BEUDAMED
    FDA Enforcement Class II Ongoing

    MINISCAV (tm) Vacuum Pump

    Recall: Z-2619-2023 · Reported September 27, 2023

    Enforcement

    Recall Number
    Z-2619-2023
    Event ID
    92929
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    R A Medical Services
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 27, 2023
    Initiation Date
    August 23, 2023
    Classification Date
    September 20, 2023
    Address
    Holmes House, Skipton Road, Keighley, N/A, United Kingdom

    Description

    MINISCAV (tm) Vacuum Pump

    Reason

    Inadequate documentation of acceptance activity

    Code Info

    UDI/DI: (01) 10862552000405. Serial numbers: N/AB/10514 through N/AB/10523

    Distribution

    Distribution to Ohio

    Quantity

    10 units