CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Sty...
FDA Device Recall #Z-1277-2018 — Class II — December 13, 2017
Recall Summary
| Recall Number | Z-1277-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 13, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Halyard Health, Inc |
| Location | Alpharetta, GA |
| Product Type | Devices |
| Quantity | 185 cases (10 units per case) |
Product Description
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.
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.
Distribution Pattern
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.
Lot / Code Information
Product code 20-9551TRAK2A, Lot No. 7909, 7839, 7876.
Other Recalls from Halyard Health, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1427-2018 | Class II | Halyard Closed Suction System for Adults, Doubl... | Feb 7, 2018 |
| Z-1429-2018 | Class II | Halyard Closed Suction System for Adults, Multi... | Feb 7, 2018 |
| Z-1428-2018 | Class II | Halyard Closed Suction System for Adults, Turbo... | Feb 7, 2018 |
| Z-0117-2018 | Class II | Halyard Closed Suction System for Adults with B... | Oct 6, 2017 |
| Z-0124-2018 | Class II | Halyard Closed Suction System for Adults, 14 F,... | Oct 6, 2017 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.