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Teleflex stylet, endotracheal kit and flexi-set
Official notice
22 Dec 2022
Last checked
22 Dec 2022
An official Health Canada notice concerns Teleflex stylet, endotracheal kit and flexi-set. Teleflex has initiated a voluntary field safety corrective action due to reports of pilot balloon non-inflation or cuff non-deflation. In the event of pilot balloon non-inflation, there is a potential risk of injury to the patient as the pilot balloon no longer reflects the condition of the cuff, which may lead to over-inflation of the cuff. The risk persists in situ, therefore clinicians should evaluate the risk benefit to individual patients of extubation and reintubation. In the event of cuff non-deflation, there is the potential risk of injury if the device is removed from the patient with the cuff still inflated. If extubation and removal of the endotracheal tube is planned and the cuff cannot be deflated via the bespak valve, then the inflation line should be cut in order to facilitate passive deflation of the cuff. Recall start date: December 9, 2022 Published 2022-12-22.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72404
Official notice
2022-12-22
The hazard
The hazard
Teleflex has initiated a voluntary field safety corrective action due to reports of pilot balloon non-inflation or cuff non-deflation. In the event of pilot balloon non-inflation, there is a potential risk of injury to the patient as the pilot balloon no longer reflects the condition of the cuff, which may lead to over-inflation of the cuff. The risk persists in situ, therefore clinicians should evaluate the risk benefit to individual patients of extubation and reintubation. In the event of cuff non-deflation, there is the potential risk of injury if the device is removed from the patient with the cuff still inflated. If extubation and removal of the endotracheal tube is planned and the cuff cannot be deflated via the bespak valve, then the inflation line should be cut in order to facilitate passive deflation of the cuff. Recall start date: December 9, 2022
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Brand: Teleflex Medical, Teleflex Stylet Endotracheal Kit And Flexi-set.
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Documents, notices & source
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