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Em2400 exactamix valve set

Official notice

25 Jul 2022

Last checked

25 Jul 2022

Medium riskHealth Canada

An official Health Canada notice concerns Em2400 exactamix valve set. Baxter is issuing an urgent medical device correction communication regarding the potential for leaking valves in the Exactamix 2400 valve sets. Baxter has observed an increase in complaints for leaking of ports 1 and 2 when in the closed position, resulting in unintended ingredient transfer into the compounded admixture. This leak would be most noticeable when the Exactamix compounder is pumping and moving fluid through the common fluid pathway. The affected product has been distributed since 11/28/2021 in Canada. Recall start date: July 18, 2022 Published 2022-07-25.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64398

Official notice

2022-07-25

The hazard

Baxter is issuing an urgent medical device correction communication regarding the potential for leaking valves in the Exactamix 2400 valve sets. Baxter has observed an increase in complaints for leaking of ports 1 and 2 when in the closed position, resulting in unintended ingredient transfer into the compounded admixture. This leak would be most noticeable when the Exactamix compounder is pumping and moving fluid through the common fluid pathway. The affected product has been distributed since 11/28/2021 in Canada. Recall start date: July 18, 2022

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

64398

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Affected products

Product 1

Affected products - Em2400 Exactamix Valve Set, Lot or serial number - Lot 60316024 and higher, Model or catalogue number - H938724

Risk / hazard

Baxter is issuing an urgent medical device correction communication regarding the potential for leaking valves in the Exactamix 2400 valve sets. Baxter has observed an increase in complaints for leaking of ports 1 and 2 when in the closed position, resulting in unintended ingredient transfer into the compounded admixture. This leak would be most noticeable when the Exactamix compounder is pumping and moving fluid through the common fluid pathway. The affected product has been distributed since 11/28/2021 in Canada. Recall start date: July 18, 2022

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: Baxter Healthcare, Em2400 Exactamix Valve Set.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64398

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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