Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, which may have been transported under unacceptable temperatures after collection, were distributed.
Blood product, collected from a donor who was considered at risk for human immunodeficiency virus (HIV) Group O, was distributed.
Community Blood Centers of South Florida, Inc.
Blood product, with an unacceptable platelet yield, was distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood product, that was irradiated twice, was distributed
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Blood products, which were not tested for viral markers, were distributed.
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Blood products, collected from a donor who was not asked follow-up questions regarding increased risk for vCJD, were distributed.
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed..
Red Blood Cells Leukocytes Reduced Irradiated
Utah, Nevada, Washington DC, California, North Carolina and Pennsylvania
Blood products, possibly contaminated with air, were distributed.
Plasma Frozen Within 24 Hours After Phlebotomy (FP24)
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
Community Blood Centers of Florida, Inc.
Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
Blood Centers of the Pacific - Irwin Center
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed
Red Blood Cells Deglycerolized Leukocytes Reduced
Blood products, with an unacceptably low red cell recovery rate, were distributed.
Beth Israel Medical Center, The Ralph Gore Blood Bank
Blood product, labeled as leukoreduced, but which had not undergone leukoreduction, was distributed.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Hoxworth Blood Center  UC Medical Center
Blood products, which were collected from a donor who lived in a malarial endemic area, were distributed.
West Tennessee Regional Blood Center Inc
Blood product, which wase collected from a donor who traveled to a malarial endemic area, was distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Blood products, leukodepleted greater than five days after collection, were distributed.
Dried mushrooms sold under the following brand names:    1) CURIOSITY OF DASHAN brand DRIED MUSHROOM, N.W. 100G (3.5 OZ), UPC 6 939457 003484, Product of China --- Imported By: DZH Import & Export Inc. 70-21 51 Avenue, Woodside, NY 11377  Tel: 718-205-8312   Fax: 718-205-8146 --- Nutrition Facts: Serving Size 1/2 cup (7g dry) (30g  reconstituted) -- Servings Per Container about 4.  --- The product is packed on a plastic tray inside a plastic bag.    2) MOUNTAINS brand DRIED MUSHROOM, NET WT: 35G (1.23 OZ) , UPC 6 931653  104064, Product of China --- Imported By: DZH Import & Export Inc. 70-21 51 Avenue, Woodside, NY 11377  Tel: 718-205-8312   Fax: 718-205-8146 --- Nutrition Facts: Serving Size 100g -- Servings Per Container 3  --- The product is packed on a plastic tray inside a plastic bag.
1) BEST BEFORE: MAY 3rd, 2013.  2) Best Before: Nov.30, 2013.
1) 15 cases (50 x 35 gram packages per case) 2) unknown
1) The product contained undeclared sulfites (7984 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets. 2) The product contained undeclared sulfites (7943 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
Product was distributed to the following states: AL, AZ, CA, CO, GA, IL, IN, KS, KY, LA, MD, MI, MO, NC, NE, NJ, NV, NY, OK, PA, SD, TN, TX, VA, WA, WI & WV.  Product was also shipped to Canada and the United Kingdom.
BUFFALO TRACE BOURBON FLAVORED CARAMEL SAUCE 8 oz glass jars Net Wt. 8 fl. oz./227 g, PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: greatboubon@buffalotrace.com website: www.buffalotrace.com UPC 7 95436 00105 8 Best By 2/16/14
The firm failed to include allergen milk on the label of this sauce.
BUFFALO TRACE BOURBON FUDGE SAUCE 8 oz glass jars Net Wt. 8 fl. oz./227 g, PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: greatboubon@buffalotrace.com website: www.buffalotrace.com UPC 7 95436 00103 4 Best By 1/30/14
The firm failed to include allergens of milk and soy on the label of this sauce.
BUFFALO TRACE MARINADE FOR MEAT Net Wt. 12 fl. oz.  PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: greatboubon@buffalotrace.com website: www.buffalotrace.com UPC 7 95436 00107 2 Best By 10/30/14
The firm failed to include allergens of wheat and anchovy on the label of this marinade.  Soy sauce is listed, but soy is not listed as the source of the sauce.
BUFFALO TRACE ORIGINAL FLAVOR BARBEQUE SAUCE Net Wt. 16 fl. oz./532 ml PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: greatboubon@buffalotrace.com website: www.buffalotrace.com UPC 7 95436 00106 5 Best By 1/19/15
The firm failed to include allergens of soy and anchovy on the label of this sauce.
BUFFALO TRACE HOT BARBEQUE SAUCE Net Wt. 16 fl. oz./532 ml PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: greatboubon@buffalotrace.com website: www.buffalotrace.com UPC 7 95436 00017 4 Best By 11/7/14
The firm failed to include allergens of soy and anchovy on the labels of this sauce.
Worldwide Distribution - USA Nationwide and the countries of:  Algeria, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam.
Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S.  Sterile and Non-Pyrogenic.   Product Usage:    The deep brain stimulation system delivers electrical stimulation to selected targets in the brain. DBS Leads are indicated for Dystonia, Essential Tremor (ET), Obsessive-Compulsive Disorder (OCD), Parkinsons Disease (PD), and epilepsy.
all product is affected as the lead kits are not being removed from the market.  Medtronic is providing Additional Instructions for Capping the Lead and Removing the Lead Cap.
There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits.  Medtronic has received reports of DBS leads being damaged at the connector end of the lead when the lead cap is used. The connector end of the lead is the end of the lead connected to the lead extension. Tightening or loosening of the setscrew may twist the setscrew connector block and may damage the proximal connector end of the lead.  If this happens, the damage would most likely occur at lead contact #3 which could affect electrode contact #3.
Medtronic DBS Therapy for Dystonia Kit,  models 3317, 3319, 3337 and 3339.  Sterile and Non-Pyrogenic.      Product Usage:  Dystonia Therapy Kit is indicated for unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) to aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis).
Femhrt (norethindrone acetate and ethinyl estradiol) tablets,  0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx only,  Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866
Chemical contamination: Firm's inspection discovered the  presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Distributed by Watson Pharma, Inc. Corona, CA 92880.
Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bottle ( NDC#: 0430-0544-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866
Nationwide Distribution including the states of AZ, CA, DE, FL, GA, HI, IA, ID, IL, KS, KY, LA, MN, MO, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, UT, WA and WV.
Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367.   Intended to filter bacteria and endotoxins from dialysis fluid.
There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over time, which results in the reduction of the membrane permeability (ultrafiltration coefficient).
CareStream Dental CS 2100 X-ray system   Product Usage:  The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.
CareStream Dental CS 2200  X-ray system   Product Usage:  The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
CareStream Dental Kodak 2100 X-ray system   Product Usage:  The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
CareStream Dental Kodak 2200 X-ray system   Product Usage:  The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
Nutrex Research Lipo 6 Black Ultra concentrate Fat Destroyer
Product samples contain DMAA (Methylhexanamine).
Nationwide Distribution including AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MO, MT NH, NJ, NM, NV, NY, OH, PA, SD, TX, UT, VA, and WA.
SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street, Culver City CA 90232.   The SL3 is a soft-tissue diode laser intended to be used for dental procedures
The firm is initiating this recall of  the SL3 Soft Tissue Laser equipped with a fiber optic Unifiber system which contains a fragile glass filament because the fiber broke near the hand piece.
Nationwide, Bahamas, and Turks & Caicos Islands
Infants Gripe Mixture, Each 5 mL contains: Light Magnesium Carbonate BP, 200.0 mg; Sodium Bicarbonate BP, 100.0 mg; Sucrose, 487.5 mg; Alcohol, 0.362 mL; Fennel Oil BP, 0.004 mL; Dill Oil BP, 0.005 mL), 120 mL bottle, Manufactured by: P.A. Benjamin Manufacturing Co. Ltd., 97 East Street, Kingston, JAMAICA; UPC 0 83276 34324 8.
CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was not manufactured under current good manufacturing practices.
Worldwide distribution: USA (nationwide) and countries of: ALGERIA, ANDORRA, ANTILLES (Netherlands), ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBADJAN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL, BRUNEI, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CONGO, COSTA RICA, CROATIA, CUBA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR,   ESTONIA, YUGOSLAVIA (Former), FIJI, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HONDURAS, HONG KONG,  HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KENYA, KUWAIT, KYRGYZSTAN, LATVIA, LIBYA, LITHUANIA, LUXEMBURG, MACAU, MACEDONIA, MALAYSIA, MALDIVES, MARTINIQUE (French), MEXICO, MOLDAVIA, MOROCCO, NEPAL, NETHERLANDS, NEW CALEDONIA (French), NEW ZEALAND, NICARAGUA,   NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA, PAPUA NEW GUINEA, PARAGUAY, PERU, PHILIPPINES, POLAND, POLYNESIA (French),   PORTUGAL, QATAR, REUNION (French), ROMANIA, RUSSIA, SAUDI ARABIA,   SERBIA, SEYCHELLES, SINGAPORE, SLOVAK REPUBLIC, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SUDAN, SURINAM, SWEDEN, SWITZERLAND, SYRIA, TADJIKISTAN, TAIWAN, TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VATICAN city state, VENEZUELA, VIETNAM and YEMEN.
Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180).   Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respiratory failure or insufficiency. The ventilator is equipped with at least 2, NiMH battery modules (Part No. 6487180) which automatically supply 12V DC Power in case of an AC power failure, ensuring that ventilator settings and stored data remain intact in the event of an AC power failure. The battery modules give the user a possibility to use the SERVO-i during intra-hospital transportation.
SERVO-i Battery Module part number is 6487180.  Notice pertains to Battery Modules manufactured between February 2010 and October 2012 with date codes between 1005 and 1243.
When using the SERVO-i on battery power, in a very small number of cases, some battery modules distributed after January 31, 2010 have a shorter battery run time than expected.
Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC 63824-711-16 b) Institutional Size, 576-count, NDC 63824-711-98, OTC,  Dist. by: Reckitt Benckiser, Parsippany, NJ  07054
27,718 cases 16 count and 7,551 cases 576 count
Subpotent Drug: Product did not conform  to the 18-month stability test specification for active Free Benzocaine.
Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5552-3.
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), Rx only Manufactured By: West-ward Pharmaceutical, 435 Industrial Way West, Eatontown, NJ 07724  Manufactured For: PBM Pharmaceuticals, Inc. Gordonsville, VA  22942.
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration date of Apr 2015.  The correct expiration is Apr 2013.
Mozzarella Bites distributed under the following labels: Farm Rich Cheese In a Pizzeria Style Crust,  Product Code 36450 Net Wt. 22-oz bag-UPC Code 0 41322 37443 1;  Product Code 37443 Net Wt. 22-oz bag-UPC Code 0 41322 37443 1;  Product Code 37433 Net Wt. 22-oz bag-UPC Code 0 41322 37813 2;   Product Code 37691 Net Wt. 7-oz cartons-UPC Code 0 41322 37691 6;  Product Code 32521 and 32522; Net Wt. 44-oz cartons-UPC 0 41322 32521 1;  Product Code 37455 Net Wt. 2 lb. cartons-UPC Code 0 41322 37455 4,  Market Day, Net Wt.. 22-oz cartons-UPC Code 0 41322 80435 8, Product Code 80435;   Schwan's Baked Mozzarella Bites Net Wt.. 22 oz bags- UPC Code 0 72180 61008 9, Product Code 61008, the production date range for these products is 3G1182XXXX - 3G3088XXXX.
Julian Dates 15821182 to 15823088; Best By Dates January 1, 2013 - September 29, 2013
Products potentially contaminated with E. coli O121.
Farm Rich Stuffed Crust Pizza Dippers-Pizza Dough Stuffed with Mozzarella Cheese, Net Wt. 27-LBS (10 X 2.7-LB), UPC Code 10041322652659, Product Code 65265; Net Wt. 25-LB (1 X 25-LB) UPC Code 10041322652680, Product Code 65268.
21,874 cases (product code 65265), 185,646 cases ( product code 65268)
Farm Rich Better For You Pizza Dippers-Pizza Dough made with Whole Wheat Flour and Stuffed with Mozzarella Cheese and Reduced Fat Mozzarella Cheese, Net Wt. 27-LBS (10 X 2.7-LB), UPC Code 00041322652782, Product Code 65278.
Farm Rich Better For You Pizza Dippers-Pizza Dough Stuffed with Reduced Fat Mozzarella Cheese, Net Wt 25-LBS (5 X 5-LB), UPC Code 10041322652338, Product Code 65233.
Worldwide Distribution - USA (nationwide) including the countries of  Africa, Asia, Australia/New Zealand, Europe, Canada, Latin America, and Middle East / SW Asia.
Rad-8 Pulse Oximeters    The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button.
Nationwide Distribution including IL, SC, TX, VA, FL, AR, and NY.
NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case    The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Worldwide Distribution -- USA, excluding RI and SD and including DC and PR, and the countries of ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELARUS, BOLIVIA, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GREECE, GUAM, HONDURAS, HONG KONG, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN,JORDAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOSCOW, MYANMAR, NAMIBIA, NETHERLANDS, NEW ZEALAND, NIGERIA, NORTHERN IRELAND, NORWAY, OMAN, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SERBIA AND MONTENEGRO, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIETNAM, and YEMEN.
Vitrea CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite.   Noninvasive post-processing application designed to evaluate areas of brain perfusion.
Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing a brain perfusion scan on Vitrea CT Brain Perfusion 2D when the scan was performed using a wide coverage shuttle acquisition technique.  This may result in patient treatment delays, misdiagnosis or mistreatment.
Worldwide Distribution - USA (nationwide) and internationally to Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.   The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required.
List Number 13000: 25,119 pumps; List Number 13100: 185 pumps; List Number 13150: 13,497 pumps
Pump shutting off during use without warning.
List Number 13086: 286 pumps; List Number 13087: 45,376 pumps; List Number 13088: 23,942 pumps
Worldwide Distribution - USA (nationwide) Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.
GemStar Pump  - Battery     Product Usage:  The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.
List Number 13000: 25,119 pumps; List Number 13100: 185 pumps; List Number 13150:  13,497 pumps
Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.
GemStar Pump  - Battery   Product Usage:  The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.
List Number 13086: 286 pumps; List Number 13087: 45,376 pumps; List Number 13088: 23,492 pumps
Worldwide Distribution - USA including US (AL, AR, AZ, CA, CO, CT, DE, FL, GA, lA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, WA, and WI. Internationally to Argentina, Australia, Bangladesh, Belgium, BoliVia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Ecuador, Egypt, France, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Ireland, Italy, Japan, Kazakhstan, Kosova, Lebanon, Lithuania, Malaysia, Mexico, Nambia, Nepal, Norway, Oman, Paraguay, Peru, Philippines, Poland, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Sri Lanka, Switzerland,  Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.
Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries  Model number: HT70 and HT70 Plus.     The HT70 and HT70 Plus ventilator systems are intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces.
Model number: HT70 and HT70 Plus   Power Pac battery serial number range: 2096134110001 to  2292048120050, Rev. C through Rev. F
2528 ventilators and 1864 power pac batteries
Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries due to customer reports of Newport HT70 and HT70 Plus ventilators alarming and going to internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery.
US Distribution to the state of California and International Distribution to the country of Venezuela.
3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
Model/Catalog Number 391-15-708.  Lot/Serial Number 59602230.
U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts.  There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were incorrectly labeled.
Worldwide distribution:  USA (nationwide) and countries of: Afghanistan, Albania, Argentina, Australia, Austria,  Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegowina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cambodia, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic Of, Kuwait, Laos, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Malta, Mexico, Mongolia, Morocco, Namibia, Nepal, Netherlands (Antilles), New Caledonia, New Zealand, Nicaragua, Nigera, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Puerto, Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, SRI Lanka, Sweden, Switzerland, Taiwan (Province of China), Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Veit Nam, and Yemen.
HeartStart MRx Monitor/Defribillator; Product Codes:  M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6.     The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.
Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode.
Worldwide Distribution-USA (nationwide) and the countries of  Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa.
Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R.    Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
Defibrillation  Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient
Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P.    Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90
cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.
Worldwide Distribution - USA including AL, CA, CO, FL, ID, IL, MA, NH, NJ, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI; Worldwide: Argentina, Australia, Austria, Brazil, Canada, Chile, Denmark, Egypt, Finland, Germany, India, Italy, Japan, Korea, Malaysia, Netherlands, Norway, Peru, Poland, Russia, Singapore, South Africa, Spain, Sweeden, Switzerland, UK, Ukraine, and UAE.
MSK EXTREME MR SCANNER, MODEL AA5000   The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the thigh), knee, ankle, foot, forearm, elbow, wrist and hand.
Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.
Optima MR430s MRI Scanner; 5000-0002   is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand.
Worldwide Distribution-USA (nationwide) including DC and the states of AZ, CA, CO, CT, FL,GA, IL, IN, KY, MA, MI, MS,MO, NH, NJ, NM, NY, NC, OK, OR, PA, SC, SD, TX, UT, VA, WA, and WI and the countries of ALBANIA ARGENTINA AUSTRALIA BELGIUM BRAZIL CANADA CHINA COLOMBIA COSTA RICA CZECH REPUBLIC DENMARK ECUADOR EGYPT FINLAND FRANCE GREECE HONG KONG HUNGARY INDIA IRELAND ITALY JAPAN KOREA, REPUBLIC OF MEXICO MOROCCO NIGERIA NORWAY POLAND RUSSIAN FEDERATION SINGAPORE SPAIN SWEDEN SWITZERLAND TURKEY UKRAINE UNITED KINGDOM.
GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD.   Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from the gantry and hit the inside of the covers and other components of the gantry possibly resulting in the oil conduit breaking, spilling oil within the gantry and outside the system. This issue affects GE Healthcare VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD.
Wegmans Food You Feel Good About Roasted Red Pepper Dip, Net Wt 8 oz. (227g) Product is packaged in plastic containers, 12 containers per case. UPC: 77890 23286 with a best-by date of 5/17/2013.  Commodity Code: 23286, Item #: DIPWG23286
Wegmans Foods Markets issued a Press Release on April 16, 2013 and is recalling affected units of Roasted Red Pepper Dip because some of the tubs may have an incorrect ingredient label that does not list milk and eggs.
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, excluding the state of RI and the countries of Yugoslavia YEMEN Viet Nam Venezuela Uzbekistan Uruguay United Arab Emirates Tunisia Thailand Tanzania Taiwan Turkey Syria Switzerland Sweden Spain South Korea South Africa Slovenia Slovakia Singapore Saudi Arabia Russia Romania Reunion Qatar Portugal Poland Philippines Peru Pakistan Paraguay Philippines Oman Norway Nigeria New Zealand Netherlands Morocco Mexico Martinique Malaysia Macedonia Mauritania Luxembourg Lithuania Libya Lebanon Latvia Kuwait Kenya Korea Korea (Republic Of [South] Korea) KUWAIT Kazakhstan Jordan Japan Jamaica Italy Israel Ireland Iran Iraq Indonesia India Hungary Hong Kong Honduras Guadeloupe Greece Germany Georgia, Republic of French Polynesia France Finland Estonia Ecuador Egypt Denmark Dominican Republic Czech Republic Croatia Colombia China Chile Canada Bulgaria Brazil Bosnia And Herzegovina Belgium Belarus Barbados Bahrain Austria Australia Argentina Arab Emirates Algeria and United Kingdom.
GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant.   Indicated for use as a diagnostic imaging device.
GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products.   The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip .  In addition, the acquired sagittal images may be annotated with left-right location annotation reversed. This issue may lead to incorrect localization of  findings, particularly where symmetric anatomy is present.
GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM.   Indicated for use as a diagnostic imaging device.
GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR System.   Indicated for use as a diagnostic imaging device.
MediChoice Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002.   Product Usage:  Usage:  An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.
Owens & Minor Distribution, Inc. is conducting a market withdrawal of MediChoice Applicator OB-GYN 8 inch product that does not meet our quality standards because the rayon may loosen or unravel from the applicator during use.
Nationwide Distribution including the states of AL, AZ, IL, KY, LA,  NJ,  NC, FL, CA,  NM,  MO, TN, VA, CO, MA, TX,  IN and MT.
Stryker Howmedica Osteonics Corp.  AxSOS  System Instrument.   The AxSOS Locking Plate System is designed to treat periarticular or intraarticular fractures of the Distal Femur, Proximal Humerus, Proximal Tibia, and the Distal Tibia. Per the operative technique, '' A 4.3 mm Drill (REF 702743) is then used to drill the core hole for the locking screw. Using a fluoroscopy, check the correct depth of the drill, and measure the length of the screw. The Drill Sleeve should now be removed, and the correct length 5.0 mm Locking Screw is inserted using the Screwdriver T20 and Screw Holding Sleeve.''
Stryker Orthopaedics has received a report indicating that the scale of the AxSOS Calibrated Drill Bit 4.3,,X263mm, flat , manufactured by Stryker Osteosynthesis, is incorrect.  The incorrect scale could result in the surgeon selecting a screw that is 10mm longer than intended.
Worldwide Distribution - USA (nationwide) and internationally to Poland, India, Canada, Germany, United Kingdom, New Zealand, Belgium, Malaysia, Republic Korea, Ireland, Australia, Norway, Japan, Turkey, Croatia, Saudi Arabia, Colombia, P.R. China, Brazil, Thailand, Romania, Lebanon, Mexico,  Italy, Sweden, Czech Republic, Russian Federation, and South Africa.
Software correction applies to customers who use the RT Therapist  RTT4.2.108 and RT Therapist Connect RTT 4.2.108  on Siemens ARTISTE, ONCOR and PRIMUS systems.    ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Syngo RT Therapist RTT 4.2.108; part number 8162815: Syngo ST Theratpist Connect RTT 4.2.108; part number 8168754
Software update to fix multiple safety related issues.
Pineapple Fruit Bar, 4 oz. Undeclared FD&C Yellow # 6 and Red # 40 packaged in clear flexible plastic  ingredients: water, pineapple, sugar, citric acid, yellow 5 UPC Code 8 94163 00210 6
Product labeling is incorrect, FD&C colors are undeclared.
Mango Dessert Bar, 4 oz. Undeclared FD&C Yellow # 6 and Blue # 1  in clear flexible plastic. Ingredients: water, sugar, mango, partially hydrogenated palm kernel oil, nonfat milk solids  UPC Code 8 94163 00220 5
Vanilla Eskimo Dessert Bar , 4 oz. Undeclared FD&C Yellow # 6 in clear flexible package, ingredients: water, chocolate coating (coconut oil, sugar, partially hydrogenated coconut and soybean oil, cocoa, corn starch, soy lecithin, etc.) red 40, yellow 5 UPC Code 8 94163 00230 4
Spicy Mango Dessert Bar  , 4 oz. Undeclared FD&C Yellow # 6 and Blue # 1 in clear flexible plastic, ingredients: water, mango, sugar, lime juice, salt, citric acid, chili powder, yellow 5, red 40
Spicy Cucumber Fruit Bar , 4 oz. Undeclared FD&C Yellow # 6 and Blue # 1  in clear flexible plastic ingredients: water, cucumber, sugar, orange juice, lime juice, salt, citric acid, chili powder, yellow 5, red 40  UPC Code 8 94163 00210 6
Guava Fruit Bar  , 4 oz. Undeclared FD&C Red # 40 in clear flexible plastic, ingredients: water, guava fruit, sugar, tumeric, blue 1,  UPC Code 8 94163 00210 6
Watermelon Fruit Bar , 4 oz. Undeclared FD&C Blue # 1 packaged in clear flexible plastic ingredients: water, watermelon, sugar, red 40 UPC Code 8 94163 00210 6
Pina Colada Dessert Bar  , 4 oz. Undeclared FD&C Red # 40 in clear flexible plastic, ingredients: water, sugar, partially hydrogenated palm kernel oil, nonfat milk solids, cream of coconut, whey powder,
Strawberry Milk Dessert Bar  , 4 oz. Undeclared FD&C Blue # 1  ingredients: water, sugar, partially hydrogenated palm kernel oil, nonfat milk solids, red 40,  UPC Code 8 94163 00220 5
Bubble Gum Frozen Dessert Bar   , 4 oz. Undeclared FD&C Red # 3 packaged in clear flexible plastic, ingredients: water, sugar, citric acid, blue 1 UPC Code 8 94163 00210 6
Strawberry Fruit Bar  , 4 oz. Undeclared FD&C Blue # 1 ingredients: water, strawberries, sugar, citric acid, red 40 UPC Code 8 94163 00210 6
Strawberry Eskimo Dessert Bar  , 4 oz. Undeclared FD&C Blue # 1 packaged in clear flexible plastic, ingredients: water, chocolate coating (coconut oil, sugar, partially hydrogenated coconut and soybean oil, cocoa, corn starch, soy lecithin, etc.) red 40, UPC Code 8 94163 00230 4
Vanilla Dessert Bar , 4 oz. Undeclared FD&C Yellow # 6 packaged in clear flexible plastic, ingredients: water, sugar, partially hydrogenated palm kernel oil, nonfat milk solids, corn syrup, whey powder, raisins....red 40, yellow 5 UPC Code 8 94163 00220 5
Shipped to one distibutor, Putney Inc in Maine.  No foreign, military, or government consignees.
Amoxicillin Capsules, USP, 500mg, 500 count bottles, NDC 26637-222-50.
Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500mg due to potential contamination with fragments of stainless steel wire mesh.
Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals
''Well at Wallgreens'' Regular Strength Antacid Liquid (Alumina/Magnesia/Simethicone/Antacid & Anti Gas); Mint, a)12 oz bottle (NDC 0363-0073-02), b) 26 oz. bottle (NDC 0363-0073-26), Distributed by Walgreens CO., 200 Wilmot Rd, Deerfield, IL 60015.
Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination.
Worldwide Distribution - Nationwide Distribution including the states of AR, AL, AK, AZ, CA, CT, CO, DE, FL, GA, HI,  IA, IL, IN, ID,  KY, LA, MA, ME, MD, MI, MS, MN, MO, MT, NC, ND, NE, NJ, NY, NV, NH, NM, OH, OR, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV.,  and the countries of AR, AU, BE, BR, CA, CL, CN, CO, DO, EC, GT, HK, ID, IN, JP, KR, MV, MX, PA, PE, PH, PR, RU, SG, TH, TW, UY, VE and VN.
STERRAD CYCLESURE 24 Biological Indicator (BI)   The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indicator product because it may not have adequate data to support the entire duration of the labeled shelf-life.
Percocet 10/325 mg tablets, 100-count tablets per bottle, Rx only, Dist. By: Physicians Total Care, Tulsa, OK  74146; Mfg. By: Novartis Consumer Health I, Lincoln, NE  68581; NDC 54868-4710-0, Barcode 47101006IHD.
Presence of Foreign Tablets/Capsules: One bottle of Percocet 10/325 mg was found to contain a tablet of Endocet 10/25 mg, the generic form.
Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1.
Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.