INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-…
CooperSurgical, Inc. · 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 pr…
Open FDA's page for this record- Cfres ID
- 222061
- Product res number
- Z-3139-2026
- Event date initiated
- 2026-08-11
- Event date posted
- 2026-09-18
- Recall status
- Open, Classified
- Res event number
- 99643
- Product code
- BZD
- Firm FEI number
- 1216677
- Recalling firm
- CooperSurgical, Inc.
- Address 1
- 95 Corporate Dr
- City
- Trumbull
- State
- CT
- Postal code
- 06611-1350
- Additional info contact
- Matthew Kelleher 203-601-5200
- Root cause description
- Device Design
- Product quantity
- 2,643 boxes (13,215 units)
- Distribution pattern
- Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru.
- Product description
INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710, 44-2712, 44-2715.
- Code info
1. Model Number: 44-2707. UDI-DI: (01)20888937009433. Lot Code: 550019722. 2. Model Number: 44-2709. UDI-DI: (01)60888937009448. Lot Codes: 550031617, 550033781, 550031621. 3. Model Number: 44-2710. UDI-DI: (01)20888937009457. Lot Codes: 550031615, 550031616, 550031620, 550034760. 4. Model Number: 44-2712. UDI-DI: (01)20888937009464. Lot Codes: 550031611, 550031614, 550033779, 550031619. 5. Model Number: 44-2715. UDI-DI: (01)20888937009471. Lot Codes: 550031618, 550033780, 550034763.
- Reason for recall
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.
- Action
CooperSurgical notified consignees on about 08/11/2026 via "URGENT Medical Device Recall" letter. Consignees were notified of the issue and potential hazard, and were instructed to identify affected units on hand, if any loose connection is recognized during the use of the CPAP, replace the tubing with another tubing or CPAP device, and remove all product of the subject lots from inventory and note the number of units to be returned on the attached Recall Response Form that is provided. Distributors were instructed to remove all product of the subject lots from inventory and note the number of units to be returned on the attached Distributor Only Acknowledgement Form. Additionally, they were instructed to communicate the recall notification to all customers that they distributed these devices to.
- K numbers
- K911780
- Harmonized identifiers (openFDA)
- Device name
- Ventilator, Non-Continuous (Respirator)
- Medical specialty description
- Anesthesiology
- Regulation number
- 868.5905
- Device class
- 2
- K number
- K090243, K060067, K162905, K040862, K083656, K982530, K121692, K242547, K200480, K923590, K031470, K060273, K970173, K931484, K133009, K080079, K160836, K110008, K023306, K992384, K211274, K050072, K113801, K090804, K231313, K170924, K091843, K193206, K061057, K040566, K102746, K081014, K203126, K030798, K062291, K792722, K980721, K072993, K161686, K132168 +421 more
- Registration number
- 8043439, 1417592, 3019385742, 3006157842, 3006783791, 1314417, 3015895383, 3006182632, 3003660459, 3004748541, 3010272829, 1222088, 9680215, 3004802249, 3011120183, 3014499739, 3030733800, 3013380372, 9680455, 9681384, 3011191255, 3043709870, 9680721, 3030446844, 2435947, 3020283264, 3025360937, 1924066, 3008770104, 3004672275, 3009107628, 3007709321, 3013154126, 3031869923, 3042191921, 2000044808, 3010042047, 3033530343, 3007009701, 3010817335 +79 more
- FEI number
- 1417592, 3001104093, 3006157842, 3002807626, 3006783791, 1314417, 3015895383, 3006182632, 3003660459, 3004748541, 3010272829, 1222088, 3009843463, 3004802249, 3011120183, 3014499739, 3030733800, 3013380372, 3000957797, 3011191255, 3043709870, 1000160458, 3030446844, 3004411059, 3020283264, 3025360937, 1924066, 3008770104, 3004672275, 3009107628, 3007709321, 3013154126, 3031869923, 3042191921, 2000044808, 3010042047, 3000210616, 3033530343, 3007009701, 3010817335 +79 more