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  1. LDN Labor Diagnostika Nord GmbH & Co. KG, DE/0000040010, Androstanediol-Glucuronide ELISA

    For the product AA E-1500 Androstanediol Glucuronides ELISA Lot 230083( it has been detected that the standards D (AA E-1504 Lot ...

    Waarschuwing | 08-12-2023

  2. Olympus Medical Systems Corporation, QIL FY24-EMEA-29-FY24-EMEA-14-White Tape on Scope, Olympus Flexible Endoscopes

    Olympus recently received complaints indicating that the insertion tube of a repaired endoscope was wrapped with white tape. This ...

    Waarschuwing | 08-12-2023

  3. VOSTRA GmbH, 36063/23, U473, Rhinotamp und Rhinotamp latexfrei

    As part of the PMS activities, VOSTRA has become aware of a case of use with the product RHINOTAMP in which a user pulled on the ...

    Waarschuwing | 08-12-2023

  4. The Insides Company Limited, CFR-162, The Insides System

    As you may be aware, on the 12th of October a Driver overheated at a hospital in Europe. We traced it back to a small number of ...

    Waarschuwing | 08-12-2023

  5. Caesarea Medical Electronics Ltd., FSN-MMS-23-4881, BodyGuard™ Infusion Pumps Systems (LVP)

    Eerder heeft BD, in het kader van een Bericht inzake de veiligheid in het veld, referentie MMS-21-4135, als tijdelijke maatregel ...

    Waarschuwing | 07-12-2023

  6. Maquet Cardiopulmonary GmbH, 924014, Tubing Set, heart-lung bypass

    Maquet Cardiopulmonary GmbH received customer complaints for CTP reporting the perforation of the Tyvek, the upper part of the ...

    Waarschuwing | 07-12-2023

  7. Insulet Corporation, 9056196-11222023-001-C, Omnipod 5 Automated Insulin Delivery System

    Decimal/Comma separator entry failing to register when adjusting a bolus amount

    Waarschuwing | 07-12-2023

  8. Gyrus ACMI, Inc. (Olympus Surgical Technologies America), QIL FY24-EMEA-26-FY24-OSTA-07, EZDilate Fixed Wire (Guided) Balloon

    Olympus is taking this recall action after investigating reported complaints about issues inflating, deflating and/or retrieving ...

    Waarschuwing | 07-12-2023

  9. Drägerwerk AG & Co. KGaA, PR136065, Atlan Family

    Within our market surveillance activities regarding our anesthesia workstation Atlan we be­ came aware of a few cases in which ...

    Waarschuwing | 05-12-2023

  10. Medtronic, Inc., FA1367, SynchroMed™ II

    Medtronic heeft onlangs vastgesteld dat als de SynchroMed II-pomp overschakelt naar de telemetriemodus vanwege de ...

    Waarschuwing | 05-12-2023