Agency classClass IOur severity:Severe FDA (Devices)·Z-0958-2014·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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The tracheal tube can kink during patient use."

Plain-English summary

Teleflex Medical is recalling specific lots of ISIS HVT Tracheal Tubes Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, size 6.5. The recall is due to a defect where the tracheal tube 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.

The affected product is identified by Product Code 5-14013 and Lot numbers 01A1200341 and 01B1200423. The recall covers 190,871 units distributed worldwide, including the United States (nationwide), Puerto Rico, and various international locations such as Canada, Mexico, and several countries in Europe and Asia.

Healthcare providers and facilities should stop using the affected tracheal tubes and contact Teleflex Medical for instructions on return or replacement. Patients who have had these devices inserted should consult their healthcare provider for evaluation and potential replacement.

The recalled product

Product: ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.5, 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: kinking
airway-compromise

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 (2)

Product Code: 5-14013
Lot numbers: 01A1200341 and 01B1200423.

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 →

Same manufacturer · Teleflex Medical

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Same hazard · kinking