BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1108-2022 · Initiated April 1, 2022

    Recall

    Recall Number
    Z-1108-2022
    Event Number
    90042
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    MQK
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    April 1, 2022
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350

    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.

    Action

    On April 1, 2022, the firm distributed URGENT Medical Device Safety Notices to affected customers. Customers were informed of the potential breach to the sterile barrier of the affected lot. Customers should discontinue use of the affected lot and quarantine the product for return to CooperSurgical. If you have additional questions, please contact a CooperSurgical Product Surveillance representative at 203.601.5200 Ext. 3300 or email the firm at [email protected].

    Distribution

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

    Quantity

    2,340 (US only)