Agency classClass IOur severity:Severe FDA (Devices)·Z-0960-2014·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 use, potentially compromising the patient's 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 ISIS HVT Tracheal Tubes, Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, size 7.5. 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 recall was initiated because 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. If the tube kinks, it may fail to maintain the airway as intended.

Healthcare providers and patients should stop using the affected tracheal tubes immediately. Affected lots include 01B1200107, 01J1200211, 01C1200387, 01H1200157, 01E1300478, and 01K1300343. Users should contact Teleflex Medical for further instructions on replacement or return.

The recalled product

Product: ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.5, 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 (6)

Product Code: 5-14015
Lot numbers: 01B1200107
01J1200211
01C1200387
01H1200157
01E1300478 and 01K1300343.

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

See all →

Low
Teleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
Low
Teleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
Moderate
Teleflex Sheridan Endobronchial Tubes Recalled for Incorrect Labeling
FDA (Devices) · 2019-12-25
High
Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
High
Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25

Same hazard · kinking