Merit Medical 10Fore Hemostasis Valve Recalled Due to Manufacturing Defect
Merit Medical is recalling 10Fore Hemostasis Valves due to a manufacturing defect where the silicone quad ring may be deformed or damaged, posing a risk of foreign body in the fluid pathway.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a manufacturing defect that could result in a foreign body in the fluid pathway. The recall meets the 'High' severity criterion as a risk-of-harm product where injury has not yet been reported. No illnesses or injuries are documented in the source material.
Plain-English summary
Merit Medical Systems is recalling the 10Fore Hemostasis Valve (Catalog Numbers MAPTEN4, MAPTEN42, MAPTEN452) due to a manufacturing defect in the silicone quad ring. The ring may be deformed or otherwise damaged, creating a risk of foreign body contamination in the fluid pathway.
The affected medical device is intended to maintain hemostasis during the introduction, withdrawal, and use of diagnostic and interventional devices. Approximately 447 units have been distributed to healthcare facilities and users in the United States, including California, Florida, Louisiana, Montana, New York, South Dakota, and Wisconsin, as well as in Canada and Korea.
Healthcare providers and facilities that possess the recalled devices are advised to stop using them and contact Merit Medical Systems regarding replacement or return options.
The recalled product
- Product
- 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore Hemostasis Valve is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional d
- Manufacturer
- Merit Medical Systems, Inc.
- Hazard
- foreign-body-risk
- manufacturing-defect
Distribution
Distributed nationwide across the United States.
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