Public recall detail

Tracheal Tube Reusable Introducer And Guides

2024-11-01

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Recall Safety notice
Quick summary

Quick summary: Tracheal Tube Reusable Introducer And Guides. Date: 2024-11-01.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Tracheal Tube Reusable Introducer And Guides. Date: 2024-11-01.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandSmiths Medical Asd Inc.
ProductTracheal Tube Reusable Introducer And Guides
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-76428

Affected products

ProductTracheal Tube Reusable Introducer And Guides
LotMore than 10 numbers, contact manufacturer.
Model14-504-17 14-504-76
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionTracheal Tube Reusable Introducer And Guides

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Anaesthesiology
CompaniesSmiths Medical Asd, Inc. 6000 Nathan Lane N., Minneapolis, Minnesota, United States, 55442
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76428
Background{}
CompaniesSmiths Medical Asd, Inc. 6000 Nathan Lane N., Minneapolis, Minnesota, United States, 55442
AudiencesHealthcare
Source updated2024-11-01

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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