BEUDAMED
    FDA Enforcement Class II Ongoing

    Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)

    Recall: Z-1823-2022 · Reported October 5, 2022

    Enforcement

    Recall Number
    Z-1823-2022
    Event ID
    90782
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 5, 2022
    Initiation Date
    August 12, 2022
    Classification Date
    September 28, 2022
    Address
    95 Corporate Dr, N/A, Trumbull, CT, 06611-1350, United States

    Description

    Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)

    Reason

    There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the sterile barrier may result in use of an unsterilized device, which may cause contamination and degradation or loss of embryo during incubation.

    Code Info

    Lot Numbers 18-1265 18-1268 18-1268 / G004639 G004637 G004638 G004639

    Distribution

    Domestic distribution to the following states: AL AZ CA CT DE FL GA HI IL KS MA MI MN MO NJ NY OH OR SC TX VA VT WA WI WV Foreign distribution to Barbados, Canada, Chile, Micronesia Federate, and Panama.

    Quantity

    5,182 kits