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Blue line uncuffed tracheostomy tube - single use
Official notice
2 Aug 2024
Last checked
2 Aug 2024
An official Health Canada notice concerns Blue line uncuffed tracheostomy tube - single use. Manufacturer has identified an issue related to the neck plate/flange of the device. Specifically, this failure mode can manifest itself during use as a complete or partial detachment of the neck plate from the tracheostomy tube on the device. This failure mode can lead to inadequate ventilation for the patient and complete dislodgement of the tracheostomy tube. Hypoxia, underdose, cardiopulmonary collapse, bradycardia, hypotension, respiratory arrest, or asphyxia can potentially result from the partial or complete detachment of the flange. To date, manufacturer has received five (5) reports of serious injury, and zero (0) deaths potentially related to this issue. Recall start date: July 29, 2024 Published 2024-08-02.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75894
Official notice
2024-08-02
The hazard
The hazard
Manufacturer has identified an issue related to the neck plate/flange of the device. Specifically, this failure mode can manifest itself during use as a complete or partial detachment of the neck plate from the tracheostomy tube on the device. This failure mode can lead to inadequate ventilation for the patient and complete dislodgement of the tracheostomy tube. Hypoxia, underdose, cardiopulmonary collapse, bradycardia, hypotension, respiratory arrest, or asphyxia can potentially result from the partial or complete detachment of the flange. To date, manufacturer has received five (5) reports of serious injury, and zero (0) deaths potentially related to this issue. Recall start date: July 29, 2024
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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Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
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Brand: Smiths Medical Asd, Blue Line Uncuffed Tracheostomy Tube - Single Use.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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