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Enforcement Report - Week of January 2, 2013

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Biologics Devices Drugs Food / Cosmetics Veterinary

Class I Devices Event

Event ID	63123
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	GE Healthcare, LLC
City	Waukesha
State	WI
Country	US
Distribution Pattern	Worldwide 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 Description	GE Giraffe and Panda T-Piece Resuscitation System labeled *T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 MaskM1091335 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 Info	7742443, 7785387, 7860461, 7875369, 7909560, and 8145199.
Classification	Class I
Reason for Recall	Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check out procedure.
Product Quantity	209,805 circuits
Recall Number	Z-0606-2013

Class I Food/Cosmetics Event

Event ID	63658
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Nov-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Spence & Co., Ltd.
City	Brockton
State	MA
Country	US
Distribution Pattern	FL,NC, GA ,NJ, NY ,VA, OH, NV,OK,KY, TN, CO, IL, MA ,MO, RI,VT, NH ,ME, SC, IN, MI

Associated Products

Product Description	Spence & Co New York-Style Nova Lox 4oz , refrigerated Spence & Co Smoked Salmon Trimmings, 2lb bulk (bag)
Code Info	Code: 9720704
Classification	Class I
Reason for Recall	Product contaminated with Listeria monocytogenes
Product Quantity	1563 units (4 oz) ; 25 (2Lb)
Recall Number	F-0853-2013

Class I Devices Event

Event ID	63683
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Zimmer, Inc.
City	Warsaw
State	IN
Country	US
Distribution Pattern	Worldwide 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 Description	Ardis 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 Info	Ardis Inserter, Part number: 3256-01 Lot numbers - 52ZW, 50CL, 53BB, 55AB, 580S, 580T, 60JY, 60JZ, 62KP, 63HJ, 64EY, 68AX, 71JE, and 75LE
Classification	Class I
Reason for Recall	The 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 Quantity	315
Recall Number	Z-0594-2013

Class I Food/Cosmetics Event

Event ID	63697
Status	Completed
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Oct-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Golub Corp
City	Schenectady
State	NY
Country	US
Distribution Pattern	Worcester, MA

Associated Products

Product Description	CMC Pumpkin Coffee Cake 16 oz UPC: 041735225726 Price Chopper/Box
Code Info	UPC # 41735-225726 expiration date between October 17 and October 25, 2012
Classification	Class I
Reason for Recall	CMC Cinnamon Coffee Cake was incorrectly labeled as Pumpkin Coffee Cake and therefore did not list walnuts as an ingredient
Product Quantity	9 cakes
Recall Number	F-0852-2013

Class I Devices Event

Event ID	63729
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Praxair Inc.
City	Danbury
State	CT
Country	US
Distribution Pattern	Worldwide distribution: USA (nationwide) and countries of: Brazil, Canada, China, Columbia, Costa Rica, India, Paraguay and Uruguay.

Associated Products

Product Description	Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pressure in oxygen-containing cylinder.
Code Info	OX 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.
Classification	Class I
Reason for Recall	Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwise subject to significant physical impact.
Product Quantity	320,451 units (255,690 US ; 55,884 Canada; 8877 OUS)
Recall Number	Z-0525-2013

Class I Food/Cosmetics Event

Event ID	63870
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Dec-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Taylor Farms Retail, Inc.
City	Salinas
State	CA
Country	US
Distribution Pattern	CA and FL

Associated Products

Product Description	Taylor 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 Info	Code TFRS 332A09; Best By 12-13-12 06:51 B
Classification	Class I
Reason for Recall	Positive IEH sample of Listeria Monocytogenes found in Taylor Farms Hearts of Romaine
Product Quantity	101 cases, 6 x 10 oz packages per case.
Recall Number	F-0854-2013

Class II Biologics Event

Event ID	39116
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Apr-07
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Community Blood Bank of Lancaster County Medical Society
City	Lincoln
State	NE
Country	US
Distribution Pattern	NE

Associated Products

Product Description	Red Blood Cells (Apheresis) Leukocytes Reduced
Code Info	3743751- part 1, 3743751- part 2
Classification	Class II
Reason for Recall	Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity	2 units
Recall Number	B-0268-13

Class II Biologics Event

Event ID	39526
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Dec-04
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	American National Red Cross
City	Salt Lake City
State	UT
Country	US
Distribution Pattern	Idaho, Montana, and Utah and California

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	20FC26689; 20J98938; 20LE04227; 20LE04232; 20LY55656
Classification	Class II
Reason for Recall	Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity	5 units
Recall Number	B-0244-13

Class II Biologics Event

Event ID	39982
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Apr-05
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Community Blood Center of the Ozarks
City	Springfield
State	MO
Country	US
Distribution Pattern	Missouri

Associated Products

Product Description	Red Blood Cells
Code Info	6557165
Classification	Class II
Reason for Recall	Blood product, which did not meet the acceptable product specifications, was distributed.
Product Quantity	1 unit
Recall Number	B-0304-13

Class II Biologics Event

Event ID	40903
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Sep-05
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	American National Red Cross (The)
City	Portland
State	OR
Country	US
Distribution Pattern	Oregon and California

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	21FS42335
Classification	Class II
Reason for Recall	Blood products, collected from a donor with a history of Hepatitis A, were distributed.
Product Quantity	1 unit
Recall Number	B-0229-13

Product Description	Blood and Blood Products for Reprocessing
Code Info	21FS42335
Classification	Class II
Reason for Recall	Blood products, collected from a donor with a history of Hepatitis A, were distributed.
Product Quantity	1 unit
Recall Number	B-0230-13

Class II Biologics Event

Event ID	41190
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Oct-05
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	American National Red Cross
City	Portland
State	OR
Country	US
Distribution Pattern	Oregon and Ohio

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	21FV07851
Classification	Class II
Reason for Recall	Blood products, collected from a donor with a history of Hepatitis, were distributed.
Product Quantity	1 unit
Recall Number	B-0242-13

Product Description	Plasma Frozen
Code Info	21FV07851
Classification	Class II
Reason for Recall	Blood products, collected from a donor with a history of Hepatitis, were distributed.
Product Quantity	1 unit
Recall Number	B-0243-13

Class II Biologics Event

Event ID	41936
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Mar-06
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	American National Red Cross
City	Portland
State	OR
Country	US
Distribution Pattern	Florida, Oregon, and Washington

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	21LH29445
Classification	Class II
Reason for Recall	Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity	1 unit
Recall Number	B-0232-13

Product Description	Cryoprecipitated AHF, Pooled
Code Info	21LH29445
Classification	Class II
Reason for Recall	Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity	1 unit
Recall Number	B-0233-13

Product Description	Blood and Blood Products for Reprocessing
Code Info	21LH29445
Classification	Class II
Reason for Recall	Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity	1 unit
Recall Number	B-0234-13

Class II Biologics Event

Event ID	42883
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Aug-06
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Community Blood Bank of Lancaster County Medical Society
City	Lincoln
State	NE
Country	US
Distribution Pattern	NY

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	9121046
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity	1 unit
Recall Number	B-0272-13

Class II Biologics Event

Event ID	43037
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Sep-06
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	International BioResources, LLC
City	Colorado Springs
State	CO
Country	US
Distribution Pattern	NC

Associated Products

Product Description	Source Plasma
Code Info	366020863; 366020554; 366009883; 366009338; 366008981; 366007812; 366007488; 366006391; 366006082; 366004975; 366004698; 366000802; 366000830
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity	13 units
Recall Number	B-0305-13

Class II Biologics Event

Event ID	43239
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Sep-06
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Community Blood Bank of Lancaster County Medical Society
City	Lincoln
State	NE
Country	US
Distribution Pattern	NJ

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	9122839
Classification	Class II
Reason for Recall	Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity	1 unit
Recall Number	B-0271-13

Class II Biologics Event

Event ID	44449
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-Jan-07
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	American National Red Cross (The)
City	Columbus
State	OH
Country	US
Distribution Pattern	OH and PA

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	16LK41465
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-0239-13

Product Description	Platelets Leukocytes Reduced
Code Info	16LK41465
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-0240-13

Product Description	Fresh Frozen Plasma
Code Info	16LK41465
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-0241-13

Class II Biologics Event

Event ID	47179
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Jan-08
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Community Blood Bank of Lancaster County Medical Society
City	Lincoln
State	NE
Country	US
Distribution Pattern	NE

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	3711224; 3705229
Classification	Class II
Reason for Recall	Blood products, which was collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity	2 units
Recall Number	B-0306-13

Class II Biologics Event

Event ID	47322
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Feb-08
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Community Blood Center of the Ozarks
City	Springfield
State	MO
Country	US
Distribution Pattern	Missouri

Associated Products

Product Description	Platelets
Code Info	6868490
Classification	Class II
Reason for Recall	Blood product, was not quarantined subsequent to receiving post donation illness information, was distributed.
Product Quantity	1 unit
Recall Number	B-0310-13

Class II Biologics Event

Event ID	47620
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Feb-08
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Community Blood Center Of Gtr KC
City	Kansas City
State	MO
Country	US
Distribution Pattern	Missouri and Indiana

Associated Products

Product Description	Fresh Frozen Plasma
Code Info	W045007125365
Classification	Class II
Reason for Recall	Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Product Quantity	1 unit
Recall Number	B-0311-13

Product Description	Blood and Blood Products for Reprocessing
Code Info	5116010
Classification	Class II
Reason for Recall	Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Product Quantity	1 unit
Recall Number	B-0312-13

Class II Biologics Event

Event ID	48282
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Apr-08
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Community Blood Center Of Gtr KC
City	Kansas City
State	MO
Country	US
Distribution Pattern	Missouri

Associated Products

Product Description	Fresh Frozen Plasma
Code Info	W045007145917
Classification	Class II
Reason for Recall	Donor Screening/Donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked.
Product Quantity	1 unit
Recall Number	B-0309-13

Class II Biologics Event

Event ID	48537
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Apr-08
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Community Blood Center Of Gtr KC
City	Kansas City
State	MO
Country	US
Distribution Pattern	Austria

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	W045007111458
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity	1 unit
Recall Number	B-0302-13

Class II Biologics Event

Event ID	53064
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-Jun-08
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Bio-Medics
City	Provo
State	UT
Country	US
Distribution Pattern	Austria

Associated Products

Product Description	Source Plasma
Code Info	8120001398, 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
Classification	Class II
Reason for Recall	Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	27 units
Recall Number	B-0308-13

Class II Devices Event

Event ID	61212
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Jul-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Beckman Coulter Inc.
City	Brea
State	CA
Country	US
Distribution Pattern	Worldwide 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 Description	Access 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 Info	019818, 021654, 024072
Classification	Class II
Reason for Recall	A 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 Quantity	6,634 units total (2,742 units in US)
Recall Number	Z-0613-2013

Class II Drugs Event

Event ID	62664
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Jul-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Lloyd Inc. of Iowa
City	Shenandoah
State	IA
Country	US
Distribution Pattern	Distribution was nationwide and to Puerto Rico. There was no foreign, military, or government distribution.

Associated Products

Product Description	Thyro-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 Info	Lot HB23111 and HC23111
Classification	Class II
Reason for Recall	Subpotent; 9-month stability interval
Product Quantity	3,789,426/50-mcg. tablets
Recall Number	D-100-2013

Product Description	Levothroid (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 Info	Lot 1093992 and 1094095, exp. date 9/2012
Classification	Class II
Reason for Recall	Subpotent; 9-month stability interval
Product Quantity	37,441/100-tablet bottles
Recall Number	D-101-2013

Product Description	Thyro-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 Info	Lot HF23111
Classification	Class II
Reason for Recall	Subpotent; 9-month stability interval
Product Quantity	1,924,133/75-mcg. tablets
Recall Number	D-102-2013

Product Description	Levothroid (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 Info	Lot 1094098, exp. date 9/2012
Classification	Class II
Reason for Recall	Subpotent; 9-month stability interval
Product Quantity	16,548/100-tablet bottles
Recall Number	D-103-2013

Class II Biologics Event

Event ID	63194
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Aug-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	LifeServe Blood Center
City	Des Moines
State	IA
Country	US
Distribution Pattern	IA

Associated Products

Product Description	Plasma Frozen within 24 hours (FP24)
Code Info	W044112107840
Classification	Class II
Reason for Recall	Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity	1 unit
Recall Number	B-0119-13

Class II Devices Event

Event ID	63394
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Philips Medical Systems (Cleveland) Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	Worldwide 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 Description	Computed 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 Info	Model #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.
Classification	Class II
Reason for Recall	Philips 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 Quantity	265 units
Recall Number	Z-0479-2013

Class II Devices Event

Event ID	63457
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Stryker Howmedica Osteonics Corp.
City	Mahwah
State	NJ
Country	US
Distribution Pattern	Worldwide 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 Description	Stryker 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 Info	Catalog No: 1806-0073S Lot Code:123596
Classification	Class II
Reason for Recall	During the manufacturing of the affected lot a manufacturing error has led to embrittlement of the tube material of the T2 Humerus Teflon Tube.
Product Quantity	100 units (73 units US; 27 units OUS)
Recall Number	Z-0610-2013

Class II Devices Event

Event ID	63497
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	02-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Brookstone Company, Inc.
City	Merrimack
State	NH
Country	US
Distribution Pattern	Nationwide Distribution.

Associated Products

Product Description	Brookstone 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 Info	All lot codes
Classification	Class II
Reason for Recall	Additional Warning Statement to prevent burns to the skin
Product Quantity	109,956 units
Recall Number	Z-0616-2013

Class II Drugs Event

Event ID	63608
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Alara Pharmaceutical Co
City	San Juan
State	PR
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San Juan, PR
Code Info	11T7011A, Exp. Date: 12/2012
Classification	Class II
Reason for Recall	Subpotent; 15 month stability
Product Quantity	7,432 bottles
Recall Number	D-104-2013

Class II Devices Event

Event ID	63632
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Beckman Coulter Inc.
City	Brea
State	CA
Country	US
Distribution Pattern	Worldwide Distribution-USA (nationwide) and the country of Canada.

Associated Products

Product Description	Access 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 Info	Part Numbers: Access 81600; Access 2 81600N, 386220, A69186, A25656, A12900; Access 2 (LXi) A15642; Access 2 Section, DxC 600i A25640
Classification	Class II
Reason for Recall	It 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 Quantity	6,858 units
Recall Number	Z-0612-2013

Class II Drugs Event

Event ID	63656
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Sep-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	F. Hoffmann-LaRoche Ltd.
City	Basel
State
Country	CH
Distribution Pattern	No product distributed in the USA. Bulk product distributed to Switzerland, with further distribution in Europe, Scandinavia, Korea.

Associated Products

Product Description	Cymevene 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 Info	bulk lot N0019, Expiration Date: 11 2014 Warennummer: 10131968 Chargennummer:NXXXX 2000609D Finished product Lot N0019B01-N0019B12
Classification	Class II
Reason for Recall	Lack of Assurance of Sterility; container closure issues with the bulk batch.
Product Quantity	42010 vials
Recall Number	D-105-2013

Class II Devices Event

Event ID	63676
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Greatbatch Medical
City	Minneapolis
State	MN
Country	US
Distribution Pattern	Worldwide 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 Description	Biosense 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 Info	LOT: 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.
Classification	Class II
Reason for Recall	Greatbatch 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 Quantity	10,201 units
Recall Number	Z-0611-2013

Class II Devices Event

Event ID	63803
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Sep-12
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	sanofi-aventis US, Inc.
City	Bridgewater
State	NJ
Country	US
Distribution Pattern	Worldwide distribution.

Associated Products

Product Description	Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.
Code Info	n/a
Classification	Class II
Reason for Recall	Diamigo, 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 Quantity	1600 downloads (140 US; 1460 Foreign)
Recall Number	Z-0609-2013

Class II Devices Event

Event ID	63814
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Roche Molecular Systems, Inc.
City	Branchburg
State	NJ
Country	US
Distribution Pattern	Distributed in the states of GA, CA, NC, and MN.

Associated Products

Product Description	COBAS 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 Info	CAP 394436 to 394663
Classification	Class II
Reason for Recall	Certain 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 Quantity	7 units
Recall Number	Z-0614-2013

Class II Devices Event

Event ID	63857
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Arjo, Inc. dba ArjoHuntleigh
City	Addison
State	IL
Country	US
Distribution Pattern	USA (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 Description	Flowtron 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 Info	Model 512003, all serial numbers
Classification	Class II
Reason for Recall	The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.
Product Quantity	2,859 unts
Recall Number	Z-0615-2013

Class III Devices Event

Event ID	37530
Status	Completed
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Jun-06
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Radiometer America Inc
City	Westlake
State	OH
Country	US
Distribution Pattern	Distributed to KY, NC, and NY.

Associated Products

Product Description	Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
Code Info	Lot R0040, expiration date February 2008; Lot R0042, expiration date April 2008.
Classification	Class III
Reason for Recall	The 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 Quantity	840 Ampules
Recall Number	Z-0608-2013

Class III Biologics Event

Event ID	47982
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Feb-08
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Community Blood Center Of Gtr KC
City	Kansas City
State	MO
Country	US
Distribution Pattern	California

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	W045006066878
Classification	Class III
Reason for Recall	Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Product Quantity	1 unit
Recall Number	B-0303-13

Class III Biologics Event

Event ID	50646
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Dec-08
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Mercy Medical Center Blood Bank
City	Springfield
State	MA
Country	US
Distribution Pattern	MA

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	93GC07180; 93GC07182; 93GC07183; 93GC07184; 93GC07186
Classification	Class III
Reason for Recall	Blood products, collected using a machine for which quality control testing was not performed, were distributed
Product Quantity	5 units
Recall Number	B-0307-13

Mixed Classification Biologics Event

Event ID	41526
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Dec-05
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	American National Red Cross (The)
City	West Henrietta
State	NY
Country	US
Distribution Pattern	PA

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	30GR14000
Classification	Class II
Reason for Recall	Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-0235-13

Product Description	Blood and Blood Products for Reprocessing
Code Info	30GR14000
Classification	Class III
Reason for Recall	Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-0236-13

Mixed Classification Biologics Event

Event ID	41935
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Mar-05
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	American National Red Cross
City	Portland
State	OR
Country	US
Distribution Pattern	Oregon and Florida

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	21FJ45454
Classification	Class II
Reason for Recall	Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-0237-13

Product Description	Blood and Blood Products for Reprocessing
Code Info	21FJ45454
Classification	Class III
Reason for Recall	Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	1 unit
Recall Number	B-0238-13

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