Getinge announced 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 packaging. To mitigate potential breaches in the sterile packaging a field safety corrective action has been introduced.
All affected customers received communication from Getinge regarding this field action according to local regulations. Pending on the HLS Set Advanced version, instructions may vary for customers.