Recall Z-0062-2025
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
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.
Codes / lots: Catalog Number: K05T-02159 UDI-DI code: 00884450140840 Lot Number: T2417859 T2434208 T2509792 T2549931 T2561788 T2625814 T2675576 T2762716 T2801089 T2893877
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-0062-2025
- Initiated
- August 30, 2024
- Posted by FDA
- October 11, 2024
- Product code
- DXT – Injector And Syringe, Angiographic
- Quantity
- 432 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-0058-2025 Class II | Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion…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 |