Recalling Firm
Kapiolani Medical Center for Women and Children
Community Blood Centers of Florida, Inc.
Horiba Instruments, Inc dba Horiba Medical

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
New Jersey, California, New York, Switzerland
Distributed in the states of IL, ID, LA, MA, NJ, NY, OH, PA, and SD.
Worldwide Distribution - USA (nationwide) and Internationally to Internationally distributed to Argentina, Australia, Austria, Bahamas, Brunei, Canada, Chile, Curacao, Denmark, France, Germany, Greece, Ireland, Italy, Lebanon, Mexico, Netherlands, Norway, Oman, Paraguay, Portugal, Puerto Rico, Russia, Saudi Arabia, Serbia, South Korea, Spain, Switzerland, Turkey, and United Kingdom.
Worldwide Distribution-USA (nationwide) including the states of AR, CA, FL, HI, ID, IN, KS, KY, LA, MA, MI, MN, MO, NC, ND, NM, NV, NY, OH, OK, PA, SD, TN, TX, VA, WA, and WI and country of: Europe.
Nationwide Distribution including NC, VA, WI, TN, KY, IN, FL, MI, IA, IL, TX, LA, AR, HI, CA, NV, OR, and WA,
Product was distributed to one firm in Utah, USA.
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, 10, IL, IN, KS, KY, LA, MA, MD, ME, Ml, MN, MO, MS, MT, NC, NO, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SO, TN, TX, UT, VA, VI, VT, WA, WI,WV, and WY, and the countries of Russia and Ukraine.
Distributed in the states of Pennsylvania, Texas, and New York.
Worldwide Distribution - (USA) Nationwide Distribution including the states of AL, AR, AZ, CA, FL, GA, IA, IN, LA, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, TN, TX, WA, WI & WV. and the countries of Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Monaco, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand & United Kingdom
Worldwide Distribution - USA including AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV. Shipped internationally to Canada, Ireland, Hong Kong, the Netherlands, New Zealand, and Thailand.
Nationwide (AL, CA, CO, FL, GA, IA, IL, IN, MA, MI, MN, MO, NE, OH, PA, TN, TX, and WI)
Worldwide Distribution- USA (nationwide) including Puerto Rico and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Republic of Panama, Singapore, Spain, and Venezuela.
Distributed within the US to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
CA, GA, NC, NY, PA, OR, TX, OK, MO, VA, MI, NJ, CT, UT and to Australia, Canada, Belgium, China, India, South Korea, Taiwan.
Worldwide Distribution - USA Nationwide and the following countries: Australia, Austria, Belarus, Belgium, Canada, Columbia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Iceland, Iran, Ireland, Italy, Jordan, Kazakhstan, Korea, Kuwait, Luxembourg, The Netherlands, Norway, Oman, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates and the United Kingdom.
Worldwide Distribution USA Nationwide and the countries of Australia and Canada.
Nationwide Distribution including CA, FL, GA, MA, MI, NC, SC, OH, and MO.
Worldwide Distribution-USA (nationwide) and the countries of Canada, South Africa, Netherlands, Italy, Brazil, Singapore, Russia, Hong Kong, Argentina, South Korea, Philippines, El Salvador, Indonesia, and Trinidad.
Worldwide Distribution - USA (nationwide), Europe, Japan, Australia, Canada, Singapore, South Africa, and Costa Rica.
Worldwide Distribution - USA including AL, AR, CA, CO, IA, MI,MN, MO, NY, NC, OH, OR, PA, TX, and UT. Internationally to AUSTRIA, BELGIUM, CANADA, CHINA, COLOMBIA, GEORGIA, JAPAN, KOREA, MACEDONIA, NETHERLANDS, POLAND, PORTUGAL, RUSSIAN FEDERATION, SINGAPORE, SWEDEN, SWITZERLAND, TURKEY, UKRAINE, UNITED KINGDOM.
Nationwide Distribution-USA including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.
Worldwide Distribution including USA (nationwide)
Worldwide distribution, including Nationwide in the US and the countries of Korea, Myanmar, Canada, Belgium, England, Czech Republic, Finland, France, Germany, Greece, India, Italy, Poland, Russia, Spain, Switzerland, Turkey, Columbia, Mexico, Japan and Saudi Arabia.
Worldwide Distribution - USA (nationwide) and the countries of Australia and China.
Product was distributed in Puerto Rico only (wholesalers and distributors).
Worldwide Distribution - USA including the states of AL, CA, CO, DC, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MO, NC, NE, NH, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WI, WV, and WY. and the countries of Canada and Australia.
Nationwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.
Worldwide Distribution -- USA, including all states except ME, and the U.S. Virgin Islands; and, the countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, MALAYSIA, NETHERLAND, NEW ZEALAND, NORWAY, PHILIPPINES,S QATAR, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
Worldwide Distribution.-USA (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.
Worldwide Distribution - USA Nationwide including the states of AZ, CA, FL, GA, NM, NY, TX, VA and WA and countries of Netherlands, Canada and Russia.
USA Nationwide Distribution including the states of: FL, MA, MI, NY, PA, TX.
Nationwide Distribution including TN, WA, UT, KS, KY, MN, GA, MA, PA, NY, VT, and the Dist. of Columbia
Distributed within the state of California.
Worldwide Distribution - USA (nationwide) and countries of: Austria, Australia, Belgium, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Panama, Spain, Sweden, Switzerland, Tunisia, United Kingdom and Yemen.
Nationwide Distribution including the states of AL, AK, AZ, AR, CA, CO, CT, DC, GA, HI, ID, IL, IN, IA, KS, KY, MD,MI, MN, MS, MO, NV, NH, NJ, NM, NY,NC, OR, OK, OH, PA, TN, TX, VA and WA.
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.
Nationwide Distribution including the states of AL, CA, GA, IL, IN, KY, MA, MD, NC, NY, OK and VA.
Worldwide Distribution - Nationwide Distribution including the states of FL, IL, IN, LA, MI, MN, NJ, NM, NY, OH, PR, SC, TX and VA and the countries of Vietnam, Latvia, Italy, Israel, Indonesia, Hong Kong, United Kingdom, Finland, Spain, Czech Republic, Canada, Bahrain and Australia.
Worldwide Distribution - USA Nationwide including the states of: AK, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IL, IN, IA, LA, MD, MI, ,N, ,S, MO, MT, NJ, NM, NY, NC, OH, OK, PA, SC, SD, TN,TX, UT, VA, WA, WI. and the countries of : AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA, BRAZIL, CANADA, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUADELOUPE, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KOREA, LIBYA, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, POLAND, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY and UNITED ARAB EMIRATES.

Product Description
Red Blood Cells Leukocytes Reduced Irradiated
Blood and Blood Products for Reprocessing
Red Blood Cells (Apheresis) Leukocytes Reduced
Platelets Pooled Leukocytes Reduced Irradiated
Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA
EphBurn 25, 90 count bottle with red capsules
Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7929-09.
Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS
Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED syringes and 33 Alcohol Preps (swabs) per box, Marketed by: TEVA Neuroscience, Inc., Kansas City, MO 64131; Distributed by: TEVA Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 68546-317-30
Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2. Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer planned, linear accelerator (Linac) based treatment.
Clinical Chemistry Phenobarbital, list number 1E08
Siya Green Mukwhas Net Wt. 200 gm (7 oz) Distributed by: Miami Growers, Inc. 80 Broadway, Jersey City, NJ 07306 Phone: 201-985-9322, Fax: 201-985-9569 Email: miamigrowers@yahoo.com Visit us: www.miamigrowersinc.com A Product of India
Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA; NDC 0409-7929-09.
Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXVP0827, PXVP2284AT3, PXVP23X3AT3, T398807D, T100605B, T001762A, T391T00A, VP2. Blood sampling system used on patients requiring periodic withdrawal of blood samples.
ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting.
Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 68180-202-03.
EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part ''EsophyX2 2-LINK Device Qty: (1) Fastener Delivery System ***'' Designed for the treatment of Gastroesophageal Reflux Disease (GERD), with erosive and non-erosive esophagitis
Canned mushrooms, #10 cans (Brites, not labeled)
ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).
CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time (''PT'').
LifeScan brand OneTouch Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.
LifeScan brand OneTouch Select Control Solution, Part Number/Model #: 02168902. Testing of Blood Glucose Levels.
OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.
Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.
Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.
Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/Inline Filter; and BE 183-R Regulator The BE 183-SUR and BE 183-SU Manual Jet Ventilators are designed to provide transtracheal ventilation in specific emergency situations of upper airway obstructions.
Metal cans; labeled as containing 29 oz of pinto beans packed in water and salt
VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Refurbished, Product Code 6801890. Intended for use in the measurement of a variety of chemistry analytes.
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. Intended for use in the measurement of a variety of chemistry analytes.
VITROS 5600 Integrated System, Product Code 6802413. Intended for use in the measurement of a variety of chemistry analytes.
Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product.
ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D.
ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the quantitative determination of Vit D.
ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the quantitative determination of Vit D.
ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the quantitative determination of Vit D.
All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter kits - Meter; Verio IQ Warranty Meter. Product Usage: The OneTouch VerioIQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The system is intended to be used by a single patient and should not be used for testing multiple patients. The OneTouch VerioIQ Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.
Ideal Protein, Sea Salt & Vinegar Ridges, 7 packets Net WT 1.4 oz (40 g) each. Total net weight 9.9 oz (280 g). Distributed by Laboratories C.O.P Inc., 60 Jean-Proulx St Gatieau QC Canada J8Z 1W1
Ideal Protein, BBQ Ridges, 7 packets Net WT 1.4 oz (40 g) each. Total net weight 9.9 oz (280 g). Distributed by Laboratories C.O.P Inc., 60 Jean-Proulx St Gatieau QC Canada J8Z 1W1
BD HLA-B27 Kit;510(k) BK050073; Manufactured by BD Biosciences 2350 Qume Drive San Jose, CA 95131
MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).
The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System
TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery
Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62), Pkg. By: Precision Dose, Inc., S. Beloit, IL 61080.
REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF 32-422763 Oxford Mlcroplasty Knee System Tibial instrument Tray small surgical hammer supplied with the Oxford Partial Knee Microplasty Instrument set, used for impacting implants.
Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and subsequent versions of VitreaWorkstation, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite, through version 6.4. Vitrea CT Multi-Chamber Cardiac Functional Analysis provides a variety of tools for working with clinical CT images of the coronary arteries, heart, and surrounding tissue.
Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.
SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters. Model# FG3105 Patient Scales. Product Usage: The FG3105 Scale is designed for Joerns Healthcare for use in portable patient weighing systems. The scale is designed to be connected between the patient hoist mechanism and patient sling apparatus. The scale is not intended to be used for patient transport.
EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a continuously rotating x-ray tube and multi-row detectors enclosed by a gantry. X-ray transmission data acquired and taken at different angles can be reconstructed into cross-sectional images. Each device also includes signal analysis and display equipment, patient and equipment supports, components, and accessories.
Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment.
HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used to measure absorbance and ion electrodes.
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
DeGotzen XRay unit XGenus Dental X-ray unit.
Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration, as well as multiple interfaces for patient registration, order entry, and external billing modules. It is not intended to treat disease or administer any medicinal substances or drugs. There is no contact between device and patient. syngo(R) Workflow SLR can be used as a separate RIS, interfacing to a Hospital Information System (HIS) or Picture Archiving and Communication Systems (PACS
Publix Deli Tri Fruit and Grain Salad with red rice, red wheat, quinoa, apricots, cranberry and raisins 12oz. In a clear plastic container.
Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
GE Healthcare Muse v7 cardiology information system. Model number 2026443-001: MUSE 7.0 app cd, Model Number 2026443-015: MUSE 7.0.2 app cd, Model number 2026443-017: MUSE 7.1 app cd, Model number 2026443-029:MUSE 7.1.1 A app cd, and Model Number 2026443-031: MUSE 7.1.1 app cd. Intended to store, access and manage cardiovascular information on adult and pediatrics patients.
IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination.
IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000. Arm drapes protect equipment from contamination.
HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.
Messerle & Sons Dewormer Mineral. Product is Type B medicated mineral premix (dewormer), formulated to contain fendendazole. The product is labeled in parts: ''***Messerle & Sons Dewormer Mineral***MEDICATED***ACTIVE DRUG INGREDIENTS Fenbendazole***4540 g/ton***Manufactured by: Wilbur-Ellis Company P.O Box 407 Clackmas, OR 97015***Net Weight 50 lbs***''.
EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired. The femoral arterial cannulae are wire-reinforced, thin-wall cannulae.
IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the diagnosis of infectious Mononucleosis.
Humboldt Fog (brand) Cypress Grove Chevre, Aged Goat Milk Cheese. Packaged in 7oz (random weight) and 5 oz (random weight). Cypress Grove Chevre # 213146 7oz (random weight) Cypress Grove Chevre # 35363 5oz (random weight) Products are random (various) weight. The 7 oz is packed 6 packs per case. The 5 oz is packed 8 packs per case.
Fructus Lycii (400g). Dried Medlar (Net Wt: 14.11 oz (400G). Ingredients: Dried Medlar. Distributed Exclusively By: Tristar Food Wholesale Company Inc. 115 Amity Street, Jersey City NJ 07304, USA. Product of P.R.C. UPC: 6931653102466
Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement.
Levoxyl (levothyroxine sodium) tablets, USP 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles ( NDC 60793-850-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Levoxyl (levothyroxine sodium) tablets, USP 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles ( NDC 60793-851-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Levoxyl (levothyroxine sodium) tablets, USP 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles ( NDC 60793-852-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles ( NDC 60793-853-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Levoxyl (levothyroxine sodium) tablets, USP 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles ( NDC 60793-854-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles ( NDC 60793-855-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles ( NDC 60793-856-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles ( NDC 60793-857-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles ( NDC 60793-858-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles ( NDC 60793-859-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles ( NDC 60793-860-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
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.
buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217; NDC 67767-142-30.
Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold support supplies for health care providers when treating patients. Bag #3 contains 5 different blood collection tubes (5 each) and 2 different gauge needles--all for drawing blood. One of the tubes is the recalled BD blue top citrate tube (5 tubes). These tubes were manufactured by BD, Franklin Lakes, NJ. The kit is used by health care providers when treating patients.
GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.
Trader Joe's Hummus Dip Size: 16 oz., 12 units/case, SKU 20411. Size: 7 oz, 24 units/case, SKU 15735.
Trader Joe's Three Layer Hummus Dip 12 oz., 12 units/case, SKU 80867.
Trader Joe's Mediterranean Hummus 16 oz., 12 units/case, SKU 90642.
Trader Joe's Spicy Hummus Dip 7 oz., 24 units/case, SKU 38056.
Trader Joe's Roasted Garlic Hummus Dip 7 oz., 24 units/case, SKU 20648.
Trader Joe's Tomato Basil Hummus Dip 7 oz., 24 units/case, SKU 21953.
Trader Joe's Chunky Olive Hummus 7 oz., 24 units/case, SKU 75347.
Trader Joe's Mediterranean Hummus Snack Pack with Pita Chips 8 oz., 24 units/case, SKU 97136.
Trader Joe's Hummus Salad Dressing 12 oz., 12 units/case, SKU 96752.
GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.
Fresh & Easy Organic 100% Apple Juice from concentrate, 64 oz, 8 units/case. UPC/Barcode: 50513790021007 ORIN: 100012615 SPORIN: 100012623

Code Info
Lot number 008A, expiration date Dec 2014, UPC code 830733002016
Lot #: 05-019-JT*, Exp 05/01/13; lot number * may be followed by 01, 90, or 91.
Catalog No: TR7100-L and TR7100-R Lot Code: All
Lot #s: MSA 2021A, MSA 2024A, MSA 2025A, Exp July 2014
Lots 401378, 401392, 401409, and 401416 Additional lots manufactured from 11/26/12 to 12/07/12 had a stop ship issued issued on 11/21/12 and the product was placed in quarantine (it was not distributed). This represents an additional 175 units from a total of 187 units manufactured during this time period. 12 units were used for bench testing. The lot numbers of units in quarantine are 401432, 401434, 401436, and 401441.
Finished Good (FG) Kit Lot# KL01009-3TI, TRUEtrack Test Strip Lot# RL3435; FG Kit Lot# KL01009-12TI, TRUEtrack Test Strip Lot# RL3435; FG Kit Lot# KL01233-4TI, TRUEtrack Test Strip Lot# RL3476; FG Kit Lot# KM0548TI, TRUEtrack Test Strip Lot# RM3547; FG Kit Lot# KM0645TI, TRUEtrack Test Strip Lot# RM3562; FG Lot# KM0692TI, TRUEtrack Test Strip Lot# RM3562.
UPC: 071524020034; Producty Code: PINTO LP; Best By Date: 01/03/2015; Lot Code: 3003; Time Code: All Time Codes
Serial Numbers 46000108 through 46000217
Serial Numbers 56000118 through 56001583
Catalog Number KC460, SMN 10472284, lot 2KD052, exp 5/1/14 and Catalog Number KC460A, SMN 10476471, lot 2KD053, exp 5/1/14.
Lot Number: C3410 Kit Lot Number/Exp. Date: 95010A10 8/16/2013
Part numbers: Verio IQ Systems Kits: 022 267-01, 022 267-01, 022 267-03; Verio IQ Starter Kits: 022 268 01, 022 268-02; Verio IQ Warranty Kits: 022 275 01, 022 275 02. All lots and serial numbers
Model number 340183;Lot numbers 3029914 and 3035581
Catalog Number: 70104.8012 Cardiohelp-i. Multiple serial numbers.
Biomet Product code: 506076, Lot 829182. Synvasive Part Number: 11-3629.
Item numbers: TUS-A300/Wl and TUS-A500/Wl
Gemini Dual, Gemini 16 Power, Gemini GXL, Gemini LXL, Gemini TF 16, Gemini TF Base/Ready, Gemini TF 64, Gemini TF Big Bore, Precedence SPECT/CT, Brilliance CT (6, 10,16, 16P, 40, 64, and Big Bore), Brilliance iCT, Brilliance iCT SP
Model Numbers: P400ISE110EN02 and P400ISE110US02. All Serial Numbers. Versions 5.0.7 and below
unit model 8015 with software version 9.12
Model numbers 10558922, 10558933 and 10558980 with software version VA31A SP1/SP2/SP3
MESRL003 03/2010; Lot 644370; Expiration date: September 2014
The affected control lot number is 11030386. Lot/Unit Codes: MON1040008 & MON1040016.
No codes. Products sold prior to 04/04/2013.

Product Quantity
VITROS 5,1 FS: USA: 670 units, Foreign: 1249 units; VITROS 5,1 FS Refurbished: USA: 52 units, Foreign: 2 units
195 units total (140 units Domestic, 55 units Foreign)
19 cartons (each carton containst 50 400 g plastic bags)
1) List Number 13000: 25,119 pumps; 2) List Number 13100: 185 pumps; 3) List Number 13150: 13,497 pumps
1) List Number 13086: 286 pumps; 3) List Number 13087: 45,376 pumps; 4) List Number 13088: 23,492 pumps

Reason for Recall
Blood product, which were collected from a donor who traveled to malarial endemic areas, was distributed.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood products, collected from donors in which donor suitability was not adequately determined, were distributed.
Blood product, collected from a donor, whose screening/donor record was incomplete, was distributed.
Blood products, collected from a donor who received a piercing within 12 months of the donation, were distributed.
Blood product, collected from a donor who traveled to malarial endemic areas, was distributed.
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood product, collected from a donor for whom the acceptance criteria for hematocrit was not met, was distributed.
Blood products, collected from a donor with a history of surgery within the previous 12 months, were distributed.
Blood product, which was collected from a donor who traveled to malarial endemic area, was distributed.
Blood product, collected from a donor possibly at increased risk for Creutzfeldt-Jakob Disease (CJD), was distributed.
Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Blood products, collected from a donor taking the drug Finasteride, were distributed.
Blood products, collected from a donor who traveled to a malaria risk area, were distributed.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were 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 previously deferred after disclosing high risk behavior, were distributed.
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
Blood products collected from a donor whose scheduled physical exam had not been performed, were distributed.
Blood products collected from a donor who was previously deferred for unsuitable lab test results, were distributed.
Blood products, collected from a donor, whose suitability to donate were not adequately determined, were distributed.
Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction
Brand New Energy is recalling all lot codes of EphBurn 25 because it may contain ephedrine alkaloids, making it an unapproved drug.
Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.
Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of sildenafil, the active ingredient in a FDA approved product used for erectile dysfunction, making it an unapproved new drug
Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.
Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occurs if a beam plan is transmitted from XKnife using DICOM-RT.
Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to imprecision issues which increase with the age of the reagent lot. The imprecision of the Phenobarbital assay is d 7% Total CV%; however, internal testing confirmed CVs up to approximately 12% for in-date reagent lots over five months old. Although lot 52803UN12 is now expired, it exhibited similar imprecision issues. As a precaution, future replacement lots will have reduced dating until root cause is identified and preventive measures are implemented.
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood product, which label was applied to blood unit with incorrect or missing information, was distributed.
Siya Brand Green Mukwhas contain unapproved and undeclared colors.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood product, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed.
Non-Sterility: Confirmed customer complaint of product contaminated with mold.
The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples.
With regard ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become aware that there are potential issues associated with internal processes for planning cases and producing ShapeMatch Cutting Guides.
Discoloration; Product may not meet specifications for color description once reconstituted.
EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.
Some isolated spoilage was found in this lot of #10 cans.
Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards.
Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards. Errors have been confirmed with the EAN 13 barcodes which should not be used for patient or operator identification.
When OneTouch Ultra and OneTouch Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial label even though the system is working properly.
The firm's retesting procedure was not validated.
Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.
Distribution of an unapproved device into interstate commerce.
Philips was notified of a problem using the IntelliSpace Portal with software version 4.0.2 with the URL PACS integration. Philips was informed that when loading a study to an analysis application while using URL PACS integration configuration, after another study was opened by a review application, the Analysis monitor is updated with the study of the current patient, but the Review monitor continues to display the study from the previous patient. If the issues were to re-occur, it could pose a risk for the patient.
Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use.
Some cans may not have been fully processed which could result in product contamination by spoilage organisms or by pathogens, which could lead to illness if consumed.
Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS Systems may be out of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal evaluation in its manufacturing facility, it was discovered that an extension spring had insufficient force. If the extension spring does not provide sufficient force, MicroSlides may not be properly positioned within the MicroSlide incubator which has the potential to cause imprecise results. Extension springs are just one component in the slide alignment assembly. OCD's evaluation determined that the probability of an out of specification extension spring alone adversely affecting results is unlikely.
Siemens has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(R) Digoxin(DIGXN) Flex(R) reagent cartridge when calibrating DIGXN with either Drug 4 Cal (KC460) lot 2KD052 or Drug 4 Cal (KC460A) lot 2KD053. Internal testing has shown an average 15% low bias in the therapeutic range of 0.9 to 2.0 ng/mL.
Negative bias in patient samples for Vitamin D
The Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead of displaying EXTREME HIGH GLUCOSE.
Dakota Specialty Milling informed Zumbro River Brand (ZRB) that they are recalling Multigrain Whole Meal Flour Blend 100 (Multigrain Flour) because of a potential contamination with fine wire pieces. This Multigrain Flour is a component in an extruded base called Whey multigrain Ridges, so these fine wire pieces could be contained in the Whey Muligrain Ridges. The fine wire is too thin to be detected by metal detection, therefore ZRB is recalling the products made with the recalled Multigrain Flour which include Sea Salt & vinegar Ridges and BBQ Ridges (USA & Canada).
Certain lots of HLA-B27 FITC/CD3 PE reagent contained in the HLA-B27 kit, contaminated with CD4 PE, were distributed.
It has come to the attention of MAQUET that there have been episodes of brief unexpected shutdown, followed by an automatic device restart of the human machine interface (touch screen) of the CARDIOHELP device. The human machine interface (HMI) is the central display of the CARDIOHELP device, where measured values, settings and alarms are displayed and adjusted/confirmed, with the exception of blood flow which is set by a separate rotary knob located at the front of the device.
Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump parameter input from either the electronic medical record (EMR) or the Alaris Auto-ID module for a continuous infusion with a bolus dose option may result in a loss of information from the Guardrails Data set while programming a bolus dose.
One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter).
The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT AST cassette, and it has the potential for humidity changes to impact results for certain analytes on the Alere Cholestech LDX System.
Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word ''Children's'' which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose.
Investigation of complaints found excessive use of the instrument could result in cracking on the weld between the head and the handle, which could lead to part of the head becoming detached from the handle.
Vital Images has made a decision to perform a field correction to the Vitrea CT Multi-Chamber Cardiac Functional Analysis application. Vital Images has identified a defect in which numerical values may be incorrect in the Results Table under the Cardiac Analysis portion of the user interface.
Toshiba Medical Systems has received reports of startup issues with the Toshiba TUS-500 and TUS-300 ultrasound systems. The startup issue is predominant when attempting to bring the system up from standby mode when the system is used remotely. It has been determined that this may potentially cause damage to the system.
SR Instruments Inc. is implementing a field correction for the Joerns Healthcare Patient Lifts after they received two incident reports regarding two field failures of a tensile type load cell involving the FG3105 Patient Scale. The failures resulted in patient falls.
Advanced Sterilization Products (ASP) has determined that a limited number of EVOTECH ECRs manufactured between 2011 and 2012 did not receive sufficient High Potential (HIPOT) DC voltage testing.
Philips Healthcare discovered the customer was performing CTDI measurements for facility accreditation and received results that were 15 to 25% higher than Philips protocol parameters stated.
A defect on the master-side connector block of the pneumatic tool changer could introduce a tilt in the collimator housings, resulting in a potential shift to the central axis of the radiation beam. The issue could pose significant clinical impact to plans created using the smallest collimators.
HORIBA Medical is informing all ABX PENTRA 400 Analyzer with I.S.E. Module customers that there are no Linearity Limit Flags for the I.S.E. assays currently programmed into the ABX PENTRA 400 Analyzer software. All other assays run on this analyzer do have Linearity Limit Flags to alert the user to values that fall below or above the validated linearity range for each assay.
The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached.
It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification
An audit to the purified water supplier revealed deficiencies related to the Ozone purification system and particulates, the analytical results show that mold was found on one of the batches
Under certain conditions, when using the Search functionality, the potential exists for the wrong patient's Interactive Documents to display when viewing a signed report in the single patient view. This can occur when the Interactive Document is viewed or auto displayed, dismissed by the user, and then a different patient and signed exam is selected in single patient view. The Notes Viewer will display Interactive Document notes for the previously selected patient. The problem is when a signed report is selected, the internal list of selected exams is not being reset. The potential for a safety issue occurs when the Radiologist selects a signed report for a patient and then selects a signed report for a different patient. If the Radiologist is performing an addend on the second signed report and bases the addend on information from the incorrect note, this could then contribute to an incorrect diagnosis if this is not recognized by the Radiologist. Furthermore, if the Radiologist creates and saves a new note, the note could be saved against the previously selected patient.
Product may be adulterated with Listeria monocytogenes.
Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers.
GE Healthcare conducted a recall on the Muse v7 because incorrect medications were displayed on the MUSE, which could result in incorrect treatment.
Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.
Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.
Messerle & Sons Dewormer Mineral is recalled because Fenbendazole drug concentration was exceeded the AV allowed.
Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because they have received reports of smoke emanating from the system due to a circuit board malfunction that may occur in the Channel Control Manifold sub-assembly.
Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach.
Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.
DPI Specialty Foods has been notified that some Cypress Grove Humboldt Fog Goat Cheese was labeled with incorrect ingredients. This product is produced with pasteurized goat milk, and was labeled as containing cultured raw cow's milk.
The product contains undeclared sulfites (as a preservative).
Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors include: (1) The pouch says oscillating saw blade when it actually contains a reciprocating saw blade; (2) The box bar code date does not match the human readable expiration date; and (3) The label incorrectly states use with Zimmer/Synthes handset and not the Zimmer Universal Power System.
Chemical contamination: emission of strong odor after package was opened..
Chemical contamination: emission of strong odor after package was opened.
Chemical contamination: emission of strong odor after package was opened
During an inspection by FDA, it was found that the Little Mermaid Smoked Herring and Little Mermaid Pickled Herring were uneviscerated. The firm initiated the recall due to potential for Clostridium botulinum.
ACIST Medical Systems is issuing a voluntary recall notice for three specific lots of BT2000 Automated Manifold Kits. For these specific lots, ACIST has received field reports related to ingress of air into the manifold body. This has been detected by the Air Column Detect Sensor halting the injection, and normally replacement of the BT2000 Automated Manifold Kit is necessary in order to proceed with the injection. To date, there has been no evidence or report of any air injection to a patient, injury or adverse health consequence associated with this issue.
During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.
The product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results.
As part of GE Innova IQ table introduction, a label was designed to be affixed on the front Cover of the Gantry Pivot section. This safety label is missing on systems manufactured between March 2010 and July 2011. In the situation a staff member (doctor, nurse, operator, anesthetist, etc&) stands in the region between the C-arm gantry pivot and the head section of the table, there is a risk of collision or jam when the head section of the table moves toward the C-arm gantry pivot. To date no collision or injury has been reported related to this condition.
Two Chefs on a Roll is recalling humus products because they may contain small pieces of material from food grade equipment.
GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server. After starting the Results Viewer with the selected series of a patient, the pixel and certain annotation data from a different patient is displayed in one of the viewports. This occurs on an occasional basis, when multiple users are simultaneously accessing the Results Viewer.
Fresh and Easy is recalling Fresh & Easy Organic Apple Juice because it may be contaminated with patulin.