CooperSurgical INCA infant nasal CPAP recalled for loose tubing connection risk
What this means
CooperSurgical's INCA infant nasal CPAP devices may develop a loose connection between the flexible tubing and nasal cannula during assembly or use. This loose connection could cause a loss of CPAP pressure, reducing treatment effectiveness and potentially lowering oxygen levels until the connection is restored.
- Check your device for a secure connection between the tubing and nasal cannula before each use
- Contact CooperSurgical or your healthcare provider if you have one of the affected model numbers (44-2707, 44-2709, 44-2710, 44-2712, 44-2715)
- Do not use the device if the connection feels loose or unstable
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3139-2026More CooperSurgical recalls
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