Product Wiki · Recalls · Health Canada — Medical Devices

NIV Angled Mouthpiece with Notch 22F/15F — recall 74572

Health Canada — Medical Devices · Canada · 2023-11-09 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
74572
Date of alert
2023-11-09
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Anaesthesiology
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/niv-angled-mouthpiece-notch-22

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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