BEUDAMED
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    X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541

    FDA Recall
    Terminated ·Gambro Renal Products, Incorporated·Product code FLD·July 18, 2014

    MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code FLD·December 21, 2017

    Allez Spine Del Mar Pedicle Screw System: IT-FN 1007, Del Mar Sterilization Tray (Part Number: 30013)

    FDA Recall
    Terminated ·Allez Spine, LLC·Product code NKB·April 14, 2008

    PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch

    FDA Recall
    Terminated ·Gambro Renal Products, Incorporated·Product code FLD·July 18, 2014

    Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

    FDA Recall
    Terminated ·AURIS HEALTH INC·Product code EOQ·April 19, 2019

    Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.

    FDA Recall
    Terminated ·Mar Cor Purification·Product code FIP·June 27, 2012

    LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables (product#, model) [#101447, KP-05 Sulflux Plasma Separator], [#101473, HDE KP-05 Sulflux Plasma Separator], [#101785, LA-15 (AU) LDL Adsorption Column (Luer Lock Type)], [#101786, NK-M3R(UL) Tubing (Luer Lock Type)], [#101788, HDE LA-15(AU) LDL Adsorption Column (Luer Lock Type)], [#101789, HDE NK-M3R(UL) Tubing (Luer Lock Type)]. Associated labeling: 1) Instructions for Use (6): IFU LIPOSORBER LA-15 LDL Adsorption Columns FH, IFU SULFLUX KP-05 PLASMA SE-PARATOR FH, IFU TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(UL) FH, IFU LIPOSORBER LA-15 LDL Adsorption Columns FSGS, IFU SULFLUX KP-05 PLASMA SE-PARATOR FSGS, IFU TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(UL) FSGS, 2) Operators Manuals for the following (2): LIPOSORBER LA-15 SYSTEM OPERATOR's MANUAL FH, LIPOSORBER LA-15 SYSTEM OPERATOR's MANUAL FSGS 3) Patients Guide (1): A PATIENT GUIDE TO THE LIPOSORBER LA-15 SYSTEM FSGS

    FDA Recall
    Terminated ·Kaneka America Corp·Product code MMY·February 17, 2022

    Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body fluids and cells, in particular oocyte aspiration.

    FDA Recall
    Terminated ·Cook Inc.·Product code MQG·March 22, 2018

    Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intended for the aspiration of body fluids and cells; in particular oocyte aspiration.

    FDA Recall
    Terminated ·Cook Inc.·Product code MQG·March 22, 2018

    100-120V 2001 Pulse Oximeter With Mars - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code DQA·November 19, 2009

    100-120V 2001 Pulse Oximeter with Mars, Refurbished - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code DQA·November 19, 2009

    Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..

    FDA Recall
    Terminated ·Mar Cor Purification·Product code FIP·June 26, 2013

    Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients.

    FDA Recall
    Terminated ·Mar Cor Purification·Product code FIP·April 24, 2014

    Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field.

    FDA Recall
    Terminated ·Mar-Med Co·Product code GAX·December 28, 2020

    100-120V 2001 Pulse Oximeter with Mars Nurse Call - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code DQA·November 19, 2009

    100-120V 2001 Pulse Oximeter with Mars Nurse Call, Refurbished - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code DQA·November 19, 2009

    Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. " Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS system to conduct MARS treatments for patients weighing 20 kilograms or more. All treatments administered via the Prismaflex control unit must be prescribed by a physician.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·April 24, 2018

    Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. " Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS system to conduct MARS treatments for patients weighing 20 kilograms or more. All treatments administered via the Prismaflex control unit must be prescribed by a physician.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·April 24, 2018

    Prismaflex 7.XX ROW, Product Code 114870 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. " Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS system to conduct MARS treatments for patients weighing 20 kilograms or more. All treatments administered via the Prismaflex control unit must be prescribed by a physician.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·April 24, 2018

    Prismaflex 7.20 US, Product Code 955542 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. " Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS system to conduct MARS treatments for patients weighing 20 kilograms or more. All treatments administered via the Prismaflex control unit must be prescribed by a physician.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·April 24, 2018