BEUDAMED
    FDA Enforcement Class II Ongoing

    PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.

    Recall: Z-0932-2023 · Reported January 18, 2023

    Enforcement

    Recall Number
    Z-0932-2023
    Event ID
    91350
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stradis Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 18, 2023
    Initiation Date
    December 15, 2022
    Classification Date
    January 11, 2023
    Address
    3600 Burwood Dr, Waukegan, IL, 60085-8399, United States

    Description

    PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.

    Reason

    Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

    Code Info

    Assembly Number 477944, UDI-DI: M7524779441, Lot Numbers: 220974270, 220915145

    Distribution

    US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

    Quantity

    300 units