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.
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 where a mechanical failure (kinking) poses a risk of harm to the patient's airway, 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 and Preloaded Stylet, size 9.0. 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. If the tube kinks, it may fail to perform its intended function of keeping the airway open.
The affected product is identified by Product Code 5-14018 and Lot numbers 01B1200213 and 01B1200336. The recall covers 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. Healthcare providers and patients should stop using these specific lots and contact Teleflex Medical for instructions.
The recalled product
- Product
- ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 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
- 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 (2)
- Product Code: 5-14018
- Lot numbers: 01B1200213 and 01B1200336.
Distribution
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.
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