BEUDAMED
    FDA Recall Terminated

    VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144

    Recall: Z-2085-2019 · Initiated September 1, 2016

    Recall

    Recall Number
    Z-2085-2019
    Event Number
    83281
    Firm
    CellEra LLC
    FEI Number
    3007594734
    Product Code
    NAE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 1, 2016
    Terminated
    February 9, 2021
    Address
    1045 Reed Dr, Ste C, Monroe, OH, 45050-1717

    Description

    VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144

    Reason

    Adhesive border was not sticky enough.

    Action

    firm contacted the facilities (via phone) that were shipped the merchandise and offered to take the product back.

    Distribution

    OH, PA, VA

    Quantity

    2110 units