Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. C.R. Bard, Inc., UCC-25-5238, Bard Minnesota Four-Lumen Esophagogastric Tamponadade Tube

   Based on customer feedback, BD (C. R. Bard, Inc.) has identified that users are potentially unable to, or are finding it ...

   Waarschuwing | 18-04-2025

2. Baxter Healthcare SA (CH-MF-000026124), FAV-2024-007, EXTENDED LIFE PD TRANSFER SET, MINICAP EXTEND LIFE

   This communication is a follow-up to the FSN you received from Vantive, formerly Baxter Kidney Care, dated December 17th, 2024. ...

   Waarschuwing | 05-03-2025

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-24-FY25-012 BML-V442QR-30 Distal Tip, Single Use Mechanical Lithotriptor V

   Olympus is initiating a product removal Field Action for specific lots of the BML-V442QR-30, Single Use Mechanical Lithotriptor ...

   Waarschuwing | 23-12-2024

5. Olympus Medical Systems Corporation, QIL FY25-EMEA-25-FY25-016 MAJ-891, Forceps/Irrigation Plug (Isolated Type)

   Olympus’ investigation into reported infection and contamination complaints associated with the MAJ-891 revealed a potential risk ...

   Waarschuwing | 19-12-2024

6. Baxter Healthcare SA (CH-MF-000026124), FAV-2024-007, EXTENDED LIFE PD TRANSFER SET, MINICAP EXTEND LIFE

   Baxter is op de hoogte van de verschillende terugroepacties door andere fabrikanten met het mogelijke risico van blootstelling ...

   Waarschuwing | 18-11-2024

7. Baxter Healthcare SA, FAV-2024-005, MiniCap Extended Life PD Transfer Sets

   Vantive, dat deel uitmaakt van de Baxter-groep, brengt een veiligheidswaarschuwing uit voor de hieronder vermeldeMiniCap Extended ...

   Waarschuwing | 14-11-2024

8. Gambro Lundia AB, FAV-2024-006, AK 98

   Baxter is in the process of evaluating whether these same risks are present with the AK 98 machines. Although our internal ...

   Waarschuwing | 14-11-2024

9. Boston Scientific Corporation, 97273653-FA, AMS 800™ Artificial Urinary Sphincter

   Boston Scientific is begonnen met het verwijderen van specifieke partijen van de AMS 800™ Artificial Urinary ...

   Waarschuwing | 31-10-2024

10. Olympus Medical Systems Corporation, QIL FY25-EMEA-20-FY25-024 GIF-1TH190 IFU Update, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    Olympus previously issued revised cleaning instructions for the GIF-1TH190 in October 2023 to issue new updated channel drying ...

    Waarschuwing | 23-10-2024