BEUDAMED
    FDA Recall Open, Classified

    Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handle covers are designed to fit over surgical light handles for sterile surgeon control. REF: LB53

    Recall: Z-1475-2023 · Initiated March 17, 2023

    Recall

    Recall Number
    Z-1475-2023
    Event Number
    92040
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    FTA
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 17, 2023
    Posted
    April 28, 2023
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handle covers are designed to fit over surgical light handles for sterile surgeon control. REF: LB53

    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

    Action

    Steris issued Urgent Medical Device Recall Letter on 3/17/23 via FedEx. Letter states reason for recall, health risk and action to take: 1. Please immediately inspect your on-hand inventory for product affected by this recall. For the full list of lots affected by this recall, please reference Attachment A to this letter. 2. Please complete the Medical Device Recall Response Form included with this letter and destroy any remaining product in your inventory. If product was transferred to any other entities within your organization, please forward this recall notice accordingly. STERIS will coordinate shipment of replacement product upon receipt of the completed Recall Response Form. 3. Return the completed Recall Response Form via email to: [email protected] or via fax to (440) 392-8963. Users are reminded to report any adverse events via FDA s MedWatch Database should an event occur. If you have questions regarding this recall, please contact STERIS Customer Service at 1-800-548-4873, or email the RMA Team at [email protected].

    Distribution

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

    Quantity

    1,358,520 covers