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Volara system patient ciruit

Official notice

29 May 2026

CriticalHealth Canada

An official Health Canada notice concerns Volara system patient ciruit. Baxter Corporation is issuing an urgent medical device correction for Volara System patient circuits due to reports of air and medication leakage from the nebulizer cup during therapy. The leakage can lead to patient desaturation and ineffective nebulization, impacting the delivery of prescribed therapy. Published 2026-05-29.

What to do now

Contact the manufacturer if you require additional information.

Recall number

82135

Official notice

2026-05-29

The hazard

Baxter Corporation is issuing an urgent medical device correction for Volara System patient circuits due to reports of air and medication leakage from the nebulizer cup during therapy. The leakage can lead to patient desaturation and ineffective nebulization, impacting the delivery of prescribed therapy.

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.

Skus

M08473, M08085, M08474, PVL1ACCA, PVL1HCCA

Other

RA RA-82135

Model Numbers

M08473, M08085, M08474, PVL1ACCA, PVL1HCCA

Recall Numbers

82135

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Affected products

Product 1

Lot or serial number - All lots., Model or catalogue number - M08473

Product 2

Lot or serial number - All lots., Model or catalogue number - M08085

Product 3

Lot or serial number - All lots., Model or catalogue number - M08474

Product 4

Lot or serial number - All lots., Model or catalogue number - PVL1ACCA

Product 5

Lot or serial number - All lots., Model or catalogue number - PVL1HCCA

Risk / hazard

Baxter Corporation is issuing an urgent medical device correction for Volara System patient circuits due to reports of air and medication leakage from the nebulizer cup during therapy. The leakage can lead to patient desaturation and ineffective nebulization, impacting the delivery of prescribed therapy.

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: Hill-rom.

Source & status

Source

Health Canada

Tier

beta

Category

HEALTH

Classification

Type II

App estimate

critical

Recall details

Recall number

82135

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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