Recall Monitor
Health ProductsType I recall

AK 96 and AK 98 Dialysis Machines

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Gastroenterology and urology
Product: AK 96 and AK 98 Dialysis Machines
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: General public, Healthcare
Recall class: Type I
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Products

Affected productsLot or serial numberModel or catalogue number
AK 98, 115V, Self-CareAll lots.115251
AK 98 V2 115v Bio Self-CareAll lots.955407
AK 96, 115 V, Self-CareAll lots.110661
AK 98v3 115v Self-CareAll lots.955606
AK 96, 115 V, Bio20072
19489		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

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