Z-0540-2021Class II

CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector

Name: Z-0540-2021 CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector
Creator: Avanos Medical, Inc.
Published: 2020-10-16
License: https://open.fda.gov/license/

Halyard Health / initiated 2020-10-16 / Terminated

FDA source

Avanos Medical, Inc. began a recall of CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector on 2020-10-16. FDA classified it as Class II and gives the reason as "Detachment of the Male AIV Adaptor from the Y-Connector". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0540-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-16
Posted: 2020-12-07
Terminated: 2022-09-30
Recalling firm: Halyard Health
Product: CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: Detachment of the Male AIV Adaptor from the Y-Connector.
FDA 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 [email protected] -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 in commerce: 710 units
Distribution: Domestic distribution only: CA, CO, IL, LA, OH, VA.
Product codes and lots: Product Code:20-1225AIV, Lot Number: 0002983985

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0540-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0540-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-16	2020-12-07

Product code KNT

K043044Class IIAnti-i.v. Enteral Feeding SystemViasys Medsystems / cleared 2005-05-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)