07FJ84940(Parts A, B and C); 07GJ13755(Parts A, B and C)
Fresh Frozen Plasma products, not manufactured in accordance with GMPs, were distributed.
Blood products, collected from a donor who immigrated from a malarial endemic country, were distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Blood products, collected from a donor who was previously deferred, were distributed.
Worldwide distribution: US (nationwide) including sates of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, ID, KY, KS, LA, MA, MD, MI, MN, MO, MS, MT, PA, NC, NE, NH, NJ, NY, OH, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and PR; and country of: UK.
Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB   The Urinary / Cerebrospinal Fluid Protein method is an in vitro diagnostic test for the quantitive measurement of protein in urine and cerebrospinal fluid on the Dimension Vista System.
Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista Urinary/Cerebrospinal Fluid Protein (U CFP) Flex Reagent Cartridge lot 11349 BB.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Central Texas Regional Blood & Tissue Center
Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
The American National Red Cross South Carolina Region
Blood product, labeled as leukoreduced which did not meet the requirements for a leukoreduced product, was distributed.
Blood product, labeled with an extended expiration date, was distributed.
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
Blood products, collected from donors whose donor suitability was not adequately determined, were distributed.
Lions Medical Eye Bank & Research Center of Eastern VA
Mislabeled human cornea was distributed.
Blood Systems, Inc. dba United Blood Services Texas
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood product, incorrectly determined to be negative for the Fya antigen, was distributed.
Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Belgium, Canada, Croatia, Denmark, France, Germany, Greece, Italy, Japan, Malaysia, Netherlands, Norway, Philippines, Portugal, South Korea, Singapore, Slovenia, Spain, Switzerland, Thailand, Turkey, United Kingdom and Vietnam.
ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter)   The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.
All serial numbers connected to the ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide.
311 units total (US: 51 units; Foreign: 260 units)
Siemens determined that if an autosampler rack jam error occurs during operation of an ADVIA 2120/2120i connected to an ADVIA Autoslide, it is possible that the next slide processed by the Autoslide could be labeled with the wrong sample identification information.
Nationwide Distribution, including the states of MI, PA, SC, IA, MA, CA, WI, IL, and KS.
Synthes Midfoot Fusion Bolt 6.5 mm.  It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
A post market safety review following several customer complaints indicated additional clarification was necessary in the Midfoot Fusion Bolt Technique Guide to reduce potential for bolt back-out or migration by emphasizing the need for supplemental fixation.
Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, IA, IS, LA, MA, MO, NH, NM, NY, OH, OK PA, SC, TX, UT, VA, WA, and WI, and the countries of UNITED KINGDOM, DENMARK, CHILE, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, CANADA, CZECH REPUBLIC, ECUADOR, EGYPT, ETHIOPIA, FINLAND, FRANCE, FRANCE GUIANA, GERMANY, GUADELOUPE, GUATEMALA, GUYANA, INDIA, INDONESIA, IRAQ, ITALY, JAPAN, JORDAN, KAZAHSTAN, KOREA, KUWAIT, LATVIA, MYANMA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, POLAND, ROMANIA, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, UZBEKISTAN, and VIETNAM.
GE, Optima CT660.   Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID, although all images are correctly annotated. This issue can cause additional images from a different patient and images from two or more  patients to appear in one exam.
GE PET Discovery 610, PET Discovery 710.   Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.
Human corneas, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
USA Nationwide in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and internationally in Canada.
Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196   Product Usage:  The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Model # 46-4,  Serial # range SEV0521184-SEV0838137
143 units (142 domestically & 1 unit internationally)
Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating.
Allergenic Extracts, reprocessed by an unapproved process, were distributed.
Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Albania, Algeria, Argentina, Austria, Australia, Azerbaijan, Bangladesh, Bahamas, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Burkina, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, El Salvador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Iraq, Ireland, Israel,  Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mali, Mauritania ,Mexico, Moldova, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen,  Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Tajikistan, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks and Caicos, United Arab Emirates, United Kingdom, Uruguay and Vietnam.
Clinical Chemistry Phosphorus Reagent    The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.
For List Number: 7D71-22, Lot Numbers 64736UN12 (Exp Date on Label is 14 JAN 2014), 03991UN13 (Exp Date on Label is 01 APR 2014), and 51611UN13 (Exp Date on Label is 13 JUL 2014).  For List Number: 7D71-31, Lot Numbers 74805UN12 (Exp Date on Label is 14 JAN 2014) and 03992UN13 (Exp Date on Label is 01 APR 2014).
Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration dates assigned by Supplier.
Hartley's Potato Chips Salt & Vinegar 4.5 oz and 2.5 oz bags Hartley's Potato Chip Co., Inc, Lewistown, PA     Ingredients: potatoes, vegetable shortening, salt, lactose, sodium diacetate, salt, malic acid, sodium citrate, with not more than 2% silicon dioxide and partially hydrogenated soybean and/or cottonseed oil.
Sell by Dates: Oct 7 2013 and Oct 30 2013
Undeclared lactose (milk) in seasoning sub-ingredient used in the manufacturing of Hartley's Salt & Vinegar Potato Chips.
Worldwide Distribution-USA (nationwide) including Guam and Puerto Ricoand the countries of Argentina, Aruba, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Chile, Hong Kong, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Finland, France, Gabon, Germany, Greece, Hungary, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Malaysia, Mexico, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Peru, Poland, Portugal, Saudi Arabia, Singapore, Si Lanka, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, UK, United Arab Republic, and Venezuela.
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.    Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009, may be compromised over time, causing increased current drain that can lead to premature battery depletion.
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.    Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
Worldwide Distribution-USA including the states of AL, AR, CA, FL, GA, IL, IN, KY, MS, NC, NJ, NV, NY, OH, PA, and VA; and countries of: Albania, Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Cambodia, China, Ghana, Greece, India, Indonesia, Ireland, Italy, Jordan, Latvia, Lebanon, Libya, Lithuania, Malawi, Mexico, Nepal, Netherlands, Oman, Palestine, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, Uganda, Ukraine, Uzbekistan, Venezuela and Vietnam.
MX 16-Slice CT Scanner System.   Used as a whole-body computed tomography X-Ray system.
A pinch point at the end of the table top can cause injury.
Worldwide Distribution-USA (nationwide) including the states of US: AK, AZ, CA, CO, DE, FL, GA, IL, KY, LA, MD, MI, MN, MS, MT, NV, NY, NC, OH, OR, PA, SC, TX, WY, and WI and the countries of AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COST ARICA, CROATIA, CZECH REPUBLIC, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, INDIA, INDONESIA, IRAQ, ITALY, JAPAN, KAZAHHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LITHUANIA, MAURITITUS, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, PAKISTAN, PERU, PHILIPPINES, POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM, and VENEZUELA.
GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom.   Intended for volume or pressure control ventilation.
GE Healthcare has recently become aware of a potential safety issue involving unresponsive buttons on the display of the Engstrm ventilator and the Aespire View, Aisys, and Avance anesthesia machines.   As a result of a manufacturing issue, the buttons on the left, right, and bottom keypads may not always detect button presses. This may result in the inability to access certain menu functions which could possibly lead to delay in treatment.
AZ, CO, CT, DE, GA, IA, IN, MA, MD, MN, MO, NC, NH, NY, PA, TX and WI.
Talenti German Chocolate Cake Gelato, One Pint (473 mL), Crafted By: Talenti, Marietta, GA 30062.
Product contains undeclared Allergen; Almonds.
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and except ND, SD and VT, and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA ARICA, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY,GREECE, GUADELOUPE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN,IRELAND, ITALY, JAMAICA, JAPAN,JORDAN, KAZKHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LIBYA ARAB JAMHIRIYA, LITHUANIA, MALAYSIA MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SLOVAKIA, SPAIN, SWEDEN, SYRIA, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UKRAINE, UNITED KINGDOM, and VENEZUELA.
GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ.   Intended for general purpose diagnostic fluoroscopy and radiography studies.
GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the  Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular X-ray imaging systems.
Worldwide Distribution - USA Nationwide: TX, NJ, MI, AZ, GA, LA, ME, MD, AR, MO, VA, MN, GA, MA, NY, PA, CO, CA and in the countries of Australia, Brazil, China, Singapore, Vietnam, Dominican Republic.
Harvest Graft Delivery System; Model Number: GDP-10   Product Usage:  The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for die delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s), I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.
Potential for leur connector to leak or have cracks.
Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.
Concentrated Motrin (ibuprofen) Infants' Drops Oral Suspension, Original Berry Flavor 1/2 fl oz bottles, 50 mg per 1.25ml, Distributed by McNeil Consumer Healthcare, Fort Washington, PA.
Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed
Worldwide Distribution - USA (nationwide) including DC., and the countries of AUSTRALIA, CANADA, CHILE, GERMANY, CHANA, GUATEMALA, ICELAND, ISRAEL, ITALY, JAMAICA, JAPAN, RUSIAN FEDERATION, UNITED ARAB EMIRATES and UNITED KINGDOM.
GE Healthcare, Precision 500D, Legacy, RFX, and SFX X.    This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions. - The Expedio 500D is designed to perform radiographic and fluoroscopic x-ray examinations. - The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle.   There is a potential for the internal bolts on the power assist handle to be loose or to loosen and/or fall out. This issue, if present, can result in a loss of calibration and offset of the power assist handle and/or, under extreme condition, sticking of the handle in the ON position. These conditions could cause the system to strike the patient. No injuries have been reported to date related to this issue.
Honey Roasted Peanuts, net wt. 11 oz.., packed in a clear plastic bag.  Ingredients: peanuts, sugar, peanut and/or canola and/or cottonseed oil, honey, salt, modified potato starch, xanthan gum.    Allergen info: peanut and soy ingredients.      Also states that facility also processes products containing, milk and wheat ingredients.     Distributed by: Dutch Valley Food Distributors Inc., Myerstown, PA 17067.
All products with UPC code 8 77245 00143 3 and Best By date up to 1/21/14.
Honey Roasted Peanuts were recalled due to undeclared milk (lactose) and wheat (wheat starch) allergens in the ingredient statement.
Roasted Salted Mixed Nuts w/ Peanuts, net wt. 12 oz., packed in a clear plastic bag.    Ingredients: blanched peanuts, unblanched peanuts, unblanched almonds, unblanched Brazil nuts, unblanched filberts, cashews cooked in canola oil, salt.      Allergen info: peanut and tree nuts (almonds, Brazil nuts, filberts, cashews).     Labeling also states that the facility also processes products containing tree nuts.     Distributed by Dutch Valley Food Distributors Inc., Myerstown, PA 17067.
All products with UPC code 8 77245 00140 2 and Best By date up to 1/21/14.
Roasted Salted Mixed Nuts with Peanuts were recalled for undeclared tree nuts (pecans) in the ingredient statement.
Worldwide Distribution - US  (nationwide) and the countries of UK, Saudi Arabia, Dubai, Kuwait, Poland, Spain, India and Romania
Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe).    The Test is a qualitative assay (in vitro diagnostic) that employs  immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears    The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD.
The following are part numbers and lot number combinations.   PN:173E,  LN:121272.  PN:173,  LN:121273.  PN:173,  LN:121273A.  PN:173E,  LN:131155.  PN:173,  LN:131156.
Sekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. difficile Toxin A/B Test Kit, because it has been determined that there is potential for false negative results.
Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AR, AZ, CA, CO, CT, GA, HI, IL, IN, KS, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR,TN, TX, UT, VA, VT and WV., and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Chile, China, Denmark, Egypt, France, Germany, Honduras, India, Indonesia, Italy, Kazakhstan, Latvia, Lebanon, Libyan Arab Jamahiriya, Mexico, Netherlands, Norway, Palestine, Philippines, Poland, Russia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom and Vietnam.
Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air)   Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories.
There are artifacts appearing on the Tracker images during threshold-triggered bolus scans with protocols using a Rotation Time of 0.4 seconds.
New York, Pennsylvania, New Jersey, Maryland, Virginia, and Massachusetts.
Wegmans Bakery Mini Muffins APPLE CINNAMON, NET WT 14 OZ (397g) , UPC 77890 18951 --- Baked By Wegmans Food Markets Inc., Rochester, NY 14603
All date codes up to and including ''Best if used by 9/24/13''
The Apple Cinnamon Mini Muffins contain undeclared soy, a known allergen.
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico except DE, ME, NM, RI, and VT, and the countries of UNITED ARAB EMIRATES, JAPAN, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MACEDONIA , MALAYSIA, MEXICO, MOLDOVA, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERATION,SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, TANZANIA, THAILAND, TURKEY, UNITED KINGDOM, VIETNAM, URUGUAY, and VENEZUELA.
GE Healthcare, Aisys, Amingo, Avance, and Avance CS2.   Intended for volume or pressure control ventilation.
GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices.   While operating in Pressure Control Ventilation  Volume Guarantee (PCV-VG) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit).    Exposure to excessive tidal volumes while pressure limits are maintained can result in pulmonary volutrauma and/or an increased pulmonary vascular resistance that can negatively affect cardiac filling pressure and/or stroke volume.