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Enforcement Report - Week of January 9, 2013

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Biologics Devices Drugs Food / Cosmetics Veterinary

Class I Food/Cosmetics Event

Event ID	63657
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Nov-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Fresh Express Incorporated
City	Salinas
State	CA
Country	US
Distribution Pattern	AZ, CA, CO, HI, ID, KS, MO, MT, NE, NV, NM, OK, OR, SD, TX, UT, WA and WY.

Associated Products

Product Description	Fresh Express brand, Fresh Spinach, 9 oz.
Code Info	Lot #S299B25
Classification	Class I
Reason for Recall	Product tested positive for Salmonella
Product Quantity	6610 units
Recall Number	F-0859-2013

Class I Devices Event

Event ID	63794
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Nov-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Fisher & Paykel Healthcare, Ltd.
City	North Shore City
State
Country	NZ
Distribution Pattern	Worldwide Distribution - USA including IL, IN, AR and GA.

Associated Products

Product Description	Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
Code Info	Lots 110810 and 111020
Classification	Class I
Reason for Recall	FPH 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 Quantity	200 units total, 26 units US
Recall Number	Z-0621-2013

Class I Food/Cosmetics Event

Event ID	63816
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Aug-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Gourmet Cuisine, Inc.
City	Mesquite
State	TX
Country	US
Distribution Pattern	TX only

Associated Products

Product Description	La Madeleine Potato Soup, 5 lb clear Cryovac pouches, 4 pouches per case.
Code Info	All potato soup manufactured 08/09&10/2012. Expiration dates Aug 21 - Oct 21, 2012
Classification	Class I
Reason for Recall	The potato in the potato soup is treated with sulfites. Sulfites were not declared on the firm's product label.
Product Quantity	127 crates
Recall Number	F-0857-2013

Class II Biologics Event

Event ID	39106
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	02-Apr-07
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Mississippi Valley Reg Bld Ctr
City	Davenport
State	IA
Country	US
Distribution Pattern	Iowa; Illinois

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced Irradiated
Code Info	K42637
Classification	Class II
Reason for Recall	Blood products, for which the quality control testing was incomplete, were distributed.
Product Quantity	1 Unit
Recall Number	B-0343-13

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	K42721;K42646
Classification	Class II
Reason for Recall	Blood products, for which the quality control testing was incomplete, were distributed.
Product Quantity	2 Units
Recall Number	B-0344-13

Class II Biologics Event

Event ID	39109
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-May-07
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Mississippi Valley Reg Bld Ctr
City	Davenport
State	IA
Country	US
Distribution Pattern	Missouri; Iowa; New York

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	K43528; K43528; K43528
Classification	Class II
Reason for Recall	Blood products, for which the quality control testing was incomplete, were distributed.
Product Quantity	3
Recall Number	B-0342-13

Class II Biologics Event

Event ID	45721
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Sep-07
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	BioLife Plasma Services L.P.
City	Springfield
State	MO
Country	US
Distribution Pattern	CA

Associated Products

Product Description	Source Plasma
Code Info	06FMOD0209
Classification	Class II
Reason for Recall	Blood product, identified as unsuitable due to a donor screening deviation, was distributed.
Product Quantity	1 unit
Recall Number	B-0347-13

Class II Biologics Event

Event ID	49684
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Jul-08
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	American National Red Cross (The)
City	Little Rock
State	AR
Country	US
Distribution Pattern	AR

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	55C41646;55C38742;55C36864
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	3 components
Recall Number	B-0341-13

Class II Biologics Event

Event ID	50434
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	31-Oct-08
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	BioLife Plasma Services L.P.
City	Springfield
State	MO
Country	US
Distribution Pattern	CA

Associated Products

Product Description	Source Plasma
Code Info	08FMOD0324
Classification	Class II
Reason for Recall	Blood product, collected from a donor who did not have a required physical examination, was distributed.
Product Quantity	1 unit
Recall Number	B-0346-13

Class II Devices Event

Event ID	62413
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Hill-Rom, Inc.
City	Batesville
State	IN
Country	US
Distribution Pattern	Worldwide 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 Description	Liko 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 Info	The 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.
Classification	Class II
Reason for Recall	Liko/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 Quantity	261 units
Recall Number	Z-0622-2013

Class II Drugs Event

Event ID	62454
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-Jun-12
Initial Firm Notification of Consignee or Public

Recalling Firm	Mylan LLC.
City	Caguas
State	PR
Country	US
Distribution Pattern	Natiowide.

Associated Products

Product Description	Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01
Code Info	Lots: 3027684 Exp. 5/13, 3027688 Exp. 6/13 & 2002157 Exp. 9/12
Classification	Class II
Reason for Recall	Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
Product Quantity	15181 bottles.
Recall Number	D-066-2013

Class II Biologics Event

Event ID	63461
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Oct-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Blood Systems Inc/dba United Blood Services
City	Meridian
State	MS
Country	US
Distribution Pattern	Mississippi; Switzerland

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	W0416120040230;
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
Recall Number	B-0285-13

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W0416120040230;
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
Recall Number	B-0286-13

Class II Biologics Event

Event ID	63462
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Aug-11
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W037911147282;
Classification	Class II
Reason for Recall	Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed.
Product Quantity	1
Recall Number	B-0287-13

Class II Biologics Event

Event ID	63463
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Aug-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Blood Bank Of Delmarva, Inc
City	Newark
State	DE
Country	US
Distribution Pattern	Delaware

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced Irradiated
Code Info	W036912222319;
Classification	Class II
Reason for Recall	Blood product, labeled with an incorrect expiration date, was distributed.
Product Quantity	1
Recall Number	B-0288-13

Class II Biologics Event

Event ID	63474
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Oct-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Blood Centers of the Pacific - Irwin Center
City	San Francisco
State	CA
Country	US
Distribution Pattern	California

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced Irradiated
Code Info	W117012518302Q; W117012518302Q;
Classification	Class II
Reason for Recall	Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell counts, were distributed.
Product Quantity	2
Recall Number	B-0290-13

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W117012326743U; W117012326743U; W117012326743U; W117011507369G; W117011507369G; W1170114535114;
Classification	Class II
Reason for Recall	Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell counts, were distributed.
Product Quantity	6
Recall Number	B-0291-13

Class II Biologics Event

Event ID	63476
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Sep-12
Initial Firm Notification of Consignee or Public	FAX

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W045012008969;
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
Recall Number	B-0292-13

Class II Biologics Event

Event ID	63507
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-May-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Community Blood Centers of Florida, Inc.
City	Lauderhill
State	FL
Country	US
Distribution Pattern	Illinois; Florida

Associated Products

Product Description	Red Blood Cells
Code Info	W036810255653; W036810190296;
Classification	Class II
Reason for Recall	Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-0293-13

Product Description	Platelets Pooled Leukocytes Reduced
Code Info	W036810814828; W036811813763;
Classification	Class II
Reason for Recall	Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-0294-13

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W036811169821;
Classification	Class II
Reason for Recall	Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity	1
Recall Number	B-0295-13

Product Description	Fresh Frozen Plasma
Code Info	W036810255653; W036811169821; W036810190296;
Classification	Class II
Reason for Recall	Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity	3
Recall Number	B-0296-13

Class II Biologics Event

Event ID	63514
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Jul-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Southern California Permanente Medical Group Blood Donor Ctr
City	Downey
State	CA
Country	US
Distribution Pattern	California

Associated Products

Product Description	Red Blood Cells (Apheresis) Leukocytes Reduced
Code Info	W071812000498;
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor who lived in a malarial endemic area, were distributed.
Product Quantity	1
Recall Number	B-0297-13

Product Description	Fresh Frozen Plasma
Code Info	W071812000498;
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor who lived in a malarial endemic area, were distributed.
Product Quantity	1
Recall Number	B-0298-13

Class II Biologics Event

Event ID	63515
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Sep-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Sanford Medical Center (blood Bank)
City	Sioux Falls
State	SD
Country	US
Distribution Pattern	Pennsylvania

Associated Products

Product Description	Red Blood Cells
Code Info	W089212004412;
Classification	Class II
Reason for Recall	Blood product, collected from a donor who emigrated from an area considered endemic for malaria, was distributed.
Product Quantity	1
Recall Number	B-0248-13

Class II Biologics Event

Event ID	63526
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Oct-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Talecris Plasma Resources
City	Minneapolis
State	MN
Country	US
Distribution Pattern	North Carolina

Associated Products

Product Description	Source Plasma
Code Info	5090183875; 5090182331;
Classification	Class II
Reason for Recall	Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-0299-13

Class II Drugs Event

Event ID	63589
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Hospira Inc.
City	Lake Forest
State	IL
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Epinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., Lake Forest, IL --- NDC 0409-7241-01
Code Info	Lot 100953A, Exp 01OCT2013; Lot 120803A Exp 01DEC2013
Classification	Class II
Reason for Recall	Presence of Particulates; may contain glass particles
Product Quantity	361,600/1-mL ampules
Recall Number	D-106-2013

Class II Devices Event

Event ID	63602
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Dec-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Stryker Medical Division of Stryker Corporation
City	Portage
State	MI
Country	US
Distribution Pattern	Worldwide Distribution - Nationwide and Canada

Associated Products

Product Description	Medical 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 Info	Model 3002SEX, Serial Number 120315371-120315379
Classification	Class II
Reason for Recall	Stryker 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 Quantity	9
Recall Number	Z-0628-2013

Product Description	Medical 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 Info	Model 3005S3EX, Serial Number 120415087 - 120515468,
Classification	Class II
Reason for Recall	Stryker 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 Quantity	1004
Recall Number	Z-0629-2013

Class II Devices Event

Event ID	63616
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-May-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Mindray DS USA, Inc. d.b.a. Mindray North America
City	Mahwah
State	NJ
Country	US
Distribution Pattern	Nationwide Distribution including OH and GA

Associated Products

Product Description	DPM 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 Info	510 K K080192 P/N 300BF-PA200002
Classification	Class II
Reason for Recall	There 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 Quantity	two units
Recall Number	Z-0630-2013

Class II Food/Cosmetics Event

Event ID	63700
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Nov-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Focus Products Group Llc
City	Lincolnshire
State	IL
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Cocoa~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 Info	West Bend brand - model number 65032; Back to Basics brand - model numbers CM300BK, CM300BKL, CM300BLSS, CM300BR, CM300BR-BRL, CM300BRL and CM300W
Classification	Class II
Reason for Recall	The Cocoa~Latte Hot Drink Maker was manufactured with a small brass metal bushing in the liquid containing vessel that may leach lead.
Product Quantity	568,000 units
Recall Number	F-0856-2013

Class II Devices Event

Event ID	63719
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Nov-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Cooper Vision Caribbean Corp.
City	Juana Diaz
State	PR
Country	US
Distribution Pattern	US Nationwide, including Puerto Rico, and Canada.

Associated Products

Product Description	AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Code Info	10447500016006, 10519550007006, 10537500016014
Classification	Class II
Reason for Recall	The lenses exceeded the acceptance limit for silicone oil residual.
Product Quantity	246
Recall Number	Z-0631-2013

Class II Devices Event

Event ID	63746
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Abbott Molecular
City	Des Plaines
State	IL
Country	US
Distribution Pattern	Worldwide 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 Description	Abbott 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 Info	list 09K14, all serial numbers and all software versions 1.0 - 5.0
Classification	Class II
Reason for Recall	An 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 Quantity	215 units - U.S., 693 units - ROW
Recall Number	Z-0634-2013

Class II Devices Event

Event ID	63769
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Medtronic Inc. Cardiac Rhythm Disease Management
City	Saint Paul
State	MN
Country	US
Distribution Pattern	Worldwide 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 Description	Medtronic 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 Info	Pack 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
Classification	Class II
Reason for Recall	Medtronic 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 Quantity	1552
Recall Number	Z-0618-2013

Class II Devices Event

Event ID	63772
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Hospira Inc.
City	Lake Forest
State	IL
Country	US
Distribution Pattern	Worldwide 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 Description	Plum 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 Info	list numbers 11971, 11973, 12391, 20679, and 20792; all serial numbers
Classification	Class II
Reason for Recall	The 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 Quantity	297,833 units
Recall Number	Z-0624-2013

Product Description	Plum 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 Info	list numbers 12348, 12618, and 20678; all serial numbers
Classification	Class II
Reason for Recall	The 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 Quantity	28,599 units
Recall Number	Z-0625-2013

Product Description	Plum 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 Info	list number 11005; all serial numbers
Classification	Class II
Reason for Recall	The 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 Quantity	180 units
Recall Number	Z-0626-2013

Class II Drugs Event

Event ID	63791
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Abbott Laboratories
City	Abbott Park
State	IL
Country	US
Distribution Pattern	US Nationwide and Puerto Rico

Associated Products

Product Description	Synthroid (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 Info	LOT # 18262A8 Exp. 09/13
Classification	Class II
Reason for Recall	Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
Product Quantity	28, 524 bottles
Recall Number	D-107-2013

Class II Food/Cosmetics Event

Event ID	63802
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Cho Fuku Group (usa) Inc
City	El Monte
State	CA
Country	US
Distribution Pattern	California and Washington

Associated Products

Product Description	Sanh Yuan Preserved Plum Candy (Sweet and Sour Prune), 5 oz (142g)
Code Info	The manufacturer did not use lot number or code number
Classification	Class II
Reason for Recall	CHO Fuku Group Inc. is recalling Sanh Yuan Preserved Plum Candy (Sweet and Sour Prune) because of unacceptable levels of lead.
Product Quantity	430 packs
Recall Number	F-0855-2013

Class II Food/Cosmetics Event

Event ID	63828
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Natural Organics
City	Melville
State	NY
Country	US
Distribution Pattern	Nationwide and Puerto Rico

Associated Products

Product Description	Nature'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 Info	Lot /Batch Number 1243522, Best By Date 06/2016
Classification	Class II
Reason for Recall	One 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 Quantity	1,966 individual packets (1.2 oz.)
Recall Number	F-0860-2013

Class II Devices Event

Event ID	63838
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Horiba Instruments, Inc dba Horiba Medical
City	Irvine
State	CA
Country	US
Distribution Pattern	Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.

Associated Products

Product Description	ABX 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 Info	Lot number: 00456-4108
Classification	Class II
Reason for Recall	Horiba 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 Quantity	66886 units
Recall Number	Z-0632-2013

Product Description	PENTRA 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 Info	Lot number: 00456-4108
Classification	Class II
Reason for Recall	Horiba 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 Quantity	384 units
Recall Number	Z-0633-2013

Class II Devices Event

Event ID	63862
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	23-Mar-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	B. Braun Medical, Inc.
City	Allentown
State	PA
Country	US
Distribution Pattern	Worldwide Distribution--US (nationwide) including the states of AL, AZ, NC and TN.

Associated Products

Product Description	Space 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 Info	Model 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.
Classification	Class II
Reason for Recall	Firm has become aware of the potential for breakage of the pole clamp locking grids, or rasters, in the Space Pole Clamps.
Product Quantity	13,078
Recall Number	Z-0623-2013

Class II Food/Cosmetics Event

Event ID	63869
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Dec-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Nature'S Path Foods Inc
City	Blaine
State	WA
Country	US
Distribution Pattern	Distributed to CO, CA, CT, FL, GA, HI, IA, IN, NH, OR, PA, TX, and WA.

Associated Products

Product Description	Hemp 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 GranolaINGREDIENTS: 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 molasses25 lb.Nature's Path Foods, Blaine, WA 98230www.naturespath.com*".
Code Info	Best 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.
Classification	Class II
Reason for Recall	Undeclared almond. Vanilla Almond Granola which contains almonds but it was mis-labeled as Hemp Plus Granola and almond was not declared on label.
Product Quantity	2872 cases (25 lb. per case)
Recall Number	F-0858-2013

Class II Devices Event

Event ID	63878
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	Maquet Inc.
City	Wayne
State	NJ
Country	US
Distribution Pattern	Worldwide 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 Description	Maquet 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 Info	Class I exempt Device Listing Number A922956
Classification	Class II
Reason for Recall	There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.
Product Quantity	63 devices
Recall Number	Z-0627-2013

Class II Devices Event

Event ID	63915
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Dec-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	SynCardia Systems Inc.
City	Tucson
State	AZ
Country	US
Distribution Pattern	Worldwide Distribution -- US (nationwide)

Associated Products

Product Description	Companion 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
Classification	Class II
Reason for Recall	Syncardia 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 Quantity	81 units
Recall Number	Z-0620-2013

Class III Biologics Event

Event ID	48856
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-May-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	Kansas; Missouri

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W045008906241; W045008906253; W04500905684; W045008905688; W045008900312; W045008906240; W045008906244; W045008906405; W045008906405; W045008903920; W045008905682; W045008905696; W045008906241
Classification	Class III
Reason for Recall	Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed.
Product Quantity	13 Units
Recall Number	B-0348-13

Class III Biologics Event

Event ID	49169
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Jul-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	Missouri; Kansas; Iowa

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W045008906919; W045008904192; W045008904744; W045008906497; W045008906041; W045008906040; W045008905082; W045008907864; W045008907896; W045008905476
Classification	Class III
Reason for Recall	Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed.
Product Quantity	10 Units
Recall Number	B-0349-13

Class III Biologics Event

Event ID	49241
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Jun-08
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	ZLB Bioplasma, Inc.
City	Tulsa
State	OK
Country	US
Distribution Pattern	Switzerland

Associated Products

Product Description	Source Plasma
Code Info	0141396753,
Classification	Class III
Reason for Recall	Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-0345-13

Class III Biologics Event

Event ID	63464
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Aug-12
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	American National Red Cross The
City	Pomona
State	CA
Country	US
Distribution Pattern	California

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	06LZ34745;
Classification	Class III
Reason for Recall	Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-0289-13

Class III Devices Event

Event ID	63825
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Nov-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	HemoCue AB
City	Angelholm
State
Country	SE
Distribution Pattern	Distributed 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 Description	Analyzing 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 Info	See serial numbers of affected devices in attachment profided by firm.
Classification	Class III
Reason for Recall	Incorrect 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 Quantity	48 affected analyzers
Recall Number	Z-0619-2013

Class III Devices Event

Event ID	63855
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Mar-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	St Jude Medical Inc
City	Saint Paul
State	MN
Country	US
Distribution Pattern	US Distribution only including the states of FL, KY and OK.

Associated Products

Product Description	Fast-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 Info	Model no. 406586 Batch no. 3619533
Classification	Class III
Reason for Recall	St. 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 Quantity	26
Recall Number	Z-0617-2013

Mixed Classification Drugs Event

Event ID	63305
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Sep-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	New England Compounding Center
City	Framingham
State	MA
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Methylprednisolone 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 Info	All Lot codes
Classification	Class I
Reason for Recall	Non-Sterility
Product Quantity	23,897 vials
Recall Number	D-108-2013

Product Description	Methylprednisolone 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 Info	All lot codes
Classification	Class I
Reason for Recall	Non-Sterility
Product Quantity	9062 vials
Recall Number	D-109-2013

Product Description	Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Code Info	All lot codes
Classification	Class I
Reason for Recall	Non-Sterility
Product Quantity	5130 vials
Recall Number	D-110-2013

Product Description	Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Code Info	All lot codes
Classification	Class I
Reason for Recall	Non-Sterility
Product Quantity	3822 vials
Recall Number	D-111-2013

Product Description	Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA
Code Info	All lot codes
Classification	Class II
Reason for Recall	Lack of Assurance of Sterility
Product Quantity
Recall Number	D-112-2013

Product Description	Betamethasone 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 Info	All lot codes
Classification	Class II
Reason for Recall	Lack of Assurance of Sterility
Product Quantity
Recall Number	D-113-2013

Product Description	Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA
Code Info	All lot codes
Classification	Class II
Reason for Recall	Lack of Assurance of Sterility
Product Quantity
Recall Number	D-114-2013

Product Description	Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA
Code Info	All lot codes
Classification	Class II
Reason for Recall	Lack of Assurance of Sterility
Product Quantity	2747 vials
Recall Number	D-115-2013

Product Description	Dexamethasone 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 Info	All lot codes
Classification	Class II
Reason for Recall	Lack of Assurance of Sterility
Product Quantity	20 vials
Recall Number	D-116-2013

Product Description	Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
Code Info	All lot codes
Classification	Class II
Reason for Recall	Lack of Assurance of Sterility
Product Quantity	165 vials
Recall Number	D-117-2013

Product Description	Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Code Info	All lot codes
Classification	Class II
Reason for Recall	Lack of Assurance of Sterility
Product Quantity	10,865 vials
Recall Number	D-118-2013

Product Description	Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA
Code Info	All lot codes
Classification	Class II
Reason for Recall	Lack of Assurance of Sterility
Product Quantity	7055 vials
Recall Number	D-119-2013

Product Description	Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, Framingham, MA
Code Info	All lot codes
Classification	Class II
Reason for Recall	Lack of Assurance of Sterility
Product Quantity
Recall Number	D-120-2013

Product Description	Lidocaine 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 Info	All lot codes
Classification	Class II
Reason for Recall	Lack of Assurance of Sterility
Product Quantity	3,321 vials
Recall Number	D-121-2013

Product Description	Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA
Code Info	All lot codes
Classification	Class II
Reason for Recall	Lack of Assurance of Sterility
Product Quantity	8919 vials
Recall Number	D-122-2013

Product Description	Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Code Info	All lot codes
Classification	Class II
Reason for Recall	Lack of Assurance of Sterility
Product Quantity	54 vials
Recall Number	D-123-2013

Product Description	Triamcinolone 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 Info	All lot codes
Classification	Class II
Reason for Recall	Lack of Assurance of Sterility
Product Quantity	56,655 vials
Recall Number	D-124-2013

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