Health product recall

Smoothbore Breathing System

Last updated

Summary

Product
Smoothbore Breathing System
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

22mm Smoothbore Adult, Cough Assist Breathing System With Mask And Flo-Guard System

32510470

5001011

Smoothbore Breathing System

32527207

5183000

Smoothbore Breathing System

32517823

5183000

Smoothbore Breathing System

32516907

5183000

Smoothbore Breathing System

32511321

5183000

Smoothbore Breathing System

32527207

5191000

Smoothbore Breathing System

32517823

5191000

Smoothbore Breathing System

32516907

5191000

Smoothbore Breathing System

32511321

5191000

Bilevel Breathing Systems

32517459

5805044

Bilevel Breathing Systems

32518657

5805044

Bilevel Breathing Systems

32515237

5805044

CPAP Breathing System

32511639

5804000

Issue

During manufacturing, insufficient tetrahydrofuran (THF) solvent is used to bond the soft connectors onto the Smoothbore tube. Following reports received from the market of disconnection of the soft connectors from the tube, our investigation and testing of internal stock has identified insufficient amount of solvent used to ensure a secure connection.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies

Intersurgical Ltd.

1185 Corporate Drive, Burlington, Ontario, Canada, L7L 5V5

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82926

Get notified

Receive emails about new and updated recall and safety alerts.

Subscribe