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U.S. Department of Health and Human Services

Class 2 Device Recall Benchtop Incubator

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  Class 2 Device Recall Benchtop Incubator see related information
Date Initiated by Firm January 12, 2018
Date Posted April 13, 2018
Recall Status1 Terminated 3 on May 08, 2020
Recall Number Z-1377-2018
Recall Event ID 79711
510(K)Number K983642  
Product Classification Accessory, assisted reproduction - Product Code MQG
Product MINC Benchtop Incubator (Mini Incubator)
catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.
Code Information All lots
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Cook Medical
812-339-2235 Ext. 10214
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
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
Quantity in Commerce 483
Distribution Nationwide (K-IMNC-100 -US G46022) . (K-IMNC-100 G20079 manufactured in Australia and distributed worldwide)
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQG and Original Applicant = COOK OB/GYN
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