Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Johnson & Johnson International, Vicryl™ Plus Suture - 2207555, Coated VICRYL™ PLUS Antibacterial suture

   Ethicon has initiated a voluntary medical device recall (removal) of one (1) lot of Coated VICRYL™ Plus Antibacterial ...

   Waarschuwing | 12-01-2023

2. Vascular Solutions, LLC (subsidiary of Teleflex Incorporated), HRA00089, Expro Elite Snare, 10mm, Intl, Expro Elite Snare, 15mm, Intl Expro Elite Snare, 25mm, Intl, Expro Elite Snare, 35mm, Intl

   Deze vrijwillige FSCA is voor de hierboven vermelde producten, omdat is vastgesteld dat het product corrosie (ijzeroxide) op de ...

   Waarschuwing | 02-01-2023

3. Aesculap AG, FSCA 266, Nasal snare single-use

   Aesculap AG as a legal manufacturer has voluntarily decided to recall the affected products under point 1.2 as a precaution due ...

   Waarschuwing | 30-12-2022

4. Bolton Medical Inc, 2247858-12-06-2022-001R, RelayPro Thoracic Stent Graft System

   The Efficia External Paddles are intended to be used with the Efficia DFM100 and HeartStart Intrepid Monitor/Defibrillators – by ...

   Waarschuwing | 30-12-2022

5. Safe Orthopaedics, FSN-22-03, CEMENT PUSHER KIT

   Safe Orthopedics has detected an anomaly concerning the instructions for use of the Cement Pushers and Kit Needle kits. The ...

   Waarschuwing | 28-12-2022

6. Merit Medical Systems Inc, 1721504-08.01.22-004R, CorVocet Biopsy System

   Merit Medical Systems, Inc. is voluntarily conducting a recall of the CorVocet™ Biopsy System due to a product defect resulting ...

   Waarschuwing | 07-12-2022

7. Tobrix BV, 202203, radial fiber 600 mu

   Concerning LOT 2111049 of the 600mu radial fiber TXMF600R. Tip breaks of with little force. The broken tip can remain in the ...

   Waarschuwing | 01-12-2022

8. Leica Microsystems (Schweiz) AG, FSN-CAPA-LIS-MD-22-001, M530 OHX, PROvido, Proveo 8

   Leica Microsystems has become aware of process weaknesses of the sub-supplier producing the affected Power Supply Unit. These ...

   Waarschuwing | 29-11-2022

9. Boston Scientific Corporation, FSN-92926415-FA, ORISE™ Gel Submucosal Lifting Agent

   Boston Scientific heeft onlangs ontdekt dat er bijwerkingen optraden die werden gekoppeld aan een reactie op vreemde voorwerpen ...

   Waarschuwing | 24-10-2022

10. Edwards Lifesciences LLC, FSN-FCA-173, Fogarty Arterial Embolectomy Catheters Pouch-Pack, Fogarty FORTIS Arterial Embolectomy Catheters Pouch-Pack & Fogarty Biliary Balloon Probes Pouch-Pack

    Edwards Lifesciences heeft meldingen ontvangen dat het niet mogelijk is de ballon op te blazen of de integriteit van de ballon te ...

    Waarschuwing | 24-10-2022