Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Medtronic CoreValve LLC,FSN-FA977, Medtronic CoreValveTM EvolutTM R System, Medtronic CoreValveTM EvolutTM PRO System

   Dringende veiligheidskennisgeving EnVeo™ R- en EnVeo™ PRO-plaatsingskatheter. Geproduceerd vóór 11 juli 2020 of in partij ...

   Waarschuwing | 11-06-2021

2. Ethicon Endo-Surgery LLC, FSN-ECHELON FLEX™ Powered Plus Stapler, Powered Plus Articulating Endoscopic Linear Cutter

   DRINGENDE VEILIGHEIDSINFORMATIE: ECHELON FLEX™ Powered Plus Stapler: product code PSEE60A, lot U94V47. Vrijwillige terugroepactie ...

   Waarschuwing | 03-06-2021

3. Brightwake Limited BW001-25 - Algivon Honey Dressing and Activon Tube

   Brightwake’s Algivon Honey Dressing and Activon Tube products were stolen when in transit to be sterilised. Both products are ...

   Waarschuwing | 27-05-2021

4. Institut Straumann AG, FSN-ER21-0077, SCS Screw driver for Ratchet, short/long

   Urgent Field Safety Notice SCS Screwdriver 046.401 (lot EHG85) and 046.402 (lot FAP78).

   Waarschuwing | 20-05-2021

5. Stryker Trauma GmbH, FSN-PFA 2644769, Nail Insertion Sleeve, elastic T2 Tibia SPI

   The purpose of this notification is to advise you that Stryker Trauma GmbH is conducting a voluntary recall for the Nail ...

   Waarschuwing | 20-05-2021

6. Angiomed GmbH & Co. Medizintechnik KG, FSN-PI-21-4000, Venovo Venous Stent System

   BD is issuing this Field Safety Notice to remove all unexpired lots of Venovo™ Venous Stent System.

   Waarschuwing | 19-05-2021

7. Anika Therapeutics S.r.l. FSN 13.05.2021 - Hyalobarrier® Gel (Endo), Hyaloglide® Anti-adhesion Gel

   Hulpmiddelen voor het manipuleren en herstellen van lichaamsweefsels GMDN, Anti-adhesief verband voor organen

   Waarschuwing | 13-05-2021

8. ConvaTec Limited, FSN-FSCA 2020-001, Aquacel Ag Hydrofiber Dressing with silver

   ConvaTec initieert vrijwillig een veldactie voor de Aquacel Ag Hydrofiber Dressing with silver, omdat in sommige gevallen is ...

   Waarschuwing | 05-05-2021

9. C.G.M. SPA divisione medicale META, FSN-FSCA 01-2021, sterile scraper for use as a collecting bone flakes in oral surgical operations, Set for Uterine Suction with tube and canula, membrane fixation tacks for oral surgical operations, Umbilical Cord Clamp, Closed Circuit Urine Bag, Amniotic Membrane Perforator, Magnetic Mat for Surgical Instrument.

   Deze veiligheidswaarschuwing maakt onderdeel uit van een groter Europees onderzoek naar vervalste certificaten. Doordat de ...

   Waarschuwing | 04-05-2021

10. Medtronic Sofamor Danek USA, Inc., FSN-FA973, Break-off set screw

    Medtronic is voluntarily recalling two lots of the Braive™ Break off Set Screw that are impacted by a thread profile defect due ...

    Waarschuwing | 30-04-2021