Z-1277-2018Class II

CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and...

Name: Z-1277-2018 CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and...
Creator: Halyard Health, Inc
Published: 2017-12-13
License: https://open.fda.gov/license/

Halyard Health / initiated 2017-12-13 / Terminated

FDA source

Halyard Health, Inc began a recall of CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI-IV* Connector, 10... on 2017-12-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1277-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-13
Posted: 2018-03-30
Terminated: 2021-11-04
Recalling firm: Halyard Health
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.
Product code: FPB Filter, Infusion Line
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 root 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: [email protected] 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: [email protected] 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.
Product codes and lots: Product code 20-9551TRAK2A, Lot No. 7909, 7839, 7876.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1277-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1277-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-03-30

Product code FPB

K083210Class IICorflo Anti IV Enteral Feeding TubeCorpak Medsystems / cleared 2008-12-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)