Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Maquet Cardiopulmonary GmbH, 812435, Rotaflow II drive flex.compact

   In October 2022 Maquet Cardiopulmonary received a complaint on issues connected to the yellow locking mechanism unlocking on ...

   Waarschuwing | 11-07-2023

2. INTEGRA LifeSciences, FSN-2021-HHE-008, Accudrain/Hermetic/LimiTorr/MoniTorr

   Integra AccuDrain®, Hermetic™, LimiTorr™, MoniTorr™ - Alert about Potential User Error of CSF Access port – Information to users

   Waarschuwing | 14-10-2021

3. Integra LifeSciences Production Corporation, FSN-N-2020-HHE-014, CODMAN® BACTISEAL® EVD CATHETER SET

   The purpose of this letter is to notify you that the legal manufacturer Integra LifeSciences, is voluntarily issuing a Field ...

   Waarschuwing | 08-10-2020

4. VitreQ PRE-20190003 - VitreQ

   During routine production, VitreQ B.V. identified a small tear of the sterile pouch in the products listed above. Investigation ...

   Waarschuwing | 06-12-2019

5. 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

6. Atrium Medical Corporation, 3011175548-12/13/2023-002-C, Drains Express Single

   On November 8, 2023, Getinge received notice from Nurse Assist, LLC that its Sterile Water, USP, 30mL syringes were being ...

   Waarschuwing | 22-01-2024

7. Covidien, FA866, MAHURKAR™* en Argyle™* acute hemodialysekatheters

   Met deze kennisgeving willen we verduidelijken dat de waarden van de voorvulvolumes die op de MAHURKAR™* en Argyle™* acute ...

   Waarschuwing | 03-05-2019

8. Datex-Ohmeda FMI 32070 - Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation and Giraffe OmniBed Carestation

   The bedside panels of Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation can be ...

   Waarschuwing | 03-01-2020

9. Bausch & Lomb Incorporated, FSN-CAC-2021-005, various Lens Solutions

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

   Waarschuwing | 05-05-2021

10. Arrow_Teleflex EIF-000320 - Arrow Two-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter

    De afdekking van het product bevat een etiketteringsfout. De afdekking vermeldt het verkeerde vulvolume. De op de verlenglijnen ...

    Waarschuwing | 24-01-2019