BEUDAMED
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    Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma Siemens Material Number (SMN): 11097635

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·January 5, 2022

    Atellica CH 2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of 2-microglobulin in human serum and plasma Siemens Material Number (SMN): 11097635

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JZG·December 1, 2021

    i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. The cartridge is to be used with the i-Stat Analyzer, but not with the i-Stat Portable Clinical Analyzer or the Philips Medical System (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-Stat System, the cTnl test is to be used by trained health care professionals in accordance with a facility's policies and procedures.

    FDA Enforcement
    Class II ·Terminated·Abbott Point Of Care Inc.·August 15, 2012

    BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682000977, and the Arm part number in the kit is 01000221456. The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.

    FDA Enforcement
    Class II ·Terminated·Stryker Communications·July 23, 2014

    BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as component of kit part number 0682000976, and the Arm part number in the kit is P17087. The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.

    FDA Enforcement
    Class II ·Terminated·Stryker Communications·July 23, 2014

    Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case. Cardiopulmonary bypass catheter.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DWF·January 25, 2016

    BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682000977, and the Arm part number in the kit is 01000221456. The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.

    FDA Recall
    Terminated ·Stryker Communications·Product code BRY·March 17, 2014

    BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as component of kit part number 0682000976, and the Arm part number in the kit is P17087. The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.

    FDA Recall
    Terminated ·Stryker Communications·Product code BRY·March 17, 2014

    i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. The cartridge is to be used with the i-Stat Analyzer, but not with the i-Stat Portable Clinical Analyzer or the Philips Medical System (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-Stat System, the cTnl test is to be used by trained health care professionals in accordance with a facility's policies and procedures.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code MMI·February 1, 2012

    Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027

    FDA Recall
    Terminated ·Hospira Inc.·Product code FRN·February 5, 2013

    Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026

    FDA Recall
    Terminated ·Hospira Inc.·Product code FRN·February 5, 2013

    Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.

    FDA Recall
    Terminated ·Hospira Inc.·Product code FPK·February 19, 2013

    TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-Regulation System TECOTHERM NEO is designed for controlled cold & heat treatment procedures. By means of a mattress, cold and heat is provided to the patient, depending on the therapy objective.

    FDA Recall
    Terminated ·Tec Com Gmbh Eingang B Am Krummling 1 Kabelsketal Germany·Product code DWJ·August 14, 2018

    LAERDAL Silicone Resuscitator (LSR), Adult size, containing Intake/Reservoir Valve. Sold as Part Nos: 870050-Adult Basic w/o Mask in Carton; 870051-Adult Complete in Carton; 870052-Adult Standard with Adult Mask 4-5+ in Carton; 870053-Adult Complete in Compact Case; 870055-Adult Complete in Display Case; 875500-Adult Update Kit. Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, NY, Made in Norway.

    FDA Recall
    Terminated ·Laerdal Medical Corporation·Product code BTM·December 23, 2003

    LAERDAL Silicone Resuscitator (LSR), Preterm Size, containing an Intake/Reservoir Valve. Sold as Part Nos: 850050-Preterm Basic w/o Mask in Carton; 850051-Preterm Complete in Carton; 850053-Preterm Complete in Compact Case; 850055-Preterm Complete in Display Case; 855500-Preterm Update Kit. Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, NY, Made in Norway.

    FDA Recall
    Terminated ·Laerdal Medical Corporation·Product code BTM·December 23, 2003

    Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.

    FDA Recall
    Terminated ·Ventlab Corporation·Product code BTM·July 11, 2012

    Pediatric Manual Pulmonary Resuscitator. Product ID # 12-8708. Packaged under the name of Evergreen.

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    Pediatric Manual Pulmonary Resuscitator w/Luer-lock Sampling Elbow & Reservoir bag (No mask). Product ID# 12-8707. Packaged under the name of Evergreen.

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    STAT-Check Infant Disposable Manual Resuscitators with Built-in Pressure Monitor, , with 40 cmHO Pressure Limiting System & Pressure Port Adapter, Single Patient Use, Non-Sterile, Re-Order SC7100 Series, Non Latex, Ventlab Corporation, 155 Boyce Drive, Mocksville, NC 27028, (336) 753-5000, (336) 753-5002 FAX.

    FDA Recall
    Terminated ·Ventlab Corporation·Product code BTM·March 26, 2004

    STAT-Check Infant Disposable Manual Resuscitators, with 40 cmHO Pressure Limiting System & Pressure Port Adapter, Single Patient Use Non-Sterile, Re-Order SC7000 Series, Non Latex, Ventlab Corporation, 155 Boyce Drive, Mocksville, NC 27028, (336) 753-5000, (336) 753-5002 FAX

    FDA Recall
    Terminated ·Ventlab Corporation·Product code BTM·March 26, 2004