BEUDAMED
    FDA Enforcement Class III Ongoing

    eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal

    Recall: Z-3263-2024 · Reported October 2, 2024

    Enforcement

    Recall Number
    Z-3263-2024
    Event ID
    95241
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    T.G. Eakin Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 2, 2024
    Initiation Date
    August 8, 2024
    Classification Date
    September 25, 2024
    Address
    15 Ballystockart Road, Comber, N/A, Ireland

    Description

    eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal

    Reason

    On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005.

    Code Info

    UDI/DI 00768455108732, Lot number 109357C553

    Distribution

    US: KY

    Quantity

    35,400 cartons of 20 individually packaged seals