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Niv angled mouthpiece with notch 22f 15f

Official notice

9 Nov 2023

Last checked

9 Nov 2023

Medium riskHealth Canada

An official Health Canada notice concerns Niv angled mouthpiece with notch 22f 15f. 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 Published 2023-11-09.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74572

Official notice

2023-11-09

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

74572

Lots

determined

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Affected products

Product 1

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

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Breas Medical, Niv Angled Mouthpiece With Notch 22f 15f.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

74572

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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