FDA-Device2024-01-24Class II
MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429
Cook Medical Llc
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.
Sold states
Domestic distribution to CA IN LA MD NY International distribution to AUSTRALIA AUSTRIA SPAIN FINLAND FRANCE INDIA IRELAND ITALY KUWAIT SWITZERLAND TURKEY UNITED KINGDOM
Affected count
14 US; 101 OUS
Manufactured in
1025 W Acuff Rd, N/A, Bloomington, IN, United States
Products
MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0722-2024Don't want to check this manually?
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