Recalling Firm
University of Miami Miller School of Medicine Tissue Bank
American Natl Red Cross Mid Atlantic Region
American National Red Cross, Greater Ozark-Arkansas Region
Mindray DS USA, Inc. dba Mindray North America
Blood Systems, Inc. DBA United Blood Services
Zimmer Trabecular Metal Technology, Inc.

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

Distribution Pattern
Nationwide Distribution including AZ, OH, WA.
Arizona, California, Delaware, Florida, Illinois, Montana, Nebraska, New Jersey, New Mexico, New York, North Dakota, Ohio, South Dakota, Tennessee, Texas, Virginia, Puerto Rico, Greece, Korea, and Panama.
Directly to patients and physicians in FL, NJ, NY, and Puerto Rico
Nationwide Distribution including PR and the states of AK, AL, AR, AZ, CA, CO, CT, MD, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
Worldwide Distribution-US (nationwide) and the countries of Canada, Austria, AUSTRALIA, SWITZERLAND, COTE D'IVOIRE, CYPRUS, CZECH REPUBLIC, GERMANY, DENMARK, FINLAND, FRANCE, UNITED KINGDOM, GEORGIA, HONG KONG, CROATIA, HUNGARY, IRELAND, INDIA, ICELAND, JAPAN, KENYA, MACEDONIA, MALTA, NETHERLANDS, NORWAY, NEPAL, NEW ZEALAND, POLAND, ROMANIA, RUSSIA, SWEDEN, SLOVENIA, UNITED REPUBLIC OF TANZANIA, and SOUTH AFRICA.
Worldwide Distribution -- Austria, Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic Korea, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, and United States.
North Carolina; Oregon; Pennsylvania; New York; Washington; New Jersey; California
Worldwide Distribution - USA Distribution including to the states of AL, CA, CT, FL, GA, HI, IL, IN, KS, MI, MN, MO, MS, NH, NY, OH, OK, PA, TX, WI and WV., and to the countries of Austria, Australia, Belgium, China, Czech Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Italy, Jordan, Malaysia, Morocco, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, Switzerland, Turkey and the United Arab Emirates.
US Distribution to the states of AZ, GA, CA, OH, and VA., and one Internationally to France.
Distributed to the states of AL, CA, CO, FL, GA, IA, IL, IN, LA. MA, MO, MS, MT, NC, ND, NY, OH, PA, SC, TX, VA, WA and WV.
Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
Distributed to the states of FL, MO, OH and WI.
Worldwide Distribution: US (nationwide) and countries of: France, Germany, Iran, Romania, Serbia, Singapore, Taiwan, and United Kingdom.
Distributed US (nationwide) and the country of Canada.
Worldwide Distribution: US (nationwide) including Puerto Rico; and countries of: ALBANIA, ALGERIA, ANDORRA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BELARUS, BRAZIL, BRUNEI, BULGARIA, CHILE, CHINA, COLUMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, FRANCE, GABON, GEORGIA, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, KENYA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA, MEXICO, NEW ZEALAND, PAKISTAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, TURKEY, UAE, UGANDA, UKRAINE, UNITED KINGDOM, AND URUGUAY.
Nationwide Distribution including AZ, CA, NY, and MA.
US Distribution to the states of FL and OH.
Worldwide Distribution - US Distribution and the countries of Australia and Denmark.
The affected product was distributed to domestic Kroger-owned stores in the following states: Alaska, California, Colorado, Idaho, Kansas, Missouri, Montana, Nebraska, Nevada, Oregon, Utah, Washington, Wyoming.
The product was distributed throughout the U.S. and to foreign countries, including Canada and other countries TBD. The affected product was also distributed to eight government consignees.
Worldwide Distribution - USA (Nationwide) in the states of NM, VT, MN, IL, MO, OH, MI, OR, ND, KY, PA, TX, WA, FL, NE, AR, VA, DE, GA, NY, CA, TN, AZ, RI, MA, and PR; and countries of: Thailand and South Korea.
Distributed in the states of MN; NJ; NC; PA; AL; MI; OR; FL; OH; CO; IL and CA, and the countries of Australia, India, UAE, Germany, and Italy.
Worldwide Distribution: US (nationwide) AL, AR, AZ, CA, CT, FL, GA, IN, KS, KY, MA, ME, MI, MO, MS, MT, ND, NH, OH, OK, OR, PA, TN, UT, VA, and WV; and countries of: Australia, Canada, Europe (i.e., France, Germany, Great Britain, Ireland, Italy, Netherlands, Portugal, Sweden, & Switzerland), Hong Kong, New Zealand, and United Arab Emirates.
Within the U.S.; HI, TX, MO, Washington D.C., Internationally within the following coutires: Canada, Saudi Arabia, Lebanon, Austria, and Taiwan.
US Nationwide Distribution in the states of OH and TX.
Worldwide Distribution - US Distribution to the states of UT, TX, and IL, and to the countries Austria, Germany, Spain, Switzerland, and Netherlands. No VA/military/govt consignees.
Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Venezuela.
The affected product was distributed to four consignees in the states of Ohio and Michigan. The affected product was not directly distrubuted to any government consignees or to any foreign countries.
Nationwide and International: Bahamas and Jamaica

Product Description
BD Vactuainer SST glass and plastic tubes.
BD Vacutainer Partial Draw serum tubes (with or without gel).
BD Vacutainer Microtainer Serum tubes (with or without gel).
Red Blood Cells (Apheresis) Leukocytes Reduced
Red Blood Cells Leukocytes Reduced Irradiated
Walgreens ASPIRIN FREE TENSION HEADACHE, Pain Reliever/Pain Reliever Aid, Acetaminophen & Caffeine, 100 Coated Caplets, OTC --- Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, Item # 427594, NDC 0363-0428-12, UPC Code 311917134925
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities, workstations) Communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction that other systems have with the Centricity Enterprise archive. The intended users for Centricity Enterprise Archive are service personnel and system administrators and non clinical users. As of V4.0 XDS enabled systems can communicate with the archive using the XDS and XDS-1 profiles (published by IHE).
New Life Nutritional SUPER FAT BURNER, bottle contains 30 CAPSULES, product is packaged in a white plastic bottle with black, red and green font. Distributed by: New Life Nutritional under the following addresses: 714 West 181st Street New York, NY 10033, 153 East 188th Street Bronx, NY 10468, 316 Monroe Street Passaic, NJ 07055 and 200 Dyckman Street New York, NY 10040.
MAXI GOLD WEIGHT LOSS PILL, bottle contains 30 CAPSULES, product is packaged in a clear plastic bottle with blue lid, gold and orange label with orange font. Distributed by: New Life nutritional, www.newlifenutritional.com under the following telephone numbers: (212) 923-6386, (212) 304-8880, (718) 329-1636 and (862) 591-2188.
Esmeralda, bottle contains 30 Softgels, product is packaged in a white plastic bottle with green labeling and black font. Distributed by: New Life Nutritional, www.newlifenutritional.com under the following addresses: 714 West 181st Street NY, NY 10033, 200-9 Dyckman Street NY, NY 10040, 153 East 188th Street Bronx, NY 10468 and 316 Monroe Street Passaic, NJ 07055.
Vascular Graft; Length 176 cm; Inflow Diameter 4mm; Outflow Diameter 5mm
Organic English Cucumber, 12 pieces per box, PLU 94593, UPC 8 24660 20100 9
Juice Beauty Illuminating Eye Color 1.5 grams (0.5 oz.); Color: Champagne Fard a Paupieres; Contains Certified Organic Ingredients; UPC: 834893006500 Manufactured for Juice Beauty. Inc.San Rafael, CA 94901-3566 Made in USA
Juice Beauty Illuminating Eye Color 1.5 grams (0.5 oz.); Color: Chocolate; Fard a Paupieres; Contains Certified Organic Ingredients; UPC: 834893006524 Manufactured for Juice Beauty. Inc.San Rafael, CA 94901-3566 Made in USA
Juice Beauty Illuminating Eye Color 1.5 grams (0.5 oz.); Color: Cappuccino; Fard a Paupieres; Contains Certified Organic Ingredients; UPC: 834893006517; Manufactured for Juice Beauty. Inc.San Rafael, CA 94901-3566 Made in USA
Ascorbic Acid 500 mg/mL Sterile Injection, 50mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
Magnesium Chloride 20% (200mg/mL) Sterile Injection, 50mL Multi-Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
Tropi/Cyclo/Phenyl/Tobra/Flurb (1/1/10/0.3/0.03)% Sterile Ophthalmic Solution, 1 mL Dropper in a 3 mL bottle, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL flexible container unit, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7620-03
ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
Hydroxyprogesterone Caproate, 250 mg per mL, 5 mL vial, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
Epinephrine 1:1000, 0.15 mL packaged in 0.3 mL syringes, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
Lidocaine 4% Syr (PF) Rx, 1 mL packaged in 3 mL syringes, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
Tri-mix #4 (Papaverine 30 mg, Phentolamine 1 mg, Prostaglandin-1 10 mcg/mL), packaged in 10 mL sterile glass vials, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. Affected lots identified initially were 110705, 110706, 110715, 110716, 110717, 110718, 110719, and 110720. Subsequent investigation also identified as affected lots 1310227, 1310252, and 1310257. HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials.
1 Single-Dose 0.7 mL Vial STERILE DILUENT For Merck Sharp & Dohme Corp., Live Virus Vaccines (Sterile Water) Rx Only, Contains No Preservative, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of merck & Co., Inc., Whitehouse Station, NJ 08889 USA By DSM Pharmaceuticals, Inc., Greenville, NC 27834 USA, NDC 0006-4309-01 - 10 Single-Dose vials per carton.
Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal and certain treatments of the posterior portion of the eye.
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal and certain treatments of the posterior portion of the eye.
Blood and Blood Products for Reprocessing
Coca Cola Zero, 2 liter pet bottle, UPC 49000 05014, The Coca Cola Company
Platelets Pooled Leukocytes Reduced Irradiated
Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The MiSeqDx Universal Kit 1.0 is intended for use with the MiSeqDx instrument.
MAYHEM capsules, Proprietary Blend 525 mg, Dietary Supplement, 60-count bottles, Chaotic-Labz, UPC 6 28586 67805 7.
adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy device.
DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors . Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters.
VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature.
UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. Used to cover the opening to the biopsy/suction channel of an endoscope.
Trilogy Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
Neodent Titamax WS Cortical Implant 4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function
Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Si 3000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Xi 4000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Model #: D00A00224D The Lite DM (Lite Data Manager) is a software application developed by HORIBA Medical intended to receive, store, and manage Startup, Patient, and Quality Control (QC) results from an ABX Micros 60 Hematology Analyzer or ABX Micros CRP 200 Hematology Analyzer. Only one instrument connection is allowed per each Lite DM workstation. The Lite DM application runs on a PC within a Windows Operating System platform. Data transmitted from the instrument to the Lite DM workstation is a Serial RS-232 unidirectional ABX Format communication. The Lite DM can act as a standalone data manager for data received from the instrument, or allow transmission of this data to a Host (LIS Laboratory Information System or EMR Electronic Medical Record system). Following the completion of each blood sample analysis performed on the connected HORIBA Medical hematology analyzer, results are then communicated (uni-directional) to the Lite DM workstation. Results received will display to the user in a specific color coding format indicating any normal or panic reference range violations. Results are then rejected or accepted by the user for final reporting - formatted to guidelines stipulated by CLIA. At no time are any results interpreted; only reported for review and appropriate action.
UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
Platelets Pheresis Leukocytes Reduced Irradiated
NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP, UK Zimmer Trabecular Metal Technology, Inc 10 Pomeroy Road, Parsippany, NJ 07054 USA
Private Selection Extreme Moose Tracks Ice Cream; packaged in plastic 48 fl oz containers, UPC Code: 11110-00456
Component- Dianz Capacitor used in PerfectO2'' Oxygen Concentrator, packaged one unit per box.
ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED ''Comparable to Philips Medical HeartStart Electrodes Plug Style Connector'', Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED ''Comparable to Philips Medical HeartStart Electrodes Plug Style Connector'', Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartStart AED ''Comparable to Philips Medical HeartStart Electrodes Plug Style Connector'', Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED ''Comparable to Philips Medical HeartStart Electrodes Plug Style Connector'', Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED ''Comparable to Philips Medical HeartStart Electrodes Plug Style Connector'', Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
Dacarbazine, Injection, USP, 200mg, vials packaged in individual cartons, Rx only, Manufactured by Hospira Australia 1 Lexia Place, Mulgrave, Victoria Australia 3170. NDC 61703-327-22.
Whole Foods Tarte Aux Pomme 10 inch, packaged in a brown box. Net Wt. 2 lb 8 oz. UPC: 23072300000
HyVee Cheddar Cheese Stuffed Jalapenos. Product is breaded jalapeno stuffed with cheddar cheese designed to be cooked in either the oven or a fryer. The package contains a clear inner plastic sealed bag with the food product, inside a cardboard larger carton. The net weight is 8 ounces, and packed 12 units per case. The UPC is 0 75450 14989 0. The product is labeled in parts: ''***HyVee cheddar cheese stuffed jalapenos***jalapenos stuffed with cheddar cheese in a crispy breading***ovenable keep frozen***NET WT 8 OZ (227 g)***CONTAINS: WHEAT, MILK***PROCESSED IN A FACILITY THAT ALSO PROCESSES EGG AND SOY***DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY WEST DEMOINES, IA 50266***1-800-289-8343***''.
Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA procedures. The Persona Surgical Technique indicates that the Persona Cemented Tibial Broach Inserter/Extractor Handle is intended to broach the proximal tibia in preparation for the full seating of the tibial implant.
KimVent* Microcuff* Subglottic Suctioning, Endotracheal Tube, 7.0 m, Distributed by Kimberly Clark Global Sales, LLC. KimVent Microcuff Subglottic Suctioning Endotracheal Tubes are indicated for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
KimVent* Microcuff* Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distributed by Kimberly Clark Global Sales, LLC. KimVent Microcuff Subglottic Suctioning Endotracheal Tubes are indicated for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
KimVent* Microcuff* Subglottic Suctioning, Endotracheal Tube, 8.0 mm, Distributed by Kimberly Clark Global Sales, LLC. KimVent Microcuff Subglottic Suctioning Endotracheal Tubes are indicated for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
KimVent* Microcuff* Subglottic Suctioning, Endotracheal Tube, 8.5 mm, Distributed by Kimberly Clark Global Sales, LLC. KimVent Microcuff Subglottic Suctioning Endotracheal Tubes are indicated for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
KimVent* Microcuff* Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distributed by Kimberly Clark Global Sales, LLC. KimVent Microcuff Subglottic Suctioning Endotracheal Tubes are indicated for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
Micro SSP Generic HLA Class I DNA Typing Trays Catalog Identification: SSP1L Intended Use: For use in DNA typing of Class I or Class II HLA alleles. Contents: 10 96-Well Primer Set trays 1 test/tray 15 Tray Seals 10 D-mix Aliquots 1000 ul/tube One Lambda, Inc. OLI, 21001 Kittridge Street, Canoga Park, CA 91303 U.S.A. The Micro SSPTM DNA Typing Tray provides sequence-specific oligonucleotide primers for amplification of HLA alleles and the human -globin gene by the polymerase chain reaction (PCR). Pre-optimized primers are presented (dried) in different wells of well thin-walled tube tray for PCR. The tray is ready for the addition of DNA samples, recombinant taq polymerase, and specially formulated dNTP-buffer mix (Micro SSPTM D-Mix). Each typing tray includes a negative control reaction tube that detects the presence of the internal control PCR product generated by the Micro SSPTM DNA Typing Tray. The internal (positive) control PCR product amplified from the Human -globin gene is amplified in every test well, along with the primer-specified HLA allele, if present in the test sample. Positive typing bands indicate amplification of specific HLA alleles. For each lot, the specific HLA alleles can be identified using the provided user documents(codesheet, resolution limitations, primer information, worksheet) and using the procedure described in the provided product insert.
GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . Product Usage: Usage: Skintact Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only.
Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. Englewood, CO 80112 USA. DISCPAC Syringe Tip Caps. RER H93866100 x 1000. Sterile
Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Best Choice, DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, 0 70038 47011 3; b) CVP, Distributed by Salado Sales, Inc., Temple, Texas 76503, UPC: 7 61706 16500 3; c) Equaline, DISTRIBUTED BY SUPERVALU INC. EDEN PRAIRIE, MN 55344, UPC: 0 41163 25110 6; d) exact, Prepared For/Prepare Pour: Loblaws Inc., Montreal H4N 3L4, Tonronto M4T 2S8, Calgary T2E 7S9, CANADA, Imported by/Importe par: Arrow OTC, Mississauga, ON L5N 2B8, UPC: 0 60383 73613 2; e) FAMILY wellness, Distributed by: Family Dollar Services, Inc., 10401 Monroe Rd., Matthews, NC 28105, UPC: 0 32251 00459 9; f) Good Neighbor Pharmacy, Distributed By: AmerisourceBergen 1300 Moris Drive, Chesterbrook, PA 19087, UPC: 0 87701 14975 7, NDC: 24385-075-05; g) GOODSENSE, Manufactured By: KC Pharmaceuticals, Pomona, CA 91768, UPC: 1 80410 00015 6, NDC: 48879-009-07; h) H-E-B, Made with Pride and Care for H-E-B, San Antonio, TX 78204, UPC: 0 41220 94731 7; i) Health Mart PHARMACY, Distributed by McKesson One Post STreet, San Francisco, CA 94104, UPC: 0 52569 13472 6, NDC: 62011-0102-1; j) healthy accents, Distributed by: DZA Brands, LLC, 2110 Executive Drive, Salisbury, NC 28147, UPC: 7 25439 93380 3; k) HyVee, Distributed by HY-VEE, Inc., 5820 Westown Parkway, West Des Moines, IA 50266, UPC: 0 75450 29604 4; l) Kroger, Distributed by The Kroger Co., Cincinnati, Ohio 45202, UPC: 0 11110 38597 0; m) life BRAND, Imported for SHOPPERS DRUG MART PHARMAPRIX, Toronto, M2J 4W8, UPC: 057800-19616-7; n) life BRAND, Importe pour: SHOPPERS DRUG MART PHARMAPRIX, Toronto, M2J 4W8, UPC: 0 57800 19616 7; o) LiveBetter, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, UPC: 0 41310 62042 7; p) meijer, Dist. By Meijer Distribution, Inc., 2929 Walker Ave NW, Grand Rapids, MI 49544, UPC: 0 41250 82916 4; q) Our Family, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN, 55435, UPC: 0 70253 96684 2; r) Publix, D
Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Astringent Redness Reliever, Distributed by Safeway Inc., P.O. Box 99, Pleasanton, CA 94566-0009, UPC: 3 21130 70067 8; b) Best Choice, Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC: 0 70038 47010 6; c) EQUALINE, Distributed by Supervalu Inc., Eden Prairie, MN, UPC: 0 41163 25114 4; d) GOODSENSE, Manufactured By: KC Pharmaceuticals, Pomona, CA 91768, UPC: 1 80410 00018 7, NDC: 48879-010-07; e) H-E-B, Made for: H-E-B, San Antonio, TX 78204, UPC: 0 41220 86936 7; f) healthy accents, Distributed by: DZA Brands, LLC 2110 Executive Drive, Salisbury, NC 28147, UPC: 7 25439 93382 7; g) HyVee, Distributed By Hy-Vee, Inc., 5820 Westown Parkway, West Des Moines, IA 50266, UPC: 0 75450 29777 5; h) Kroger, Distributed by The Kroger Co., Cincinnati, Ohio 45202, UPC: 0 11110 38599 4; i) life, Imported for/Importe pour: SHOPPERS DRUG MART PHARMAPRIX., Toronto, M2J 4W8, by/par: Arrow OTC Inc., Mississauga, Ontario L5N 2B8, UPC: 0 57800 19617 4; j) LiveBetter, Distributed By Onpoint. Inc., 2 Paragon Drive, Montvale, NJ 07645, UPC: 0 41310 62041 0; k) meijer, Dist. by Meijer Distribution, Inc., 2929 Walker Ave NW, Grand Rapids, MI 49544, UPC: 0 41250 82918 8; l) Publix, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, UPC: 0 41415 01176 2; m) QUALITY CHOICE, Distributed by Quality Choice, Novi, MI 48376, UPC: 6 35515 99505 5; n) REDNESS RELIEF ASTRINGENT, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC: 0 50428 79686 3; o)Rexall, Manufactured for: Rexall Brands Corp., Mississauga, Ontario L4Z 1R9, Imported by: Arrow OTC Company, Mississauga, Ontario L5N 2B8, UPC: 7 71058 10159 8; p) Rexall, Fabrique pour: Rexall Brands Corp., Mississauga, Ontario L4Z 1R9, Importe par: Arrow OTC Company, Mississauga, Ontario L5N 2B8, UPC: 7 71058 10159 8; q) select brand, Distributed by: SELECT BRAND DISTRIBUTORS,
Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Manufactured for: Petragon, Inc., Edwardsville, KS 66111; b) SWIFT, Distributed by Swift First Aid, Inc., Valencia, Calif. 91355, UPC: 6 69635 24082 5; c) Xpect First aid, Manufactured for Cintas First Aid & Safety, Mason, OH 45040; d) ZEE, Distributed by ZEE MEDICAL, INC., Irvine, CA 92606, UPC: 6 90689 00609 9.
Eye Drops Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Advanced Relief, Distributed by Safeway Inc., P.O.Box 99, Pleasanton, CA 94566-0009, UPC: 3 21130 70064 7; b) Best Choice, Distributed By: Valu Mercahndisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC: 0 70038 47009 0; c) EQUALINE, Distributed By Supervalu Inc., Eden Prairie, MN 55344, UPC: 0 41163 25392 6; d) equate, Manufactured for/Fabrique pour: Wal-Mart Canada Corp, 1940 Argentia Rd, Mississauga Ontario L5N 1P9, Imported by/ Importe par: Arrow OTC Company, Mississauga, Ontario L5N 2B8, UPC: 1 83164 00022 9; e) exchange select, Manufactured For: Your Military Exchanges By: KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC: 6 14299 39625 8; f) GOOD NEIGHBOR PHARMACY, Distributed By AmerisourceBergen 1300 Morris Drive, Chesterbrook, PA 19087, UPC: 0 87701 10663 7, NDC: 24385-077-05; g) GOODSENSE, Manufactured By: KC Pharmaceuticals, Pomona, CA 91768, UPC: 1 80410 00019 4, NDC: 48879-007-07; h) H-E-B, Made for H-E-B, San Antonio, TX 78204, UPC: 0 41220 89137 5; i) Health Mart, Distributed by McKesson, One Post Street, San Francisco, CA 94104, UPC: 0 52569 13474 0, NDC: 62011-0104-1; j) healthy accents, Distributed by: DZA Brands, LLC, 2110 Executive Drive, Salisbury, NC 28147, NDC: 7 25439 93383 4; k) HyVee, Distributed By Hy-Vee, Inc., 5820 Westown Parkway, West Des Moines, IA 50266, UPC: 0 75450 29778 2; l) Kroger, Distributed by The Kroger Co., Ohio 45202, UPC: 0 11110 38598 7; m) life, Imported for/ Importe pour: SHOPPERS DRUG MART PHARMAPRIX, Toronto, M2J 4W8, by/par: Arrow OTC Inc., Mississauga, Ontario L5N 2B8, UPC: 0 57800 15640 6; n) LiveBetter, Distributed by Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, UPC: 0 41310 62043 4; o) Medic's Choice, KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC: 0 95072 01251 8, NDC: 055654-025; p) meijer, Dist. By Meijer Distribution, Inc., 2929 Walker Ave NW, Grand Rapids, MI 49544, UPC:
RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid separation of whole blood contained in original collection tubes.
Willy's Just Peachy Salsa, packaged in 16-oz. plastic deli containers
Pea River Raw Shelled Raw Fine Alabama Grown Peanuts, Net Wt. 2.5 lbs
White Tahina, Net Wt. 907 g, 12 jars/case
sulfur8(R) medicated anti-dandruff conditioner, dandruff treatment for Braids, spray, Active Ingredient: Salicylic Acid, 2%, 12 FL OZ (356ml) spray bottle, OTC, Made in the U.S.A. J. Strickland & Co., OLIVE BRANCH, MS 38654 UPC: 0 7561044510 7
Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Alprazolam tablets, USP, CIV, 0.25 mg, Rx Only, a) 500 count bottle, b) 1000 count bottle, Distributed by: Greenstone LLC, Peapack, NJ, 07977, a) NDC 59762-3719-3, b) NDC 59762-3719-4.
Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; 100-bottle capsules - NDC 68382-247-01 500-bottle capsules - NDC 68382-247-05

Code Info
There is no linkage to any particular lot of BD product.
Lot Number P78221, expiration date 05/14; Lot Number P78222, expiration date 05/14
Centricity Enterprise Archive versions: 4.0.x
W036214114275 (triple collection) W036214114276 (double collection)
All distributed Natus neoBLUE 2 systems with LED PCB replacements received after February 16, 2012. For use only with neoBLUE devices manufactured between 2002 and 2007 (neoBLUE2)
Lot/Serial #(s): N/A Software Version(s): Versions 2.0.0.19 and lower. Expiration Date (s): N/A
All Lots. Catalog / Part Number C100-PHILIPS
All Lots. Catalog / Part Number C100AC-PHILIPS
All Lots. Catalog / Part Number T100LO-PHILIPS
All Lots. Catalog / Part Number T100-PHILIPS
All Lots. Catalog / Part Number T100AC-PHILIPS
Best By Dates between 11/20/2014 and 12/01/2014
The manufacturing date code: 14311402. Best if Use by date: 05/07/2016. The lot code used is a Julian Production Date Code and broke down as: 14 = 2014 Year of production 311 = 311th day in the year, or November 7th 4 = Line of production 0 = Film Used 0 = Clear Film 2 = Nampa Production Facility
Model No.: SSP1L Product Code: N/A Lot/Serial No.: Lot 010; Batches 001-006
Product Code H93869100, Lot 1001380 and Product Code H93866100, Lot 1001365
On Retail Unit: Prod. date: 9/2014 Exp. date: 8/2016 On Master Carton: DATE MFG: 09/10/2014

Product Quantity
There is no linkage to any particular lot of BD product
1907 total (1413 in US and 494 international)
551 total: USA: 547 units, Canada: 4 units
sold in boxes of ten electrodes: 4663.8 boxes; 46638 units total
sold in boxes of ten electrodes: 116 boxes; 1160 units total
sold in boxes of ten electrodes: 1791.3 boxes; 17913 units total
sold in boxes of ten electrodes: 4692.9 boxes; 46929 units total
sold in boxes of ten electrodes: 209 boxes: 2090 units total
45 (33 within U.S. and 12 internationally); 1 lot

Reason for Recall
''Please be aware tht this not a new recall. The firm has taken action; but, due to administrative issues additional products are now being classified by the agency''. There is an apparent bias in the determination of Total T3, Total T4, HBsAg, Folate BA, VB 12, BR, FSH and Cortisol hormones used to determine thyroid disease states, and adrenal gland function. The immunoassay results are high when BD serum separator tubes are used in certain instruments platforms.
''Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-0052-05). The firm has taken action; but, due to administrative issues additional products are now being classified by the agency''. There is an apparent bias in the determination of Total T3, Total T4, HBsAg, Folate BA, VB 12, BR, FSH and Cortisol hormones used to determine thyroid disease states, and adrenal gland function. The immunoassay results are high when BD serum separator tubes are used in certain instruments platforms.
Blood products, not properly tested appropriately for syphilis, were distributed.
Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache Caplets due to the presence of sucralose, which was not declared on the label.
GE Healthcare has become aware of a potential data loss issue associated with empty path names resulting from HL-7 updates when the cache disk is almost full.
Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to the presence of undeclared and unapproved drugs.
Human tissue allograft, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, was distributed.
Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Tricar is recalling Organic English Cucumbers because they may be contaminated with E.coli.
Product lots in question tested positive for the presence of Bacillus cereus
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.
A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.
Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Batches of HemoCue Glucose 201 Microcuvettes show discoloration and provide results outside the specification at the end of their shelf life, approx. after 6 months. The HemoCue Glucose 201 Analyzer with plasma conversion multiplies the measured whole blood glucose value by a factor of 1.11 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are for In Vitro Diagnostic use only, and are only to be used with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. For professional use only.
Blood product, with an unacceptable pH, was distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
A single lot of Sterile Diluent, with the potential for the lot number and expiry to be missing from the primary label, was distributed.
Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Reagent probe performance may decline more quickly than anticipated and have an effect on assays with similar formulations when processed sequentially on the same reagent server.
Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide.
Blood products, collected from ineligible donors, were distributed.
Blood products, collected from an ineligible donor, was distributed.
Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay on the MiSeqDx instrument.
A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
Equipment malfunction led to ingredients to be blended at levels that are inconsistent with approved formulations.
Platelets, with lack of assurance of proper storage temperatures, were distributed.
It was discovered a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. The software cannot report insertions or deletions at specific genomic locations with respect to the primer.
Plateletpheresis products, with low platelet counts, were distributed.
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.
Two issues were identified: 1. In the release of adaPT insight v1.3.2., the kV/kV Single Source acquisition workflow was linked to a wrong geometrical calibration file, resulting in an alignment offset for this specific mode of acquisition. 2. A gantry collision incident required the IBA service team to verify the gantry alignment and protons I x-ray beams colinearity, during which the colinearity parameters was changed. This was done for the Cone Beam Computed Tomography and kV/kV Dual Sources acquisition modes (the associated config ration file was modified), but not for the kV/kV Single Source acquisition mode (which requires to change another configuration file).
Mindray has identified an issue that involves the IBP module used with the DPM 6 and DPM 7 Monitor where the IBP measurement data may be displayed in an incorrect IBP tile on the monitors display.
Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.
Maquet has confirmed through a customer complaint that while the oxygenators and the pouches for a single lot of Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioliine Coating are labeled correctly with the Bioline coating, the individual cartons and 4-pack shipping containers of this lot incorrectly bear Softline coating labels instead of the bioline coating labels.
Packaging non-conformance related to the integrity of the sterile pouch seal.
Zimmer received a single complaint wherein a Trilogy&reg; Fiber Metal Multi-Hole Acetabular Shell would not attach to the inserter/impactor instrumentation. Subsequent investigation found the polar-hole threads to be present but non-conforming to specifications, in that the minor diameter was undersized. Investigation also indicates that the issue is isolated and affects only lot 62714305, which comprises 68 units. The threads are intended only for engagement with instrumentation, and the polar hole is not for use with bone screws or supplemental fixation. CAPA000001048 has been initiated to investigate root cause and define corrective actions. As a result, Zimmer is initiating a voluntary recall of this single lot. Return of additional product from the affected lot will facilitate root cause investigation.
Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subject of a Field Safety Notification because the system will exhibit a higher light intensity output than the original device. While some customers may prefer using these lights at the higher intensity levels, some are concerned that patients may receive more intensity than desired.
Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the washer and disinfector of Getinge 46-Series (CM302) with PACS 300/350 control. After performing detailed root cause analysis, the firm has identified the problem as insufficient water flow throughout the manifold due to formation of air pockets where sedimentation may occur.
Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prior to June 2014) exhibit a yellow/brownish color after reconstitution (yellow color or darker) instead of the typical white to off-white color. Vials exhibiting this yellow/brownish color were observed to cause prolonged prothrombin (PT) clotting times.
The recalled product was distributed with an incorrect serial number printed on the device's label.
The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure Kit box, the six-kit box, and the shipping box. If heat were to damage the material, the result would be a loss of fluorescence.
HORIBA Medical is informing all HORIBA Medical Lite DM customers using software version 2.0.0.19 and lower of a software bug related to the potential for results received being applied to the wrong order in the Lite DM Worklist. This bug has not been seen in software versions above V2.0.0.19 IMPACT: Potential for results received being applied to the wrong order in the Lite DM Worklist. The issue can occur from a specific sequence of steps 1. The Lite DM Worklist must be enabled (and) 2. Multiple orders must be created in the Lite DM Worklist (and) 3. The order panel is changed or selected after the order is created and left in edit mode a. panel edit mode = drop down arrow for the panel selection is still visible
Failure to submit a 510(k) for device labeling changes.
Platelets, with misbranded product volumes, were distributed.
Blood products, misbranded for Rh antigen typing, was distributed.
During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle.
The ice cream product may contain peanuts not listed on the ingredient statement.
The firm has found that the Component- Dianz&reg; Capacitor has ruptured which results in a potential fire hazard.
Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user may not discover the incompatibility issue until the AED must be used. This may result in a delay in electrical therapy, which can lead to death or serious adverse consequences.
Blood products, collected from an ineligible donor, were distributed.
Blood products, collected from an inelgible donor, were distributed.
Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions.
HyVee Cheddar Cheese Stuffed Jalapenos is recalled due to undeclared egg.
The affected lot was supplied by contract manufacturer and are potentially subject to disassociation of the magnet cover. Zimmer received one complaint indicating the magnet cover of a Persona Cemented Tibial Broach Inserter/Extractor Handle lot 62085420 was missing after broaching the tibia. Postoperative radiographs were inspected and the magnet cover was not identified. The investigation indicated a mismatch of print revision B for the magnet cover and print revision F for the guide for one purchase order. This purchase order consisted of the following lots: 62072307, 62072565, 62085420, and 62192754. The primary anchor for the magnet cover is the press fit between the cover and the guide. The mismatch of print revision B with print revision F results in a clearance fit between the magnet cover and the guide. Quality Hold was placed an A and B hold on the lots indicated by the manufacturer to have been made with the mismatched print revisions. Zimmer is initiating a voluntary recall of the lots manufactured with the mismatched print revisions.
The cuff inflation line may detach from the endotracheal tube during use.
HLA Class I DNA Typing Trays, missing allele specific lot documentation, were distributed.
One lot of raw peanuts was found to contain 26 ppb Aflatoxin
The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. This could lead to a situation, in which a patient who is in a life threatening situation requiring a defibrillation can receive such therapy only with a delay or not at all.
Baxter Corporation initiated a recall of two lots of Self-Righting Luer Lock Tip Caps because they were distributed prior to closure of the validation.
Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Iris International is recalling the RTH8 Rotor used in the StatSpin Express 4 Horizontal Centrifuge because the RTH8 rotor may develop cracks with use over time.
The firm did not list food color, FD & C yellow #5, on the label.
Product testing at the supplier found aflatoxin above 20 ppb
Zacares USA is recalling White Tahina because it may be contaminated with Salmonella.
Failed pH specification: Product pH test value of 5.72 failed to meet its product specification of 6.0 to 7.5.
A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleeve instruments (the Sleeves) allow the mating Drill and Awl instruments to penetrate 1.0 mm beyond their intended depths during screw hole preparation.
Failed Stability Specifications: Two lots of Alprazolam 0.25 mg tablets, were found to be below specification for assay (potency).
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.