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    VITROS Chemistry Products ALC Slides, 90 slides/pack; catalog number 8046872 VITROS ALC Slides quantitatively measure ethanol (ALC) concentration 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 DMT·June 12, 2013

    Immutest Cup CLIA Waived w/Adulteration, Item No. IMCA-7MT-W

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

    5F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No.: PSS-5F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DYB·April 14, 2009

    6F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No: PSS-6F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DYB·April 14, 2009

    7F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No.: PSS-7F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DYB·April 14, 2009

    7F Prelude Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DYB·February 16, 2017

    8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No.: PSS-8F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DYB·April 14, 2009

    GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code CCL·May 23, 2014

    Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of immunoglobulin M in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin M in the sample.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code DFT·May 16, 2018

    Clinical Chemistry Immunoglobulin M, List Number 1E01-20

    FDA Recall
    Terminated ·Abbott Laboratories Diagnostic Div·Product code DFT·November 10, 2005

    AEROSET Immunoglobulin M, list number 1E01-01, manufactured by Abbott Laboratories, South Pasadena, CA

    FDA Recall
    Terminated ·Abbott Laboratories Diagnostic Div·Product code DFT·July 31, 2002

    IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code DFT·November 1, 2022

    On-Site Alcohol IVD A single use enzymatic assay for qualitative detection of alcohol in urine or saliva. Catalog numbers: 47464 Roche Diagnostics Label A305-02 Varian, Inc. label

    FDA Recall
    Terminated ·Varian, Inc.·Product code DML·July 18, 2003

    HoverMatt Patient Transfer Solution/Air Transfer Mattress

    FDA Recall
    Terminated ·D.T. Davis Enterprises Ltd.·Product code FRZ·September 13, 2005

    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

    FDA Recall
    Terminated ·Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India·Product code EZL·March 17, 2020

    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

    FDA Recall
    Terminated ·Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India·Product code EZL·March 17, 2020

    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

    FDA Recall
    Terminated ·Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India·Product code EZL·March 17, 2020

    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

    FDA Recall
    Terminated ·Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India·Product code EZL·March 17, 2020

    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

    FDA Recall
    Terminated ·Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India·Product code EZL·March 17, 2020

    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

    FDA Recall
    Terminated ·Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India·Product code EZL·March 17, 2020