Class 2 Device Recall CORTRAK 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes w/ ANTIIV Connector

• Date Initiated by Firm: December 13, 2017
• Create Date: March 30, 2018
• Recall Status: Terminated on November 04, 2021
• Recall Number: Z-1277-2018
• Recall Event ID: 79479
• 510(K)Number: K083210
• Product Classification: Filter, infusion line - Product Code FPB
• Product: CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI-IV* Connector, 10 Fr, 140 cm The device is used in patients that require intermittent or continuous tube feedings via the nasogastric or nasoenteric route.
• Code Information: Product code 20-9551TRAK2A, Lot No. 7909, 7839, 7876.
• FEI Number: 3011270181
• Recalling Firm/ Manufacturer: Halyard Health, Inc; 5405 Windward Pkwy; Alpharetta GA 30004-3894
• For Additional Information Contact: Thomas Kozma; 470-448-5681
• Manufacturer Reason for Recall: The transmitting stylet within CORTRAK* 2 nasogastric/Nasointestinal (NG/NI) Feeding Tubes with ANTI-IV* connector (Product Code 20-9551Trak2A) may be visible within the window of the exit port of the feeding tube. Based on specifications, the transmitting stylet in the NG tube should not be visible within the port window.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm, Halyard, sent an "URGENT: Product Advisory Notice" letter dated 12/13/2017 to its customers on about 12/13/2017. The letter described the product, problem and actions to be taken. The Customers were instructed to do the following: Instructions for distributors included to examine unsold inventory for impacted lots, complete and return the Distributor Product Advisory Notice Acknowledgement Form, and send the attached End-User/Customer Product Advisory Notice and Acknowledgement Form to all end user customers who would have potentially received impacted product by email to: monica.king@hyh.com or by FAX to: 678-254-0347. A Halyard Customer Service Representative will contact the distributors if affected product was on hand. Instructions for End-User/Customers included to evaluate the clinical facility's unused inventory for impacted lots, inform all clinicians in the facility who may use potentially impacted devices to verify that the stylet tip is not visible within the window of the exit port after engaging the stylet with the port connector of the NG/NI Feeding Tube, and if it is visible, do not use the device. Additionally they were asked to complete and return the Product Advisory Notice Acknowledgement Form by email to: monica.king@hyh.com or by FAX to: 678-254-0347. If you require further assistance, please call Halyard Regulatory Affairs at 678-477-4165. You may also contact Halyard Customer Service at 1-844-HALYARD (1-844-425-9273, OPTION 1, OPTION 3).
• Quantity in Commerce: 185 cases (10 units per case)
• Distribution: Worldwide Distribution: US (nationwide) to states of: AR, CA, CO, GA, IA, LA, MI, MN, NM, TX; and country of Germany. Distributed internationally to Germany.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = FPB