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Express mini 500 and pneumostat chest drain valve

Official notice

15 Mar 2023

Last checked

15 Mar 2023

Medium riskHealth Canada

An official Health Canada notice concerns Express mini 500 and pneumostat chest drain valve. The instructions for use (IFU) for the Pneumostat Chest Drain Valve and for the Express Mini 500 do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting. The notices for this recall give the appropriate precautions to the end users. Recall start date: March 6, 2023 Published 2023-03-15.

What to do now

Contact the manufacturer if you require additional information.

Recall number

73332

Official notice

2023-03-15

The hazard

The instructions for use (IFU) for the Pneumostat Chest Drain Valve and for the Express Mini 500 do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting. The notices for this recall give the appropriate precautions to the end users. Recall start date: March 6, 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

73332

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Affected products

Product 1

Affected products - Express Mini 500, Lot or serial number - All lots., Model or catalog number - 16400

Product 2

Affected products - Pneumostat Chest Drain Valve, Lot or serial number - All lots., Model or catalog number - 16100

Risk / hazard

The instructions for use (IFU) for the Pneumostat Chest Drain Valve and for the Express Mini 500 do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting. The notices for this recall give the appropriate precautions to the end users. Recall start date: March 6, 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: Atrium Medical, MINI.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

73332

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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