BEUDAMED
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    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015

    ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31 Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX SYSTEM is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Recall
    Terminated ·Sendx Medical Inc·Product code CHL·February 20, 2009

    HOTLlNE Disposable Administration Sets, Product Code L-370 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood and Fluid Warmers (HL-90 and HL-290), for the warming and delivery of blood and I.V. solutions, at normothermic flow rates of 50 - 5,000 ml/hr.

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code LGZ·November 21, 2011

    Smiths Medical HOTLINE Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code LGZ·March 17, 2014

    ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporation, Medical Systems Division, Japan. Distributed by Abbott Laboratories Diagnostic Division, Irving, Texas

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code CGZ·June 10, 2004

    Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120

    FDA Recall
    Terminated ·RanD S.r.l. Strada Statale 62 Medolla Italy·Product code LGZ·April 30, 2021

    Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.

    FDA Recall
    Terminated ·RanD S.r.l. Strada Statale 62 Medolla Italy·Product code LGZ·April 30, 2021

    Extension Line Slide Clamps; Product codes: SA-09847

    FDA Recall
    Terminated ·Arrow International Inc·Product code KGZ·April 11, 2018

    VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CGZ·September 10, 2019

    Arrow Percutaneous Sheath Introducers

    FDA Recall
    Terminated ·Arrow International Inc·Product code KGZ·February 11, 2009

    enFlow IV Fluid Warmer Part number 980105VS; (510K name: enFlow IV Fluid Warmer Model 100, EFlow Disposable Cartridge, Model 200 and EFlow AC Power Supply Model 120) Intended for warming blood, blood products, and intravenous solutions, prior to administration. Intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

    FDA Recall
    Terminated ·Vital Signs Devices, a GE Healthcare Company·Product code LGZ·June 30, 2011

    Smiths Medical HOTLINE Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code LGZ·March 17, 2014

    HOTLlNE Disposable Administration Sets, Product Codes L-70NI Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood and Fluid Warmers (HL-90 and HL-290), for the warming and delivery of blood and I.V. solutions, at normothermic flow rates of 50 - 5,000 ml/hr.

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code LGZ·November 21, 2011

    Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures

    FDA Recall
    Terminated ·Cook Inc.·Product code KGZ·April 15, 2016

    Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.

    FDA Recall
    Terminated ·Cook Inc.·Product code KGZ·February 1, 2017

    ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures

    FDA Recall
    Terminated ·Smisson-Cartledge Biomedical, LLC·Product code LGZ·February 18, 2021

    Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE 3 L-370 Fluid Warming Set are intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures. These products are intended for use by appropriately trained healthcare professionals in clinical environments

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code LGZ·June 27, 2012

    AMSCO Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications.

    FDA Recall
    Terminated ·Steris Corporation·Product code LGZ·November 20, 2015

    HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions.

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code LGZ·October 31, 2016

    Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,

    FDA Recall
    Terminated ·Galt Medical Corporation·Product code KGZ·May 2, 2018