Recall Z-0058-2025 ยท DXT Injector And Syringe, Angiographic
Merit Medical Systems, Inc.
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 t
| Date | Oct 11, 2024 (initiated Aug 30, 2024) |
| Status | Open, Classified |
| Reason | Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| 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, Ja |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011811 | MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE Merit Medical Systems, Inc., Aug 22, 2001 |