BEUDAMED
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    Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C

    FDA Recall
    Open, Classified ·Medivance Inc.·Product code DWJ·February 16, 2024

    Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU UK/600001; Arctic Sun Stat Taiwan/600006; Arctic Sun Stat Japan/600020; Arctic Sun 5000, NA/5000-00-00; Arctic Sun 5000, NA w/ Transmission Interface Module/5000-00-00E; Loaner, Arctic Sun M5000, NA/5000-00-00L; Arctic Sun 5000, EU/5000-1-01; Loaner, Arctic Sun M5000, EU/5000-01-01L; Arctic Sun 5000, UK/5000-01-02; Arctic Sun 5000, Australia/5000-01-03; Arctic Sun 5000, China/5000-01-04; Arctic Sun 5000, Brazil/5000-01-05; Arctic Sun 5000, Switzerland/5000-01-07; Arctic Sun 5000, South Africa/5000-01-08

    FDA Recall
    Open, Classified ·Medivance Inc.·Product code DWJ·June 27, 2024

    REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros Closed Male Luer, Purple Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code N/A·March 16, 2021

    InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA, MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA.

    FDA Recall
    Open, Classified ·Companion Medical, Inc.·Product code NDC·November 8, 2022

    RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX

    FDA Recall
    Open, Classified ·Bolton Medical Inc.·Product code MIH·December 20, 2022

    RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator.

    FDA Recall
    Open, Classified ·Reflexion Medical, Inc.·Product code QVA·April 16, 2024

    Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791RD (Red)

    FDA Recall
    Open, Classified ·Medical Depot Inc.·Product code ITJ·June 14, 2024

    REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code ONB·March 16, 2021

    Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compression on the spring which retracts the brush back into the sheath. A protector tip on the end of the brush prevent contamination of the sample during the endoscopy procedure. The force required to dislodge the tip from the bristle is greater than to break the brush wire at the handle body.

    FDA Recall
    Open, Classified ·Hobbs Medical, Inc.·Product code FDX·December 28, 2021

    6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code FMG·August 1, 2022

    3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile

    FDA Recall
    Open, Classified ·Medical Modeling, Inc.·Product code DZJ·May 17, 2022

    Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6352

    FDA Recall
    Open, Classified ·Hobbs Medical, Inc.·Product code FGE·July 29, 2022

    Hobbs Transbronchial Aspiration Needle Catalog Number: 4621

    FDA Recall
    Open, Classified ·Hobbs Medical, Inc.·Product code GAA·July 29, 2022

    Freeman Pancreatic Flexi-Stent Catalog Number: 6535

    FDA Recall
    Open, Classified ·Hobbs Medical, Inc.·Product code FGE·July 29, 2022

    Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility.

    FDA Recall
    Open, Classified ·Outset Medical, Inc.·Product code FIP·January 24, 2023

    ASM Replacement Battery, Component Number SUB0000594

    FDA Recall
    Open, Classified ·ICU Medical Inc·Product code FRN·March 22, 2023

    Halyard CPT EP PACK - Medical convenience kits Model Number: SHAN442-04

    FDA Recall
    Open, Classified ·AVID Medical, Inc.·Product code LRO·September 20, 2024

    Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02

    FDA Recall
    Open, Classified ·AVID Medical, Inc.·Product code LRO·September 20, 2024

    Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018

    FDA Recall
    Open, Classified ·AVID Medical, Inc.·Product code OES·September 20, 2024

    Halyard EP TRAY - Medical convenience kits Model Number: VAST038-04

    FDA Recall
    Open, Classified ·AVID Medical, Inc.·Product code OEZ·September 20, 2024