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 NuMED, Inc. Z-MED II-X Catheter [Model or catalog number: PDZ733; Lot or serial number: JZX-5322] [HKMD No.: 240296].
According to Health Canada, these units are being recalled due to them being manufactured with the incorrect balloon. The balloon that was placed on this catheter has a lower rated burst pressure than what the PDZ733 is labeled for. The size and length are correct, but the labeled rated burst pressure is different.
For further information, please visit: https://recalls-rappels.canada.ca/en/alert-recall/z-med-ii-x-catheter
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 31 Oct 2024