Medical devices
CooperSurgical recalls INCA infant CPAP sets over loose connections
The FDA says not to use affected sets because a loose connection could reduce CPAP pressure and lower a patient's oxygenation.
CooperSurgical recalled certain lots of its INCA Neonatal Nasal CPAP Complete Set and Replacement Set after the tubing may develop a loose connection with the nasal cannula, according to the FDA. The FDA identified the recall as its most serious type and said the devices could cause serious injury or death if use continues.
A loose connection can cause a leak or disconnect, leading to loss of CPAP pressure and decreased oxygenation until the connection is restored, CooperSurgical said. As of August 11, the company had reported no serious injuries or deaths associated with the issue. The FDA advises customers to identify affected products, stop using and distributing them, and return them to CooperSurgical.
