Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. BD_CareFusion PI-21-3987 - Illinois Bone Marrow Aspiration_Intraosseous Needle

   Based on customer feedback, BD has identified that there is the potential for the needle protector to become dislodged within the ...

   Waarschuwing | 12-10-2021

2. Blink Medical Ltd, FSN-#362, Cannula Liposuction 30cm x 3mm

   Return of Medical Device Cannula Liposuction 30cm x 3mm to Blink Medical.

   Waarschuwing | 10-09-2020

3. Maquet Cardiovascular, LLC, 2242352 -01/18/2019-001-R --- NL, AXIUS Blower Mister

   The Axius Blower Mister was reported to have had no CO2 flow, i.e. these devices did not output a mist, which is an indication ...

   Waarschuwing | 26-01-2019

4. Organ Assist Products FSCA-CAP-264 - Liver Assist, Kidney Assist and Lung Assist

   Waarschuwingen en foutmeldingen die een te hoge perfusietemperatuur moeten voorkomen, zijn geprogrammeerd in de ingebouwde ...

   Waarschuwing | 16-04-2020

5. Medline FSN 21-15 - Removable L-connector for Medline MED-SOFT Liner

   Hoewel er geen ernstige incidenten zijn gemeld, heeft Medline een potentieel risico op defecten aan de MEDSOFT liner vastgesteld ...

   Waarschuwing | 22-12-2021

6. Stryker Neurovascular, RA2024-3598122, Trevo Retrievers/Microcatheters/Synchro Guide wire

   Stryker Neurovascular has distributed multiple lots of Trevo Retrievers, Trevo Microcatheters, FlowGate2, DAC and Synchro devices ...

   Waarschuwing | 12-06-2024

7. XVIVO B.V., FSN-CP9876, Liver Assist Perfusion Set

   In zeldzame gevallen kan er lekkage optreden bij de slangaansluitingen van de pompkop. Elke perfusieset bevat twee pompkoppen met ...

   Waarschuwing | 29-11-2022

8. 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

9. Siemens Healthcare GmbH, FSN-AX057-22-S AX058-22-S FSCA AX059-22-S FSN, Sensis, Sensis Vibe Hemo, Sensis Vibe Combo

   In rare cases (e.g., if an unplanned and unguided shutdown is triggered via the power button) it is possible that during a later ...

   Waarschuwing | 29-11-2022

10. Ivor Shaw_Pennine Healthcare FSCA 2021-2 - Nasogastric devices

    The manufacturer has been alerted to two reports stating that the manufactured Nasogastric tubing does not have side eyes ...

    Waarschuwing | 25-11-2021