Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Medline International France SAS, FSN-25/01, infusion sets, transfusion sets and associated accessories with luer lock manufactured by Didactic, which are included in the Medline’s Caresets and Sterile Procedure Trays.

   Het doel van deze brief is om u te informeren dat Didactic heeft besloten, naar aanleiding van verschillende meldingen van ...

   Waarschuwing | 21-02-2025

2. Micro Therapeutics, Inc., FA1466, Pipelin Vantage Embolization Device with Shield Technology

   Medtronic heeft meldingen ontvangen van onvolledige wandappositie en/of vervorming van het vlechtwerk tijdens en na de procedure ...

   Waarschuwing | 11-02-2025

3. Ovesco Endoscopy AG, CC-2025-002, colonic FTRD Set

   In this LOT, an incorrect endoscope sleeve was accidentally included. This sleeve is too short for the system. This does not lead ...

   Waarschuwing | 29-01-2025

4. Olympus Medical Systems Corporation, QIL FY25-EMEA-28-FY25-013 Guide Sheath Component, Olympus Guide Sheaths single use

   The preliminary findings from Olympus’ investigation have identified that the disassociation of the tip from the guide sheath is ...

   Waarschuwing | 22-01-2025

5. Intact Vascular Inc., 2024-IGT-IGTD-005, Tack Endovascular System

   Philips verzoekt met onmiddellijke ingang alle klanten om het Tack Endovascular System niet langer te gebruiken. Philips is op de ...

   Waarschuwing | 20-01-2025

6. Dongguan QueenMed Equipment Mfg Co Ltd [EN], FSN-24/02, Electrosurgical Electrode

   Deze brief volgt op de terugroepactie voor elektrochirurgische elektroden van Medline met referentie FSN-24/02, gelanceerd in ...

   Waarschuwing | 20-01-2025

7. Swemac Innovation AB, Cannulated Drill for Metacarpal III. Large

   Cannulated diills with an incorrect measuring scale have been released to the market.

   Waarschuwing | 15-01-2025

8. Medicon eG, REK24-0000386, Gubisch Osteotom 20cm 2mm

   In the course of a complaint, it was discovered that the end tip and the handle could be screwed, but not glued. In the world ...

   Waarschuwing | 30-12-2024

9. Nobel Biocare AB, PFA2420, Nobel Biocare N1 TiUltra TCC

   One of the plastic components of the packaging that is used to hold the OsseoShaper in place may contain a manufacturing error.

   Waarschuwing | 27-12-2024

10. Boston Scientific Corporation, AXIOS Stent and Electrocautery Enhanced Delivery

    Boston Scientific is begonnen met het terugroepen van specifieke partijen van de AXIOS™-stent en - plaatsingssysteem met ...

    Waarschuwing | 24-12-2024