The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-0956-2014·Announced 2014-03-05

Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk

Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA classified this as a Class I recall, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The rubric mandates a score of 5 for FDA Class I recalls.

Plain-English summary

Teleflex Medical is recalling ISIS HVT Tracheal Tubes Cuffed with Subglottic Secretion Suction Port, size 9.0. The recall involves 190,871 units distributed nationwide in the United States, Puerto Rico, and internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Belgium, South Korea, Thailand, New Zealand, and the Netherlands.

The FDA has classified this as a Class I recall because the tracheal tubes can kink during patient use. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth to maintain an open airway. Kinking of the tube presents a risk of serious adverse health consequences or death.

Healthcare providers should stop using the affected devices immediately. Patients who have had these tubes inserted should contact their healthcare provider for evaluation and replacement. The affected product code is 5-13018, and specific lot numbers are listed in the official recall notice.

The recalled product

Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Manufacturer
Teleflex Medical
Category
Medical Device — Airway Management
Hazard

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 (13)

  • Product Code: 5-13018
  • Lot numbers: 01A1000435
  • 01D1000122
  • 01G1000099
  • 01J1000398
  • 01A1100276
  • 01A1100516
  • 01B1100012
  • 01F1100336
  • 01C1100113
  • 01A1200212
  • 01G1200208
  • 01G1100440 and 01D1100342

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 14 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

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