Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Bard, FA2017-50, MAX-CORE

   Deze terugroepactie geldt voor een specifieke partij disposable biopsie-instrumenten van Max-Core®.

   Waarschuwing | 16-10-2017

2. Rochester Medical_Bard FA2017 51 - Magic3, HydroSil Gripper

   Bard heeft vastgesteld dat er in de productcode-/lotnummercombinaties zoals vermeld in bijlage 1 mogelijk een scheur in de ...

   Waarschuwing | 05-10-2017

3. LifeCell Corporation, Revolve Advanced Adipose System

   The Revolve System is labelled as “Non-Pyrogenic”, however there were no prior release criteria for finished product endotoxin ...

   Waarschuwing | 19-09-2017

4. Field Safety Notice: Vygon - UMBILICAL CATHETER

   We have identified a non-systematic wrong marking on our devices umbilical catheter: the first marking from the distal tip may be ...

   Waarschuwing | 19-07-2017

5. Field Safety Notice: Terumo, Safety Valve; LH130, LN130B en Extracorporele set

   Terumo Cardiovascular Systems (Terumo CVS) heeft meldingen ontvangen van het ontbreken van flow door de OPS-klep.

   Waarschuwing | 17-07-2017

6. Field Safety Notice: Haemonetics S.A., Cell Saver Elite

   Bij sommige centrifugebowls in deze sets veroorzaakt de buitendiameter aan de onderkant van de bowl problemen wanneer de bowl in ...

   Waarschuwing | 08-06-2017

7. Field Safety Notice: Argon Medical Devices, Argon Arterial Access Needle

   Argon Medical has received a complaint from one of our distributors of a potential packaging defect. Fabrikant: Argon Medical ...

   Waarschuwing | 24-05-2017

8. Field Safety Notice: Abbott Medical Optics (AMO) - Healon OVDs

   AMO has voluntarily initiated this Action because a remote possibility exists that certain HealonOVD solutions in the affected ...

   Waarschuwing | 20-04-2017

9. Field Safety Notice: Abbott Medical Optics (AMO) - Vitrectomy Cutter

   AMO has voluntarily initiated this Action because a possibility exists that, due to a packaging error, 20GA Vitrectomy Cutters ...

   Waarschuwing | 19-04-2017

10. Field Safety Notice: Arrow_Teleflex - ARROW® Kits with BD Eclipse™ Needles

    According to the BD letter, a copy of which is attached, Becton-Dickinson (BD) has received reports of safety cover disengagement ...

    Waarschuwing | 10-04-2017