BEUDAMED
    FDA Enforcement Class II Ongoing

    VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.

    Recall: Z-1108-2022 · Reported May 25, 2022

    Enforcement

    Recall Number
    Z-1108-2022
    Event ID
    90042
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 25, 2022
    Initiation Date
    April 1, 2022
    Classification Date
    May 17, 2022
    Address
    95 Corporate Dr, N/A, Trumbull, CT, 06611-1350, United States

    Description

    VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.

    Reason

    Products in this lot may have compromised barrier seals, introducing a risk to sterility.

    Code Info

    GTIN for UDI on Pouch: 00888937014792 GTIN for UDI on Box: 20888937014796 Lot 264453

    Distribution

    Domestic distribution to AZ, CA, FL, IL, MI, MO, NY, OR, TX, and WV. No foreign distribution.

    Quantity

    2,340 (US only)