Z-0060-2025 Class II Ongoing
FDA device recall Z-0060-2025 was initiated by Merit Medical Systems, Inc. on Aug 30, 2024 and is designated Class II. Reason for recall: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. The recall status is ongoing. Affected quantity: 6,565 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 23, 2024
- Initiation Date
- Aug 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,565 devices
Product Description
Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 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.
Reason for Recall
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
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.
Code Information
Catalog Number: IN2430/B UDI-DI code: 00884450298053 Lot Number: H2298615 H2305035 H2309343 H2320982 H2326310 H2353508 H2369554 H2385820 H2395793 H2398305 H2413092 H2416388 H2421988 H2426107 H2432428 H2435884 H2442968 H2446110 H2453676 H2457934 H2462756 H2466450 H2478394 H2486953 H2492841 H2497956 H2507120 H2517518 H2522878 H2528487 H2540012 H2545411 H2554635 H2568222 H2574049 H2579554 H2584201 H2589843 H2594941 H2599815 H2614054 H2618904 H2622809 H2633299 H2639296 H2645647 H2649894 H2655507 H2660062 H2664663 H2669780 H2673558 H2697508 H2713941 H2733075 H2746745 H2751196 H2765642 H2806015 H2815182 H2819813 H2834412 H2842698 H2849884 H2861491 H2907143 H2918428
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0060-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026