Maquet Cardiopulmonary Gmbh (MCP) has received customer complaints of damage to the primary packaging of the Hls Set Advanced. In all it was reported that the Tyvek cover was damaged. Investigation suggest that the Tyvek damage only occurs if the set drops upside down so either the velcro straps, holding the Hls modules, come loose or the Hls module detaches. A shift of the Hls module may cause the venous probe tab(s) to perforate the Tyvek cover. Possible sterility compromise. Recall start date: July 18, 2022.
RecallTracker