CooperSurgical, Inc. — Class I: INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing c
CooperSurgical, Inc. has initiated a Class I recall for specific models of INCA Neonatal Nasal CPAP Replacement Sets due to a potential loose connection between the Stay-Flex tubing and the nasal cannula. This defect can lead to a loss of CPAP pressure and decreased oxygenation during clinical use.
This recall affects CooperSurgical, Inc., healthcare providers using neonatal nasal CPAP systems, and clinical staff responsible for infant respiratory care and medical device procurement.
The FDA's classification as Class I indicates a significant risk of serious adverse health consequences or death. The mechanical failure of the tubing connection directly compromises the delivery of life-sustaining pressure in a vulnerable neonatal population. From a regulatory perspective, this suggests a critical failure in component assembly or material compatibility that necessitates immediate corrective action and robust post-market field safety notifications.
QA and manufacturing teams should evaluate joining processes for flexible tubing components to ensure connection integrity under pressurized use. Regulatory teams should verify that all units of the specific model numbers (44-0712, 44-0707, 44-0709, 44-0715) are identified and isolated in accordance with the Class I recall status. Clinical engineering should monitor for instances of pressure loss in neonatal CPAP setups until the recall is resolved.
Class I. Reason: Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.. Product: INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712, 44-0707, 44-0709, 44-0715.. Firm: CooperSurgical, Inc. (Trumbull CT United States). Status: Ongoing.
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