The Recall Desk
HighFDA (Devices)·Z-0954-2014·Announced 2014-03-05

Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Hazard

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

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device (tracheal tube) where a defect (kinking) poses a direct risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Teleflex Medical is recalling ISIS HVT Tracheal Tubes Cuffed with Subglottic Secretion Suction Port, size 8.0. The recall affects 190,871 units distributed nationwide in the United States, Puerto Rico, and internationally to various countries including Canada, Mexico, and several nations in South America, Europe, and Asia.

The FDA has identified that the tracheal tubes can kink during patient use. A tracheal tube is a medical device inserted into a patient's trachea via the nose or mouth to maintain an open airway. Kinking of the tube poses a risk to patient safety by potentially obstructing the airway.

Healthcare providers and facilities should stop using the affected tracheal tubes immediately. Teleflex Medical is the recalling firm responsible for managing the recall. The specific lot numbers affected are listed in the official recall documentation.

The recalled product

Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, 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 (20)

  • Product Code: 5-13016
  • Lot numbers: 01A1000317
  • 01C1000059
  • 01D1000386
  • 01D1000112
  • 01G1000245
  • 01J1000396
  • 01M1000284
  • 01B1100011
  • 01B1100070
  • 01C1100114
  • 01C1100529
  • 01E1100227
  • 01C1100606
  • 01B1100505
  • 01B1100248
  • 01H1100103
  • 01A1200116
  • 01B1200547
  • 01B1200422

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 →

Related recalls

Same manufacturer · Teleflex Medical

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Same hazard · kinking

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