The Food and Drug Administration has flagged a potentially high-risk issue with breathing equipment used on newborns, warning that tubing can loosen or disconnect from the nasal cannula, interrupting the pressure support that keeps a baby's airway open.
The agency issued an early alert covering nine lot-specific products in the CooperSurgical INCA Infant and Neonatal Nasal CPAP Complete Set and Replacement Set lines. The instruction to facilities is direct: do not use the affected product; identify it; stop its use and distribution; and return it to the company.
