Z-0722-2024 Class II Ongoing
FDA device recall Z-0722-2024 was initiated by Cook Medical Llc on December 7, 2023 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 14 US; 101 OUS.
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