Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042.    The solution is used for quality check of blood gas analyzers.
Lot R0040, expiration date February 2008; Lot R0042, expiration date April 2008.
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.
Community Blood Bank of Lancaster County Medical Society
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood product, which did not meet the acceptable product specifications, was distributed.
Blood products, collected from a donor with a history of Hepatitis A, were distributed.
Blood and Blood Products for Reprocessing
Blood products, collected from a donor with a history of Hepatitis A,  were distributed.
Blood products, collected from a donor with a history of Hepatitis, were distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, which was collected from a donor who  traveled to a malarial endemic area, were distributed.
Blood product, was not quarantined subsequent to receiving post donation illness information, was distributed.
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Donor Screening/Donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked.
Blood products, collected using a machine for which quality control testing was not performed, were distributed
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.
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.
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.
Distribution was nationwide and to Puerto Rico.  There was no foreign, military, or government distribution.
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.
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.
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
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.
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,
GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask  Size O;  M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask, Size 1, Lot 1981713 *** Ohmeda Medical, A Division of Datex-Ohmeda, Inc. A General Electric Company Laurel, MD 20723 USA MADE IN USA***   Provides the basic equipment required for pulmonary resuscitation of infants.
Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check out procedure.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
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
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.
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.
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.
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,
Catalog No: 1806-0073S   Lot Code:123596
During the manufacturing of the affected lot a manufacturing error has led to embrittlement of the tube material of the T2 Humerus Teflon Tube.
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.
Additional Warning Statement  to prevent burns to the skin
Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San Juan, PR
Worldwide Distribution-USA (nationwide) and the country of Canada.
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.
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.
No product distributed in the USA.  Bulk product distributed to Switzerland, with further distribution in Europe, Scandinavia, Korea.
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
bulk lot N0019, Expiration Date: 11 2014 Warennummer: 10131968  Chargennummer:NXXXX 2000609D  Finished product Lot N0019B01-N0019B12
Lack of Assurance of Sterility; container closure issues with the bulk batch.
FL,NC, GA ,NJ, NY ,VA, OH, NV,OK,KY, TN, CO, IL, MA ,MO, RI,VT, NH ,ME, SC, IN, MI
Spence & Co  New York-Style  Nova Lox 4oz  , refrigerated Spence & Co Smoked Salmon Trimmings, 2lb bulk (bag)
Product contaminated with Listeria monocytogenes
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
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.
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).
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.
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.
Ardis Inserter, Part number: 3256-01   Lot numbers - 52ZW, 50CL, 53BB, 55AB, 580S, 580T, 60JY, 60JZ, 62KP, 63HJ, 64EY, 68AX, 71JE, and 75LE
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).
CMC Pumpkin Coffee Cake 16 oz  UPC: 041735225726 Price Chopper/Box
UPC # 41735-225726 expiration date between October 17 and October 25, 2012
CMC Cinnamon Coffee Cake was incorrectly labeled as Pumpkin Coffee Cake and therefore did not list walnuts as an ingredient
Worldwide distribution: USA (nationwide) and countries of: Brazil, Canada, China, Columbia, Costa Rica, India, Paraguay and Uruguay.
Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG     Usage: Regulator reduces pressure in oxygen-containing cylinder.
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.
Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwise subject to significant physical impact.
Diamigo i-Phone App    The Diamigo app was intended for use as an educational tool in the management of diabetes.
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.
Distributed in the states of GA, CA, NC, and MN.
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
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.
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.
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.
The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.
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
Positive IEH sample of Listeria Monocytogenes found in Taylor Farms Hearts of Romaine