BEUDAMED
    FDA Enforcement Class II Ongoing

    LAP CHOLE PACK. Medical convenience kit.

    Recall: Z-2253-2025 · Reported August 13, 2025

    Enforcement

    Recall Number
    Z-2253-2025
    Event ID
    97149
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    AVID Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 13, 2025
    Initiation Date
    June 11, 2025
    Classification Date
    August 4, 2025
    Address
    9000 Westmont Dr, N/A, Toano, VA, 23168-9351, United States

    Description

    LAP CHOLE PACK. Medical convenience kit.

    Reason

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

    Code Info

    Model No. VCIH007-06; UDI: 10809160379479, 10809160450758; Kit Lot No. 1569227, 1569228, 1569229, 1589126, 1608615, 1623944, 1643426.

    Distribution

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

    Quantity

    85 units