Agency classClass IOur severity:Severe FDA (Devices)·Z-0961-2014·Announced 2014-03-05

Teleflex Recalls ISIS HVT Tracheal Tubes Due to Kinking Risk

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

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 8.0. The recall involves 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 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. Kinking of the tube could interfere with its intended function of keeping the airway open.

Healthcare providers and facilities should stop using the affected lots immediately. The affected product codes and lot numbers are 5-14016; 01B1200214, 01E1200462, 01B1200335, 01C1200468, 01J1300036, and 01J1300339. Users should contact Teleflex Medical for instructions on returning the product.

The recalled product

Product: ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 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: device-malfunction
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: 5-14016
Lot numbers: 01B1200214
01E1200462
01B1200335
01C1200468
01J1300036 and 01J1300339.

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 · device malfunction