CooperSurgical issues recall of INCA infant nasal CPAP sets over loose connection risk
CooperSurgical has announced a recall of its INCA infant nasal CPAP complete and replacement sets.
The recall is due to a potential loose connection between the flexible tubing and the nasal cannula, which could reduce the device's effectiveness and lower oxygen delivery to infants.
The FDA has classified the recall as the most serious type, indicating a risk of serious injury or death if the devices continue to be used.
CooperSurgical has instructed customers to stop using the affected products, identify them by part number and lot codes, cease distribution, and return the units to the company.
This writeup was produced by pharmadog from original reporting by fda medwatch.
Original headline: “Ventilator Recall: CooperSurgical Removes INCA Infant Nasal CPAP Sets”
read at fda medwatch ↗
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