CLASS II Device recall · Reported 11 Apr 2018 · FDA Enforcement Report
Cortrak* 2 Nasogastric/Nasointestinal recalled by Halyard Health
Halyard Health is recalling Cortrak* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic, distributed nationwide in the US. The recall was initiated on 13 Dec 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1277-2018
- FDA event ID
- 79479
- Recalling firm
- Halyard Health, Alpharetta, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Dec 2017
- FDA classified
- 30 Mar 2018
- Reported
- 11 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 13 Dec 2017 | Recall initiated by company | |
| 30 Mar 2018 | Classified by FDA | +107 days |
| 11 Apr 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide ArkansasCaliforniaColoradoGeorgiaIowaLouisianaMichiganMinnesotaNew MexicoTexas
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Product code 20-9551TRAK2A, Lot No. 7909, 7839, 7876.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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