AK 96 and AK 98 Dialysis Machines
Brand(s)
Last updated
Summary
Product
AK 96 and AK 98 Dialysis Machines
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
AK 98, 115V, Self-Care |
All lots. |
115251 |
AK 98 V2 115v Bio Self-Care |
All lots. |
955407 |
AK 96, 115 V, Self-Care |
All lots. |
110661 |
AK 98v3 115v Self-Care |
All lots. |
955606 |
AK 96, 115 V, Bio |
20072 |
110373 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies
| Gambro Lundia Ab |
| Magistratsvagen 16, Lund, Sweden, 22010 |
Published by
Health Canada
Audience
General public
Healthcare
Recall class
Type I
Identification number
RA-76839
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