BEUDAMED
    FDA Enforcement Class II Ongoing

    STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192

    Recall: Z-1289-2024 · Reported March 20, 2024

    Enforcement

    Recall Number
    Z-1289-2024
    Event ID
    94037
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 20, 2024
    Initiation Date
    February 14, 2024
    Classification Date
    March 12, 2024
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192

    Reason

    Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the traction system. If an impacted device is used during surgery, the boot may detach from the traction system, potentially leading to patient harm and a delay in surgery.

    Code Info

    UDI/DI 00615521000851, Lot Numbers: 23-140, 23-268, 23-314

    Distribution

    US Nationwide distribution in the state of Alabama.

    Quantity

    14 units