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 Infl

Hazard

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

Details from the source

Reason for recall: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. 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. Quantity: 41,411 devices Lot/code info: 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

UPC codes

00884450298039

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.