FDA Enforcement
Class II
Ongoing
MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429
Recall: Z-0722-2024
·
Reported January 24, 2024
Enforcement
- Recall Number
- Z-0722-2024
- Event ID
- 93673
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cook Medical Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 24, 2024
- Initiation Date
- December 7, 2023
- Classification Date
- January 12, 2024
- Address
- 1025 W Acuff Rd, N/A, Bloomington, IN, 47404-9295, United States
Description
MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429
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.
Code Info
UDI-DI 00827002444294 Lots AM109365 AM109363 AM109356 AM111934 AM111932 AM111933 AM112041 AM112042 AM112039 AM112040 AM112043 AM112071 AM112072 AM112316
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