Health product recall

Tracheal Tube Reusable Introducer And Guides

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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