BEUDAMED
    FDA Enforcement Class II Ongoing

    Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060

    Recall: Z-1348-2023 · Reported April 12, 2023

    Enforcement

    Recall Number
    Z-1348-2023
    Event ID
    91794
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 12, 2023
    Initiation Date
    February 13, 2023
    Classification Date
    April 6, 2023
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350, United States

    Description

    Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060

    Reason

    It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and development.

    Code Info

    UDI-DI: 00815965020433; LOT 221118-010694

    Distribution

    Worldwide - US Nationwide distribution in the states of NY, UT and the countries of Argentina, Belgium, Bulgaria, Ecuador, France, Germany, Hong Kong, Italy, Malaysia, Mexico, Peru, Singapore, Spain, Switzerland, Thailand, Turkey, the United Kingdom.

    Quantity

    190 units