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 Cook Incorporated Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter (ULT16.0-38-25-P-6S-MCL-HC); Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter (ULT12.0-38-45-P-6S-CLM-RH) [HKMD number: 120037].
According to the FDA, product labels state the incorrect expiration dates that extends beyond their true expiration date
For further information, please visit: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=94696
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 02 Jul 2024