Ak98 Hemodialysis Machine
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Ak98 Hemodialysis Machine | More than 10 numbers, contact manufacturer. | 955406 955407 115251 955606 955605 |
Issue
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
Additional information
Details
Gambro Lundia Ab
Magistratsvagen 16, Lund, Sweden, 22010
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