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 devices.
Reported: September 17, 2025 Initiated: July 25, 2025 #Z-2553-2025
Product Description
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 devices.
Reason for Recall
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
Details
- Recalling Firm
- Merit Medical Systems, Inc.
- Units Affected
- 447
- Distribution
- Worldwide - U.S. Nationwide distribution in the states of CA, FL, LA, MT, NY, SD, and WI. The countries of Canada and Korea
- Location
- South Jordan, UT
Frequently Asked Questions
What product was recalled? ▼
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 devices.. Recalled by Merit Medical Systems, Inc.. Units affected: 447.
Why was this product recalled? ▼
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 17, 2025. Severity: Moderate. Recall number: Z-2553-2025.
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