Recall Z-0540-2021 ยท KNT Tubes, Gastrointestinal (And Accessories)
Avanos Medical, Inc.
CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector
| Date | Oct 16, 2020 |
| Status | Terminated |
| 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 attac |
| Quantity | 710 units |
| Distribution | Domestic distribution only: CA, CO, IL, LA, OH, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043044 | ANTI-I.V. ENTERAL FEEDING SYSTEM Viasys Medsystems, May 6, 2005 |