FDA Medical Device Recalls (openFDA)
Avanos Medical, Inc.: CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector
- Recall number
- Z-0540-2021
- Recalling firm
- Avanos Medical, Inc.
- Product
- CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector
- Status
- Terminated
- Initiated
- 2020-10-16
- Posted
- not on file
- Terminated
- 2022-09-30
- Reason
- Detachment of the Male AIV Adaptor from the Y-Connector.
- Root cause
- Under Investigation by firm
- Action
- On 10/16/2020 the firm sent a notification to its consignees with the following instructions: - CHECK all storage and usage locations to determine if any impacted product remains within your possession. Product Currently In-Use -DISCONTINUE using the impacted product (Note: If you decide not to replace the device, please consider taping over the adaptor to prevent any potential detachment and be sure to check on the tube and adaptor frequently throughout the day for potential detachment). -REPLACE the impacted product with a unit of a different lot. -IMMEDIATELY COMPLETE and RETURN the attached Recall Acknowledgement Form to Avanos . Via email to fieldactioncare@avanos.com -DESTROY the devices in your inventory following your facility's destruction procedures . Unused Inventory -SEGREGATE and QUARANTINE the devices according to your facility's procedures. -IMMEDIATELY COMPLETE and RETURN the attached Recall Acknowledgement Form to Avanos. Via email to fieldactioncare@avanos .com -DESTROY the devices in your inventory following your facility's destruction procedures.
- Quantity
- 710 units
- Distribution
- Domestic distribution only: CA, CO, IL, LA, OH, VA.
- Lot, serial or model codes
- Product Code:20-1225AIV, Lot Number: 0002983985
- 510(k) numbers
- ["K043044"]
- PMA numbers
- not on file
- Product code
- KNT
- Firm FEI
- 3011270181
- Firm city
- Alpharetta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28