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 Ireland Limited EchoTip Ultra High Definition Ultrasound Access Needle & EchoTip Ultra Endoscopic Ultrasound Needle [Ref: ECHO-HD-19-A, ECHO-19] [HKMD number: 090443, 100200].
According to the MHRA, out of specification levels of bacterial endotoxin were identified during the routine endotoxin program.
For further information, please visit: https://mhra-gov.filecamp.com/s/d/UkMETCX10OB47hVE
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 10 Apr 2024