Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Health Canada has posted a medical device safety alert concerning Gambro Lundia AB Ak98 Hemodialysis Machine [HKMD No.: 160157].
According to Health Canada, the manufacturer is in the process of implementing an urgent medical device correction for the Ak98 hemodialysis machines. 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.
The manufacturer 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.
For further information, please visit: https://recalls-rappels.canada.ca/en/alert-recall/ak98-hemodialysis-machine
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 01 Nov 2024