Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning William A. Cook Australia Pty. Ltd. (Cook Medical LLC) MINC+ Benchtop Incubator [Reference Part Number (RPN): K-MINC-2000, Order Number (GPN) G44429; UDI-DI 00827002444294 Lots AM109365 AM109363 AM109356 AM111934 AM111932 AM111933 AM112041 AM112042 AM112039 AM112040 AM112043 AM112071 AM112072 AM112316] [HKMD No.: 230502].
According to the FDA, 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.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=93673
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 Jan 2024