Getinge informs about a medical device recall for Custom Tubing kits for Heart Lung Machine
Getinge is informing about a medical device recall for the custom tubing kits for Heart Lung Machines. To date, there are no known adverse events associated with illness or injuries for the products. Getinge has reported to relevant authorities according to applicable regulations and the cost for the field correction and recall is not material.The Heart Lung Machine (HLM) Tubing Set is part of an extracorporeal system and is used exclusively in combination with other devices of that system, e.g. blood pumps, oxygenators etc. The HLM Tubing Sets are designed to be used for circulation of