BEUDAMED
    FDA Enforcement Class II Terminated

    Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit with FitPad consists of a foam pad, a section interface (Invia FitPad) and Transparent Film (one or more pieces depending on the kit size).

    Recall: Z-0773-2020 · Reported January 8, 2020

    Enforcement

    Recall Number
    Z-0773-2020
    Event ID
    84368
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medela Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 8, 2020
    Initiation Date
    December 2, 2019
    Classification Date
    January 2, 2020
    Termination Date
    November 2, 2020
    Address
    1101 Corporate Dr, N/A, McHenry, IL, 60050-7006, United States

    Description

    Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit with FitPad consists of a foam pad, a section interface (Invia FitPad) and Transparent Film (one or more pieces depending on the kit size).

    Reason

    Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.

    Code Info

    Lots: 17110012731 / Exp 17-Nov-19, 17110022736 / Exp 22-Nov-19, 17120012746 / Exp 8-Dec-19, 18010012767 / 4-Jan-20, 18070012913 / 31-Jul-20, 18090012960 / Exp 28-Sep-20, 18110013046 / 5-Nov-20.

    Distribution

    AL, AZ, CA, CO, FL, GA, IL, MN, MO, NC, NY, PA, SC, TN, TX, WA

    Quantity

    331