Drugs & medicalClass II

Merit Medical Systems, Inc. recalls 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329…

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.

Read the official notice →
Date
2025-09-17
Country
United States
Brand
Merit Medical Systems
Product
10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The…
Classification
Class II
Units
Worldwide - U.S. Nationwide distribution in the states of CA, FL, LA, MT, NY,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

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  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

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