Z-1277-2018 Class II Terminated
FDA device recall Z-1277-2018 was initiated by Halyard Health, Inc on December 13, 2017 and is designated Class II. 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… The recall status is terminated (terminated November 4, 2021). Affected quantity: 185 cases (10 units per case).
Recall Details
- Product Type
- Devices
- Report Date
- April 11, 2018
- Initiation Date
- December 13, 2017
- Termination Date
- November 4, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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.
Code Information
Product code 20-9551TRAK2A, Lot No. 7909, 7839, 7876.