November 26, 2018 Gothenburg, Sweden
Getinge informs about a voluntary Medical Device Recall for the QUADROX‐i Neonatal Oxygenator
Getinge is informing about a global voluntary Medical Device Recall for the QUADROX‐i Neonatal Oxygenator. To date, there are no known adverse events associated with serious injury or death. Getinge has reported to relevant competent authorities according to applicable regulations and does not expect the cost for the recall to be material.
The QUADROX‐i Neonatal Oxygenator is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery for neonatal patients. The recall concerns an enclosed adapter to the device, which can cause blood leakage at the blood inlet connector. In total 22,749 units of Quadrox-i Neonatal have been distributed globally between October, 2016 and October 2018. The adapter is used in 10% of the therapy cases. In the US, the recall affects 9 customers, and has been classified as a Class I recall by the FDA. Since December 2017 the product is no longer distributed to the US market.
All concerned customers have received communication to either remove the screw adopter before usage or return the product to Getinge.
This information is released in order to inform users of mentioned Getinge products, according to standard procedure recommended by regulatory authorities.
Anna Appelqvist, Vice President Corporate Communications
Phone: +46 (0)10 335 5906
Jeanette Hedén Carlsson, Executive Vice President Communication & Brand Management
Phone: +46 (0)10 335 1003