Recall Z-0722-2024 ยท MQG Accessory, Assisted Reproduction
Cook Medical Llc
MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429
| Date | Jan 12, 2024 (initiated Dec 7, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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 ba |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.