Getinge is announcing a medical device recall/field action related to packaging of QUADROX-iD Pediatric Oxygenators

Getinge is announcing a global medical device recall/field action related to the packaging of QUADROX-iD Pediatric Oxygenators. To date, there are no known adverse events associated with illness or injuries related to damage to the sterile barrier. Getinge has reported to relevant authorities according to applicable regulations and the cost for the field correction and recall is not material.

The QUADROX-iD Pediatric Oxygenator is a product used in extracorporeal support. This global recall/field action is initiated due to an identified potential packaging integrity issue of the product with BIOLINE Coating. The affected QUADROX-iD Pediatric Oxygenators with BIOLINE Coating were distributed between October 31, 2017 – July 25, 2019

All concerned customers have received communication. Customers are requested to remove and return affected products for collection and destruction.

This information is released in order to inform users of mentioned Getinge products, according to standard procedure 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.