Cucumbers, 44 lbs/box. Brand: Malichita (green, yellow, red and white background color on each cartons)
Altiza is recalling Malichita brand cucumbers because they may be contaminated with Salmonella.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), 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.
Blood and Blood Products for Reprocessing
Blood product, for which Collection/Aperesis device was not used within acceptable time period, was distributed.
Red Blood Cells Leukocytes Reduced collected on 5/31/2005
Blood products, collected using equipment for which quality control was not performed, were distributed.
Donor Screening /incorrect ID used during deferral search, donor previously deferred due to testing.
Blood products, collected from a donor who was previously deferred by another donor center, were distributed.
Blood products, collected from a donor who did not have a complete physical examination, were distributed.
Blood product, collected from a donor, whose suitability to donate was not adequately determined, 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 previously deferred due to testing, were distributed.
Blood product, collected from a donor who was previously deferred, was distributed.
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood products, collected from a donor taking the medication Accutane, were distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, in which quality control and distribution of products did not meet specifications, were distributed.
Blood product, which was possibly contaminated with penicillium species, was distributed.
Blood products, for which the quality control testing was incomplete, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, where the blood collection of the products may have been compromised, were distributed.
Community Blood Bank of Lancaster County Medical Society
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Blood Products, which were contaminated with Corynebacterium species, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood product, which exceeded time allowed for storage and shipping temperatures, was distributed.
Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.
Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. The accuracy on any cuvette size did not meet the specifications.
HEB Deli General Joes Chicken Entree, UPC 0026966900000;   HEB Deli HE Bowl General Joes Chicken,  UPC 0026967400000; HEB Deli General Joe's Chicken Retail Pack, UPC 0026520900000; HEB Deli General Joes Chicken UPC 0026703700000
The product has the potential to be contaminated with salmonella.
HEB Deli Lemon Grass Chicken Entree UPC 0026967100000;  HEB Deli HE Bowl Lemon Grass Chicken UPC 0026967600000; HEB Deli Lemon Grass Chicken Retail Pack UPC 0026521800000; HEB Deli Lemon Grass Chicken UPC 0026705200000
HEB Deli Sesame Chicken Entree UPC 0026960600000;  HEB Deli HE Bowl Sesame Chicken UPC 0026967700000; HEB Deli Sesame Chicken Retail Pack UPC 0026521900000; HEB Deli Sesame Chicken UPC 0026704500000
HEB Deli Sweet and Sour Chicken Entree UPC 0026967200000; HEB Deli HE Bowl Sweet and Sour Chicken UPC 0026967800000; HEB Deli Sweet and Sour Chicken UPC 0026705000000
Nationwide Distribution including MI, PA and TX.
Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet & RT-ANG Guide   Central Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
The deflector may not move freely on the ventricular catheter.  The deflector comes pre-positioned at the 5 cm mark on the catheter.  In some cases the surgeon will want to adjust the deflector to a different location on the catheter before placing it in the ventricle.  There is a small percentage of cases where aggressively attempting to adjust the deflector has a potential to cause the catheter to tear.
Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty;  Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109;  and Graft ID# B090056-675 Bone void filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects.
Graft ID# B090056-664 and Graft ID#: B090056-675, both with Donor# B090056 and Expiration Date: 12/25/2011
2  packages each containing 2.5cc of putty
Expired product was shipped to two customers.
Nationwide Distribution  - ALL STATES IN CONTINENTAL USA INCLUDING PR and DC excluding AK, DE, ND, and VT.       ALGERIA, AUSTRALIA, ANGOLA, ARGENTINA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CUBA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GHANA, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNG ARIA, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAHSTAN, KENYA, KOREA, KUWAIT, LATIVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, MALAYSIA, MEXICO, MALTA, MOROCCO, NEPAL, NETHERLAND, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PALESTINIAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN THAILAND, TRINIDAD AND TOBAGO,K TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARB EMIRATES , UNITED KINGDOM, URUGUAY.    PUERTO RICO
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories.
GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor.    These issues may occur when the Ethernet controller in the XPC823 CPU on the Dash and DashPort 2  motherboard functions intermittently. GE Healthcare has identified that these issues occur most often at sites with large Unity Network installations. It should be noted that the Dash 3000/4000/5000 patient monitor continues to monitor parameters and alarms as a stand-alone bedside with no issues.
Worldwide Distribution and US (nationwide) including DC and the countries of ALGERIA, ARAB EMIRATES, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, CYPRUS, CZECH REPUBLIC, DENMARK, EGYPT, FRANCE, GERMANY, INDIA, ISRAEL, ITA LY, JAPAN, JORDAN, KUWAIT, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE SLOVENIA, SOUTH KOREA, SPAIN SWEDEN SWITZERLAND, TAIWAN, TURKEY, UNITED KINGDOM.
GE Healthcare, Dash Port 2 Docking Station.   Product Usage: is a docking station (quick mount/dismount base) for a Dash patient monitor.  The system is to monitor physiologic parameter data on adult, pediatric, and neonatal patients.
GE has become aware of multiple issues affecting the Dash 3000/4000/5000 and DashPort 2 monitor. This report of correction encompasses the DashPort 2 device, in which the DashPort 2 stops  communicating with the Dash, resulting in Loss of Monitoring at the CIC. The DashPort 2 status LEDs  in the back of the unit indicate Unity Network and DashPort 2 to Dash communication has stopped.
Regular Chicken 50#    Ingredients: Corn, Wheat, Oats, Oyster shells, Medium Grit, CCC, ADS, Plant Protein Products, Animal Protein Products, Processed Grain By-Products, Roughage Products, Animal Fat procession with DHA, etc
During an FDA sample collection, the firms 50# Regular Chicken Feed was found to contain mammalian protein. The label does not contain the warning statement.
Worldwide Distribution - Worldwide Distribution - USA including AL, AZ, CA, CO, FL,GA, IA, ID, IL, KY, MA,  MD, MI, MN, MO, MS, MT, NC, ND ,NE, NM, NV, NY, OH, OR, PA ,TX,  VT, WA, WI and WV; and the countries of Australia, Belgium, Canada, China, France, New Zealand, Poland, Saudi Arabia, Switzerland and United Kingdom.
GE Healthcare - Giraffe and Panda T-Piece Resuscitation System   The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.
276 units total, 109 of those nationwide.
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
Giraffe and Panda Bag and Mask Resuscitation System   The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.
Worldwide Distribution - US Nationwide including: CA, WI, NC, FL, PA, IN, NM, NJ, IA, WA, OH, FL, MD, MA, WY, NY, AZ, NH, MN, TN, OK, KY, TX, AK, MI, VT.  Internationally: Japan, Nepal, India, UK, South Korea, Netherlands, Germany, Australia, China, Canada, Turkey, Spain, Italy, Egypt, Mexico, Bulgaria, Utd. Arab, Emir., Poland, Kuwait, Hong Kong, Saudi Arabia, Yemen, Qatar, Czech Republic, New Zealand, Malaysia, Portugal, France, Argentina, Singapore, Romania, Chile, Colombia, Switzerland, Bahrain, Brazil, Serbia/Montenero, Taiwan, Israel, Indonesia, Peru, Pakistan, Nepal, Belarus, Latvia, Sri Lanka, Russian Fed, Thailand, Azerbaijan, Belgium, and Denmark.
The Lumenis VersaCut Tissue Morcellator     Product Usage:  is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.
Model Numbers 0637-245-01 (starter kit) and 0636-470-01 (Control Box) which includes all products since initial product release 1998.
Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective labeling as a result of three reported events of air embolism secondary to incorrect reversal tubing system hook-up.
Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only, Manufactured for Upsher Smith Laboratories, Inc Minneapolis MN 55447  ---  NDC 0245-0085-11, UPC 3 0245-0085-11 9
Cloth electrodes with Carbon construction:  P/N 201-1231, Cat Nos.:  201-123, 202-454, 203-118, 203-342, 203-454, 203-493, 203-672, 400-877, and 400-877-BJC, 2 x 2 Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010   P/N 201-1241, Cat Nos.:  201-124, 202-455, 203-340, 203-674, and 400-872, 2 Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 201-1251, Cat Nos.: 201-138, 202-276, 202-456, 203-336, 203-680, and 400-879, 3 Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 201-1381, Cat Nos.: 201-126, 203-678, and 400-856, 2 x 3.5 Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 201-1501, Cat Nos.: 201-150 and 400-863, 1.25 Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 201-1521, Cat No. 400-852, 3 x 5 Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 201-1541, Cat Nos.:201-154 and 400-865 1.5 x 2.5 Oval Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010    Cutaneous electrode.
All Serial Numbers distributed between 11/01/2009 and 01/31/2010
Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
Cloth electrodes with Silver-Carbon construction: P/N 202-9231, Cat No. 400-899, 2 x 2 Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 202-9241, Cat No. 400-895, 2 Round Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 202-9381, Cat No. 400-889, 2 x 3.5 Electrode, Cloth AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 202-9501, Cat No. 202-9501, 1.25 Round Electrode, Cloth AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 400-8991, Cat Nos.:  400-877T and 400-899T, 2 x 2.25 Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010.    Cutaneous electrode.
Foam Electrodes with Carbon construction: P/N 201-1261, Cat Nos.: 201-126, 203-678, and 400-856, 1.5 x 3.5 Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 201-1271, Cat Nos.: 201-127, 202-093, 203-483, 203-565, 203-673, and 400-873, 2 x 2 Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 201-1281, Cat Nos.: 201-128, 202-277, 203-675, and 400-873, 2 Round Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 201-1291, Cat Nos.: 201-129, 203-677, and 400-882, 3 Round Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 201-1301, Cat Nos.: 201-130, 203-679, and 400-855, 1.5 x 3.5 Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 201-1371, Cat Nos.: 201-137, 202-278, 203-484, 203-681, and 400-880, 2 x 3.5 Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 202-5671, Cat No. 202-567, 2 x 2 Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010.    Cutaneous electrode.
Foam electrodes with Silver-Carbon construction: P/N 202-9271, Cat No. 400-898, 2 x 2 Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 202-9281, Cat No. 202-9281, 2 Round Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 202-9251, Cat No. 400-893, 3 Round Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 202-9291, Cat No. 400-892, 3 Round Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 202-9371, Cat No. 400-888, 2 x 3.5 Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 202-9491, Cat No. 400-869, 1.25 Round Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 202-9511, Cat No. 400-853, 3 x 5 Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 300-1541, Cat No. 300-154, 2 x 2.25 Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 300-1561, Cat No. 300-156, 2 Round Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 300-1611, Cat No. 300-161, 4 x 2.25 Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010, 22818  P/N 300-1631, Cat No. 300-163, 3 Round Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010  P/N 400-8701, Cat No. 400-870, 2 x 4 Oval Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010.    Cutaneous electrode.
Lone Star 22-10-.5 Instant Medicated Calf Milk Replacer 25lb bag, manufactured for Texas Farm Products Company, Nacogdoches, Texas 75963
Category II drug NeoOxy 100/100 MR used in milk replacer was expired as of December 2011.
''ESTRELLA***Empanadillas de Pizza'' (Pizza turnovers)***5 units, 12 units and 24 units***Elaborado y Empacado por: Estrella Food Products, Inc., Bayamon, PR 00959-1906***''.
Undeclared wheat and undeclared milk as the source of cheese.
''Estrella Food Products, Inc***Pastelillos de Queso (Cheese Mini Turnovers)***6 units***Manufactured by: Estrella Food Products, Inc., Minilla Industrial Park, Bayamon, PR 00959-1906***''.
Casein is listed as a sub-ingredient of cheese, but common name ''milk'' is not declared in the list of ingredients and/or ''Contains'' statement.
''Estrella Food Products, Inc***Pastelillos de Pizza (Pizza Mini Turnovers)***6 units***Manufactured by: Estrella Food Products, Inc., Minilla Industrial Park, Bayamon, PR 00959-1906***''.
''Estrella Food Products, Inc***Empanadillas Sabor a Carne(Meat flavorTurnovers)***5 units, 12 units and 24 units***Elaborado y Empacado por: Estrella Food Products, Inc., Bayamon, PR 00959-1906***''.
''Estrella Food Products, Inc***Plantillas Para Pastelillos, tacos, Empanadillas, etc. (Yellow dough shells)***12 units, and 20 units***Manufactured by: Estrella Food Products, Inc., Minillas Industrial Park,Bayamon, PR 00959-1906***''.
''Estrella Food Products, Inc***Pastelillos de Guayaba (Guava Mini Turnovers)***6 units***Manufactured by: Estrella Food Products, Inc., Minillas Industrial Park,Bayamon, PR 00959-1906***''.
USA Distribution -- Worldwide Distribution  including the states of  AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and WY., and the countries of Australia, Canada, Egypt, Finland, France, Germany, China, Israel, Italy, Japan, Netherlands, New Zealand, P.R. China, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Taiwan R.O.C.,UAE and UK.
Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
Table model 5855, sub assembly 5855-901 Orthopedic Table Spar manufactured between 1996 and 2007.
Possible instability of Orthopedic Table Top.  If the epoxy bond fails, the aluminum plug may migrate out of the carbon fiber tube. If this occurs, the Orthopedic Table Spar may need to be replaced to ensure stability of the Orthopedic Table Top.
Worldwide Distribution - USA (nationwide) and internationally to Korea, Norway, Germany, Chile, Hong Kong, Switzerland, Netherlands, Thailand, Japan, China, and the UK
Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to misdiagnosis.
Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15'' camera systems Laser pointer and illuminator used for law enforcement surveillance from aircraft. Models DNV, TS and DS
These camera systems were  manufactured by LMGS and found to fail to comply with the FDA laser performance standard during an FDA inspection.  These camera systems incorporate Class IIIb surveying, leveling, and alignment lasers and were entered into US commerce without a variance.  Additionally, the manufacturer did not submit a product report to FDA for the camera system.
Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA
Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.
Worldwide Distribution - US Nationwide and the countries of:  AUSTRALIA, AUSTRIA, BELGIUM,CANADA, CHILE, DENMARK, FRANCE  GERMANY, ICELAND, INDIA, IRELAND,ISRAEL,ITALY, JORDAN, KENYA  KUWAIT, LEBANON, MALAYSIA, NAMIBIA, NETHERLANDS, NEW ZEALAND  NORWAY,PALESTINE, POLAND,PORTUGAL, SAUDI ARABIA, SINGAPORE  SLOVENIA, SOUTH AFRICA, SOUTH KOREA,SPAIN,SWEDEN, SWITZERLAND  THAILAND, TRINIDAD AND TOBAGO, UNITED ARAB EMIRATES  UNITED KINGDOM
Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2  Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature    Product Usage:  The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.
VS2+ screen may lock up and stop monitoring during patient use
Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ, 07724, NDC 0143-1250-01.
Subpotent Drug: Test results for assay were confirmed Out Of Specification (OOS) at 92.8% (specification of 97.0 - 103.0%).
Nationwide Distribution-including the states of Florida, Michigan, South Carolina, California, Texas, Maryland, New York, Tennessee, Virginia, Illinois, Ohio, Massachusetts, Arizona and Washington.
Chenica Gunnell Rehab Series of Wheelchairs (GRSW);  Mechanical Wheelchair, Sold as Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Rehab Kidster (Kidster). Provide mobility to individuals limited to a seating position.
The wheelchairs may not meet the specifications of WC-19 (crash testing), therefore the WC-19 verbiage and corresponding logo are removed from the flyers on the Gunnell Rehab Series of Wheelchairs (GRSW).
Worldwide Distribution-USA (nationwide) and the United Kingdom.
Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK).   Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
All units are affected. List of affected serial numbers were provided as Excel spreadsheet due to the large volume.
Domestic: 19,106 units; Foreign: 267 units
Viterion telehealth monitors do not transmit ''HI'' (above the meter's measurable range) and ''LO'' (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, or from Roche's Accu-Chek Advantage 03 and 04 meters to healthcare professionals.
Viterion TeleHealth Monitor Model Number V100-BGM,  Product Code 81842478 (US) -- Common Name: Telehealth monitor, Classification Name: Monitor, physiological, patient (without arrhythmia detection or alarms) --- Manufactured in Japan for: Bayer HealthCare LLC Tarrytown, New York USA.   Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
The company received complaints reporting that ''HI'' readings on certain blood glucose meters were not transmitting from the patient end through Viterion V100 telehealth monitors to healthcare professionals on the other end, who monitor the patient. A ''HI''  reading indicates that the blood glucose result obtained was beyond the measurable range of the meter.  Subsequent investigation confirmed that the Viterion V100, V100-BGM and V500 telehealth monitors do not transmit both ''HI'' (above the meter's measurable range) and ''LO'' (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, as well as from Roche's Accu-Chek Advantage 03 and 04 meters.
Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) ---  Common Name: Telehealth monitor, Classification Name: Monitor, physiological, patient (without arrhythmia detection or alarms) --- Manufactured in Japan for: Viterion TeleHealthcare LLC Tarrytown, New York USA.   Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
Domestic - 296 units, Foreign - 73 units
Mindray DS USA, Inc. d.b.a. Mindray North America
Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices.
Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG waveform may produce a unique step pattern (instead of a flat line) if Lead 1 or V is being utilized for detecting cardiac arrhythmia.
Nationwide Distribution-including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TX, VA, WA, and WI.
St. Jude Medical, AGA Medical corporation, AMPLATZER TorqVue FX Delivery System. Model #'s: 9-ITVFX06F45/60, 9-ITVFX07F45/60, 9-ITVFX007F45/80, 9-ITVFX08F45/60, 9-ITVFX08F45/80, 9-ITVFX09F45/80, 9-ITVFX10F45/80 9-ITVFX12F45/80, 9-ITVFX13F45/80. Cardiac surgical instrument, used to close atrial septal defects between the right and left atriums.
The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when exposed to a combination of certain cardiac anatomies and usage conditions.
AZ, MN, CA , TX, ND, WI, NE, WA, AL, FL, NV , CO, AL, MO, KY, PA, SC.
Stringless Sugar Snap Peas, Sunny Shores' Mann's. Net Wt 8 oz (227 g); Perishable, Preservative Free, keep refrigerated.  Product of Guatemala  UPC 7 16519 13004  Distributed by Mann Packing,  Salinas, CA.
California Department of Food and Agriculture randomly sampled Sunny Shores Mann's snap peas and found them to contain 0.278 and 0.195 ppm of Carbendazim. Carbendazim is a pesticide that is not allowed in the US but is approved for use in the EU>
Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216.   Acute and chronic peritoneal dialysis.
There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis.
Worldwide Distribution-USA (nationwide) and the countries of  Australia, Singapore, Chile, Latvia.
BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER,  Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect.
Affected product will be identified by date of manufacture  from January 2010 through October 2012.
The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance.
BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410. Local anesthetic effect.
Affected product will be identified by date of manufacture from January 2010 through October 2012
12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 mL), labeled as a) 12 HOUR SINUS Nasal Spray, Best Choice, Proudly Distributed By: Valu Merchandisers, Co., Kansas City, MO  64111, UPC 0 70038 61226 1; b) Nasal Spray Sinus, Distributed by Discount Drug Mart, Medina, Ohio 44258, UPC 0 9335112623 9; c) sinus relief nasal spray, Distributed By DUANE reade, 440 Ninth Avenue, NY, NY  10001, UPC 6 39194 04551 3; d) 12 Hour Nasal Relief Sinus Nasal Spray, Distributed by: Lee Pharmaceuticals, South El Monte, CA  91733, UPC 0 23558 69230 5;  e) Sinus Nasal Spray, Premier Value, Distributed By: Chain Drug Consortium, LLC, 2300 NW Corporate Blvd., Suite 115, Boca Raton, FL  33431, UPC 8 40986 01517 5, NDC 68016-0307-03; f) Nasal Relief Sinus Squeeze Spray, Distributed By Quality Choice, Novi, Michigan 48376-0995, UPC 6 35515 99012 8, NDC 63868-0062-30; g) sinus relief nasal spray, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA  17011, UPC 0 11822 14576 3; h) Sinus Nasal Spray, Distributed by: Select Brand Distributors, Pine Bluff, AR  71603, UPC 015127 02305 4, NDC 15127-889-30.
Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeling are being recalled due to microbial contamination identified during testing.
36 distributors nationwide in AZ, CA, CO, CT, FL, GA, IA, IL, IN, MD, NJ, NJ, NV, OR, PA, SC, TN, TX, WA.
Pamela's Baking and Pancake Mix; Gluten Free, Wheat Free  24 oz package.  UPC 93709-30010  Pamela's Products,  Ukiah, CA 95482
Product Code 93709-30010, Best Before Sep 26, 2013.
Firm received complaints for on four (4)  products which may contain glass or plastic fragments.
Pamela's Chocolate Chunk Cookie Mix; Gluten Free, Wheat Free, Non Dairy  13.9 oz. package.  UPC 93709-30050  Pamela's Products,  Ukiah, CA 95482
Product Code 93709-30050, Best Before Oct 7,  2013.
Pamela's Chocolate Cake Mix; Gluten Free, Wheat Free, Non Dairy  21 oz. package.  UPC 93709-30040  Pamela's Products,  Ukiah, CA 95482
Product Code 93709-30040, Best Before Sept 11,  2013; Sep 19, 2013 and Oct 4, 2013.
Pamela's Peanut Butter Chocolate Chip Cookies; Gluten Free  5.29 oz. package.  UPC 93709-40180  Pamela's Products,  Ukiah, CA 95482
Product Code 93709-40180, Best Before Apr 14, 2013.
Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, FL, GA,IL,IN, IA, KS, KY,LA, MD, MA, MI, M, MO, NE, NE,NJ, NM, NY, NC, OH, OK PA, SC, TN, TX, UT, VA, WI.  Internationally to UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, ROMANIA, PORTUGAL, POLAND, PERU, NORWAY, NEW ZEALAND, NETHERLAND, MALAYSIA, LITHUANIA, KUWAIT, JAPAN, ITALY, ISRAEL, IRELAND, INDIA, ICELAND, HONG KONG, GERMANY, FRANCE, FINLAND, EGYPT, DENMARK, CZECH REPUBLIC, COLOMBIA, CHILE, CANADA, BELGIUM BAHRAIN, AUSTRIA, AUSTRALIA.
GE Healthcare, CARESCAPE Monitor B650.   The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.
GE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650.     There have been no reported illnesses or injuries that have occurred with the use of the device.
RhoGAM syringes, with lack of assurance of proper temperature monitoring during shipment, were distributed.
ARO PISTACHIO/ ORANDI FARMS PISTACHIO HALVES N PIECES 30LB WHITE CORRUGATED BOXES-Pistachios Raw
Hoop Nuts is recalling Pistachios due to Salmonella.
ARO PISTACHIO/ ORANDI FARMS PISTACHIO HALVES N PIECES 30LB WHITE CORRUGATED BOXES-Pistachios Dry Roasted
Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.
Incorrect packaging of regular set and fast set cartridges.
Ultradent Product, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.
Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy, Jacksonville, FL 32257 USA, NDC 10631-098-14.
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tubes), NDC 10631-099-28; b) 385 g bottle, NDC 10631-099-38; Rx only, Ranbaxy, Jacksonville, FL 32257 USA.
Labeled in part: ''All Natural Chia ReCharged Stix Mix***Chia Seed Sticks***Net Wt. 5oz'', UPC Code: 0 94184 01014 6
CULINARY Creations (brand) CHEESY BROCCOLI SOUP, 3F3080, CONTAINS: 20/2 LB. CHUBS, NET WT. 40 LBS. 91816 KG), DIVERSIFIED FOODS AND SEASONINGS, INC, 1115 N. CAUSEWAY BLVD. STE.200, MANDEVILLE, LA 70471 1-800-835-3374, FOR INSTITUTIONAL USE ONLY,  UPC 00732628330803
The firm received a complaint of a consumer finding shrimp in Broccoli Cheese Soup.