—#209995

Product

Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 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.

FDA product code: DXT — Injector And Syringe, Angiographic
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K011811
Affected lot / code info: Catalog Number: IN2330/B UDI-DI code: 00884450298046 Lot Number: H2369557 H2416390 H2421992 H2426112 H2492843 H2522880 H2540015 H2554505 H2560208 H2579556 H2765640 H2793109 H2806018 H2810777

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 W Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

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.

Timeline

Recall initiated: 2024-08-30
Posted by FDA: 2024-10-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209995. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.