Public recall detail

NIV Angled Mouthpiece with Notch 22F/15F

2023-11-09

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Recall Safety notice
Quick summary

Quick summary: NIV Angled Mouthpiece with Notch 22F/15F. Date: 2023-11-09.

Recommended action

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

Recall details

Quick summary: NIV Angled Mouthpiece with Notch 22F/15F. Date: 2023-11-09.

Official details

Affected product details

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

BrandBreas Medical Ab
ProductNIV Angled Mouthpiece with Notch 22F/15F
IssueMedical devices - Performance
Recall classType II
IdentificationRA-74572

Affected products

ProductNIV Angled Mouthpiece with Notch 22F/15F
Lot32305269 32304444 32306017
Model006093
Serial number32305269 32304444 32306017
DescriptionNIV Angled Mouthpiece with Notch 22F/15F

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceIndustry
CategoryHealth products - Medical devices - Anaesthesiology
CompaniesBreas Medical Ab Foretagsvagen 1, Molnlycke, Sweden, 43533
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74572
Background{}
CompaniesBreas Medical Ab Foretagsvagen 1, Molnlycke, Sweden, 43533
AudiencesIndustry
Source updated2023-11-09

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

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