Medical device manufacturer, Fresenius Medical Care, has issued a medical device safety alert concerning haemodialysis bloodline for 4008 dialysis machine [Article numbers: i) AP16661 AV-Set B DT INF-E; ii) AP16843 AV-Set DT-E. Batch numbers: i) VHC231, VHC231A, VIC252, VKC262, VLC202, VMC261; ii) VHC012, VIC011, VIC033, VIC192, VIC251, VIC263, VIC291, VKC042, VKC071, VKC094, VKC301, VLC032, VMC041, VMC172, VMC193, WAC114, WAC143, WAC163, WAC191, WAC221, WAC312].
The manufacturer has observed an increased likelihood of blood leakage between dialyzer connector and tubing during post marketing surveillance. It has been determined that a supplied material used in the dialyzer connector manufactured between August 2014 and March 2015 is causing a weak seal between the connector and tubing. The manufacturer has corrected this issue with an alternate approved and validated connector material.
Users are advised to stop using the affected products immediately.
Product recall is ongoing.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 April 2015