FDA Issues Early Alert for CooperSurgical Neonatal Ventilators Due to Connection Issue

The U.S. Food and Drug Administration (FDA) has issued an early alert concerning specific lots of CooperSurgical's INCA Neonatal Nasal CPAP Complete Set and Replacement Set, advising their removal from use or sale. The alert highlights a potential issue where a loose connection between the flexible tubing and the nasal cannula could occur during assembly or use.

This defect may lead to a loss of CPAP pressure, reducing treatment effectiveness and potentially causing decreased oxygenation in patients until the connection is restored. CooperSurgical has recommended that affected units be removed. As of August 11, CooperSurgical has reported no serious injuries or deaths associated with this issue.

The FDA's Center for Devices and Radiological Health (CDRH) said it is issuing this "Early Alert to notify the public of a potentially high-risk device issue." The agency will continue to monitor the situation and update the public as new information becomes available. Customers with questions or concerns should contact the CooperSurgical Recall Support Team.