Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Bovie Medical Corporation, FSN-FA-2021-1, Disposable Bipolar Ablators

   This letter is to inform you of an Urgent Field Safety Notification related to the Disposable Bipolar Ablators.

   Waarschuwing | 04-02-2021

2. Field Safety Notice: Mölnlycke Health Care, ProcedurePak trays containing specific item codes

   Mölnlycke has been informed by the supplier Medtronic that they are recalling specific item codes and production lots of Polysorb ...

   Waarschuwing | 23-05-2017

3. Field Safety Notice: CareFusion - Alaris™ PK Plus Syringe Pump

   CareFusion has identified a risk with the Alaris PK Plus Syringe Pump that resulted in a situation where the Near End of Infusion ...

   Waarschuwing | 01-02-2017

4. Intuitive Surgical Sàrl 2955842-070816-009-R - IS4000 EndoWrist Stapler 45

   Het bericht 'Stapler Firing Failed', onderbreekt het afschieten van de niettang voordat de volledige nietlijn is afgeschoten. Als ...

   Waarschuwing | 22-07-2016

5. Medtronic Inc., FSN-FA1342, Durepair Dura Regeneration Matrix

   Medtronic was informed by the contract manufacturer (Integra LifeSciences Boston) that based on internal investigation they have ...

   Waarschuwing | 26-06-2023

6. Occlutech GmbH FSCA-20190724 - Occlutech Delivery Set

   Occlutech Delivery Sets (ODS) bestaan uit meerdere componenten: inbrenghuls, lader, hemostaseventiel en dilatator. Occlutech ...

   Waarschuwing | 24-07-2019

7. Teleflex EIF-000216 - Percuvance® percutaan operatiesysteem

   Teleflex roept deze producten terug omdat de bek van de toolpunt kan breken, hetgeen ertoe leidt dat een fragment van de toolpunt ...

   Waarschuwing | 25-10-2017

8. Field Safety Notice: Leica Microsystems, Leica M525 F40

   Our Quality Management process has identified that instructions for use and warnings are not always followed by the the users of ...

   Waarschuwing | 05-05-2017

9. Field Safety Notice: Mölnlycke, Barrier Sets

   During an investigation of a product complaint, microholes has been detected after immersion test on some of Barrier Sets. ...

   Waarschuwing | 03-05-2017

10. Field Safety Notice: RanD - Hang&Go kits, HIPP(F)

    Specifically, one of the two lines of the table pack set included in each of the above mentioned codes had a female quick ...

    Waarschuwing | 13-04-2017