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 Apatech Limited Ostene Bone Hemostasis Material [Model or Catalogue Number: 1503832] [HKMD No.: 140281].
According to Health Canada, the manufacturer is issuing an important product information letter to communicate that the cardiovascular surgery marketing brochure (Ref ca-as32-210022 (English) and ca-as32-220004 (French)) that was distributed for the products listed above contains inaccurate content that does not align with the products' instructions for use (IFU). These products must be used by medical professionals while following the associated product IFUs to ensure they are used safely and effectively.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/ostene-bone-hemostasis-material
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 Dec 2023