Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Ethicon LLC, 2283226 (2) - PDS Clear Suture Breakage Complaints, PDS II Suture

   lnternal testing on returned product from this lot confirmed that some POS™ Il (polydioxanone) Sutures from this lot did not meet ...

   Waarschuwing | 15-08-2023

2. B.Braun Surgical, 400435480, MONOPLUS VIOLET 0(3,5) 150cm HR48 LOOP (M)DDP

   From a complaint received from the market, the company detected that some units of the above mentioned reference batch could have ...

   Waarschuwing | 04-09-2019

3. Zimmer Surgical, Inc., ZFA2023-00208, Zimmer® Dermatome Blades

   There have been 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades. The ...

   Waarschuwing | 22-09-2023

4. Xiros Ltd., FSN-2023-001, Suture/needle passer

   Xiros has received feedback that there have been a small number of instances where the CC-Hook instrument has deformed during ...

   Waarschuwing | 08-06-2023

5. Aesculap AG, FSCA 235, Synthetic vascular graft

   In the cause of an internal investigation Aesculap AG became aware of a product counterfeit of the UNI Graft K DV vascular ...

   Waarschuwing | 06-06-2019

6. Coloplast A/S, FSCA_20240223_Ureteral dilator, Ureteral Dilator (Ch/Fr 12-14, length 48 cm)

   In de faciliteit van Coloplast is bij sommige urethraledilatorproducten een mogelijk steriliteitsprobleem ontdekt. Dit probleem ...

   Waarschuwing | 26-03-2024

7. NRT X-Ray A/S, PR20230929-02, Celex

   The event made the Celex system move without being under control of the operator. This may put patients or operators at risk.

   Waarschuwing | 25-03-2024

8. Corcym S.r.l., REC-000384, Perceval Plus Sutureless Aortic Heart Valve

   Corcym ontdekte dat sommige polymeer deeltjes, afkomstig van een van de apparaten die werden gebruikt voor het ...

   Waarschuwing | 23-01-2024

9. KeriMedical SA, FSN-06072022-NCI514, KERILOCK SCREWED SUTUR ANCHOR KITS 2.0 AND 4.0

   We have detected a partial mix-up between batches 20-0629 (2.0) and 20-0631 (4.0) leading toa labelling error. This error is due ...

   Waarschuwing | 21-07-2022

10. Olympus Europa SE & Co. KG, FY25-EMEA-09-FY23-OSTA-13-SoltiveWirelessFootswitch, Soltive Laser System

    Olympus investigated complaints received where customers reported difficulties in pairing the wireless footswitch with the ...

    Waarschuwing | 01-07-2024