BEUDAMED
    FDA Enforcement Class II Ongoing

    REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile

    Recall: Z-1612-2023 · Reported May 24, 2023

    Enforcement

    Recall Number
    Z-1612-2023
    Event ID
    92138
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Sustainability Solutions
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 24, 2023
    Initiation Date
    April 14, 2023
    Classification Date
    May 19, 2023
    Address
    1810 W Drake Dr, N/A, Tempe, AZ, 85283-4327, United States

    Description

    REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile

    Reason

    Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.

    Code Info

    Lot # 0000157564, UDI-DI: 00885825013585

    Distribution

    US: WA OUS: None

    Quantity

    50 units