Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Hazard
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
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this as a Class I recall, which indicates a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or the death.
Plain-English summary
Teleflex Medical is recalling ISIS HVT Tracheal Tubes, Cuffed with Subglottic Secretion Suction Port, size 6.5. The recall involves 190,871 units distributed nationwide in the United States, Puerto Rico, and internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Belgium, South Korea, Thailand, New Zealand, and the Netherlands.
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 via the nose or mouth to maintain an open airway. If the tube kinks, it may fail to maintain the airway, posing a serious risk to the patient.
Healthcare providers and facilities should stop using the affected lots immediately. The specific lot numbers affected are: 01A1000316, 01B1000255, 01J1000392, 01A1100209, 01M1000286, 01C1100125, 01D1100298, 01F1100648, 01H1100367, 01L1100147, 01J1100232, 01L1100371, 01M1100176, 01C1200083, 01E1200461, 01E1200545, 01H1200156, 01F1200171, 01A1300637, 01F1300055, and 01F1300297. The product code is 5-13013.
The recalled product
- Product
- ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 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
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: 5-13013
- Lot numbers: 01A1000316
- 01B1000255
- 01J1000392
- 01A1100209
- 01M1000286
- 01C1100125
- 01D1100298
- 01F1100648
- 01H1100367
- 01L1100147
- 01J1100232
- 01L1100371
- 01M1100176
- 01C1200083
- 01E1200461
- 01E1200545
- 01H1200156
- 01F1200171
- 01A1300637
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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