Getinge is announcing a medical device field action of HLS Set Advanced products
Getinge is announcing an expansion of its voluntary global medical device field action for the HLS Set Advanced products due to a potential breach in sterile packaging. Getinge has reported this field action to relevant authorities according to applicable regulations. To date, there are no known adverse events associated with illness or injuries related to the mentioned issue.The HLS Set Advanced is used for extracorporeal respiratory and/or cardiovascular support. Getinge has identified that a limited number of HLS Set Advanced products delivered worldwide could have a damaged sterile