Device recall
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.
- Recall number
- Z-3140-2026
- Event id
- 99643
- Status
- Ongoing
- FDA classification
- Class I
- Recalling firm
- CooperSurgical, Inc.
- Report date
- Sep 30, 2026
- Posted
- Sep 18, 2026
- Initiated
- Aug 11, 2026
- Center classification date
- Sep 18, 2026
- Product code
- BZD
- Device type
- Ventilator, Non-Continuous (Respirator)
- 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.
- Root cause
- Device Design
- Quantity
- 149 boxes (745 units)
- Code info
- 1. Model Number: 44-0712. UDI-DI: (01)60888937009516. Lot Code: 550031624. 2. Model Number: 44-0707. UDI-DI: (01)20888937009488. Lot Code: 550021057. 3. Model Number: 44-0709. UDI-DI: (01)20888937009495. Lot Code: 550031623. 4. Model Number: 44-0715. UDI-DI: (01)20888937009525. Lot Code: 550031625.
- Distribution
- Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K911780
- Location
- Trumbull, CT, United States