BEUDAMED
    35 results · 59ms · Sources: EU EUDAMED, US FDA

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    Brand Name: Vial2Bag Advanced Product Name: Vial2Bag Advanced 20mm Admixture Device Model/Catalog Number: 6070030 Software Version: Not applicable Product Description: The Vial2Bag Advanced 20mm Admixture Device is a single use, fluid transfer device that allows for the reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution, through the IV bag administration port. The device consists of the body, Protector, IV Port, and an integrated vial adapter. The device is provided as a sterile, non-pyrogenic product. The device is intended to be used with standard drug vials with a seal diameter of 20mm and an elastomeric stopper. The Vial2Bag Advanced 20mm Admixture Device is designed to work with a standard 50, 100, or 250mL IV bag and an external IV administration set. The device does not contain any medicinal substances and there are no additional accessories needed or provided with the Vial2Bag Advanced 20mm Admixture Device for the device to meet its intended purpose. Component: No

    FDA Recall
    Open, Classified ·West Pharmaceutical Services AZ, Inc.·Product code LHI·September 24, 2024

    BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·July 22, 2022

    BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·July 22, 2022

    BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·July 22, 2022

    BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·July 22, 2022

    BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·February 13, 2023

    Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code OEQ·April 2, 2026

    Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code OEQ·April 2, 2026

    Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code OEQ·April 2, 2026

    Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846

    FDA Recall
    Open, Classified ·MICROVENTION INC.·Product code DQY·December 2, 2024

    Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The Mega Ballast 091 is designed with a semi-rigid proximal shaft and a highly flexible distal shaft. The design facilitates the advancement of the Mega Ballast to access the tortuous vasculature over a guidewire and a respective dilator. The outer surface of the Mega Ballast is coated with a hydrophilic coating to facilitate lubricity from tip to 40 cm proximal. The proximal end of the Mega Ballast incorporates a Luer fitting hub for the attachment of accessories. The Mega Ballast is provided sterile, non-pyrogenic, and is intended for single use only. Component: Not a component

    FDA Recall
    Open, Classified ·BALT USA, LLC·Product code DQY·September 25, 2025

    Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catalog SNE37ANMOF, Medical Center Odessa.

    FDA Recall
    Open, Classified ·Cardinal Health 200, LLC·Product code OFQ·August 16, 2023

    Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code CAL·July 27, 2020

    Flexible DCI Intubation Fiberscope, Part: 11301BND1, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code CAL·July 27, 2020

    Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code CAL·July 27, 2020

    Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code CAL·July 27, 2020

    Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code CAL·July 27, 2020

    Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction Manual: Z18444US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code CAL·July 27, 2020

    Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code CAL·July 27, 2020

    Flexible Intubation Video Endoscope, Part: 11302BDX, with Instruction Manual: Z18443US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code CAL·July 27, 2020