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Ak 98, 115v bio ak 98, 115v self-care and ak98 v2 115v bio version ak 98 v2 115v bio self care ak 98 v3 (2018-08-29)

Official notice

26 Mar 2024

Last checked

26 Mar 2024

High riskHealth Canada

An official Health Canada notice concerns Ak 98, 115v bio ak 98, 115v self-care and ak98 v2 115v bio version ak 98 v2 115v bio self care ak 98 v3 (2018-08-29). Baxter is communicating important safety information regarding the potential for AK 98 hemodialysis devices to generate excessive Ultrafiltration (UF) in certain situations where treatment-related alarms occur, or where there is an ultrafilter leak. Excessive UF may present hazards for sensitive patients, such as low-weight patients, for whom target UF values of zero or very low volumes are desired. Recall start date: August 29, 2018 Published 2024-03-26.

What to do now

Contact the manufacturer if you require additional information.

Recall number

58388

Official notice

2024-03-26

The hazard

Baxter is communicating important safety information regarding the potential for AK 98 hemodialysis devices to generate excessive Ultrafiltration (UF) in certain situations where treatment-related alarms occur, or where there is an ultrafilter leak. Excessive UF may present hazards for sensitive patients, such as low-weight patients, for whom target UF values of zero or very low volumes are desired. Recall start date: August 29, 2018

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

58388

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Affected products

Product 1

Affected products - AK 98, Lot or serial number - All lots., Model or catalogue number - 115249 115251

Product 2

Affected products - AK 98 (SW 2), Lot or serial number - All lots., Model or catalogue number - 955406 955407

Product 3

Affected products - AK 98 (SW 3), Lot or serial number - All lots., Model or catalogue number - 955606

Risk / hazard

Baxter is communicating important safety information regarding the potential for AK 98 hemodialysis devices to generate excessive Ultrafiltration (UF) in certain situations where treatment-related alarms occur, or where there is an ultrafilter leak. Excessive UF may present hazards for sensitive patients, such as low-weight patients, for whom target UF values of zero or very low volumes are desired. Recall start date: August 29, 2018

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

Brand: Gambro Lundia, Ak 98 115v Bio Ak 98 115v Self-care And Ak98 V2 115v Bio Version Ak 98 V2 115v Bio Self Care Ak 98 V3.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type I

App estimate

high

Recall details

Recall number

58388

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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