BEUDAMED
    FDA Recall Open, Classified

    GYN LAPAROSCOPY PACK. Medical convenience kit.

    Recall: Z-2250-2025 · Initiated June 11, 2025

    Recall

    Recall Number
    Z-2250-2025
    Event Number
    97149
    Firm
    AVID Medical, Inc.
    FEI Number
    1047429
    Product Code
    OKV
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 11, 2025
    Posted
    August 4, 2025
    Address
    9000 Westmont Dr, Toano, VA, 23168-9351

    Description

    GYN LAPAROSCOPY PACK. Medical convenience kit.

    Reason

    CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

    Action

    Consignees were sent an URGENT: MEDICAL DEVICE FIELD CORRECTION notice, dated 6/11/25, via email. The notification instructs consignees to not use the CLEARIFY Visualization System (component #5303907) and discard. All other components in the kit may be continued to be used. Consignees are to add warning labels to affected procedure trays to ensure the affected component is discarded. The provided Recall Response Form is to be completed and returned to Owens&Minor. Any quality problems or adverse events associated with recalled devices may be reported via email to [email protected]

    Distribution

    Domestic: CA, IL, MD, OH, PA, TX, WA.

    Quantity

    346 units