MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429
This recall is currently active, issued January 12, 2024. It was issued by Cook Medical Llc.
- Company
- Cook Medical Llc
- Recall Initiated
- December 7, 2023
- Posted
- January 12, 2024
- Recall Number
- Z-0722-2024
- Quantity
- 14 US; 101 OUS
- Firm Location
- Bloomington, IN
- Official Source
- View on FDA website ↗
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.
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
Lot / Code Info
UDI-DI 00827002444294 Lots AM109365 AM109363 AM109356 AM111934 AM111932 AM111933 AM112041 AM112042 AM112039 AM112040 AM112043 AM112071 AM112072 AM112316
Root Cause
Device Design
Action Taken
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.