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U.S. Department of Health and Human Services

Enforcement Report - Week of January 2, 2013

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Class I Devices Event

Event ID63123
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternWorldwide Distribution - USA, including DC and the states of AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IN, IL, KY, KS, LA, MA, MD, ME, MI, MN, MO,MS, MT, NC, NE, NJ, NM, NY, NV, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Albania, Australia, Austria, Bahrain, Bangladesh, Belgium, Canada, China, Czech Rep., Egypt, Finland, France, Germany, Great Britain, Greece, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, S. Korea, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and Arab Emirates,
 

Associated Products

Product DescriptionGE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask, Size 1, Lot 1981713 *** Ohmeda Medical, A Division of Datex-Ohmeda, Inc. A General Electric Company Laurel, MD 20723 USA MADE IN USA*** Provides the basic equipment required for pulmonary resuscitation of infants.
Code Info7742443, 7785387, 7860461, 7875369, 7909560, and 8145199.
ClassificationClass I
Reason for RecallDisposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check out procedure.
Product Quantity209,805 circuits
Recall NumberZ-0606-2013

Class I Food Event

Event ID63658
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Nov-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSpence & Co., Ltd.
CityBrockton
StateMA
CountryUS
Distribution PatternFL,NC, GA ,NJ, NY ,VA, OH, NV,OK,KY, TN, CO, IL, MA ,MO, RI,VT, NH ,ME, SC, IN, MI
 

Associated Products

Product DescriptionSpence & Co New York-Style Nova Lox 4oz , refrigerated Spence & Co Smoked Salmon Trimmings, 2lb bulk (bag)
Code InfoCode: 9720704
ClassificationClass I
Reason for RecallProduct contaminated with Listeria monocytogenes
Product Quantity1563 units (4 oz) ; 25 (2Lb)
Recall NumberF-0853-2013

Class I Devices Event

Event ID63683
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmZimmer, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) including states of: AR, AZ, CA, CO, CT, DC, FL, GA, ID, LA, MD, MI, MN, MO, NC, NV, NY, OH, OK, PA, TN, TX, WI, and WV; and countries of: Australia, El Salvador, France and Singapore.
 

Associated Products

Product DescriptionArdis Interbody System Inserter The Ardis Inserter is intended for delivery of the Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the gold and silver knobs of the inserter to thread the shaft securely to the implant. Once the implant is inserted into the disc space and its position confirmed radiographically, the inserter is removed from the implant by turning the knobs counterclockwise to loosen and unthread the shaft from the implant.
Code InfoArdis Inserter, Part number: 3256-01 Lot numbers - 52ZW, 50CL, 53BB, 55AB, 580S, 580T, 60JY, 60JZ, 62KP, 63HJ, 64EY, 68AX, 71JE, and 75LE
ClassificationClass I
Reason for RecallThe Ardis System implant may break when excessive lateral forces are applied to the implant during insertion using the Ardis Inserter. Zimmer Spine has received complaint reports at a 0.47% occurrence rate associated with this issue (data from a 54 month monitoring period).
Product Quantity315
Recall NumberZ-0594-2013

Class I Food Event

Event ID63697
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Oct-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmGolub Corp
CitySchenectady
StateNY
CountryUS
Distribution PatternWorcester, MA
 

Associated Products

Product DescriptionCMC Pumpkin Coffee Cake 16 oz UPC: 041735225726 Price Chopper/Box
Code InfoUPC # 41735-225726 expiration date between October 17 and October 25, 2012
ClassificationClass I
Reason for RecallCMC Cinnamon Coffee Cake was incorrectly labeled as Pumpkin Coffee Cake and therefore did not list walnuts as an ingredient
Product Quantity9 cakes
Recall NumberF-0852-2013

Class I Devices Event

Event ID63729
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPraxair Inc.
CityDanbury
StateCT
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and countries of: Brazil, Canada, China, Columbia, Costa Rica, India, Paraguay and Uruguay.
 

Associated Products

Product DescriptionPraxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pressure in oxygen-containing cylinder.
Code InfoOX M-AEGNGVNTG (US and Canada) and WESPRX-9500 (Global) Cyclinders in service since Jan 2009. Units with a "T" decal (T-teflon) on the fill side of the valve have the rework completed.
ClassificationClass I
Reason for RecallIsolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwise subject to significant physical impact.
Product Quantity320,451 units (255,690 US ; 55,884 Canada; 8877 OUS)
Recall NumberZ-0525-2013

Class I Food Event

Event ID63870
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Dec-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmTaylor Farms Retail, Inc.
CitySalinas
StateCA
CountryUS
Distribution PatternCA and FL
 

Associated Products

Product DescriptionTaylor Farms Hearts of Romaine Lettuce, All Natural, Fresh Hand Selected, Triple Washed and Ready to Enjoy. 10 oz. bags. Taylor Farms, Salinas, CA. UPC 0 30223 04032 3
Code InfoCode TFRS 332A09; Best By 12-13-12 06:51 B
ClassificationClass I
Reason for RecallPositive IEH sample of Listeria Monocytogenes found in Taylor Farms Hearts of Romaine
Product Quantity101 cases, 6 x 10 oz packages per case.
Recall NumberF-0854-2013

Class II Biologics Event

Event ID39116
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Apr-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Bank of Lancaster County Medical Society
CityLincoln
StateNE
CountryUS
Distribution PatternNE
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info3743751- part 1, 3743751- part 2
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity2 units
Recall NumberB-0268-13

Class II Biologics Event

Event ID39526
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Dec-04
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAmerican National Red Cross
CitySalt Lake City
StateUT
CountryUS
Distribution PatternIdaho, Montana, and Utah and California
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info20FC26689; 20J98938; 20LE04227; 20LE04232; 20LY55656
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity5 units
Recall NumberB-0244-13

Class II Biologics Event

Event ID39982
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Apr-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center of the Ozarks
CitySpringfield
StateMO
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionRed Blood Cells
Code Info6557165
ClassificationClass II
Reason for RecallBlood product, which did not meet the acceptable product specifications, was distributed.
Product Quantity1 unit
Recall NumberB-0304-13

Class II Biologics Event

Event ID40903
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Sep-05
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAmerican National Red Cross (The)
CityPortland
StateOR
CountryUS
Distribution PatternOregon and California
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info21FS42335
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of Hepatitis A, were distributed.
Product Quantity1 unit
Recall NumberB-0229-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info21FS42335
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of Hepatitis A, were distributed.
Product Quantity1 unit
Recall NumberB-0230-13

Class II Biologics Event

Event ID41190
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Oct-05
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAmerican National Red Cross
CityPortland
StateOR
CountryUS
Distribution PatternOregon and Ohio
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info21FV07851
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of Hepatitis, were distributed.
Product Quantity1 unit
Recall NumberB-0242-13
Product DescriptionPlasma Frozen
Code Info21FV07851
ClassificationClass II
Reason for RecallBlood products, collected from a donor with a history of Hepatitis, were distributed.
Product Quantity1 unit
Recall NumberB-0243-13

Class II Biologics Event

Event ID41936
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Mar-06
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAmerican National Red Cross
CityPortland
StateOR
CountryUS
Distribution PatternFlorida, Oregon, and Washington
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info21LH29445
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity1 unit
Recall NumberB-0232-13
Product DescriptionCryoprecipitated AHF, Pooled
Code Info21LH29445
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity1 unit
Recall NumberB-0233-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info21LH29445
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity1 unit
Recall NumberB-0234-13

Class II Biologics Event

Event ID42883
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Aug-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Bank of Lancaster County Medical Society
CityLincoln
StateNE
CountryUS
Distribution PatternNY
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info9121046
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity1 unit
Recall NumberB-0272-13

Class II Biologics Event

Event ID43037
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Sep-06
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmInternational BioResources, LLC
CityColorado Springs
StateCO
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionSource Plasma
Code Info366020863; 366020554; 366009883; 366009338; 366008981; 366007812; 366007488; 366006391; 366006082; 366004975; 366004698; 366000802; 366000830
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity13 units
Recall NumberB-0305-13

Class II Biologics Event

Event ID43239
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Sep-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Bank of Lancaster County Medical Society
CityLincoln
StateNE
CountryUS
Distribution PatternNJ
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info9122839
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-0271-13

Class II Biologics Event

Event ID44449
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Jan-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityColumbus
StateOH
CountryUS
Distribution PatternOH and PA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info16LK41465
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0239-13
Product DescriptionPlatelets Leukocytes Reduced
Code Info16LK41465
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0240-13
Product DescriptionFresh Frozen Plasma
Code Info16LK41465
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0241-13

Class II Biologics Event

Event ID47179
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jan-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Bank of Lancaster County Medical Society
CityLincoln
StateNE
CountryUS
Distribution PatternNE
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info3711224; 3705229
ClassificationClass II
Reason for RecallBlood products, which was collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity2 units
Recall NumberB-0306-13

Class II Biologics Event

Event ID47322
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Feb-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center of the Ozarks
CitySpringfield
StateMO
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionPlatelets
Code Info6868490
ClassificationClass II
Reason for RecallBlood product, was not quarantined subsequent to receiving post donation illness information, was distributed.
Product Quantity1 unit
Recall NumberB-0310-13

Class II Biologics Event

Event ID47620
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Feb-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternMissouri and Indiana
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code InfoW045007125365
ClassificationClass II
Reason for RecallBlood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Product Quantity1 unit
Recall NumberB-0311-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info5116010
ClassificationClass II
Reason for RecallBlood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Product Quantity1 unit
Recall NumberB-0312-13

Class II Biologics Event

Event ID48282
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Apr-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code InfoW045007145917
ClassificationClass II
Reason for RecallDonor Screening/Donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked.
Product Quantity1 unit
Recall NumberB-0309-13

Class II Biologics Event

Event ID48537
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Apr-08
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternAustria
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW045007111458
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-0302-13

Class II Biologics Event

Event ID53064
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jun-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBio-Medics
CityProvo
StateUT
CountryUS
Distribution PatternAustria
 

Associated Products

Product DescriptionSource Plasma
Code Info8120001398, 8120001495, 8120001622, 8120001725, 8120001873, 8120001954, 8120002241, 8120002291, 8120002471, 8120002534, 8120002726, 8120002806, 8120003353, 8120003445, 8120003582, 8120003690, 8120003794, 8120003905, 8120004027, 8120004135, 8120004270, 8120004451, 8120004540, 8120004655, 8120004758, 8120004888, 8120004971
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity27 units
Recall NumberB-0308-13

Class II Devices Event

Event ID61212
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jul-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBeckman Coulter Inc.
CityBrea
StateCA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Egypt, El Salvador, Ethiopia, France, Germany, Greece, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Lebanon, Libyan Arab Jamahiriya, Liechtenstein, Macao, Malaysia, Mexico, Netherlands, Nigeria, Pakistan, Panama, Philippines, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zambia.
 

Associated Products

Product DescriptionAccess Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism.
Code Info019818, 021654, 024072
ClassificationClass II
Reason for RecallA recall communication was initiated because Beckman has identified that Access Total T4 calibrator lots 019818, 021654, and 024072 do not meet their 12 month expiration date claim.
Product Quantity6,634 units total (2,742 units in US)
Recall NumberZ-0613-2013

Class II Drugs Event

Event ID62664
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jul-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmLloyd Inc. of Iowa
CityShenandoah
StateIA
CountryUS
Distribution PatternDistribution was nationwide and to Puerto Rico. There was no foreign, military, or government distribution.
 

Associated Products

Product DescriptionThyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Code InfoLot HB23111 and HC23111
ClassificationClass II
Reason for RecallSubpotent; 9-month stability interval
Product Quantity3,789,426/50-mcg. tablets
Recall NumberD-100-2013
Product DescriptionLevothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Code InfoLot 1093992 and 1094095, exp. date 9/2012
ClassificationClass II
Reason for RecallSubpotent; 9-month stability interval
Product Quantity37,441/100-tablet bottles
Recall NumberD-101-2013
Product DescriptionThyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA
Code InfoLot HF23111
ClassificationClass II
Reason for RecallSubpotent; 9-month stability interval
Product Quantity1,924,133/75-mcg. tablets
Recall NumberD-102-2013
Product DescriptionLevothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Code InfoLot 1094098, exp. date 9/2012
ClassificationClass II
Reason for RecallSubpotent; 9-month stability interval
Product Quantity16,548/100-tablet bottles
Recall NumberD-103-2013

Class II Biologics Event

Event ID63194
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternIA
 

Associated Products

Product DescriptionPlasma Frozen within 24 hours (FP24)
Code InfoW044112107840
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-0119-13

Class II Devices Event

Event ID63394
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Medical Systems (Cleveland) Inc
CityCleveland
StateOH
CountryUS
Distribution PatternWorldwide Distribution--US (nationwide) including the states of AR, OH, OR, PA, TX VA & WI., and the countries of Algeria, Australia, Brazil, China, Ecuador, Finland, France, Germany, Hong Kong, India, Italy, Lebanon, Libyan Arab Jamahiriya, Russia, South Korea & United Kingdom
 

Associated Products

Product DescriptionComputed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Code InfoModel #728260, Serial #s, 12876, 13924, 13994, 13996, 14104, 14116, 14677, 14682, 14694, 14695, 14702, 14707, 14710, 14727, 14728, 14730, 14824, 14840, 14926, 14930, 14932, 14940, 15008, 15015, 15017, 15023, 15036, 15081, 15085, 15146, 15329, 15354, 15393, 15397, 15398, 15399, 15400, 15401, 15402, 15403, 15451, 15453, 15550, 15551, 15552, 15553, 15554, 15555, 15556, 15557, 15558, 15559, 15560, 15561, 15562, 15563, 15564, 15565, 15566, 15567, 15568, 15569, 15570, 15571, 15572, 15573, 15574, 15575, 15576, 15577, 15578, 15579, 15580, 15581, 15582, 15583, 15584, 15585, 15586, 15587, 15588, 15589, 15590, 15591, 15592, 15593, 15594, 15595, 15596, 15597, 15598, 15599, 15600, 15601, 15602, 15603, 15604, 15605, 15606, 15607, 15608, 15609, 15610, 15611, 15612, 15613, 15614, 15615, 15616, 15617, 15618, 15619, 15620, 15621, 15622, 15623, 15624, 15625, 15626, 15627, 15628, 15629, 15630, 15631, 15632, 15633, 15634, 15635, 15636, 15637, 15638, 15639, 15640, 15641, 15642, 15643, 15644, 15645, 15646, 15647, 15648, 15649, 15650, 15651, 15652, 15653, 15654, 15655, 15656, 15657, 15658, 15659, 15660, 15661, 15662, 15663, 15664, 15665, 15666, 15667, 15668, 15669, 15670, 15671, 15672, 15673, 15674, 15675, 15676, 15677, 15678, 15679, 15680, 15681, 15682, 15683, 15684, 15685, 15686, 15687, 15689, 15690, 15691, 15692, 15694, 15695, 15696, 15697, 15698, 15699, 15700, 15701, 15702, 15703, 15704, 15705, 15706, 15707, 15708, 15709, 15710, 15711, 15712, 15713, 15714, 15715, 15716, 15717, 15718, 15719, 15720, 15721, 15722, 15723, 15724, 15725, 15726, 15727, 15728, 15729, 15730, 15731, 15732, 15734, 15735, 15736, 15737, 15753, 15754, 15755, 15756, 15757, 15758, 15760, 15761, 15762, 15763, 15764, 15765, 15766, 15767, 15768, 15770, 15771, 15772, 15800, 15801, 15802, 15803, 15804, 15805, 15806, 15807, 15808, 15809, 15810, 15811, 15812, 15813, 15814, 15818, 15820, 15821, 15826, 15827, 15828, 15829, 15830, 15831, 15832, 15834, 15835 & 15900.
ClassificationClass II
Reason for RecallPhilips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to software version 4.5.5. The update will provide a number of improvements to address nonhazardous reliability issues which will improve the overall quality and functionality of the EBW.
Product Quantity265 units
Recall NumberZ-0479-2013

Class II Devices Event

Event ID63457
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Howmedica Osteonics Corp.
CityMahwah
StateNJ
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) including states of: AL, CO, CT, IL, IN, MO, MS, NC, NJ, NY, OR,and TX; and countries of: Australia, Canada, France, Spain and United Kingdom.
 

Associated Products

Product DescriptionStryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is designed to treat complex fractures in Humeral, Femoral, Tibial and Ankle applications. The Teflon Tube is an optional instrument used to exchange the Ball Tip Guide Wire with the Smooth Tip Guide Wire once reaming is completed. Stryker Stryker Trauma GmbH 24232 Schonkirchen, Germany distributed in USA by: Howmedica Osteonics Corp., 235 Corporate Drive,
Code InfoCatalog No: 1806-0073S Lot Code:123596
ClassificationClass II
Reason for RecallDuring the manufacturing of the affected lot a manufacturing error has led to embrittlement of the tube material of the T2 Humerus Teflon Tube.
Product Quantity100 units (73 units US; 27 units OUS)
Recall NumberZ-0610-2013

Class II Devices Event

Event ID63497
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBrookstone Company, Inc.
CityMerrimack
StateNH
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionBrookstone Heated Body Bean, electrically heated SKU numbers: 734863 (BlNationwide Distributionue), 734864 (Plum), 734865 (Red). Brookstone 3 in 1 wrap ,SKU734397 (Brown). The Products are liquid filled bean shaped pouches that are electrically heated and then detached from the charger prior to use.
Code InfoAll lot codes
ClassificationClass II
Reason for RecallAdditional Warning Statement to prevent burns to the skin
Product Quantity109,956 units
Recall NumberZ-0616-2013

Class II Drugs Event

Event ID63608
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAlara Pharmaceutical Co
CitySan Juan
StatePR
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionLevothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San Juan, PR
Code Info11T7011A, Exp. Date: 12/2012
ClassificationClass II
Reason for RecallSubpotent; 15 month stability
Product Quantity7,432 bottles
Recall NumberD-104-2013

Class II Devices Event

Event ID63632
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBeckman Coulter Inc.
CityBrea
StateCA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the country of Canada.
 

Associated Products

Product DescriptionAccess Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part Numbers: Access  81600; Access 2  81600N, 386220, A69186, A25656, A12900; Access 2 (LXi)  A15642; Access 2 Section, DxC 600i  A25640. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The Synchron LXi and the UniCel DxC 600i are Access systems integrated with a chemistry analyzer.
Code InfoPart Numbers: Access  81600; Access 2  81600N, 386220, A69186, A25656, A12900; Access 2 (LXi)  A15642; Access 2 Section, DxC 600i  A25640
ClassificationClass II
Reason for RecallIt has been determined that, in some cases, pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive shafts. When these defects occur, the pulley may not turn at all, or may turn at an incorrect speed, resulting in inadequate washing or mixing of the contents of the reaction vessel.
Product Quantity6,858 units
Recall NumberZ-0612-2013

Class II Drugs Event

Event ID63656
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmF. Hoffmann-LaRoche Ltd.
CityBasel
State
CountryCH
Distribution PatternNo product distributed in the USA. Bulk product distributed to Switzerland, with further distribution in Europe, Scandinavia, Korea.
 

Associated Products

Product DescriptionCymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Products Limited, Welwyn Garden City, AL7 1TW, United Kingdom
Code Infobulk lot N0019, Expiration Date: 11 2014 Warennummer: 10131968 Chargennummer:NXXXX 2000609D Finished product Lot N0019B01-N0019B12
ClassificationClass II
Reason for RecallLack of Assurance of Sterility; container closure issues with the bulk batch.
Product Quantity42010 vials
Recall NumberD-105-2013

Class II Devices Event

Event ID63676
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGreatbatch Medical
CityMinneapolis
StateMN
CountryUS
Distribution PatternWorldwide Distribution-USA including the states of AL, AK, AZ, ALR, CA, CO, CT, DC, FL, GA, HI, IL IN, IA, KY, MD, MA, MI, MN, MO, NE, NV,NM, NJ, NH, NY, NC, OH, OK OR, PA, RI,SC,SD, TN, TX, UT,VT, VA, WA, and WI, and the countries of AUSTRIA, BELGIUM, SWITZERLAND, GERMANY, DENMARK, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, GREECE, HUNGARY, IRELAND, ISRAEL, ITALY, THE NETHERLAND, NORWAY, SWEDEN, AUSTRALIA, and CANADA
 

Associated Products

Product DescriptionBiosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Code InfoLOT: R1701247 , R1713591 , W2046680 , W2046681 , W2072907 , W2078460 , W2084872 , W2098771 , W2102124 , W2102133 , W2102134 , W2108295 , W2108296 , W2108298 , W2108299 , W2125688 , W2125690 , W2132584 , W2132588 , W2132590 , W2138965 , W2143147 , W2143149 , W2143152 , W2145645 , W2145677 , W2145680 , W2145681 , W2151287 , W2151305 , W2151308 , W2156746 , W2156748 , W2156750 , W2156751 , W2162496 , W2162497 , W2162498 , W2162499 , W2167986 , W2167987 , W2167988 , W2167990 , W2172705 , W2172706 , W2172707 , W2172708 , W2172710 , W2172712 , W2177727 , W2177728 , W2177733 , W2177734 , W2184476 , W2184483 , W2184484 , W2184487 , W2190457 , W2190461 , W2190464 , W2190470 , W2196349 , W2196351 , W2196352 , W2196355 , W2196359 , W2196361 , W2196363 , W2211842 , W2211844 , W2211846 , W2211849 , W2211852 , W2211853 , W2213887 , W2229974 , W2236588.
ClassificationClass II
Reason for RecallGreatbatch Medical observed some anomalies of the inner lumen of the MobiCath Bi-Directional Guiding Sheaths upon implementation of a new visual inspection tool. The anomalies may include loose, string-like liner material, liner abrasion (fraying), and/or attached string-like liner material (from scratches or damage on the inner wall of sheath lumen).
Product Quantity10,201 units
Recall NumberZ-0611-2013

Class II Devices Event

Event ID63803
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Sep-12
Initial Firm Notification of Consignee or Public Other
Recalling Firmsanofi-aventis US, Inc.
CityBridgewater
StateNJ
CountryUS
Distribution PatternWorldwide distribution.
 

Associated Products

Product DescriptionDiamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.
Code Infon/a
ClassificationClass II
Reason for RecallDiamigo, a software application, was released through the i-Phone Global Store which inadvertently allowed global access to the application as opposed to the original intended restriction of access to Brazil.
Product Quantity1600 downloads (140 US; 1460 Foreign)
Recall NumberZ-0609-2013

Class II Devices Event

Event ID63814
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRoche Molecular Systems, Inc.
CityBranchburg
StateNJ
CountryUS
Distribution PatternDistributed in the states of GA, CA, NC, and MN.
 

Associated Products

Product DescriptionCOBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland
Code InfoCAP 394436 to 394663
ClassificationClass II
Reason for RecallCertain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection flagging feature disabled during quality control release resulting in samples that may not be flagged as having clots.
Product Quantity7 units
Recall NumberZ-0614-2013

Class II Devices Event

Event ID63857
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmArjo, Inc. dba ArjoHuntleigh
CityAddison
StateIL
CountryUS
Distribution PatternUSA (nationwide) including the states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Dakota, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming.
 

Associated Products

Product DescriptionFlowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Sweden; Model 512003; a non-invasive prophylaxis system for reducing the incidence of deep vein thrombosis.
Code InfoModel 512003, all serial numbers
ClassificationClass II
Reason for RecallThe Flowtron Trio DVT Pump has been marketed without proper FDA Approval.
Product Quantity2,859 unts
Recall NumberZ-0615-2013

Class III Devices Event

Event ID37530
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Jun-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRadiometer America Inc
CityWestlake
StateOH
CountryUS
Distribution PatternDistributed to KY, NC, and NY.
 

Associated Products

Product DescriptionQualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
Code InfoLot R0040, expiration date February 2008; Lot R0042, expiration date April 2008.
ClassificationClass III
Reason for RecallThe barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 into the analyzer. The insert correctly states that the control range is 7.40-7.45.
Product Quantity840 Ampules
Recall NumberZ-0608-2013

Class III Biologics Event

Event ID47982
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Feb-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW045006066878
ClassificationClass III
Reason for RecallBlood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Product Quantity1 unit
Recall NumberB-0303-13

Class III Biologics Event

Event ID50646
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Dec-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmMercy Medical Center Blood Bank
CitySpringfield
StateMA
CountryUS
Distribution PatternMA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info93GC07180; 93GC07182; 93GC07183; 93GC07184; 93GC07186
ClassificationClass III
Reason for RecallBlood products, collected using a machine for which quality control testing was not performed, were distributed
Product Quantity5 units
Recall NumberB-0307-13

Mixed Classification Biologics Event

Event ID41526
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Dec-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternPA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info30GR14000
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0235-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info30GR14000
ClassificationClass III
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0236-13

Mixed Classification Biologics Event

Event ID41935
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Mar-05
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAmerican National Red Cross
CityPortland
StateOR
CountryUS
Distribution PatternOregon and Florida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info21FJ45454
ClassificationClass II
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0237-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info21FJ45454
ClassificationClass III
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0238-13
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