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.
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 functional defect (kinking) poses a risk of harm, 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 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
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
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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