Official recall record
Tracheal Tube Reusable Introducer And Guides
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-11-01
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.