The Recall Desk
ModerateFDA (Devices)·Z-1277-2018·Announced 2018-04-11

Halyard Health Recalls CORTRAK 2 Nasogastric Feeding Tubes

Halyard Health is recalling CORTRAK 2 feeding tubes because the internal stylet may be visible in the exit port window, deviating from specifications.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a deviation from design specifications (stylet visibility) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Halyard Health, Inc. is recalling 185 cases (10 units per case) of 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 affected product code is 20-9551TRAK2A, and the specific lot numbers are 7909, 7839, and 7876.

The recall was initiated because the transmitting stylet within the feeding tubes may be visible within the window of the exit port. According to the device specifications, the transmitting stylet should not be visible within the port window. This deviation from the intended design specifications is the basis for the recall.

The affected units were distributed nationwide in the United States to the states of Arkansas, California, Colorado, Georgia, Iowa, Louisiana, Michigan, Minnesota, New Mexico, and Texas, as well as internationally to Germany. Consumers and healthcare facilities should check their inventory for the specific product code and lot numbers listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer for further instructions.

The recalled product

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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Product code 20-9551TRAK2A
  • Lot No. 7909
  • 7839
  • 7876.

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically: