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