device recall
saveMerit Medical Systems, Inc. device recall (Cls II)
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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: 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. — Status: Ongoing
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