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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source explicitly states the agency classification is Class I. Per the rubric, FDA Class I recalls are assigned a severity score of 5 (Critical).
Plain-English summary
Teleflex Medical is recalling ISIS HVT Tracheal Tubes Cuffed with Subglottic Secretion Suction Port, size 6.0. 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 Europe and Asia.
The FDA has classified this as a Class I recall because the tracheal tubes can kink during patient use. A tracheal tube is a medical device inserted into a patient's trachea to maintain an open airway. If the tube kinks, it may obstruct the airway, posing a serious risk to the patient.
Healthcare providers and facilities should stop using the affected lots immediately. Patients who have received these devices should contact their healthcare provider for evaluation and replacement. The affected lot numbers are listed in the official recall notice.
The recalled product
- Product
- ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, 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 (20)
- Product Code: 5-13012
- Lot numbers: 01A1000055
- 01B1000254
- 01G1000275
- 01J1000399
- 01M1000285
- 01A1100083
- 01A1100448
- 01E1100345
- 01G1100116
- 01B1100212
- 01D1100297
- 01C1200082
- 01F1200369
- 01E1200460
- 01F1100482
- 01F1200401
- 01F1300054
- 01H1200296
- 01H1100157
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.
See all 14 products in this recall →Related recalls
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