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    VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog number 1914605 and packaged as 90 slides/pack catalog number 8004707 VITROS CHE Slides quantitatively measure cholinesterase (CHE) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DIH·June 12, 2013

    CDI H/S Cuvette The intended use for the CDI H IS Cuvette is as follows: The CDI H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·December 11, 2015

    CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surgery requiring cardiopulmonary bypass. It is not designed for long-term use (greater than six hours). Perfusion Packs labeled as SMART contain components that have an additive to improve blood compatibility. Non-SMART packs may contain some SMART tubing and/or connectors depending on the customer requirements.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DWF·January 19, 2016

    Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical Product Usage: This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal sub-mucosal defects less thank 3cm in the upper GI tract, bleeding ulcers, arteries les than 2 mm, and polyps less than 1.5cm in diameter in the GI tract,. This device is not intended for the repair of GI tract luminal perforations.

    FDA Recall
    Terminated ·Cook Endoscopy·Product code MND·June 7, 2011

    Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code DEH·November 28, 2012

    Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code DEH·October 15, 2021

    FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code DFH·May 20, 2021

    Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code DFH·November 18, 2020

    Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code DEH·October 28, 2016

    Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code DEH·July 5, 2016

    Baxter BM11 Blood Monitor Pump hemodialysis machine; Baxter Healthcare Corporation, Deerfield, IL 60015; product code 5M3005, 5M3005R

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code KOC·December 21, 2005

    Stryker Navigation System - Hip Module Patient Tracker, green; Model 6007-005-000.

    FDA Recall
    Terminated ·Stryker Instruments, Instruments Div.·Product code HAW·July 14, 2004

    Baxter Arena Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code KDI·February 20, 2004

    Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100

    FDA Recall
    Terminated ·Abbott Laboratories Diagnostic Div·Product code JIX·August 5, 2005

    Baxter Renal Software Suite (Renal Link and PD Link); Baxter Healthcare Corporation, McGaw Park, Illinois 60085

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code KPF--·April 12, 2004

    Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral Nozzle for use with Stryker high vacuum cement injection system, 6 pack; part 0306-563-000.

    FDA Recall
    Terminated ·Stryker Instruments, Instruments Div.·June 1, 2003

    Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Corporation, Deerfield, IL 60015 USA or Baxter Healthcare Corporation, McGaw Park, IL 60085 USA

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code FII·February 20, 2004

    Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30.

    FDA Recall
    Terminated ·Abbott Laboratories Diagnostic Div·Product code JGJ·December 22, 2003

    Baxter Renal Software Suite v.3.0 and v.3.1 - Renal Link HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085.

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code KPF·November 14, 2007

    Baxter CAPD Solution Transfer Set for use with UV-Flash Germicidal Exchange Device, 1.2 m (48''); a sterile set consisting of a bag connector (spike connector), on-off clamp assembly, tubing and double sealing male Luer lock connector; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085; product code R5C4325

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code KDJ·November 5, 2004