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Ak98 hemodialysis machine
Official notice
31 Oct 2024
Last checked
31 Oct 2024
An official Health Canada notice concerns Ak98 hemodialysis machine. Baxter Healthcare Corporation (Baxter) is in the process of implementing an urgent medical device correction for the Ak98 hemodialysis machines listed. These devices are manufactured using peroxide-cured silicone tubing within the hydraulic circuit. The Baxter Ak98 dialysis machine is intended to be used for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload. Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to nondioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and ndl polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices. The source of the NDL PCBAs and/or NDL PCBs in those recalls was due to the manufacturing process of the silicone tubing. Recall Start Date: October 21, 2024 Published 2024-10-31.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76419
Official notice
2024-10-31
The hazard
The hazard
Baxter Healthcare Corporation (Baxter) is in the process of implementing an urgent medical device correction for the Ak98 hemodialysis machines listed. These devices are manufactured using peroxide-cured silicone tubing within the hydraulic circuit. The Baxter Ak98 dialysis machine is intended to be used for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload. Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to nondioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and ndl polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices. The source of the NDL PCBAs and/or NDL PCBs in those recalls was due to the manufacturing process of the silicone tubing. Recall Start Date: October 21, 2024
How to check if you're affected
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.
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
Brand: Gambro Lundia, Ak98 Hemodialysis Machine.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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