FDA Alerts on Class I Recall of CooperSurgical INCA Infant Nasal CPAP Sets
The US Food and Drug Administration has classified the recall of certain CooperSurgical INCA Infant Nasal CPAP sets as a Class I recall, the most serious category. The action affects specific lots of both the INCA Infant Nasal CPAP Complete Set and the Replacement Set used to provide continuous positive airway pressure to newborns and infants.
The recall was initiated because the flexible tubing may form a loose connection with the nasal cannula during assembly or clinical use. This defect can lead to circuit disconnection or air leaks, resulting in a loss of CPAP pressure, compromised therapy delivery, and decreased oxygenation for the infant. As of August 11, the manufacturer reported no serious injuries or deaths linked to this problem.
Healthcare providers and facilities are instructed to stop using and distributing the affected lots immediately, quarantine remaining inventory, and return the items to the manufacturer. If a loose connection is detected while a patient is undergoing CPAP support, staff should immediately switch to alternative tubing or another CPAP system.
Key points
- The US FDA designated the recall of specific lots of CooperSurgical INCA infant CPAP sets as Class I.
- A loose connection between the tubing and nasal cannula can cause leaks, pressure loss, and reduced oxygenation in infants.
- No serious injuries or deaths were reported as of August 11.
- Clinicians are advised to immediately cease using recalled lots and replace tubing if disconnection occurs during therapy.
What it means for you
Neonatal intensive care teams and biomedical engineers in Pakistan should check their inventory for affected CooperSurgical INCA CPAP sets and immediately quarantine any matching lots. Clinicians should ensure alternative respiratory circuits are readily available at the bedside if a defect or pressure drop is detected during infant ventilation. Clinicians should also consult the Drug Regulatory Authority of Pakistan for local regulatory status, alerts, and registration details regarding these devices.
Ventilator Recall: CooperSurgical Removes INCA Infant Nasal CPAP Sets
Summarised automatically from the official announcement. For educational purposes only — check the original source before making clinical decisions.