BEUDAMED
    FDA Enforcement Class II Ongoing

    Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the lighthandle of STERIS surgical lighting systems for the purpose of maintaining a sterile surgical environment. REF: LB44

    Recall: Z-1476-2023 · Reported May 10, 2023

    Enforcement

    Recall Number
    Z-1476-2023
    Event ID
    92040
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 10, 2023
    Initiation Date
    March 17, 2023
    Classification Date
    April 28, 2023
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834, United States

    Description

    Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the lighthandle of STERIS surgical lighting systems for the purpose of maintaining a sterile surgical environment. REF: LB44

    Reason

    Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient

    Code Info

    GTIN number: 00724995192570 Lot Numbers: 9943616 / 9943616A 9943617 / 9943617A 9943619 / 9943619A 9943620 / 9943620A 9959650 / 9959650A 9959651 / 9959651A

    Distribution

    Worldwide - US Nationwide distribution including Puerto Rico and the countries of Canada, Australia.

    Quantity

    263,280 covers