BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1421-2022 · Reported July 27, 2022

    Enforcement

    Recall Number
    Z-1421-2022
    Event ID
    90469
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    July 27, 2022
    Initiation Date
    June 13, 2022
    Classification Date
    July 20, 2022
    Address
    95 Corporate Dr, N/A, Trumbull, CT, 06611-1350, United States

    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.

    Code Info

    UDI: (01)00815965020914 (17)220819 (10)GFT5-200218U (01)00815965020914 (17)220819 (10)GFT5-201026U (01)00815965020914 (17)220819 (10)GFT5-21335060 Lots: 21335060, GFT5-200218U, GFT5-201026U

    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