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

Hazard

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.

Details from the source

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 Quantity: 14 US; 101 OUS Lot/code info: UDI-DI 00827002444294 Lots AM109365 AM109363 AM109356 AM111934 AM111932 AM111933 AM112041 AM112042 AM112039 AM112040 AM112043 AM112071 AM112072 AM112316

UPC codes

00827002444294

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.