit
Recall NumberB-0343-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoK42721;K42646
ClassificationClass II
Reason for RecallBlood products, for which the quality control testing was incomplete, were distributed.
Product Quantity2 Units
Recall NumberB-0344-13

Class II Biologics Event

Event ID39109
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-May-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternMissouri; Iowa; New York
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoK43528; K43528; K43528
ClassificationClass II
Reason for RecallBlood products, for which the quality control testing was incomplete, were distributed.
Product Quantity3
Recall NumberB-0342-13

Class II Biologics Event

Event ID45721
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Sep-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services L.P.
CitySpringfield
StateMO
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info06FMOD0209
ClassificationClass II
Reason for RecallBlood product, identified as unsuitable due to a donor screening deviation, was distributed.
Product Quantity1 unit
Recall NumberB-0347-13

Class II Biologics Event

Event ID49684
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jul-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityLittle Rock
StateAR
CountryUS
Distribution PatternAR
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info55C41646;55C38742;55C36864
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity3 components
Recall NumberB-0341-13

Class II Biologics Event

Event ID50434
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.
CitySpringfield
StateMO
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info08FMOD0324
ClassificationClass II
Reason for RecallBlood product, collected from a donor who did not have a required physical examination, was distributed.
Product Quantity1 unit
Recall NumberB-0346-13

Class II Devices Event

Event ID62413
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHill-Rom, Inc.
CityBatesville
StateIN
CountryUS
Distribution PatternWorldwide Distribution -- US (nationwide) including the states of AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, MA, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OK, OR, PA, TN, TX, UT, WA, WV, and WY., and the country Canada, We have not yet defined our European or International facilities at this time.
 

Associated Products

Product DescriptionLiko Standard Slingbar 450. The Standard Slingbar 450 is a versatile sling bar which can be used for most lifting situations. It can be used with different Liko ceiling and mobile lifts.
Code InfoThe Liko Standard Slingbar 450 accessory has been supplied under multiple product numbers and combined with the sale of mobile lifts. The Standard Slingbar 450 is not serialized and has been distributed between January 1980 and the present. Here are the different Product Numbers in which the Slingbar has been shipped under: Standard Slingbar 450: 20090029, 20190024, 20190041, 31190015, 31290017, 31290043, 3156001, 3156003, 3156007, 3156014, 3156016, 31590043, and 5019013. Packaged with Golvo up to April of 2005: 2000001, 2000003, 2000005, 2000006, 2000007, 2000008, 2000009, 2000009CH, 2000009D, 2000009DK, 2000009EU, 2000009F, 2000009FIN, 2000009J, 2000009N, 2000009NL, 2000009UK, 2000009U5, 2000010, 20000100, 20000100K, 2000010EU, 2000010F, 2000010FIN, 2000010H, 2000010J, 2000010N, 2000010NL, 2000010UK, 200001OU5, 2000050, 2000051, 2000061, IN8000, and IN8061. Packaged with Viking up to December of 2004: 2040003, 2040003L, 2040004, 2040005, 2040006, 2040007, 2040013, 2040014, 2040015, 2040033, 2040034, and 2040035. Packaged with LikoLight up to December of 2004: 2030001 and 2030001H. Packaged with Uno lifts up to present: 2010001, 2010002, 2010003, 2010003D, 2010003EU, 2010003F, 2010003H, 2010003N, 2010003UK, 2010003US, 2010004, 2010004D, 2010004EU, 2010004F, 2010004H, 2010004N, 2010004UK, 2010004US, 2010005, 20100050, 2010005EU, 2010005F, 2010005N, 2010005UK, 2010005U5, 2010011, 2010012, 5E2010004, and 5E2010011. Packaged with Caroli lifts up to present: 5011001.
ClassificationClass II
Reason for RecallLiko/Hill-Rom has received reports from facilities which indicate that serious injuries have been received related to the Standard Sling bar 450. There have been 6 complaints of injury related to the product over the past 32 years (6 out of 838,687,856 estimated patient uses). One of the injuries was associated with a patient during use, four injuries occurred when the slingbar was not in use where someone tripped and fell onto the unit, and one where a child was playing on a lift and was injured when they tried to jump from the lift.
Product Quantity261 units
Recall NumberZ-0622-2013

Class II Drugs Event

Event ID62454
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Jun-12
Initial Firm Notification of Consignee or Public
Recalling FirmMylan LLC.
CityCaguas
StatePR
CountryUS
Distribution PatternNatiowide.
 

Associated Products

Product DescriptionMylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01
Code InfoLots: 3027684 Exp. 5/13, 3027688 Exp. 6/13 & 2002157 Exp. 9/12
ClassificationClass II
Reason for RecallFailed USP Content Uniformity Requirements: OOS result reported on retained samples.
Product Quantity15181 bottles.
Recall NumberD-066-2013

Class II Biologics Event

Event ID63461
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Oct-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Systems Inc/dba United Blood Services
CityMeridian
StateMS
CountryUS
Distribution PatternMississippi; Switzerland
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW0416120040230;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1
Recall NumberB-0285-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW0416120040230;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1
Recall NumberB-0286-13

Class II Biologics Event

Event ID63462
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Aug-11
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternIowa
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW037911147282;
ClassificationClass II
Reason for RecallBlood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed.
Product Quantity1
Recall NumberB-0287-13

Class II Biologics Event

Event ID63463
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Bank Of Delmarva, Inc
CityNewark
StateDE
CountryUS
Distribution PatternDelaware
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW036912222319;
ClassificationClass II
Reason for RecallBlood product, labeled with an incorrect expiration date, was distributed.
Product Quantity1
Recall NumberB-0288-13

Class II Biologics Event

Event ID63474
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Oct-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Centers of the Pacific - Irwin Center
CitySan Francisco
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW117012518302Q; W117012518302Q;
ClassificationClass II
Reason for RecallBlood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell counts, were distributed.
Product Quantity2
Recall NumberB-0290-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW117012326743U; W117012326743U; W117012326743U; W117011507369G; W117011507369G; W1170114535114;
ClassificationClass II
Reason for RecallBlood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell counts, were distributed.
Product Quantity6
Recall NumberB-0291-13

Class II Biologics Event

Event ID63476
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Sep-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045012008969;
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-0292-13

Class II Biologics Event

Event ID63507
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-May-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternIllinois; Florida
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW036810255653; W036810190296;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-0293-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036810814828; W036811813763;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-0294-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036811169821;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0295-13
Product DescriptionFresh Frozen Plasma
Code InfoW036810255653; W036811169821; W036810190296;
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity3
Recall NumberB-0296-13

Class II Biologics Event

Event ID63514
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmSouthern California Permanente Medical Group Blood Donor Ctr
CityDowney
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW071812000498;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who lived in a malarial endemic area, were distributed.
Product Quantity1
Recall NumberB-0297-13
Product DescriptionFresh Frozen Plasma
Code InfoW071812000498;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who lived in a malarial endemic area, were distributed.
Product Quantity1
Recall NumberB-0298-13

Class II Biologics Event

Event ID63515
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Sep-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmSanford Medical Center (blood Bank)
CitySioux Falls
StateSD
CountryUS
Distribution PatternPennsylvania
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW089212004412;
ClassificationClass II
Reason for RecallBlood product, collected from a donor who emigrated from an area considered endemic for malaria, was distributed.
Product Quantity1
Recall NumberB-0248-13

Class II Biologics Event

Event ID63526
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Oct-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources
CityMinneapolis
StateMN
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info5090183875; 5090182331;
ClassificationClass II
Reason for RecallBlood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-0299-13

Class II Drugs Event

Event ID63589
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionEpinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., Lake Forest, IL --- NDC 0409-7241-01
Code InfoLot 100953A, Exp 01OCT2013; Lot 120803A Exp 01DEC2013
ClassificationClass II
Reason for RecallPresence of Particulates; may contain glass particles
Product Quantity361,600/1-mL ampules
Recall NumberD-106-2013

Class II Devices Event

Event ID63602
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Dec-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmStryker Medical Division of Stryker Corporation
CityPortage
StateMI
CountryUS
Distribution PatternWorldwide Distribution - Nationwide and Canada
 

Associated Products

Product DescriptionMedical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg Bed, is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital facilities. The intended user for this product is both Health Care Providers (HCPs: nurses, nurses aides, and medical doctors) and human patients. Lockout features may limit patient accessible controls
Code InfoModel 3002SEX, Serial Number 120315371-120315379
ClassificationClass II
Reason for RecallStryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2012. The affected beds may have been built with brake rings that do not meet specifications, negatively impacting the holding force of the brakes.
Product Quantity9
Recall NumberZ-0628-2013
Product DescriptionMedical Surgical Bed, Model 3005S3EX Medical Surgical Bed The S3" MedSurg Bed, Model 3005 is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital facilities. The intended user for this product is both Health Care Providers (HCPs: nurses, nurses aides, and medical doctors) and human patients. Lockout features may limit patient accessible controls.
Code InfoModel 3005S3EX, Serial Number 120415087 - 120515468,
ClassificationClass II
Reason for RecallStryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2012. may have been built with brake rings that do not meet specifications, negatively impacting the holding force of the brakes.
Product Quantity1004
Recall NumberZ-0629-2013

Class II Devices Event

Event ID63616
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-May-11
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 including OH and GA
 

Associated Products

Product DescriptionDPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.
Code Info510 K K080192 P/N 300BF-PA200002
ClassificationClass II
Reason for RecallThere is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient.
Product Quantitytwo units
Recall NumberZ-0630-2013

Class II Food Event

Event ID63700
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Nov-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmFocus Products Group Llc
CityLincolnshire
StateIL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionCocoa~Latte Hot Drink Maker; an electric hot drink mixer and dispenser with a 32 fl.oz. heating and mixing jar, twist and lock lid, "perfect temperature" feature, mixing paddle, and dripless faucet; Focus Electrics, LLC, West Bend, WI 53095
Code InfoWest Bend brand - model number 65032; Back to Basics brand - model numbers CM300BK, CM300BKL, CM300BLSS, CM300BR, CM300BR-BRL, CM300BRL and CM300W
ClassificationClass II
Reason for RecallThe Cocoa~Latte Hot Drink Maker was manufactured with a small brass metal bushing in the liquid containing vessel that may leach lead.
Product Quantity568,000 units
Recall NumberF-0856-2013

Class II Devices Event

Event ID63719
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Nov-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmCooper Vision Caribbean Corp.
CityJuana Diaz
StatePR
CountryUS
Distribution PatternUS Nationwide, including Puerto Rico, and Canada.
 

Associated Products

Product DescriptionAVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Code Info10447500016006, 10519550007006, 10537500016014
ClassificationClass II
Reason for RecallThe lenses exceeded the acceptance limit for silicone oil residual.
Product Quantity246
Recall NumberZ-0631-2013

Class II Devices Event

Event ID63746
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAbbott Molecular
CityDes Plaines
StateIL
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and internationally to Algeria, Argentina, Australia, Austria, Azerbaijan, Belgium, Bolivia, Brazil, Burkina Faso, Burundi, Cameroon, Canada, Chad, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ethiopia, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Guinea, Haiti, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Mali, Mexico, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam and Zambia
 

Associated Products

Product DescriptionAbbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14 The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories.
Code Infolist 09K14, all serial numbers and all software versions 1.0 - 5.0
ClassificationClass II
Reason for RecallAn issue with the m2000sp Instrument software has been identified whereby, after a series of steps, if changes are made to the control or calibrator information on the Sample Extraction Assay Details screen, the changes are not saved.
Product Quantity215 units - U.S., 693 units - ROW
Recall NumberZ-0634-2013

Class II Devices Event

Event ID63769
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMedtronic Inc. Cardiac Rhythm Disease Management
CitySaint Paul
StateMN
CountryUS
Distribution PatternWorldwide Distribution--USA (nationwide) including the states of AZ, CA, CT, FL, GA, IL IA, MD, MA, MI, MS, NJ, NY, OH, OK, SC, TN, TX and WI. and the countries of CANADA and MALAYSIA.
 

Associated Products

Product DescriptionMedtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers: 0E27R16, 1A30R6, 2493R24, 2493R25, 5D56R5, 5Z93R4, 5Z93R5, 7E64R2, 7J53R2, 7M13R1, 7M14R1, 7N16R, 7P25R1, 7P93R1, 7Q11R1, BB7L63R2, BB7N26R, CB5174R11, CB175R13, CB5Q03R6, CB5Q03R7, CB6C53R6, CB7C15R2, CB7C59R2, CB7C60R2, CB7C74R2, CB7D91R5, CB7E35R2, CB7E38R1, CB7G21R4, CB7L48R1, CB7L72R1, CB7P82R1, HY6U96R2, HY6Y52R2, HY7E87R1, SS7J91R3, SSCB7L48R, SSTL7G78R1,TL5S33R7, TL6VTTR1, TL7B51R1, TL7G20R3, TL7G78R3, TL7R87R1. Sterilized Using Ethylene Oxide, Nonpyrogenic, Assembled in Mexico, Manufacturer Medtronic, Inc, Minneapolis, Mn 55432 Product is used by perfusionists as part of the extracorporeal circuit during cardiopulmonary bypass procedures, and is configured specifically as designated by each customer.
Code InfoPack Model Pack Lot 0E27R16- 11239917 11252800 11264666; 1A30R6- 12132577 12219267; 2493R24- 11187015 11199707 11224309 11227205 11556735; 2493R25- 11646941 11713200 11745242 11813334 11852673 11886412 11990393 12033630 12114699 12178107 12191642 12450856; 5D56R5- 11298229 11357085 11465358 11541270 11601193 11654853 11702415 11745232 11766305 11822320 11838721 11852677 11930380 12024708 12166379 12292156; 5Z93R4- 11713132 11736880 11749958 11766283 11808651 11860604 11878689 11911068 11948473 5Z93R5- 12236493; 12411746 7E64R2- 11933798; 7J53R2- 12172725; 7M13R1- 12168157; 7M14R1- 12349772; 7N16R- 12349786; 7P25R1- 12327801 12449801 12457250; 7P93R1- 12349795 12374420; 7Q11R1- 12344028 12456303; BB7L63R2- 12408737; BB7N26R- 12312571; CB5174R11- 11293051 11315344 11334856 11489271 11745162 11886341 11977682 12019852 12062713 12098852 12139621 12146752 12258941 12277502 12326468 12421465 206110946; CB5175R13- 11292866 11334859 11432873 11442937 12182778 12411655; CB5Q03R6- 11713162 11766245 11787583 11923139 11934952; CB5Q03R7- 12114626; CB6C53R6- 12423767; CB7C15R2- 12411647; CB7C59R2- 11731501; 11813316 11838743 11869767 11908794 11982413 12019907 12146796 12151706 12201727 12292133 12423702; CB7C60R2- 11687047 11724030 11843434 11878672; CB7C74R2- 11895167; CB7D91R5- 11961280 12130493 12146882 12191604 12277455 12411687 12423760; CB7E35R2- 11839101; CB7E38R1- 11843886 11885844 11990360 12105025 12133083 12159400; CB7G21R4- 12032413 12033728 12040524 12083359 12360622; CB7L48R1- 12301694; CB7L72R1- 12155258; CB7P82R1- 12440601; HY6U96R2- 206133995; HY6Y52R2- 11826276; HY7E87R1- 11830948 11898103 11923498 12323794 12435409; SS7J91R3- 12175428; SSCB7L48R- 12120109; SSTL7G78R1 -11986264; TL5S33R7- 12093478; 12139612 12172589 12315375; TL6V77R1- 11217931 11260111; TL7B51R1- 11559097 11622968 11664762 11687063 11712834; TL7G20R3- 12258680 12271138 12360554 TL7G78R3- 12067309; TL7R87R1- 206114578 206145379
ClassificationClass II
Reason for RecallMedtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptible to damage that can compromise product sterility.
Product Quantity1552
Recall NumberZ-0618-2013

Class II Devices Event

Event ID63772
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternWorldwide Distribution -- USA, including Puerto Rico, and the countries of Austria, Australia, Argentina, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Finland, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United Arab Emirates, and Vietnam.
 

Associated Products

Product DescriptionPlum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391 - software version 11.3; d) list 20679 - Hospira MedNet Software e) list 20792 - Hospira MedNet Software; 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 Infolist numbers 11971, 11973, 12391, 20679, and 20792; all serial numbers
ClassificationClass II
Reason for RecallThe door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump.
Product Quantity297,833 units
Recall NumberZ-0624-2013
Product DescriptionPlum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software; Product Usage: The Plum A+3 is a dual-line triple channel volumetric infusion system 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 Infolist numbers 12348, 12618, and 20678; all serial numbers
ClassificationClass II
Reason for RecallThe door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump.
Product Quantity28,599 units
Recall NumberZ-0625-2013
Product DescriptionPlum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.
Code Infolist number 11005; all serial numbers
ClassificationClass II
Reason for RecallThe door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump.
Product Quantity180 units
Recall NumberZ-0626-2013

Class II Drugs Event

Event ID63791
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAbbott Laboratories
CityAbbott Park
StateIL
CountryUS
Distribution PatternUS Nationwide and Puerto Rico
 

Associated Products

Product DescriptionSynthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; ABBOTT LABORATORIES NORTH CHICAGO, IL 60064 U.S.A.
Code InfoLOT # 18262A8 Exp. 09/13
ClassificationClass II
Reason for RecallLabeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
Product Quantity28, 524 bottles
Recall NumberD-107-2013

Class II Food Event

Event ID63802
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCho Fuku Group (usa) Inc
CityEl Monte
StateCA
CountryUS
Distribution PatternCalifornia and Washington
 

Associated Products

Product DescriptionSanh Yuan Preserved Plum Candy (Sweet and Sour Prune), 5 oz (142g)
Code InfoThe manufacturer did not use lot number or code number
ClassificationClass II
Reason for RecallCHO Fuku Group Inc. is recalling Sanh Yuan Preserved Plum Candy (Sweet and Sour Prune) because of unacceptable levels of lead.
Product Quantity430 packs
Recall NumberF-0855-2013

Class II Food Event

Event ID63828
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNatural Organics
CityMelville
StateNY
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionNature's Plus GLUTEN Free SPIRU-TEIN HIGH PROTEIN ENERGY MEAL, S'mores (Flavor), 1.2 OZ. (34g) Packet, Display Box Product No. 95903, Individual Packet Product No. 45905, UPC Code 097467459052. There are 8 foil packets per corrugated display box. --- Serving Size - 1 packet (1.2 oz.).
Code InfoLot /Batch Number 1243522, Best By Date 06/2016
ClassificationClass II
Reason for RecallOne lot of 1.2 oz. packets of Spiru-tein High Protein Energy Meal, S'mores flavor, is labeled as "Gluten Free" but actually contains gluten. Lot 1243522 of the product with Best Buy Date 06 2016 is being recalled.
Product Quantity1,966 individual packets (1.2 oz.)
Recall NumberF-0860-2013

Class II Devices Event

Event ID63838
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHoriba Instruments, Inc dba Horiba Medical
CityIrvine
StateCA
CountryUS
Distribution PatternNationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.
 

Associated Products

Product DescriptionABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry.
Code InfoLot number: 00456-4108
ClassificationClass II
Reason for RecallHoriba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L) were recorded at 280 and 199 U/L without alarm.
Product Quantity66886 units
Recall NumberZ-0632-2013
Product DescriptionPENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and uring.
Code InfoLot number: 00456-4108
ClassificationClass II
Reason for RecallHoriba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L) were recorded at 280 and 199 U/L without alarm.
Product Quantity384 units
Recall NumberZ-0633-2013

Class II Devices Event

Event ID63862
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Mar-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmB. Braun Medical, Inc.
CityAllentown
StatePA
CountryUS
Distribution PatternWorldwide Distribution--US (nationwide) including the states of AL, AZ, NC and TN.
 

Associated Products

Product DescriptionSpace Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole.
Code InfoModel number 8713130 and lot numbers 209, 309, 409, 509, 809, 909, 60939747, 60943679, 60945966, 60948966, 60959578, 60960830, 60962412, 61170378, 5048020067, 5048805107, 5048920117, 5049152127, 5049484028, 5049545028, 5049614028, 5049704038, 5049788048, 5049821048, 5050123058, 5050297068, 5050385078, 5051802039, 5051879039, 5051893059, 5051940049, 5051999049, 5052519099, 5052638099, 5052690109, 5052692109, 5052711109, 5052726119, 5052788119, 5052920119, 5053045129, 5053112010, 5053129129, 5053146010, 5053207010, 5053269020, 5053449020, 5053505030, 5053534040, 5053584030, 5053605040, and 5053645040.
ClassificationClass II
Reason for RecallFirm has become aware of the potential for breakage of the pole clamp locking grids, or rasters, in the Space Pole Clamps.
Product Quantity13,078
Recall NumberZ-0623-2013

Class II Food Event

Event ID63869
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Dec-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNature'S Path Foods Inc
CityBlaine
StateWA
CountryUS
Distribution PatternDistributed to CO, CA, CT, FL, GA, HI, IA, IN, NH, OR, PA, TX, and WA.
 

Associated Products

Product DescriptionHemp Plus Granola. The product is packaged in a 25 lb. container. The UPC is 0 58449 88001 1. The product is labeled in parts: "***HempPlus Granola***INGREDIENTS: Organic rolled oats, organic evaporated cane juice, organic soybean oil, organic brown rice flour, organic flax seeds, organic hemp seed, organic oat syrup solids (organic oat syrups solids, tocopherol, sea salt, organic molasses***25 lb.***Nature's Path Foods, Blaine, WA 98230***www.naturespath.com***".
Code InfoBest Before 2013 June 12; 2013 June 13; 2013 June 14 002 12 261 02:59. This number is explained as: 002: Internal code for Blaine production facility; 12 261: Internal code for year, product manufacturing date based on Julian calendar date (for this case 2012, September 17); 02:59: product packaging time.
ClassificationClass II
Reason for RecallUndeclared almond. Vanilla Almond Granola which contains almonds but it was mis-labeled as Hemp Plus Granola and almond was not declared on label.
Product Quantity2872 cases (25 lb. per case)
Recall NumberF-0858-2013

Class II Devices Event

Event ID63878
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMaquet Inc.
CityWayne
StateNJ
CountryUS
Distribution PatternWorldwide Distribution - USA including AR, GA, SC, TX, TN and internationally to France, United Arab Emirates, Australia, Brazil, Canada, Switzerland, China, Germany, Spain, United Kingdom, Italy, Japan, Sweden, Thailand, Turkey, Serbia, and South Africa.
 

Associated Products

Product DescriptionMaquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt,Germany Used to support the lower extremities immediately before during and after surgery. The extension device is mounted to the YUNO operating table. The product may only be operated by medically trained staff within the OR environment.
Code InfoClass I exempt Device Listing Number A922956
ClassificationClass II
Reason for RecallThere is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.
Product Quantity63 devices
Recall NumberZ-0627-2013

Class II Devices Event

Event ID63915
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSynCardia Systems Inc.
CityTucson
StateAZ
CountryUS
Distribution PatternWorldwide Distribution -- US (nationwide)
 

Associated Products

Product DescriptionCompanion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.
Code Info Serial # Lot# 00067 11/12 00071 11/12 00073 11/12 00076 11/12 00079 11/12 00085 11/12 00086 11/12 00087 11/12 00089 28/12 00091 28/12 00092 28/12 00093 28/12 00094 28/12 00095 28/12 00098 28/12 00099 28/12 00101 28/12 00102 28/12 00103 28/12 00104 28/12 00105 28/12 00106 28/12 00107 28/12 00108 28/12 00109 28/12 00110 28/12 00111 28/12 00112 28/12 00113 28/12 00114 28/12 00115 28/12 00116 28/12 00117 28/12 00118 28/12 00119 28/12 00120 28/12 00121 28/12 00122 28/12 00123 28/12 00124 28/12 00125 28/12 00126 28/12 00127 28/12 00128 28/12 00129 28/12 00130 28/12 00131 28/12 00132 28/12 00133 28/12 00134 28/12 00135 28/12 00136 28/12 00137 28/12 00138 28/12 00139 28/12 00140 28/12 00141 28/12 00142 28/12 00143 28/12 00144 28/12 00145 28/12 00146 28/12 00147 28/12 00148 28/12 00068 11/12 00069 11/12 00070 11/12 00072 11/12 00075 11/12 00077 11/12 00078 11/12 00080 11/12 00081 11/12 00082 11/12 00083 11/12 00084 11/12 00088 11/12 00090 28/12 00096 28/12 00097 28/12 00100 28/12
ClassificationClass II
Reason for RecallSyncardia Systems is recalling the Companion External Batteries used with the Companion 2 Driver System because they may potentially be at risk of thermal events and/or other physical damage such as melting, charring and/or burning.
Product Quantity81 units
Recall NumberZ-0620-2013

Class III Biologics Event

Event ID48856
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-May-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternKansas; Missouri
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW045008906241; W045008906253; W04500905684; W045008905688; W045008900312; W045008906240; W045008906244; W045008906405; W045008906405; W045008903920; W045008905682; W045008905696; W045008906241
ClassificationClass III
Reason for RecallBlood products, which may have been exposed to unacceptable temperatures during storage, were distributed.
Product Quantity13 Units
Recall NumberB-0348-13

Class III Biologics Event

Event ID49169
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Jul-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternMissouri; Kansas; Iowa
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW045008906919; W045008904192; W045008904744; W045008906497; W045008906041; W045008906040; W045008905082; W045008907864; W045008907896; W045008905476
ClassificationClass III
Reason for RecallBlood products, which may have been exposed to unacceptable temperatures during storage, were distributed.
Product Quantity10 Units
Recall NumberB-0349-13

Class III Biologics Event

Event ID49241
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Jun-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmZLB Bioplasma, Inc.
CityTulsa
StateOK
CountryUS
Distribution PatternSwitzerland
 

Associated Products

Product DescriptionSource Plasma
Code Info0141396753,
ClassificationClass III
Reason for RecallBlood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-0345-13

Class III Biologics Event

Event ID63464
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Aug-12
Initial Firm Notification of Consignee or Public Other
Recalling FirmAmerican National Red Cross The
CityPomona
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info06LZ34745;
ClassificationClass III
Reason for RecallBlood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-0289-13

Class III Devices Event

Event ID63825
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Nov-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmHemoCue AB
CityAngelholm
State
CountrySE
Distribution PatternDistributed in the states of FL, MA, CA, OR, NY, NC, MO, ID, IN, KY, PA, TX, OK, IL, GA, KS, and UT.
 

Associated Products

Product DescriptionAnalyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capillary action. The filled cuvette is inserted into the device where the contents of the cuvette are mixed through vibration. Within 90 seconds, the immunochemical reaction is completed and the turbidity is measured photometrically at 610 nm. The albumin concentration is proportional to the turbidity. When the end point is reached, the result is displayed in mg/L. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria.
Code InfoSee serial numbers of affected devices in attachment profided by firm.
ClassificationClass III
Reason for RecallIncorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made from April1 st 2011 and onwards. In addition, a warranty statement was missing in the analyzer package.
Product Quantity48 affected analyzers
Recall NumberZ-0619-2013

Class III Devices Event

Event ID63855
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Mar-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSt Jude Medical Inc
CitySaint Paul
StateMN
CountryUS
Distribution PatternUS Distribution only including the states of FL, KY and OK.
 

Associated Products

Product DescriptionFast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
Code InfoModel no. 406586 Batch no. 3619533
ClassificationClass III
Reason for RecallSt. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve style introducer as indicated on the labeling.
Product Quantity26
Recall NumberZ-0617-2013

Mixed Classification Drugs Event

Event ID63305
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNew England Compounding Center
CityFramingham
StateMA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionMethylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
Code InfoAll Lot codes
ClassificationClass I
Reason for RecallNon-Sterility
Product Quantity23,897 vials
Recall NumberD-108-2013
Product DescriptionMethylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
Code InfoAll lot codes
ClassificationClass I
Reason for RecallNon-Sterility
Product Quantity9062 vials
Recall NumberD-109-2013
Product DescriptionMethylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Code InfoAll lot codes
ClassificationClass I
Reason for RecallNon-Sterility
Product Quantity5130 vials
Recall NumberD-110-2013
Product DescriptionMethylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Code InfoAll lot codes
ClassificationClass I
Reason for RecallNon-Sterility
Product Quantity3822 vials
Recall NumberD-111-2013
Product DescriptionBetamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA
Code InfoAll lot codes
ClassificationClass II
Reason for RecallLack of Assurance of Sterility
Product Quantity
Recall NumberD-112-2013
Product DescriptionBetamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate 8 mg/mL PF Injection, Betamethasone Sodium Phosphate 12 mg/mL PF Injection, manufactured by New England Compounding Center, Framingham, MA
Code InfoAll lot codes
ClassificationClass II
Reason for RecallLack of Assurance of Sterility
Product Quantity
Recall NumberD-113-2013
Product DescriptionBupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA
Code InfoAll lot codes
ClassificationClass II
Reason for RecallLack of Assurance of Sterility
Product Quantity
Recall NumberD-114-2013
Product DescriptionClonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA
Code InfoAll lot codes
ClassificationClass II
Reason for RecallLack of Assurance of Sterility
Product Quantity2747 vials
Recall NumberD-115-2013
Product DescriptionDexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Framingham, MA
Code InfoAll lot codes
ClassificationClass II
Reason for RecallLack of Assurance of Sterility
Product Quantity20 vials
Recall NumberD-116-2013
Product DescriptionGlycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
Code InfoAll lot codes
ClassificationClass II
Reason for RecallLack of Assurance of Sterility
Product Quantity165 vials
Recall NumberD-117-2013
Product DescriptionHyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Code InfoAll lot codes
ClassificationClass II
Reason for RecallLack of Assurance of Sterility
Product Quantity10,865 vials
Recall NumberD-118-2013
Product DescriptionIsovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA
Code InfoAll lot codes
ClassificationClass II
Reason for RecallLack of Assurance of Sterility
Product Quantity7055 vials
Recall NumberD-119-2013
Product DescriptionLidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, Framingham, MA
Code InfoAll lot codes
ClassificationClass II
Reason for RecallLack of Assurance of Sterility
Product Quantity
Recall NumberD-120-2013
Product DescriptionLidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Code InfoAll lot codes
ClassificationClass II
Reason for RecallLack of Assurance of Sterility
Product Quantity3,321 vials
Recall NumberD-121-2013
Product DescriptionOmnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA
Code InfoAll lot codes
ClassificationClass II
Reason for RecallLack of Assurance of Sterility
Product Quantity8919 vials
Recall NumberD-122-2013
Product DescriptionSaline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Code InfoAll lot codes
ClassificationClass II
Reason for RecallLack of Assurance of Sterility
Product Quantity54 vials
Recall NumberD-123-2013
Product DescriptionTriamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Code InfoAll lot codes
ClassificationClass II
Reason for RecallLack of Assurance of Sterility
Product Quantity56,655 vials
Recall NumberD-124-2013
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