BEUDAMED
    FDA Enforcement Class II Ongoing

    NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697

    Recall: Z-1552-2022 · Reported August 24, 2022

    Enforcement

    Recall Number
    Z-1552-2022
    Event ID
    90668
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stradis Medical, LLC dba Stradis Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 24, 2022
    Initiation Date
    July 25, 2022
    Classification Date
    August 18, 2022
    Address
    3025 Northwoods Pkwy, Peachtree Corners, GA, 30071-1524, United States

    Description

    NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697

    Reason

    The sterile barrier may be compromised.

    Code Info

    SKU/Part Number: ZZ-0697; Lots: 22026482044 and 22152487922 UDI/DI: M752ZZ06970

    Distribution

    US Nationwide distribution in the state of SC.

    Quantity

    50 units