Recall Z-0058-2025
Merit Medical Systems, Inc. · initiated August 30, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 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.
Codes / lots: Catalog Number: IN2230/B UDI-DI code: 00884450298039 Lot Number: H2287420 H2292343 H2298614 H2305033 H2309342 H2312490 H2320981 H2326309 H2331538 H2337132 H2343845 H2348707 H2353507 H2360151 H2379871 H2385818 H2395792 H2398304 H2413090 H2416387 H2421986 H2432426 H2435878 H2442961 H2446109 H2453675 H2457933 H2458274 H2466447 H2474177 H2478393 H2483314 H2486956 H2492840 H2497955 H2503844 H2507119 H2511930 H2517517 H2522877 H2528486 H2540011 H2545410 H2550516 H2554634 H2560206 H2564557 H2568221 H2574048 H2579553 H2584200 H2589842 H2594940 H2599814 H2604238 H2610524 H2614052 H2618903 H2622808 H2629605 H2633298 H2639295 H2645646 H2649893 H2655505 H2660061 H2664662 H2669779 H2673553 H2675990 H2683251 H2701290 H2709357 H2713928 H2733074 H2739475 H2746858 H2751186 H2760546 H2765638 H2789805 H2819396
Reason for recall
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
FDA-determined cause: Nonconforming Material/Component
Action taken
On 08/30/2024, the firm email and/or UPS overnight delivery an "URGENT MEDICAL DEVICE RECALL NOTICE" informing customers that specific lots of MONARCH Inflation Devices due to a packaging defect, there may be a small hole in the Tyvek sterile barrier of the device packaging. Use of the affected product may result in exposure to pathogens/pyrogens which could lead to infection. Customer are instructed to: 1. Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution. 2. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Additional distribution details may be required by health authorities. 4. Please fill out, scan, and email the completed CRF to Customer Service at response@merit.com within 7 calendar days. All affected product shipped to you must be accounted for on the CRF. 5. Please immediately return all affected lots in your possession to Merit, per the instructions in the attached CRF. For questions - contact your Merit Sales Representative or Merit Customer Service via email at RESPONSE@merit.com or via phone at +1 800 356 3748 | Hours: 6 am to 6 pm MST | Mon-Fri.
Details
- Recall number
- Z-0058-2025
- Initiated
- August 30, 2024
- Posted by FDA
- October 11, 2024
- Product code
- DXT – Injector And Syringe, Angiographic
- Quantity
- 41,411 devices
- Distribution
- 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.
- Recalling firm
- Merit Medical Systems, Inc., South Jordan, UT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0057-2025 Class II | Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe…Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | 08/30/2024Open, Classified |
| Z-0059-2025 Class II | Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool…Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | 08/30/2024Open, Classified |
| Z-0060-2025 Class II | Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool…Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | 08/30/2024Open, Classified |
| Z-0061-2025 Class II | Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal…Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | 08/30/2024Open, Classified |
| Z-0062-2025 Class II | Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe…Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | 08/30/2024Open, Classified |