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 Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Cook Medical Europe Ltd Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter and Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter [Reference Part Numbers (RPNs): PTA3-14-150-2.5-8, PTA3-14-150-2.5-3, and ULT16.0-38- 25-P-6S-LMCL; Order Numbers (GPNs): G26677, G26646, and G07340, respectively; Affected serial or lot number range: 14110999, 14111001, NS13527160, 14012749, and 14007378] [HKMD No.: 140061].
According to the MHRA, specific product lots were distributed throughout Europe, Middle East, and Africa (EMEA) after the manufacturer removed the products from the Declaration of Conformity. As such, the products should not have been distributed.
For further information, please visit https://mhra-gov.filecamp.com/s/d/eV2ivloO8Zv3yqcQ
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 6 Apr 2023