Health product recall

NIV Angled Mouthpiece with Notch 22F/15F

Brand(s)
Last updated

Summary

Product
NIV Angled Mouthpiece with Notch 22F/15F
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Industry

Affected products

Affected products Lot or serial number Model or catalog number
NIV Angled Mouthpiece with Notch 22F/15F 32305269 32304444 32306017 006093

Issue

The manufacturer of the NIV angled mouthpiece with Notch 22F/15F, advised that devices in lots 32304444, 32305269 and 32306017 were produced with unintended open slits on the side of the mouthpiece body. This allows some of the respiratory gas to escape and thus reduces effectiveness of the related Vivo 45 LS US device.  Breas Medical traced these lots and determined that shipments from April 4th, 2023 until July 31st, 2023 could be affected by the issue. 

Recall Start Date: October 13, 2023

Additional information

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

Breas Medical Ab

Foretagsvagen 1, Molnlycke, Sweden, 43533

Published by
Health Canada
Audience
Industry
Recall class
Type II
Identification number
RA-74572