43 results
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21ms
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Sources: EU EUDAMED, US FDA
Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DRS·October 16, 2018
Triathlon MIS Femoral Adjustment Block;Catalog Number: 6541-5-601;Stryker Orthopaedics, Mahwah, New Jersey
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code JWH·September 19, 2006
Triathlon MIS Modular Capture;Catalog Number: 6541-5-723; Stryker Orthopaedics, Mahwah, New Jersey
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code JWH·September 19, 2006
Triathlon MIS AP Sizer Body - Left and Right; Catalog Number: 6541-5-508- left; Catalog Number: 6541-5-509 - right, Stryker Orthopaedics, Mahwah, New Jersey
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code JWH·September 19, 2006
Sequoia Oxymatic electronic oxygen conservers. Models OM-302, OM-311 ***and OM-312***.
FDA Recall
Terminated
·Chad Therapeutics Inc·Product code BZD·March 25, 2005
ORTHOPEDIC SURGICAL PACK HOSPITAL SAN CRISTOBAL CONTENTS: (I) CAUTERY TIP POLISH ER LIF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT W' X 1 2' LIF (1) BAG GLASSINE (2) LITE GLOVE (1) TABLE COVER BTC 77" X 11 0" HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED LIF (5) TOWELS ABSORBENT 1 5" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF ( 1 ) DRAPE SHEET 70" X 100" L/ F (5) LAP SPONGE PREWASH 18" X 1 8" XRD LIF (1 ) MAYOTRAYLARGE (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS LIF (1) SKIN STAPLER WIDE 35 LIF ( 1) DRAPE INCISE ANTI M I CROBIAL 23" X 1 7" LIF (1) SKIN MARKER WITH RULER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 2 1 " LIF (1 ) PAD ABDOM INAL 8" X 7"h.'' (1) YAUNKAUER SUCTION TUBE WITHOUT VENT LIF (1) SOLUTI ON SURG ICAL DURAPREP 26ML LIF (1 ) BLADE SURG ICAL #10 STAINLESS STEEL (I) SPLIT SHEET WITH ADHESIVE 108" X 77" STD SMS LIF (2) *Prs. GLOVE # 8.5 SURGEON NEUTRALON LATEX ( I ) *Pr. GLOVE# 8 SURGEON NEUTRALON LATEX ( I ) GOWN SURG. REINFORCED XL TOWEL/WRAP AAMI Ill (3) GOWN XL SMS IM PERVIOUS REINFORCED AAM I III LIF ( I ) CAUTERY PENCIL ROCK ER SWITCH (2) *Prs. GLOVES SURG. # 8 POWDER (4) Prs. GLOVES SURG. 8.5 Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OJH·May 20, 2014
Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CDD·May 8, 2012
Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CHH·December 15, 2014
Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of total cholesterol in serum and plasma.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code CHH·May 7, 2015
Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total cholesterol in serum and plasma.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code CHH·May 7, 2015
Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000). Anesthesia Vaporizer
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code CAD·April 21, 2016
IMMULITE /IMMULITE 1000 Vitamin B12
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CDD·January 2, 2018
Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414
FDA Recall
Terminated
·Polymer Technology Systems, Inc.·Product code CHH·January 16, 2019
PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc. Catalog # 1710.
FDA Recall
Terminated
·Polymer Technology Systems, Inc.·Product code CHH·June 5, 2009
Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination of Cholesterol concentrations in human serum on Beckman Coulter AU analyzers.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CHH·April 13, 2016
PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1711. Intended to provide a quantitative measurement of total cholesterol in whole blood.
FDA Recall
Terminated
·Polymer Technology Systems, Inc.·Product code CHH·April 2, 2009
Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
FDA Recall
Terminated
·Polymer Technology Systems, Inc.·Product code CHH·January 16, 2019
Vapofils with Stainless Steel Block Ends, Item Number V0507S (Sevofluane). The vapofil is a keyed anesthetic transfer tube that transfers the anesthetic from the bottle to the vaporizer.
FDA Recall
Terminated
·Southmedic Inc
Po Box 1365
Barrie Canada Ontario·Product code CAD·April 21, 2006
Sample Management System software for in vitro diagnostic testing Product # 030102-03
FDA Recall
Terminated
·Siemens Medical Solutions Diagnostics·Product code CDD·January 15, 2007
Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic.
FDA Recall
Terminated
·Alere San Diego·Product code CHH·November 16, 2010