FDA Identifies CooperSurgical Infant Nasal CPAP Recall as Class 1

FDA has classified as Class 1 a CooperSurgical recall of certain INCA Infant Nasal CPAP Complete Sets and Neonatal Nasal CPAP Replacement Sets due to a loose tubing connection that could result in loss of respiratory support and decreased oxygenation in newborns and infants.

The recall involves specific lots of nine product configurations that may exhibit a loose connection between the flexible tubing and nasal cannula during assembly or use. According to FDA, the connection may leak or disconnect, resulting in a loss of continuous positive airway pressure (CPAP) that could reduce treatment effectiveness and lead to decreased oxygenation until the connection is restored.

The affected devices are used to provide respiratory support to newborns and infants. The INCA system delivers CPAP through a soft nasal cannula connected to flexible tubing designed to maintain positioning and minimize patient movement and nasal trauma.