BEUDAMED
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    MAC VU360, Electrocardiograph

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code DPS·October 27, 2020

    MAC VU360, Model Number 2030360-001, Electrocardiograph

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code DQK·June 28, 2019

    (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7 - 7.5 Fr. Catheters, Product Number: ASK-21242-MMC1; (3) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21242-UCD; (4) ARROWg+ard Blue MAC" Two-Lumen Central Venous Access Kit, Product Number: CDC-21242-1A; (5) ARROWg+ard Blue PSI Kit, Product Number: CDC-29803-1A; (6) ARROWg+ard Blue PSI Kit, Product Number: CDC-29903-1A

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·December 22, 2017

    GE Healthcare MAC 800 RESTING ECG ANALYSIS SYSTEM. The MAC 800 is a portable EGG acquisition, analysis and recording system. The MAC 800 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years. The MAC 800 is intended to be used by trained operators in a hospital or medical professional's facility environment to record EGG signals from surface electrodes. The basic system shall provide 2 modes of operation: (I) Resting EGG mode and (2) Arrhythmia mode. The basic systems shall print 3, 6-leads of EGG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code DPS·December 10, 2009

    Crystal Metal Disposable Blades size Mac 4 (part number 50674, 50674/F, 50674/BMI) and Mac 3 (part numbers 50675, 50675/F, 50675/BMI) Product Usage: Disposable laryngoscope blades.

    FDA Recall
    Terminated ·Penlon, Ltd. Abingdon Science Park Barton Lane Abingdon United Kingdom·Product code CCW·September 21, 2011

    Mac Pin Non-Cannulated Screw, 6.5 x 60mm

    FDA Recall
    Terminated ·Amendia, Inc·Product code NKB·July 7, 2017

    Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.

    FDA Recall
    Terminated ·Teleflex Medical·Product code CCW·January 10, 2017

    GE Medical Systems Mac-Lab System, cardiac catheterization data system. Software Version 6.5 2021423-015 Revision D GE Medical Systems, Information Technologies, Inc., 8200 West Tower Avenue, Milwaukee, WI 53223 USA.

    FDA Recall
    Terminated ·General Electric Medical Systems Information Technology·Product code DQK·February 16, 2007

    GE Healthcare Systems ComboLab System. Made up of both Mac-Lab System, Software Version 6.5 2021423-015 Revision D and CardioLab System, Software Version 6.5 2021423-016 Revision D. Electrophysiological data systems. GE Medical Systems, Information Technologies, Inc., 8200 West Tower Avenue, Milwaukee, WI 53223 USA

    FDA Recall
    Terminated ·General Electric Medical Systems Information Technology·Product code DQK·February 16, 2007

    ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The MAC Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·March 20, 2017

    (1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow MAC" Two- Lumen Central Venous Access Kit, Product Number: CDC-11242-1A

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·December 22, 2017

    MAC-LAB 3000EX systems

    FDA Recall
    Terminated ·General Electric Medical Systems Information Technology·Product code KMI·April 14, 2003

    MAC-LAB 5000EX systems

    FDA Recall
    Terminated ·General Electric Medical Systems Information Technology·Product code KMI·April 14, 2003

    MAC-LAB (Classic) systems

    FDA Recall
    Terminated ·General Electric Medical Systems Information Technology·Product code KMI·April 14, 2003

    MAC-LAB 1000EX systems

    FDA Recall
    Terminated ·General Electric Medical Systems Information Technology·Product code KMI·April 14, 2003

    Bio-MAC Cannula (Needle) Set

    FDA Recall
    Terminated ·Biologic Therapies, Inc·Product code FGY·January 23, 2015

    Arrow Two-Lumen Central Venous Access (MAC)

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

    1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 4) ARROWg+ard Blue PSI Kit The MACTM two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·May 9, 2017

    RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used to remove and/or neutralize chemical warfare agents and T-2 Toxin from the skin.

    FDA Recall
    Terminated ·Emergent Protective Products USA Inc·Product code MAC·November 24, 2022

    ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·March 20, 2017