BEUDAMED
    FDA Recall Terminated

    MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.

    Recall: Z-1377-2018 · Initiated January 12, 2018

    Recall

    Recall Number
    Z-1377-2018
    Event Number
    79711
    Firm
    Cook Inc.
    FEI Number
    1820334
    Product Code
    MQG
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 12, 2018
    Posted
    April 13, 2018
    Terminated
    May 8, 2020
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    Description

    MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 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.

    Action

    Cook plans to begin notifying consignees of the recall on January 12, 2018 Written recall communication letters will be mailed via courier to US consignees

    Distribution

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

    Quantity

    483