BEUDAMED
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    DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors . Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters.

    FDA Recall
    Terminated ·Mindray DS USA, Inc. dba Mindray North America·Product code MHX·October 6, 2014

    AutoCAT 2 Series Intra-Aortic Balloon Pumps Catalog No: IAP-0400, IAP-0435, IAP-0500, and IAP-0535, Arrow International, Everett, MA 02149

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·November 12, 2007

    Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.

    FDA Recall
    Terminated ·Mindray DS USA, Inc. dba Mindray North America·Product code MHX·January 23, 2015

    Invasive Blood Pressure Interface Cables: a) Medrad 9500 Multigas monitor for MRI, Invasive Blood Pressure Interface Cable (Part # 3006314) for use with Abbott/Hospira IBP Transducer b) Invasive Blood Pressure Interface Cable (Part # 3008772) for use with Braun IBP Transducers. The product is an accessory to patient physiological monitor.

    FDA Recall
    Terminated ·Medrad Inc·Product code MWI·September 29, 2006

    The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which pressure is measured.

    FDA Recall
    Terminated ·C.R. Bard Inc·Product code PHU·January 13, 2020

    The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The CAM02 monitor measures and displays intracranial ICP) and intracranial temperature (ICT).

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code GWM·April 14, 2015

    BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries.

    FDA Recall
    Terminated ·Brasseler USA I Lp·Product code GFF·October 18, 2019

    Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures.

    FDA Recall
    Terminated ·Brasseler USA I Lp·Product code HTY·December 11, 2019

    Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw, Pediatric Product Code:80-1197 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the cranium for various Neurosurgical procedures.

    FDA Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code GWM·October 25, 2011

    Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Stainless Steel Subarachnoid Screw Product Code:80-1190 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the cranium for various Neurosurgical procedures.

    FDA Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code GWM·October 25, 2011

    Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw,, Adult Product Code:80-1196 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the cranium for various Neurosurgical procedures.

    FDA Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code GWM·October 25, 2011

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0400E

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·May 20, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·May 20, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·May 20, 2020

    AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring device containing aspiration tubing, infusion tubing, valves and optional pressure transducers for the measurement of intra- abdominal bladder pressure. The device attaches directly to the patient s existing urinary catheter/drain system providing both an enclosed fluid path for infusing fluid into the bladder catheter in order to monitor the hydrostatic pressure in the bladder.

    FDA Recall
    Terminated ·ConvaTec, Inc·Product code FEN·July 3, 2018

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·May 20, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·May 20, 2020

    INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code OWB·December 29, 2017

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·May 20, 2020

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·May 20, 2020