Recalling Firm
Presbyterian Intercommunity Hospital, Inc. Blood Bank
Hoxworth Blood Center University of Cincinnati Medical Center
Stryker Medical Division of Stryker Corporation
Medtronic Inc. Cardiac Rhythm Disease Management
Vital Signs Devices, a GE Healthcare Company
Showline Automotive Products, Inc. dba US Soaps Mfg. Company

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

Distribution Pattern
MO; NY; MA; IL; WA; CA; NJ; NC; IA; WI; PA; Switzerland
Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, China, India, Japan, Singapore, England, France, Germany, Italy and Spain.
Nationwide distribution: AL, AR, CA, CO, CT, FL, GA, IA, IL, KS, MA, MD, MI, MO, NM, NV, NY, OH, PA, TX, WA, and WI.
The bulk tablets were distributed to MO where they were repackaged into bottles. There was no foreign/military/government distribution.
Worldwide Distribution-USA including the states of FL, OH, MA, and TX, and the countries of Mexico, and Dominican Republic.
US Nationwide in the states of AZ, CA, CO, DE, FL, GA, IL, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NY, OH, PA, TX, UT, WA
Worldwide distribution: USA (nationwide) including states of: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, GUAM, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, NV, NH, NH, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY; and countries of: Albania, Australia, Bahrain, Belgium, Canada, Chile, Czech Republic, Dominican Republic, France, Germany, Great Britain, Honduras, Hungary, Ireland, Israel, Italy, Japan, Korea, Kuwait, Netherlands, Nigeria, Norway, Romania, Saudi Arabia, Spain, United Arab Emirates and Venezuela.
Distributed in DC and the states of MA, and OK.
Distribution to the state of Massachusetts, and the foreign countries of Australia, Belgium, Spain, Denmark, France, Luxembourg, Switzerland, Germany, Bonaire, Sweden, and Italy.
Worldwide Distribution-USA (nationwide) including the District of Columbia, US Virgin Islands and Puerto Rico, and the states of CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MS, NC, ND, NE, NH, NJ, NM, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, VE, WA, WI, and WV and the coutries of India, Argentina, Australia, Azerbaijan, Belarus, Canada, China, Colombia, Egypt, Germany, Guatemala, Israel, Japan, Malaysia, Mexico, Nepal, Netherlands, Peru, Philippines, Russia Fed., Singapore, South Africa, South korea, Thailand, and Vietnam.
Worldwide distribution: USA (nationwide) including DC and Puerto Rico and countries: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIDJAN, BELARUS, BELGIUM, BOLIVIA, BOSNIA-HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREAT BRITAIN, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN,JORDAN, KAZAKHSTAN, KENYA, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIAN, LUXEMBOURG, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU. PHILIPPINES, POLAND, PORTUGAL, REPUBLIC OF MACEDONIA, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAK REPUBLIC, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TUR,EKY, UKRAINE, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA, VIETNAM, YUGOSLAVIA, MALAWI, MAURITANIA, NIGERIA, UKRAINE, IVORY COST, OMAN, ZAMBIA, UZBEKISTAN, ESTONIA, IRAQ, and JAMAICA.
Distribution was made to IA and CA. No international or military distribution was made.
Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CT, FL, GA, HI, IL, IN, IA, KY,ME, MD,MA, MI,MN, MS, NV, NH, NJ, NY, NC, PA, TN, TX, VA, WA,WV, and WI; and countries of: AUSTRALIA, BELGIUM, BRAZIL, CANDA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN,JORDAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, NEW ZEALAND, POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SWEDEN, SWITZERLAND, TUKEY, and UNITED KINGDOM.
Nationwide Distribution-USA including the states of OH, ME, IL, CO , FL, TX, MI, GA, and VA.
Worldwide Distribution - USA (nationwide) including the countries of Australia, Dubai, Hong Kong, Indonesia, Singapore, China, Mexico, British Columbia, Taiwan, Thailand, Chile, Malaysia, Japan, Belgium, United Arab Emirates (UAE), South Korea, Manila and Canada.
Worldwide Distribution - USA (nationwide) including the countries of Austria, Australia, Belgium, Canada, China, Finland, France, Germany, Italy, Korea, Kuwait, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
Worldwide Distribution - US Nationwide in the states of :AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MSMT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and countries of AUSTRALIA, UNITED ARAB EMIRATES (UAE),Hong Kong,Indonesia, Singapore, Taiwan, Thailand,Philippines, CHILE,Malaysia, South Korea, BELGIUM,Japan,Mexico,CANADA
Worlwide Distribution - US Nationwide: AL,AR,AZ, CA, CO, CT, DC, DE, FL,GA, HI, IA, ID, IL, IN, KY, LA, MA , MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of: AUSTRALIA,UNITED ARAB EMIRATES (UAE),Hong Kong, onesia,Singapore,Taiwan,Thailand, Philippines,CHILE, Malaysia,USA,South Korea,BELGIUM,Japan,Mexico,CANADA
Worldwide Distribution - USA Nationwide in 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, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Puerto Rico and the countries of Mexico, Singapore, Venezuela, England, Germany, Italy & Spain.
Worldwide Distribution - USA (nationwide) and internationally to Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Korea, Lebanon, Malta, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, Utd.Arab.Emir.
Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CO, CT, DC, FL, GA, IL, IN, IA, LA, MA, MI, MS, MO, MT, NE, NV, NJ, NY, NC, OH, OK, PA,RI, SC, TN, TX, VA, WA, and WI; and countries of: ALGERIA, AUSTRALIA, AUSTRIA, BRAZIL, CANADA, COLOMBIA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, INDIA, INDONESIA, IRELAND, ITALY, JAPAN, LATVIA, LEBANON, MALAYSIA, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, REPUBLIC OF MOLDOVIA, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and YUGOSLAVIA.
Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
US: MI, SC, CA, NY, and OK. International: Hong Kong
Worldwide Distribution-Nationwide including PR and the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NV, NY, OH, PA, TN, TX, VA, VT, and WV and the countries of Slovakia, Germany, Turkey, TW, HK, CH, TH, BR, CN, SG, and ZA.
Direct accounts: CA, CO, FL, GA, IA, IL, MN, WA, and WI
Worldwide Distribution - USA Nationwide and the countries of Belgium, France, Germany, Netherlands, Poland, Spain, Sweden, Switzerland, and United Kingdom
The product was distributed to OK, WI, KS, IA, MO, AR, MN and IL.
USA (nationwide) including Puerto Rico and the countries of Australia Austria Bahrain Brazil Canada Chile Colombia Dominican Republic Ecuador El Salvador France Germany Great Britain Greece Honduras Hong Kong India Ireland Israel Italy Japan Jordan Korea Malaysia Mexico Netherlands New Zealand Nicaragua Norway Panama Peru Portugal Romania Saudi Arabia Singapore South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey and Venezuela.
Nationwide distribution: FL, MA, KS, NY, OH, PA, TX and WI.
Nationwide distribution: AL, AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, LA, MA, MD, MN, MO,MS, NC, NE, NH, NJ, NY, OH, PA, PR, SD, TN, TX, UT, VA, WA, and WI.
Worldwide Distribution - US Distribution only to MS and IL, and the countries of Argentina and Singapore.
US Nationwide including Canada and VA sites.
US: Nationwide (CA, FL, GA, IA, IL, KS, MN, ND, NY, OR, PA, TX)
Florida, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, New York, Ohio, Oregon and Virginia
Distributed in California, Oregon, Washington
Nationwide distribution, including the states of MO, MI, WA, FL, NY, TN, CO, AZ, VA, TX, CA, MN, LA, NC, and UT.
AL, PA, CT, NC, VA, KS, RI, AZ, NJ, and IL.
Worldwide Distribution - USA (nationwide) Nationwide, Hawaii, Puerto Rico and Guam. Internationally to: Canada, Austria, Belgium, Cyprus, France, Germany, Greece, India, Iran, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Morocco, Netherlands, Nigeria, Portugal, Qatar, Reunion, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Australia, New Zealand, Singapore, Thailand, Vietnam, China, Hong Kong,Taiwan, Korea, Japan, Brazil, Chile, Colombia, Costa Rica, Ecuador, Guatemala, Mexico, Nicaragua, and Venezuela.
Worldwide distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, Finland, France, Germany, Italy, Lebanon, Netherlands, Norway, Poland, Saudi Arabi, Singapore, South Africa, Spain, Sweden and United Kingdom.

Product Description
Platelets Pheresis Leukocytes Reduced Irradiated
Blood and Blood Products for Reprocessing
Red Blood Cells Leukocytes Reduced Irradiated
Red Blood Cells (Apheresis) Leukocytes Reduced
CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II, CellSpotter System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks AutoPrep System software 2.4.1 release notes Pub. No. J40135EN issued 2012-03-26 page 2, the document states that a new feature unique to software 2.4.1 allows the used to modify a batch in a new way. The user has additional optional fields in the edit sample information dialog box that allows one to enter expanded sample and patient information. The user can also edit the patient management setting for selected samples if not all samples have the same designation.
CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II, CellSpotter System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks Analyzer II software 2.5.1 release notes Pub. No. J40136EN issued 2012-03-26 page 1, the document states that the edit patient sample information screen now includes a patient information section, a new feature unique to software 2.5.1. This section provides a drop down for patient race and cancer type. There are also separate fields for first and last name for both the physician and patient. There is no mention of the drop down patient ID box on the right side of the user interface which auto-populates previous sample data.
Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Swabs and 20 Flu B Control Swabs, each swab is individually packaged in a foil pouch. The firm name on the label is Remel Europe, Ltd., Dartford, Kent, United Kingdom. Product is a test kit containing characterized positive and negative controls intended for use in qualitative procedures as external quality control material for the Remel Xpect Flu A&B test kit.
Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Alprostadil IN NS Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Atropine Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Bacteriostatic Water for Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
BiMix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Buprenorphine HCl Veterinary Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Cidofovir Opthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Cyclosporine Ophthalmic, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Diazepam Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Dexamethasone PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA
DMSO Aqueous Irrigation 50%, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Gentamicin Sulfate Irrigation, compounded by Pallimed Solutions Pharmacy, Woburn, MA
HCG Chorionic Gonadotropin, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Hydroxyprogesterone CAPR.(G.S.), compounded by Pallimed Solutions Pharmacy, Woburn MA
Methylcobalamin PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA
MIC with B6 and B12, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Nandrolone Decanoate Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Quadmix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Tacrolimus Ophthalmic, Pallimed Solutions Pharmacy, Woburn, MA
Testosterone Cypionate/Testosterone Enanthate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Testosterone Cypionate/Propionate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Testosterone Cypionate Injection,compounded by Pallimed Solutions Pharmacy, Woburn, MA
Trimix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Vancomycin Ophthalmic PF, compounded by Pallimed Solutions Pharmacy, Wobrun, MA
Verapamil Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Bulk tablet label: Keytabs W.O. Glandulars (pink)
KEYTABS (Without Iron, Copper or Glandulars), packaged in 180-tablet bottles, a product of The Key Company, St. Louis, MO.
3M Tekk Brand Industrial/Construction First Aid Kit, Total Resources Int'l Walnut, CA 91789
Medi-First Brand First Aid Kit, MEDI-FIRST 61 Piece Kit, Home, Workplace Travel, Sport, Total Resources International, Walnut, CA 91789
(No Brand) First Aid Kit, 326 Piece Kit. Product labeling reads in part: BE SMART GET PREPARED,326 Pieces of Name Brand & Quality First Aid Supplies, FIRST AID, Total Resources International, Walnut, CA 91789
Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A; Invue Lid: SI70095A; S-Lift Lid: SI50070A; S-Lift Base: SI50067A; Arena-C Lid: 11-72013D, 11-72014D; Generics Lid: 12-99005A. System cases are designed to hold and secure all instrumentation to be used with a surgical system.
1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40'' (1.0 m) Oxygen Reservoir Tubing, Adult Mask; 3) Adult Manual Resuscitator, 2K8017, Variable Volume Oxygen Reservoir Tubing, Adult Mask; 4) Adult Manual Resuscitator, 2K8034, 40'' (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, without Mask; 5) Adult Manual Resuscitator, 2K8035, Oxygen Reservoir Bag, PEEP Valve, Adult Mask; 6) Pediatric Manual Resuscitator, 2K8037, 40'' (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, Pediatric Mask, Pressure Limiting Valve with Lock; 7) Infant Manual Resuscitator, 2K8040, Oxygen Reservoir Bag, PEEP Valve, Infant Mask, Pressure Limiting Valve with Lock Product Usage: Pulmonary resuscitation
GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The series are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. The systems are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body pants with the patient sitting, standing, or lying in the prone or supine position. These devices are not intended for mammographic applications.
Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral.
Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)
epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE SIGNA 3.0T WITH EXCITE MR SYSTEM GE SIGNA EXCITE 1.5T MR SYSTEM GE SIGNA EXCITE 3.0T MR SYSTEM Signa HDx Signa HDxt Signa HDi Signa Vibrant GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (i.e. Signa Ovation 5 and Ovation HD) GE 1.5T SIGNA HDe MR SYSTEM GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM GE 0.7T SIGNA OPENSPEED (4) WITH EXCITE MR SYSTEM GE 0.7T SIGNA OPENSPEED (5) WITH EXCITE MR SYSTEM The GE Signa Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
IMAGIC Vegetarian Burger Mix, VB 100, textured vegetable protein, contains soy and wheat, packaged in 25-lb/bulk cartons. CHS Inc., Hutchinson, KS.
GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and Gated acquisitions for all ages.
IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.
Terumo Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns '' or similar equipment.
Terumo Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns '' or similar equipment.
Carestream DRX Evolution System, X-ray system --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment.
Terumo Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment.
Terumo Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment.
buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01
Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20
Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 Product Usage: The CM/RT incubator processes Microslide reagents with the following VITROS systems: 1) VITROS 5,1 FS Chemistry System, 2) VITROS 5,1 FS Chemistry System Refurbished, 3) VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), VITROS 5600 Integrated System.
REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 36 mm Diameter Nonsterile, Qty -1 Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to impaction with the glenospere impactor.
REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 40 mm Diameter Nonsterile, Qty -1 Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to impaction with the glenospere impactor.
Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.
5.0mm Unit steel rod, pedicle screw spinal system. Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-24; Propofol Injectable Emulsion, 500 mg/50 mL, 50 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-33
Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control
Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control
Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control
Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control
Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are kitted into Nova Max Glucose Test Strip System Kits 43435 and 45507 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control
Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control
Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control
Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control
Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control
Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control
Spartan Fresh Dark Chocolate Covered Dried Cherries 8oz
Cherry Bay Orchards Dark Chocolate Covered Dried Balaton Cherries 4lb, 8oz, and 16oz containers
Shoreline Fruit Dark Chocolate Covered Dried Balaton Cherries 25lbs
ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3, T3, T4, Tup, FT4, THEO2.
Crave Brothers Farmstead Classics Les Freres Semi-Soft French Style Cheese, LF225. 2.5 lb wheel packaged in cheese paper. Two 2.5 lbs wheels in a case.
Crave Brothers Farmstead Classics Petit Frere Soft Ripened Cheese, PF88. Net Wt. 8 oz. (227g). Packaged in cheese paper and sold inside a wooden box. Eight 8 oz wheels per case.
Crave Brothers Farmstead Classics Petit Frere with Truffles Cheese, PF88T. Net Wt. 8 oz. (227g). Packaged in cheese paper and sold inside a wooden box. Eight 8 oz. wheels per case.
ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1, 2 and 3, are intended for the quantitative determination of potassium concentration in human serum, plasma or urine.
MannaPro Goat Treats, Licorice Flavor, 6 lb bag, Manufactured by: MannaPro, St. Louis, MO. Positive Pellet Goat Dewormer packed in Goat Treat bags packaged in Positive Pellet Goat Dewormer shipping boxes. The Positive Pellet Goat Dewormer contains 880 gram Morantel Tartrate per ton.
C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.
C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
''***Gasco Golden Egg Yellow Shade Liquid***'' 32 oz plastic bottles & 15 gallon drums
Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system
Siemens AXIOM Artis zeego x-ray, angiographic system
Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. The Affinity Pediatric Arterial Filters are single-use, sterile, nonpyrogenic devices designed to filter microemboli greater than the specified micron size from the circuit for periods up to 6 hours during cardiopulmonary bypass surgery. These devices are available both in an uncoated and a Carmeda coated option. The Carmeda coating is a BioActive surface that is non-leaching and provides a thromboresistant blood contact surface.
StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.
Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an introducer, a guidewire,and a connector hub. The ThruPort catheter introducer sheath kit includes a wire reinforced cannula with hemostasis valve, an introducer, and a guidewire. The cannulae have a wire reinforced section to provide kink resistance and flexibility, tapered tips to aid in insertion and advancement into the femoral artery, a non-reinforced clamp site, a 3/8 in. (9.5 mm) barbed connector, and a hemostasis valve (available on some versions) that allows passage of catheters, such as the EndoClamp aortic catheter. The introducers accept a .038 in. (0.97 mm) guidewire and are marked to simplify assembly and indicate alignment. On some versions, a connector hub secures and immobilizes the introducer within the cannula for easier, one person insertion of the cannula/introducer assembly.
Asian Taste Sun Flower Seeds, 40pk/carton, Net Wt: 8-oz. (227g), Item #1641819, UPC 6 919037 022708.
individual 2 oz chocolate macaroons packaged in plastic wrapper labeled as '' Jennies DUTCH CHOCOLATE MACAROON, 2 oz. Red Mill Farms, Inc., Brooklyn, NY''.
Chocolate malted milk balls packaged in 6 lbs. bags and each case contains 3 x 6 lbs. bags; BEST BY 04/17/14; BRCH CHOC
FOSFOREL brand Herring Fillet in Oil 400 gram (14 oz.) in plastic packaging containers; refrigerated
Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, NDC 50383-267-15 --- For dermatologic use only. Product is packaged into tubes and then placed into unit cartons.
Tortillas Lupita White Corn Tortillas, Manufactured by Tortilleria Lupita, 235 SW 25th St, Oklahoma City, OK 73109
RYBACKA WIES brand HERRING FILLETS IN OIL (MATJES SLEDZ W OLEJU), Net Wt. 17.6 oz. (500g), UPC 0 21143 24122 8, Distributed By Gold Star, Inc., Brooklyn, NY 11231 --- The product is vacuum packed in a sealed plastic package.
Square Mile Original Hard Apple Cider is hard cider is in liquid form and is an alcoholic beverage. It is packaged in 22 fl oz glass bottles shipped in a corrugated master carton that contains 12 bottles. Individual bottle is sold at retail stores. UPC codes case: 7-02770-04812-0; UPC Bottle: 7-02770-24810-0; PDCN code: CAA12.
Square Mile Spur & Vine Hopped Apple Cider is hopped hard cider is in liquid form and is an alcoholic beverage. It is packaged in 22 fl oz glass bottles shipped in a corrugated master carton that contains 12 bottles. Individual bottle is sold at retail stores. UPC codes case: 7-02770-04912-0 UPC Bottle: 7-02770-24910-0 PDCN code: CAB12
Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10 boxes/case. Used in applying medications to or take specimens from a patient.
3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw.
Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.
Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures.
Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and IVS25 Anastaflo shunts are intended for use in preventing ischemia by shunting and/ or perfusing blood or cardioplegic solution distal to the anastomosis site during the construction of coronary artery bypass grafts30.
Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724.
Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.
Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottle, Rx only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543 by Therapex, Division of E-Z-EM Canada Inc. Anjou Quebec H1J2Z4, Canada, NDC 0270-0445-40
Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Acid Reducer, 65 count bottle Dist. By: Wal-Mart Stores, Inc., Bentonville, AR 72710, NDC 49035-404-61 b)Equaline brand maximum strength heartburn relief, , DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRIE, MN 55344, NDC 41163-404-61, c)Wal-Zan brand 150, MAXIMUM STRENGTH, 24 count bottlle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 63015, NDC 0363-0404-34
REEVA (triclosan) Antibacterial Hand Soap and Dishwashing Liquid, Green Apple, 0.10%, 24 fl oz. bottle, Distributed by Aldi Inc,. Batavia, IL 60510; UPC 0 4198 1525 8.
Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle, Manufactured by: Fabrique par Sanofi-Aventis Canada Inc., Laval, Quebec, Canada H7L4A8, DIN # 02091887

Code Info
CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below). Product Code: CT4297B (9541).
CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below). Product Code: CT1476B (9555).
Lot number: 2012101530 Exp 2017/12 Catalog #: BNSS513
Carestream DRX Evolution System using V5.5.410.33 MR2 Software
Catalog Number or Part Number: 801763 Description: 100/120V AC, Advanced Perfusion System 1
Catalog Number or Part Number: 801764 Description: 220/240V AC, Advanced Perfusion System 1
The following codes are affects by the recall: Lot #114500, Exipration Date 08/2013, repackaging date 12/04/2011.
The affected product consists of lot #261739A, expiration date OCT 2014.
Lot 07-950-DJ Exp. Date 1JUL2013, 10-101-DJ Exp. Date 1OCT2013, and 10-102-DJ Exp. Date 1OCT2013
Product with a make date of 7-1-13 or prior
Product lines with lot number 10405513 and higher
Model number 10592457, serial numbers 100219, 100201, 100473. Update dated 5/13/13 included the following additional serial numbers: 100177, 100504, 100174, 100181, 100473, and 100539.
Lot number(s): Not applicable; All kits containing the Framelink Software version 5.4 are affected by this corrective action.
Flour tortillas packaged with corn tortilla label on 07/24/13.
Expiration Date 103113 (stamped on the back of the package)
Products packaged on or before May 15, 2013. Individual bottle does not have any codes.
Product code # 14-959-81, lot #61513, expiration date: 2014-08, and lot 8710, expiration date 2014-08.
ALL Lots of the following models: Model 3717000 = 2 Level Instrument tray Model 3717001 = 3 Level tray (metal & radel) Model 3717006 = 2 Level Instruument tray with mat Model 3717026 = House Otology Set tray Model 3722301 = Wiet Chronic Ear Set tray Model 3747108 = Skykes Endobrow Lift tray Model 960374 = framelock tray Model *960-811 = Framelock Instrument set (includes tray 9603740 Model 960-619 = LandmarX tray Model *9731372XOM1 = Passive ENT Instrument Set (w/tray 960-619) Model MCOH0SC = Otology Plastic instrument tray Model MCO649SC = Middle Ear Instrument tray Model MCOS10SC = Instrument tray 2 level Model MCLS28 = MF Sataloff Complete Instrument tray Model MCLS37 = Sataloff Picks/Handles/Neddles Instrument tray Model 3319005 = Powerforma Bur Rack tray * instrument set that includes the identified tray

Product Quantity
258 units (30 in distribution at the time of the recall)
*Kitted into System Kits 43435 and 45507
48 cases - Each case contains 16 units of 14 oz. containers
1000 count bottles/61,370 and 5000 count bottles/321
12,239 units (5,002 units US, 7,237 units OUS).

Reason for Recall
Blood products, manufactured with an extended time outside of refrigeration, were distributed.
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Blood product, collected from a donor who had traveled to a malarial endemic area, was distributed.
Blood products, which did not meet the acceptable product specifications for release, were distributed.
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.
Blood product, with a low platelet count, was distributed.
Blood products, collected from a donor who was taking the medication Avodart (Dutasteride), were distributed.
Blood products, labeled as leukoreduced, but were not properly verified by White Blood Cell count, were distributed.
Blood products, leukoreduced more than five days after collection, were distributed.
Blood products, whose Viral Testing/Testing was performed, interpreted, or documented incorrectly, were distributed.
Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood products, in which donor incorrectly identified on deferral list and should have been previously deferred due to testing, were distributed.
Blood products, collected from a donor who was previously deferred, were distributed.
Blood products, collected using manufacturer collection kit greater than 24 hours, were distributed.
Blood products, in which donor screening and records were incomplete or incorrect and, were distributed.
Blood products, stored at unacceptable storage temperatures, were distributed.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Veridex, LLC has received a report that a patient's demographics were incorrectly associated with another patient's identification (PID) number. The purpose of this notification is to inform you of the issue and provide instructions to help prevent an occurrence on your CELLTRACKS AUTOPREP System and CELLTRACKS ANALYZER II.
Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit.
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Product contains higher levels of niacin than claimed on label .
CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride.
Non-toxic inks, used on the silk screen graphics of the case bases and lids, and caddy lids, were found to be either delaminating or running off from the substrate after repeated washing and sterilization cycles.
CareFusion has received four (4) customer reports of a component (oxygen connector) within the resuscitation bag being occluded which disables the flow of supplemental oxygen to the resuscitation bag and thus may pose a serious patient safety risk.
GE Healthcare conducted a recall on various mobile x-ray units (Optima XR220amx, Optima XR200amx, and Brivo XR285amx systems) because of an Erratic Drive Performance.
The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.
A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and not recognized could potentially result in the dental implant not being able to be placed into the osteotomy or seated to the desired depth if placement is attempted.
This recall is being initiated because the affected lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end of the Glucose test sensor (>400 mg/dl). Specifically, after a period of storage of three (3) to four (4) months, the Glucose sensor may report low results at the high end of the measurement range.
Screen save images are included in wrong exam due to duplicate UID creation. This may cause a safety issue due to a potential patient data mismatch.While the issue has only been observed at one customer site on the Signa HDxT 1.5T system, internal investigation revealed that the issue also impacts multiple GE healthcare MR Systems.
The product contains Soy Protein Isolate which may be contaminated with Salmonella.
GE Healthcare conducted a recall involving 2 events affecting the GE LightSpeed CT750 HD. Event 1 - There was a report regarding CT number variance in time line at posterior fossa region of head perfusion. When beam hardening and helical artifacts in this region are reconstructed into the perfusion map, these artifacts will give subtle differences in the CT numbers. Event 2 - The software does not flip S DICOM coordinates when it fills in the DICOM header for tilted images using the Recon Flip/Rotate top-bottom flip (FTB). The images created are stored with an incorrect coordinate value, which incorrectly puts the image in the wrong plane causing the image coordinates annotated on a viewer to be incorrect.
Complaints were received from the field indicating that some Air Pumps were flashing and alarming when connected to the IsoGel AIR'' surface upon turning the pump on and the setting it to the IsoGel AIR Mode. Upon further investigation, it was determined that the flashing/alarm being experienced was due to the air pressure being out of the expected range; indicating a blockage within the LAL tubing subassembly. All IsoGel AIR'' Support Surfaces come equipped with integrated Low Air Loss (LAL) tubing. Low Air Loss functionality is available only if the surface is connected to the optional Stryker Air Pump.
The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically, if the user is adjusting the System 1 centrifugal pump speed via the Central Control Monitor at the same time an alarm condition occurs with configuration for a pump coast response, the labeling in the operators manual does not fully describe how the pump will react.
To a potential for an x-ray exposure technique change.
TCVS is taking action to update the Operators Manual with the specific instructions to respond to this condition and will issue a labeling addendum for current users. In the event of a false high pressure alarm condition occurs that displays a ''999'' pressure reading and results in stopping a pump, this pressure display can be cleared and the pump re-started by disconnecting the pressure transducer from the system.
Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal Pump 'Service Pump' message may occur due to user induced motor movement. In this instance, the APS1 will identify the movement (as it is designed) and display a Service Pump message error. The user might interpret this as a pump which requires service rather than a message displayed due to pump movement while not activated.
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Labeling: Missing Label; missing label on blister card
Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to becoming worn before their replacement.
There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to fracture during use and become disassociated from the device. There have been 47 reported complaints of tab fracture.
Due to the coiled design for this product, the product is difficult to clean and the potential for corrosion on the device exists. The potential for harm exists if there is an introduction of foreign material at the operative site originating from the presence of corrosion and/or the retained undefined material that could not be adequately cleaned.
DePuy Synthes has issued a Medical Device Correction notice for the 5.0mm Stainless Steel rods. This product was produced using a finishing process not identified as part of the manufacturing specification. No adverse event reports associated with the use of this product were received, and an extensive engineering and medical safety review concluded that the product poses no incremental risk to the patient outside of the current instructions for Use. The firm has not become aware of any impact to the patient due to the finishing found on the stainless steel rods subject to this notice.
GE Healthcare became aware of a potential issue related to incorrect image measurement associated with the software of the LOGIQ S8 system. This issue was found internally. Users may notice that the system shows incorrect image measurement results on Pulsed Wave (PW) or Time Intensity Curve (TIC) or depth measurement when using Virtual Convex mode and putting a cursor (Sample Volume, Depth measurement) near the edge of the image. As a result the cursor may need to be moved from near the edge of the image area.
Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel
Reports of false abnormally high glucose readings from test strips
The firm was notified by their immediate supplier GKI, Inc that the Dark Chocolate Covered Dried Cherries contained some Dark Chocolate Strawberries. The strawberries contain sulfites which are not declared on the label. Shoreline Fruit, LLC has initiated a voluntary product recall of its Dark Chocolate Covered Dried Balaton Cherries because of a possible cross contamination with undeclared dark chocolate covered dried strawberries.
Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay.
Crave Brothers Farmstead Cheese Company is recalling 3 specialty cheese products while regulatory agencies continue a multi-state investigation of Listeria monocytogenes.
Beckman Coulter is recalling the Synchron Systems LX20/UniCel DxC ISE Reference Reagent because it has a potassium (K) response near the instrument calibration flag limits and may exceed the limits on some instruments.
Positive Pellet goat dewormer (medicated) is packaged in Goat Treats bags.
Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions
Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography images is not displayed and these images may not be properly aligned to mammography segments.
Siemens issued a customer safety notice about the overlay of system information after a functional check of the brakes on the Artis Zeego system.
Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because a limited quantity of filters may have a small breach in the filter media that may allow unwanted particulate or gaseous emboli to pass through the filter and the outlet of the device, which could result in serious injury to a pediatric patient including neurological damage, or potential patient death.
Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can be used on Medtronic Navigation StealthStation 57 and i7 systems or a Medtronic Planning Station due to the potential of discrepancy between the exam image and the displayed measurement or overlay under certain conditions of use.
Edwards Lifesciences is recalling certain lots of the EndoReturn Arterial Cannula that were built with an incorrect component. This component can create a performance problem with the IntraClude IntraAortic Occlusion device.
Walong Marketing is recalling SunFlower Seeds because it may contain undeclared sulfites.
A recall was initiated as a result of an undeclared sugar ingredient in the labeling used for Jennies' Dutch Chocolate Macaroons.
One lot of Brach's Chocolate Malted Milk Balls may contain undeclared chocolate covered peanuts and brazil nuts.
The product was found to contain Listeria monocytogenes based on sampling and analysis by New York State Department of Agriculture & Markets.
Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The actual product in the tube is Clobetasol Propionate Cream USP
The product is being recalled for undeclared wheat. The flour tortillas were mislabeled as corn tortillas.
The product was found to be contaminated with Listeria monocytogenes based on sampling and analysis by New York State Department of Agriculture & Markets.
Square Mile Original Hard Apple Cider is recalled because bottles may burst.
Square Mile Spur & Vine Hopped Apple Cider is recalled because bottles may burst.
The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presence of non-pathogenic organisms in two lots. The finding was confirmed in lot 61513 and lot 8710 is also being recalled as a precautionary measure.
OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #91300335. Only drill bits that are in their original packaging are being recalled. The description on the package of this drill bit has a wrong size in the description (3.2mm). The recall affects only packaged devices still in original packaging due to misbranding of the product. The drill bit itself has the correct etched size, part number and lot number on it.
Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen.
The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain the statement indicating 'PREVACUUM ONLY''
Edwards Lifesciences is recalling certain lots of the Anastaflo intravascular Shunt due to concerns of excessive adhesive on the shunt body that may interfere with suturing of by-pass grafts.
Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets
GE Healthcare has become aware of a potential safety issue associated with the use of GE General Purpose 9 French Temperature Probe, Disposable, 400 Series [M1024229]. GEs Disposable General Purpose 9FR Temperature Probe M1024229 is intended for oro-esophageal and rectal use. As it pertains to esophageal placement, it has been brought to our attention that some users are inserting the probe nasally which may result in epistaxis (nosebleed). Epistaxis can vary in severity and include severe bleeding that may require specialty (otolaryngology) care.
Presence of foreign substance: One lot of the product may contain black foreign particles
Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp.
Microbial Contamination of a Non-Sterile Products: Product was found to be contaminated with the bacteria, Sarcina Lutea.
Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the encapsulating equipment.