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Tracheal tube reusable introducer and guides
Official notice
1 Nov 2024
Last checked
1 Nov 2024
An official Health Canada notice concerns Tracheal tube reusable introducer and guides. Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the hypochlorite solution (200ppm) and the 4% acetic acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device. Recall Start Date: October 15, 2024 Published 2024-11-01.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76428
Official notice
2024-11-01
The hazard
The hazard
Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the hypochlorite solution (200ppm) and the 4% acetic acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device. Recall Start Date: October 15, 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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Affected products
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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, Tracheal Tube Reusable Introducer And Guides.
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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