BEUDAMED
    FDA Enforcement Class II Ongoing

    Surgicare Neuro Pack - Neurological Kit

    Recall: Z-0862-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0862-2022
    Event ID
    89671
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stradis Medical, LLC dba Stradis Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 13, 2022
    Initiation Date
    February 25, 2022
    Classification Date
    April 4, 2022
    Address
    3025 Northwoods Pkwy, Peachtree Corners, GA, 30071-1524, United States

    Description

    Surgicare Neuro Pack - Neurological Kit

    Reason

    The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

    Code Info

    SKU/Part Number 570-2224; UDI H65257022240 Lot Numbers: 20143461101, 20156461682, 20217462972, 20309467143, 20343467142, 20364467508, 20364468264, 21076471300, 21082471463, 21102472013, 21117472929, 21126473545

    Distribution

    US Nationwide distribution in the states of IN, TX, and PA.

    Quantity

    176 units