Health Canada — Medical Devices · Canada · 2025-05-23 · Type II
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Reported risk: Through complaint investigations, BD has identified that specific lots of standalone Texium™ components, and IV infusion sets and syringes containing the Texium™ closed-male luer component (as listed in attachment 1) have the potential to leak during use at the connection interface between the Texium™ component and the SmartSite™ needle-free connector. BD has confirmed that this issue is limited to the affected products listed in attachment 1. Recall start date: May 12, 2025
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