Home / Recalls / Cook Medical Llc / Z-0722-2024

Z-0722-2024 Class II Ongoing

Recalled by Cook Medical Llc — Bloomington, IN

Recall Details

Product Type: Devices
Report Date: January 24, 2024
Initiation Date: December 7, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 14 US; 101 OUS

Product Description

MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429

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 Pattern

Domestic distribution to CA IN LA MD NY International distribution to AUSTRALIA AUSTRIA SPAIN FINLAND FRANCE INDIA IRELAND ITALY KUWAIT SWITZERLAND TURKEY UNITED KINGDOM

Code Information

UDI-DI 00827002444294 Lots AM109365 AM109363 AM109356 AM111934 AM111932 AM111933 AM112041 AM112042 AM112039 AM112040 AM112043 AM112071 AM112072 AM112316