Merit Medical Systems, Inc.: Device Recall

Recall #Z-0062-2025 · 08/30/2024

Class II: Risk

Recall Details

Recall Number
Z-0062-2025
Classification
Class II
Product Type
Device
Recalling Firm
Merit Medical Systems, Inc.
Status
Ongoing
Date Initiated
08/30/2024
Location
South Jordan, UT, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
432 devices

Reason for Recall

Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

Product Description

Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.

Distribution Pattern

Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Belgium, Canada, France, Japan, Monaco, Netherlands, Qatar, United Arab Emirates, United Kingdom.

Other Recalls by Merit Medical Systems, Inc.

View all recalls by Merit Medical Systems, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.