Recall Z-0722-2024— Cook Medical Llc
Class II · Ongoing
Class II FDA medical device recall by Cook Medical Llc, initiated 2023-12-07. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Cook Medical Llc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-07
- Firm location
- Bloomington, IN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.