CooperSurgical issued a letter to affected customers recommending certain neonatal nasal CPAP (nCPAP) devices be removed from where they are used or sold, according to a USFDA early alert.
Units from specific lots of the INCA Neonatal Nasal CPAP Complete Set and Replacement Set may exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, the FDA reports.
If the loose connection is not detected during assembly and/or placement, the tubing may leak at the connection to the nasal cannula or disconnect from the nasal cannula.
According to the FDA, this can result in loss of CPAP pressure, which may reduce the effectiveness of treatment and lead to decreased oxygenation of the patient until connection is restored.
As of August 11, CooperSurgical has reported no serious injuries or deaths associated with this issue.
Affected Products
The INCA Infant Nasal CPAP Assembly is a medical device designed to deliver CPAP to newborn and infant patients requiring respiratory support. The system consists of a clear, soft nasal cannula connected to two shapeable “Stay-Flex” tubes that maintain a fixed position to minimize patient movement and nasal trauma. The assembly includes built-in tubing adapters, an in-line pressure adapter, a knit cap with fixation straps, and a chin strap to manage air leaks and secure the circuit.
| Device / Product Name | Part Number | Lot Codes | Product UDI |
|---|---|---|---|
| INCA Infant Nasal CPAP, Complete Set | 44-2707 | 550019722 | (01) 20888937009433 |
| INCA Infant Nasal CPAP, Complete Set | 44-2709 | 550031617 550033781 550031621 | (01) 60888937009448 |
| INCA Infant Nasal CPAP, Complete Set | 44-2710 | 550031615 550031616 550031620 550034760 | (01) 20888937009457 |
| INCA Infant Nasal CPAP, Complete Set | 44-2712 | 550031611 550031614 550033779 550031619 | (01) 20888937009464 |
| INCA Infant Nasal CPAP, Complete Set | 44-2715 | 550031618 550033780 550034763 | (01) 20888937009471 |
| INCA Neonatal Nasal CPAP, Replacement Set | 44-0712 | 550031624 | (01) 60888937009516 |
| INCA Neonatal Nasal CPAP, Replacement Set | 44-0707 | 550021057 | (01) 20888937009488 |
| INCA Neonatal Nasal CPAP, Replacement Set | 44-0709 | 550031623 | (01) 20888937009495 |
| INCA Neonatal Nasal CPAP, Replacement Set | 44-0715 | 550031625 | (01) 20888937009525 |
FDA Recommendations
Do not use affected product. Identify affected product, cease use and distribution, and return to CooperSurgical.
On August 11, CooperSurgical sent all affected customers a letter recommending the following actions:
- If the loose connection is recognized during the use of the CPAP, replace the tubing with another tubing or CPAP device.
- Stop further use or distribution and segregate affected product
- Notify relevant personnel in your facility who use these devices
- If any products have been forwarded to another facility, contact that facility and provide them with the firm’s notice
See full information and updates at the FDA website.
