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U.S. Department of Health and Human Services

Class 2 Device Recall MINC Benchtop Incubator

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  Class 2 Device Recall MINC Benchtop Incubator see related information
Date Initiated by Firm December 07, 2023
Date Posted January 12, 2024
Recall Status1 Open3, Classified
Recall Number Z-0722-2024
Recall Event ID 93673
Product Classification Accessory, assisted reproduction - Product Code MQG
Product MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429
Code Information UDI-DI 00827002444294 Lots AM109365 AM109363 AM109356 AM111934 AM111932 AM111933 AM112041 AM112042 AM112039 AM112040 AM112043 AM112071 AM112072 AM112316
Recalling Firm/
Manufacturer		 Cook Medical Llc
1025 W Acuff Rd
Bloomington IN 47404-9295
Manufacturer Reason
for Recall		 The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static electricity) is applied to the lid of the device. This may lead to embryo degeneration necessitating an additional medical procedure for the patient.
FDA Determined
Cause 2		 Device Design
Action The firm notified affected customers on December 7, 2023 via URGENT Medical Device Correction letters. Per the letter, customers can continue to use their MINC+ device whilst awaiting the defect correction, but Cook advises customers to be vigilant and monitor for device alerts. If the device produces audible and visual alerts to indicate an error with temperature, customers must immediately move any dishes to another incubator. If no other incubators are available, the device can be reset to normal operation by switching off mains power to the device for ten seconds then turning the power back on. The software/firmware update will undergo verification testing including compliance testing prior to release. The updated software/firmware is expected to be available on 01 February 2024. An authorized service agent will contact customers to arrange for the device to be corrected at their facility. The service agent will be updating the software/firmware of the device.
Quantity in Commerce 14 US; 101 OUS
Distribution Domestic distribution to CA IN LA MD NY International distribution to AUSTRALIA AUSTRIA SPAIN FINLAND FRANCE INDIA IRELAND ITALY KUWAIT SWITZERLAND TURKEY UNITED KINGDOM
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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