medical Class II Updated 2024-01-24

Cook Medical Llc recalls MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: CA, IN, LA, MD, NY
Lot/Code Info: UDI-DI 00827002444294 Lots AM109365 AM109363 AM109356 AM111934 AM111932 AM111933 AM112041 AM112042 AM112039 AM112040 AM112043 AM112071 AM112072 AM112316
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