Press release Gothenburg, Sweden, on July 20, 2022
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 packaging. To mitigate potential breaches in the sterile packaging a field safety corrective action has been introduced.
All affected customers will or have received communication from Getinge regarding this field action according to local regulations. Pending on the HLS Set Advanced version, instructions may vary for customers.
The cost for the field action is not material.
This information is released in order to inform users of mentioned Getinge products, according to standard procedures recommended by regulatory authorities.
Anna Appelqvist, Vice President Corporate Communications
Phone: +46 (0)10 335 5906
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions that aim to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 10,000 people worldwide and the products are sold in more than 135 countries.