FDA issues early alert on CooperSurgical infant nasal CPAP devices with loose tubing connection

The FDA’s Center for Devices and Radiological Health has posted an Early Alert about a potential high-risk issue with certain CooperSurgical infant nasal CPAP devices.

The problem involves a loose connection between the flexible tubing and the nasal cannula, which can reduce the device’s effectiveness and lower oxygen delivery to patients.

CooperSurgical has mailed a letter to affected customers advising that the identified ventilators be removed from use or sale, that they be taken out of distribution, and that the units be returned to the company. The FDA urges users to stop using the listed part numbers and lot codes immediately.