Tracheal Tube Reusable Introducer And Guides
Brand(s)
Last updated
Summary
Product
Tracheal Tube Reusable Introducer And Guides
Issue
Medical devices - Labelling and packaging
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Tracheal Tube Reusable Introducer And Guides | More than 10 numbers, contact manufacturer. | 14-504-17 14-504-76 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies
Smiths Medical Asd, Inc.
6000 Nathan Lane N., Minneapolis, Minnesota, United States, 55442
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76428
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