You are visiting a website that is not intended for your region

The page or information you have requested is intended for an audience outside the United States. By continuing to browse you confirm that you are a non-US resident requesting access to this page or information.

Switch to the US site

COVID-19 Resource Center

Healthcare professionals can find help and guidance on how to benefit from our offerings to treat your patients, as well as other practical information and advice.

Read more

News

Getinge is announcing a recall of HLS Set Advanced products

Press release Gothenburg, Sweden, on November 10, 2020

Getinge is announcing a recall of HLS Set Advanced products

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.
 

Media contact:

Anna Appelqvist, Vice President Corporate Communications
Phone: +46 (0)10 335 5906
E-mail: anna.appelqvist@getinge.com

About Getinge

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.

Files

Share: