No image published for this recall

No image published for this recall

Ak 96 and ak 98 dialysis machines

Official notice

17 Jan 2025

Last checked

17 Jan 2025

High riskHealth Canada

An official Health Canada notice concerns Ak 96 and ak 98 dialysis machines. Baxter Healthcare Corporation (Baxter) is issuing an urgent medical device correction for the AK 96 and AK 98 dialysis machines with the self-care configuration listed below due to the potential for hemolysis caused by the arterial dialyzer line kinking from the position of the remote panel arm. Recall start date: January 16, 2025 Published 2025-01-17.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76839

Official notice

2025-01-17

The hazard

Baxter Healthcare Corporation (Baxter) is issuing an urgent medical device correction for the AK 96 and AK 98 dialysis machines with the self-care configuration listed below due to the potential for hemolysis caused by the arterial dialyzer line kinking from the position of the remote panel arm. Recall start date: January 16, 2025

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

76839

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Affected products

Product 1

Affected products - AK 98, 115V, Self-Care, Lot or serial number - All lots., Model or catalogue number - 115251

Product 2

Affected products - AK 98 V2 115v Bio Self-Care, Lot or serial number - All lots., Model or catalogue number - 955407

Product 3

Affected products - AK 96, 115 V, Self-Care, Lot or serial number - All lots., Model or catalogue number - 110661

Product 4

Affected products - AK 98v3 115v Self-Care, Lot or serial number - All lots., Model or catalogue number - 955606

Product 5

Affected products - AK 96, 115 V, Bio, Lot or serial number - 20072 19489, Model or catalogue number - 110373

Risk / hazard

Baxter Healthcare Corporation (Baxter) is issuing an urgent medical device correction for the AK 96 and AK 98 dialysis machines with the self-care configuration listed below due to the potential for hemolysis caused by the arterial dialyzer line kinking from the position of the remote panel arm. Recall start date: January 16, 2025

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: Gambro Lundia, Ak 96 And Ak 98 Dialysis Machines.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type I

App estimate

high

Recall details

Recall number

76839

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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