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U.S. Department of Health and Human Services

Class 2 Device Recall CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ AntiIV Connector

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 Class 2 Device Recall CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ AntiIV Connectorsee related information
Date Initiated by FirmOctober 16, 2020
Create DateDecember 07, 2020
Recall Status1 Terminated 3 on September 30, 2022
Recall NumberZ-0540-2021
Recall Event ID 86634
510(K)NumberK043044 
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
ProductCORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector
Code Information Product Code:20-1225AIV, Lot Number: 0002983985
FEI Number 3011270181
Recalling Firm/
Manufacturer		 Avanos Medical, Inc.
5405 Windward Pkwy
Alpharetta GA 30004-3894
For Additional Information ContactMonica King, MBA
470-448-5591
Manufacturer Reason
for Recall		Detachment of the Male AIV Adaptor from the Y-Connector.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 in Commerce710 units
DistributionDomestic distribution only: CA, CO, IL, LA, OH, VA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KNT
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