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  1. ICU Medical, Inc., MA2410-01, Plum 360, Plum A+ & Plum A+3 infusion systems

    ICU Medical heeft meldingen ontvangen van immitatie CSB-batterijen die worden gebruikt met Plum Infusion Systems. Hoewel deze ...

    Waarschuwing | 21-11-2024

  2. Siemens Healthcare Diagnostics Inc., AIMC 24-04, Atellica IM Erythropoietin (EPO) Assay, ADVIA Centaur Erythropoietin (EPO) Assay

    Siemens Healthineers is communicating the resolution to Urgent Field Safety Notice (UFSN) AIMC 24-04.A.OUS(Atellica IM and ADVIA ...

    Waarschuwing | 21-11-2024

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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