BEUDAMED
    FDA Enforcement Class III Terminated

    20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box

    Recall: Z-0805-2022 · Reported March 23, 2022

    Enforcement

    Recall Number
    Z-0805-2022
    Event ID
    89453
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    CellEra LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    March 23, 2022
    Initiation Date
    December 15, 2021
    Classification Date
    March 16, 2022
    Termination Date
    October 16, 2023
    Address
    1045 Reed Dr Ste C, N/A, Monroe, OH, 45050-1717, United States

    Description

    20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box

    Reason

    Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.

    Code Info

    Lot 212299, 200999 GTIN 10850005565250, 00850005565253, 00850005565246

    Distribution

    US Nationwide distribution.

    Quantity

    11770 ea