Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: 3M Health Care, 3M™ Tegaderm PICC CVC Securement Device + CHG I.V. Securement Dressing

   De betreffende producten zijn niet voorzien van de juiste labelling zoals vereist door Europese wetgeving en mogen daarom niet ...

   Waarschuwing | 02-02-2017

2. Welland Medical Ltd, FSN-2020-09-09/4480, HydroFrame with Manuka Honey

   We, the Weiland Medical company, are proactively informing our customers of an issue related to the listed batches  of  ...

   Waarschuwing | 10-09-2020

3. Vigmed (Greiner Bio-One) FSCA AN010 - CLiP® Ported and Winged Automatic Safety IV catheter

   Following a complaint, Vigmed has identified products that show severe deformation in the primary packaging and the sterile ...

   Waarschuwing | 14-12-2021

4. ConvaTec Limited FSCA 2021-012 - Natura™ Accordion Flange Convex Cut-to Fit wafer

   The primary pack of the wafer includes an incorrect size of the accordion product such that the wafer coupling will not match the ...

   Waarschuwing | 15-03-2022

5. Ivor Shaw_Pennine Healthcare FSCA 2021-2 - Nasogastric devices

   The manufacturer has been alerted to two reports stating that the manufactured Nasogastric tubing does not have side eyes ...

   Waarschuwing | 25-11-2021

6. Max Mobility LLC, SDPT2-23-002, Smartdrive MX2 with Pushtracker E2.E3

   If the user has multiple programs running on the watch, the application may fail. If the application fails when the user is in ...

   Waarschuwing | 23-05-2023

7. James Leckey Design Ltd FSCA-25-02-20 - MyWay Harness

   Through our post-market surveillance activities and returns, we have observed a very small number of isolated complaints relating ...

   Waarschuwing | 25-02-2020

8. BD Switzerland RA-2019-01-01 - Alaris™ VP Plus Guardrails™ volumetrische pompen

   BD voert een corrigerende maatregel uit met betrekking tot de Alaris™ VP Plus Guardrails™ volumetrische pompen om alle bestaande ...

   Waarschuwing | 18-02-2019

9. Mölnlycke Health Care AB, 2024-02(02), specific batches of the Detachable EndoRetrieval Pouch, which can be either a Single Packed device or included as a component in identified Mölnlycke® Procedure trays

   The device is used to contain and extract specimens during laparoscopie surgery. The mechanism of the listed device operates in a ...

   Waarschuwing | 03-04-2024

10. Teleflex Malaysia Sdn Bdh, Malaysia, FSN-EIF-000403, Rusch TracFlex Plus Set, cuffed TracFlex Plus PDT Set, Ruschcare TracFlex Plus Set, Cuffed

    Teleflex has voluntarily issued a recall for the products Rusch TracFlex Plus Set, cuffed TracFlex Plus PDT Set, Ruschcare ...

    Waarschuwing | 06-05-2020