CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector
FDA Recall Z-0540-2021 · Posted None
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Recalling FirmAvanos Medical, Inc.
Recall StatusTerminated
Product CodeKNT
Date Initiated2020-10-16
Date Terminated2022-09-30
Product Quantity710 units
Reason for Recall
Detachment of the Male AIV Adaptor from the Y-Connector.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Domestic distribution only: CA, CO, IL, LA, OH, VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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