Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. 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

2. Micro Therapeutics Inc. DBA ev3 Neurovascular, FSN-FA929, PipelineTM Flex Embolization Device (with Shield TechnologyTM)

   Medtronic is providing this notice regarding a labeling update to ensure awareness among Pipeline™ Flex and Pipeline™ Flex with ...

   Waarschuwing | 02-09-2020

3. PAUL HARTMANN AG, FSN-10001017624, Tela® products, Longuetten and corresponding procedure trays (CombiSet®)

   The listed Tela® products and Longuetten are gauze products containing an interwoven x-ray detectable thread. The listed ...

   Waarschuwing | 01-09-2020

4. Paul Hartmann 10001017624 - Tela® products, Longuetten, and procedure trays (CombiSet®)

   Due to feedback from clinics and the information of the supplier of our x-ray products we learned that the x-ray thread of the ...

   Waarschuwing | 01-09-2020

5. Medeco (Mediq) FSN2020-1 - Klinion Kliniray (Abdominal) Gauze Compress X-Ray

   After an internal assessment of these products, it became known that under tension x-ray contrast threads in gauze compresses ...

   Waarschuwing | 01-09-2020

6. FSN-MENTOR® Breast Tissue Expanders (CPX4)-Reminder

   The Mentor team has learned that some surgeons are not aware of the presence of a magnet in the dome of MENTOR® Breast Tissue ...

   Waarschuwing | 27-08-2020

7. Covidien llc, FSN-FA923, Endo Gia™ Auto Suture™ Universal Articulating Loading Unit

   Deze brief heeft tot doel u ervan op de hoogte te stellen dat Medtronic bepaalde productcodes en partijnummers vrijwillig ...

   Waarschuwing | 20-08-2020

8. NOUVAG AG, FSN-C11607, MD11 / MD30

   The devices MD 11 and MD 30 do not comply with the latest harmonized EMC standard (60601-1-2, Edition 4).

   Waarschuwing | 14-08-2020

9. William Cook Europe ApS, FSN-2020FA0005, Zenith Alpha® Abdominal Endovascular Graft

   Cook Medical has identified that specific lots of the Zenith Alpha® Abdominal Endovascular Graft (21MB main body) may contain ...

   Waarschuwing | 10-08-2020

10. OTE Holding BV, FSN-FSCA290720NL, 042.001 Hydraclair ampoules

    Hiermee willen we u informeren over de terugroepactie uit de distributieketen van de 042.001 Hydraclair ampullen (geclassificeerd ...

    Waarschuwing | 04-08-2020