Regenerative
FDA flags Class I recall of CooperSurgical infant nasal CPAP sets over loose tubing
By Life and Health Today Staff, . Life and Health Today.
CooperSurgical has recalled specific lots of its INCA Neonatal Nasal CPAP Complete Set and Replacement Set, according to a safety alert published by the United States Food and Drug Administration's MedWatch program. The FDA has classified the action as a Class I recall, the agency's most serious designation, meaning continued use of the affected devices may cause serious injury or death.
The INCA Infant Nasal CPAP Assembly is a device used in neonatal care to deliver continuous positive airway pressure, a form of breathing support that keeps the airways of newborn and infant patients open without requiring a breathing tube. The system works by delivering a steady flow of pressurised air through a soft nasal cannula, which is the small tube placed at the nostrils, connected to two shapeable tubes that hold their position to limit movement and reduce trauma to the nose.
CooperSurgical told the FDA that units from the affected lots may have a loose connection between the flexible tubing and the nasal cannula. That looseness can appear either during assembly or while the device is already in use on a patient. If it goes undetected, the tubing may leak at the connection point or disconnect entirely. The result, the company said, is a loss of CPAP pressure, which can reduce the effectiveness of treatment and lead to decreased oxygenation in the patient until the connection is restored.
CooperSurgical sent letters to all affected customers on August 11 directing them to identify affected product, stop using it, stop distributing it, and return it to the company. The FDA's alert repeats that instruction: do not use affected product.
As of August 11, CooperSurgical had reported no serious injuries or deaths linked to the issue, according to the FDA's MedWatch alert.
Healthcare professionals and consumers who have experienced adverse reactions or quality problems with these devices can contact CooperSurgical's Recall Support Team at fieldaction@coopersurgical.com or 203-895-2789. Adverse events can also be reported directly to the FDA through its MedWatch Safety Information and Adverse Event Reporting Program.
This recall is relevant to neonatal intensive care settings rather than to consumers purchasing devices directly. The open question, which the FDA alert does not address, is how many lots are affected and how widely the devices were distributed. Healthcare facilities using INCA CPAP sets should verify whether their stock falls within the recalled lots using the unique device identifier, a standardised code the FDA uses to trace individual medical devices from distribution through to clinical use.