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10Fore™ hemostasis valve
Official notice
30 Jul 2025
Last checked
30 Jul 2025
An official Health Canada notice concerns 10Fore™ hemostasis valve. Merit Medical became aware of a manufacturing quality concern during routine QA inspection of a 10Fore™ Hemostasis Valve work order in February 2025. Initial defect assessments determined the observed damage to the silicone quad ring was due to the manual nature of operator handling and subsequent placement/positioning of the quad ring into the corresponding y body. If the ring is not gently manipulated and/or not fully seated in its intended position during the pressing process it can become deformed or otherwise damaged. Recall start date: July 25, 2025 Published 2025-07-30.
What to do now
Contact the manufacturer if you require additional information.
Recall number
77789
Official notice
2025-07-30
The hazard
The hazard
Merit Medical became aware of a manufacturing quality concern during routine QA inspection of a 10Fore™ Hemostasis Valve work order in February 2025. Initial defect assessments determined the observed damage to the silicone quad ring was due to the manual nature of operator handling and subsequent placement/positioning of the quad ring into the corresponding y body. If the ring is not gently manipulated and/or not fully seated in its intended position during the pressing process it can become deformed or otherwise damaged. Recall start date: July 25, 2025
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Merit Medical, 10fore™ Hemostasis Valve.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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