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.
Medical device manufacturer, Haemonetics S.A. has issued a medical device safety alert concerning its Blood Donor Sets [Item: 997CF-E] [HKMD No.: 240022].
The manufacturer has received reports from the field of instances in which there has been a significant leak of blood from the Latham bowl into the MCS+ equipment during the apheresis procedure. The leak results when the bottom of the bowl becomes detached, which then leads to a termination of the procedure and required cleaning and servicing of the equipment before the next use.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 Aug 2024