Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Diasorin Inc., LIAISON® QSET Device Plus, The LIAISON® Q.S.E.T. Device Plus

   Internal investigation has determined that 0.14% of the tubes in the lots identified may have loose clear caps. The loose clear ...

   Waarschuwing | 21-11-2024

2. Olympus Europa SE & Co. KG, QIL FY25-EMEA-23 FY25-026-A Vent Tubes Mispackagin, Duravent silicone ventilation tube

   Olympus has identified via customer feedback that the carton packaging of two (2) specific lots of Duravent Silicone Ventilation ...

   Waarschuwing | 19-11-2024

3. WEINMANN Emergency Medical Technology GmbH+Co.KG, FSCA MMT_MMS2_2024-10.01, MEDUMAT Standard2, MEDUMAT Transport; withCO2

   Chest compressions can lead to high-frequency air movements (typically 100–120/min) at the patient connection opening of the ...

   Waarschuwing | 19-11-2024

4. KARL STORZ SE & Co. KG, 24-0004, Aggressive Cutter, sterile Full Radius Resector, sterile Aggr. Pro Line Shaver Blade, sterile Round Burr, sterile Aggressive Barrel Burr, sterile Finish Barrel Burr, sterile Semi Hooded Barrel Burr, s

   It was found that there are holes in the sterile barrier system. This issue affects the attached lot numbers of the referenced ...

   Waarschuwing | 19-11-2024

5. Fresenius Kabi AG, ECMD202330, Aurora Plasmapheresis System

   Fresenius Kabi is issuing this letter to inform about a potential issue concerning the inspection and cleaning of pump exterior ...

   Waarschuwing | 19-11-2024

6. OneMed Group Oy, OM FSCA 2024-10-04-01, evercare® inLine 3-way stopcock, Extension line

   Evercare Medical AB voert een terugroepactie uit op de evercare® inLine 3-weg kraan (REF 10548-01,10699-01, 10575-02, 10553-01). ...

   Waarschuwing | 19-11-2024

7. KayserBetten GmbH & Co. KG, FSN-OLAF-HS-102024, KayserBett OLAF

   De opslaglocatie van de handset is binnen relatief bereik van de patiënt (kind). De handset kan van binnenuit het bed door de ...

   Waarschuwing | 18-11-2024

8. Siemens Healthcare Diagnostics Inc., POC 24-004, RAPIDPoint 500 Systems Measurement Cartridge

   After a thorough investigation, Siemens determined that the observed issue with the sodium sensor in measurement cartridges (with ...

   Waarschuwing | 18-11-2024

9. KayserBetten GmbH & Co. KG, FSN-OLAF-102024, KayserBett OLAF

   Als gevolg van een ernstig incident met een Kayser bed hebben we, als onderdeel van ons risicomanagement, verkeerd gebruik als ...

   Waarschuwing | 18-11-2024

10. American Surgical Company LLC, 439, Americot 20-01S

    American Surgical Company (ASC) is issuing an Urgent Medical Device Field Safety Noice (FSN) to the users for the Americot 20-01S ...

    Waarschuwing | 18-11-2024