BEUDAMED
    FDA Enforcement Class II Terminated

    MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.

    Recall: Z-1378-2018 · Reported April 25, 2018

    Enforcement

    Recall Number
    Z-1378-2018
    Event ID
    79711
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 25, 2018
    Initiation Date
    January 12, 2018
    Classification Date
    April 17, 2018
    Termination Date
    May 8, 2020
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120, United States

    Description

    MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.

    Reason

    The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater.

    Code Info

    All Lots

    Distribution

    Nationwide (K-IMNC-100 -US G46022) . (K-IMNC-100 G20079 manufactured in Australia and distributed worldwide)

    Quantity

    4,451