BEUDAMED
    FDA Recall Open, Classified

    LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055

    Recall: Z-1421-2022 · Initiated June 13, 2022

    Recall

    Recall Number
    Z-1421-2022
    Event Number
    90469
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    MQL
    Status
    Open, Classified
    Root Cause
    Error in labeling
    Initiated
    June 13, 2022
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055

    Reason

    There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5 seconds as indicated in the English version.

    Action

    On June 13, 2022, the firm distributed Urgent Media Safety Notice letters to affected customers. Customers were informed that setting out a thawing blastocyte for 5 minutes may be detrimental to the survival of the blastocyte. Customers were asked to complete and return an acknowledgement form. Once the firm has received the completed form, they will provide the corrected IFU.

    Distribution

    Domestic: USA AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TX, UT, VT, WA, WI, International: Belgium, Canada, Croatia, Netherlands, Portugal, Spain

    Quantity

    403 units