BEUDAMED
    FDA Enforcement Class II Ongoing

    global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer.

    Recall: Z-1089-2024 · Reported February 21, 2024

    Enforcement

    Recall Number
    Z-1089-2024
    Event ID
    93688
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2024
    Initiation Date
    December 20, 2023
    Classification Date
    February 14, 2024
    Address
    95 Corporate Dr, N/A, Trumbull, CT, 06611-1350, United States

    Description

    global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer.

    Reason

    The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage.

    Code Info

    LGGG-020: UDI-DI 00815965020044, lot 231020-018741 LGGG-050: UDI-DI 00815965020051, lot 231020-018742 LGGG-100: UDI-DI 00815965020068, lot 231020-018743

    Distribution

    Worldwide - US Nationwide including in the states of AL, AZ, CA, CO, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MO, NV, NJ, NM, NY, NC, OH, OK, OR, PA, RI, TN, TX, UT, VT, VA, WA, WV and the countries of Canada, Brazil, Mexico, Argentina, Hong Kong, Japan, Turkey, Netherlands, Belgium, Spain, Taiwan, United Kingdom, Austria, Georgia, France, Denmark, Greece, Saudi Arabia, Thailand, New Zealand, Estonia, Poland, Jordan, and Germany.

    Quantity

    994 total (481 US; 513 OUS)