Date Initiated by Firm |
January 12, 2018 |
Date Posted |
April 13, 2018 |
Recall Status1 |
Terminated 3 on May 08, 2020 |
Recall Number |
Z-1378-2018 |
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) G20079 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 |
4,451 |
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
|