Getinge is announcing a global medical device recall for the HLS Set Advanced products due to a potential breach in sterile packaging. To date, there are no known adverse events associated with illness or injuries related to the mentioned products. Getinge has reported to relevant authorities according to applicable regulations and the cost for the recall is not material.
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 beginning October 2018 could have a damaged sterile packaging. The affected products have a shelf life of 2 years and Getinge cannot estimate how many products remain with impacted customers. The cost for the recall is not material.
All affected customers will or have received communication from Getinge regarding this recall according to local requirements.
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.