Teleflex Recalls ISIS HVT Tracheal Tubes Due to 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 medical device that maintains an open airway; kinking poses a significant risk of harm (airway obstruction) even though specific injury reports are not detailed in the provided text, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Teleflex Medical is recalling ISIS HVT Tracheal Tubes, Cuffed with Subglottic Secretion Suction Port, 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 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 obstruct the airway, posing a risk to the patient.
Healthcare providers and facilities should stop using the affected lots immediately. Patients who have had these tubes inserted should contact their healthcare provider for evaluation and potential replacement. The specific lot numbers affected are listed in the official recall notice.
The recalled product
- Product
- ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 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 (20)
- Product Code: 5-13017
- Lot numbers: 01L1000137
- 01L1000160
- 01A1100210
- 01B1100506
- 01D1100318
- 01E1100525
- 01E1100348
- 01G1100439
- 01G1100118
- 01B1100199
- 01L1100332
- 01J1100026
- 01C1200267
- 01K1100240
- 01D1200088
- 01H1200524
- 01G1200207
- 01J1200353
- 01D1300077
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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