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 (airway management) where a defect (kinking) poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
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
- 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: 5-14013
- Lot numbers: 01A1200341 and 01B1200423.
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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