The product license is on hold/suspended due to the missing MDSAP certification from the supplier Biomed. Since there is no MDSAP certification the products are not meeting the regulatory requirements of the act or MDR for Health Canada (Medical Devices Recall Guide - GUI-0054, 2016). There is no defect or malfunction on these products. This is a compliance issue related to missing documentation required to commercialize products in Canada. Recall start date: Feb 15, 2022
RecallTracker