BEUDAMED
    FDA Enforcement Class II Ongoing

    Medicina Reusable Oral syringe 5ml Code: OTH05

    Recall: Z-0113-2023 · Reported October 26, 2022

    Enforcement

    Recall Number
    Z-0113-2023
    Event ID
    90849
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medicina Uk Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 26, 2022
    Initiation Date
    July 4, 2022
    Classification Date
    October 20, 2022
    Address
    Unit 2, Rivington View Business Park, Bolton, N/A, N/A, United Kingdom

    Description

    Medicina Reusable Oral syringe 5ml Code: OTH05

    Reason

    Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

    Code Info

    UDI-DI: (01)05056115403491 (01)05056115403491(17)260700(10)HM21055 Batch number: HM18043, HM20020, HM21055

    Distribution

    Nationwide

    Quantity

    26 boxes (2600 syringes)