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 Baxter Healthcare Corporation Minicap Extended Life Pd Transfer Set With Twist Clamp – Extra Short & Minicap Extended Life Pd Transfer Set With Twist Clamp [HKMD No.: 140102].
According to Health Canada, the manufacturer is issuing an urgent medical device correction for the Minicap Extended Life Pd Transfer Sets, which are manufactured with peroxide-cured silicone tubing that transfers solution to and from the patient.
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/transfer-set-minicap-extended-life-pd-transfer-set-twist-clamp
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 01 Nov 2024