Official recall record

Merit basixCOMPAK™, PhD™ Hemostasis Valve, and basixSKY™ Inflation Syringe

Health Canada — Medical Devices · 2025-08-14 · CanadaType II

Issuing authority: Health Canada — Medical Devices
Published: 2025-08-14
Country of alert: Canada
Alert level: Type II
Alert type: recall

What the authority reported

Merit Medical became aware of a manufacturing defect after an increased number of complaints. Investigation into the issue concluded that the lack of fluorinated silicone in the bleed back seal (the secondary valve) caused by the mix of incorrect silicone during production line influenced the performance of the PhD™ Hemostasis Valve. The lack of silicone was found to prevent the secondary valve from releasing and closing properly. The valve cap potentially would remain depressed causing leakage. Recall start date: July 30, 2025

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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