BEUDAMED
    FDA Enforcement Class I Ongoing

    Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)

    Recall: Z-0094-2024 · Reported October 25, 2023

    Enforcement

    Recall Number
    Z-0094-2024
    Event ID
    93105
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    EITAN MEDICAL LTD
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 25, 2023
    Initiation Date
    September 11, 2023
    Classification Date
    October 19, 2023
    Address
    29, Yad Kharutsim, N/A, Netanya, N/A, N/A, Israel

    Description

    Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)

    Reason

    Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.

    Code Info

    Software Revision: 16.10.1 or 16.10.2 REF/UDI-DI: 15031-000-0028/7290109150109, 15032-000-0027/7290109150147, 15038-000-0001/7290109150161

    Distribution

    US nationwide distribution.

    Quantity

    1383