Events

Recall of Device Recall Benchtop Incubator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cook Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79711
  • Event Risk Class
    Class 2
  • Event Number
    Z-1378-2018
  • Event Initiated Date
    2018-01-12
  • Event Date Posted
    2018-04-13
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163147
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accessory, assisted reproduction - Product Code MQG
  • 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

Device

Device Recall Benchtop Incubator
  • Model / Serial
    All Lots
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide (K-IMNC-100 -US G46022) . (K-IMNC-100 G20079 manufactured in Australia and distributed worldwide)
  • Product Description
    MINC Benchtop Incubator (Mini Incubator) || catalog (K-MINC-1000) G20079 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.
  • Manufacturer
    Cook Inc.

Manufacturer

Cook Inc.
  • Manufacturer Address
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Manufacturer Parent Company (2017)
    Cook Group Incorporated
  • Source
    USFDA