CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector
This recall has been terminated (originally issued October 16, 2020).
- Company
- Avanos Medical, Inc.
- Recall Initiated
- October 16, 2020
- Terminated
- September 30, 2022
- Recall Number
- Z-0540-2021
- Quantity
- 710 units
- Firm Location
- Alpharetta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Detachment of the Male AIV Adaptor from the Y-Connector.
Distribution
Domestic distribution only: CA, CO, IL, LA, OH, VA.
Lot / Code Info
Product Code:20-1225AIV, Lot Number: 0002983985
Root Cause
Under Investigation by firm
Action Taken
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.