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.
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 risk-of-harm product (airway obstruction) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Teleflex Medical is recalling ISIS HVT Tracheal Tubes, Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, size 8.5. 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 Europe, Asia, and South America.
The recall is being issued 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 obstruct the airway, posing a risk to patient safety.
Healthcare providers and facilities should stop using the affected tracheal tubes immediately. Patients who have had these tubes inserted should contact their healthcare provider for evaluation and potential replacement. The affected product code is 5-14017, and the lot number is 01B1200215.
The recalled product
- Product
- ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.5, 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
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: 5-14017
- Lot numbers: 01B1200215.
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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