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U.S. Department of Health and Human Services

Class 2 Device Recall Merit Medical

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 Class 2 Device Recall Merit Medicalsee related information
Date Initiated by FirmJune 11, 2024
Date PostedAugust 12, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2568-2024
Recall Event ID 94797
Product Classification Angiography/angioplasty kit - Product Code OEQ
ProductVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22C (Vein Tray Angiography kit), REF: K09T-11796F K12T-01558G K12T-01558H K12T-01822 K12T-01852L K12T-02006J K12T-02054 K12T-02091G K12T-02102B K12T-02309 K12T-02392A K12T-02416 K12T-02510N K12T-02725G K12T-02725H K12T-02890K K12T-02949A K12T-03012C K12T-03014B K12T-03058A K12T-03139 K12T-03203F K12T-03319 K12T-03321F K12T-03515 K12T-03560D K12T-03566H K12T-03638H K12T-03706A K12T-03746C K12T-03788 K12T-03839H K12T-03853C K12T-03866B K12T-03867A K12T-03868 K12T-03868A K12T-04068 K12T-04106D K12T-04106F K12T-04140J K12T-04586D K12T-04697 K12T-04959B K12T-04963A K12T-05061J K12T-05081D K12T-05093D K12T-05281C K12T-05334D K12T-05423G K12T-05442B K12T-05472H K12T-05559B K12T-05824G K12T-05824H K12T-05825H K12T-05926C K12T-05991A K12T-06033C K12T-06211B K12T-06250 K12T-06282 K12T-06374D K12T-06416A K12T-06561A K12T-06640C K12T-06732A K12T-06783B K12T-06819C K12T-06979B K12T-07003A K12T-07008G K12T-07088 K12T-07266A K12T-07305 K12T-07556C K12T-07614A K12T-07729A K12T-07845B K12T-07893B K12T-08003 K12T-08565A K12T-08614B K12T-08727B K12T-08801 K12T-08867 K12T-09267D K12T-09337A K12T-09438A K12T-09523A K12T-09595 K12T-09685 K12T-09875 K12T-09880A K12T-09889 K12T-09974A K12T-10167A K12T-10287 K12T-10338H K12T-10409 K12T-10733 K12T-11467 K12T-11524A K12T-12152A K12T-12456 K22C-00001 K22C-00001A K22C-00034 K22C-00035 K22C-00042 K22C-00043 K22C-00052 K22C-00053A K22C-00054A K22C-00056 K22C-00058A K22C-00059 K22C-00062A K22C-00064A K22C-00069 K22C-00069A K22C-00070 K22C-11010 To support various vascular or cardiac diagnostic and interventional procedures.
Code Information Catalog Number/UDI-DI code/Lot Numbers: K09T-11796F 00884450503508 T2636554 K12T-01558G 00884450352670 T2329177 T2350727 T2371542 T2406796 T2430055 T2485419 T2540319 T2558850 T2574369 T2596749 T2637263 T2659470 T2716683 K12T-01558H 00884450782934 T2779744 T2823401 T2865508 T2909943 K12T-01822 00884450048849 T2329672 T2351649 T2366410 T2418145 T2479954 T2525431 T2544260 T2571995 T2635756 T2670966 T2716684 T2721174 T2738158 T2753461 T2781018 T2827635 K12T-01852L 00884450390641 T2627432 K12T-02006J 00884450410912 T2803003 T2866385 T2872131 K12T-02054 00884450048917 T2311048 T2323911 T2380682 T2383287 T2395389 T2427758 T2449372 T2464344 T2550262 T2609831 T2626139 T2697324 T2718897 T2753113 T2806098 T2832182 T2844200 T2866387 T2885324 K12T-02091G 00884450265925 T2458700 T2545242 T2587424 T2715273 T2736377 T2753117 T2780031 T2821698 T2888650 T2918566 K12T-02102B 00884450352861 T2597046 T2637278 T2662098 T2697333 T2751272 T2844211 K12T-02309 00884450055007 T2222971 T2331208 T2339980 T2405330 T2528876 T2560752 T2606584 T2697350 T2761529 T2821644 T2902935 K12T-02392A 00884450242926 T2144921 T2218464 T2244482 T2262003 T2296102 T2314800 T2339899 T2360807 T2416467 T2465735 T2509991 T2587265 T2637343 T2702608 T2776001 T2803012 T2821648 T2899061 K12T-02416 00884450238684 T2232553 K12T-02510N 00884450558522 T2616294 T2644061 T2776005 T2816289 T2886448 K12T-02725G 00884450278260 T2194607 T2303611 T2351004 T2408869 K12T-02725H 00884450679500 T2489997 T2587462 T2614079 T2655947 T2700183 T2713211 T2761550 T2781048 T2807148 T2906805 K12T-02890K 00884450242209 T2475031 T2570328 T2605749 T2626141 T2677852 T2704266 T2780036 T2803017 T2821647 T2823617 T2900194 K12T-02949A 00884450049211 T2449187 T2643784 K12T-03012C 00884450518328 T2232391 T2271357 T2305988 T2430292 T2540019 T2549960 T2560554 T2710204 T2776052 T2805520 K12T-03014B 00884450518533 T2193400 T2262009 T2283036 T2329184 T2428130 T2470356 T2540243 T2549961 T2560555 T2605751 T2697359 T2718786 T2805521 T2817191 T2899049 K12T-03058A 00884450339459 T2300687 T2352743 T2395547 T2428132 T2458769 T2544394 T2606612 T2776053 K12T-03139 00884450353073 T2300708 T2408265 T2635768 T2703042 T2776055 K12T-03203F 00884450267486 T2269004 T2306143 T2417470 T2428136 T2479772 T2489975 T2644066 T2712913 T2718901 T2776081 T2806122 T2857395 T2866400 K12T-03319 00884450353134 T2359607 T2410114 T2507033 T2555177 T2617479 T2677938 T2806125 K12T-03321F 00884450339749 T2560565 T2805523 K12T-03515 00884450340004 T2346209 T2397238 T2458796 T2521166 T2545225 T2567501 T2606688 T2697349 T2728037 T2790684 T2834451 T2898856 K12T-03560D 00884450275887 T2577403 T2596853 T2643858 T2671300 T2697352 T2747386 T2776197 T2787641 T2793976 T2804983 T2830191 T2850900 T2903192 K12T-03566H 00884450389379 T2537241 T2600430 K12T-03638H 00884450311929 T2585651 T2596114 T2627473 T2677948 T2721179 T2741661 T2803046 T2818681 T2867227 T2933583 K12T-03706A 00884450389416 T2407423 T2492158 T2529724 T2571996 T2678885 T2740350 T2818683 T2912461 K12T-03746C 00884450632130 T2299496 T2339989 T2379382 T2402602 T2444122 T2490003 T2529732 T2545239 T2550282 T2571766 T2587602 T2626205 T2650483 T2697347 T2703287 T2718916 T2755764 T2780054 T2844782 T2850911 T2899013 K12T-03788 00884450340394 T2291263 T2449755 T2670724 T2715275 T2759267 K12T-03839H 00884450282175 T2314982 T2355772 T2408277 T2408891 T2430362 T2449461 T2489612 T2540315 T2550286 T2606738 T2619210 T2662153 T2776015 T2818120 T2818722 T2912456 K12T-03853C 00884450285442 T2314812 T2334574 T2406905 T2458811 T2465287 T2489979 T2510099 T2537718 T2540755 T2560567 T2585658 T2605755 T2630606 T2678892 T2710699 T2762750 T2818286 T2823424 T2868316 K12T-03866B 00884450340622 T2128784 T2160422 T2167696 T2246023 T2290471 T2314813 T2385073 T2417877 T2458815 T2499604 T2509798 T2567527 T2609552 T2678902 T2712059 T2779760 T2855784 T2903282 K12T-03867A 00884450340639 T2670725 K12T-03868 00884450389508 T2203856 T2248929 T2280760 T2305998 T2329188 T2444194 T2489260 T2585659 T2609553 T2624426 T2656044 T2698981 K12T-03868A 00884450782941 T2805563 T2849953 T2881577 T2899752 K12T-04068 00884450341070 T2141096 T2194821 T2306290 T2329659 T2360968 T2407254 T2428274 T2489977 T2491591 T2529768 T2545303 T2570271 T2607282 T2643862 K12T-04106D 00884450277096 T2223561 T2254305 T2269068 T2306292 T2327725 T2405834 T2428275 T2465918 T2485444 T2543106 T2567613 T2577453 T2587427 T2596180 T2610031 T2643863 T2790774 T2806206 T2818804 T2832338 K12T-04106F 00884450801710 T2896964 K12T-04140J 00884450275252 T2540750 T2552597 T2609848 T2741650 T2780060 K12T-04586D 00884450332313 T2220947 T2281688 T2300710 T2324379 T2408318 T2545360 T2567749 T2619319 T2653469 T2753590 T2776266 T2803594 T2845126 T2896979 K12T-04697 00884450342589 T2246182 T2408910 T2466059 T2503562 T2582343 T2680636 T2736394 T2803599 T2806219 T2891669 T2928029 K12T-04959B 00884450252086 T2609855 T2662181 T2762879 T2796660 T2900208 K12T-04963A 00884450702109 T2806227 T2841694 K12T-05061J 00884450257173 T2216182 T2223508 T2262161 T2410189 T2485448 T2519282 T2560764 T2726152 T2783976 T2899063 K12T-05081D 00884450267967 T2511781 T2545907 T2736402 T2806237 T2851045 T2899113 K12T-05093D 00884450310830 T2240520 T2241107 T2303710 T2335756 T2410203 T2459150 T2470607 T2555869 T2591505 T2671532 T2752057 T2801086 K12T-05281C 00884450279021 T2306296 T2407255 T2459161 T2531086 T2550653 T2627324 T2712935 T2834914 T2928080 K12T-05334D 00884450287019 T2609862 T2697191 T2712937 T2753147 T2819184 T2899058 K12T-05423G 00884450600917 T2299509 T2401835 T2428492 T2459192 T2489504 T2516383 T2545965 K12T-05442B 00884450344644 T2383177 T2531497 T2545446 T2560767 T2587619 T2631576 T2712941 T2758378 T2786094 T2828836 T2866775 T2898958 K12T-05472H 00884450389911 T2246035 T2314835 T2346704 T2383560 T2422348 T2449273 T2596942 T2643373 T2654342 T2656058 T2795238 T2805644 T2832012 T2907036 K12T-05559B 00884450257180 T2591879 T2609869 T2660527 T2690364 T2712951 T2784197 T2823648 T2851072 T2872268 T2897146 T2928207 K12T-05824G 00884450393543 T2241113 T2246043 T2306056 T2346894 T2409203 T2425896 K12T-05824H 00884450679104 T2434270 T2517983 T2545130 T2545131 T2587313 T2619589 T2624401 T2650813 T2656065 T2684323 T2704362 T2713412 T2748324 T2762769 T2779796 T2803972 T2842373 T2849540 T2872271 T2897661 K12T-05825H 00884450394199 T2241114 T2260084 T2273671 T2346895 T2409206 T2445481 T2445482 T2545990 T2580012 T2596950 T2654363 T2712082 T2762770 T2791266 T2832022 T2842294 T2865657 T2910015 K12T-05926C 00884450285183 T2246191 T2306176 T2325394 T2351048 T2484538 T2543074 T2712963 T2806285 K12T-05991A 00884450346792 T2216249 T2246192 T2297808 T2323705 T2358814 T2385300 T2418030 T2438761 T2484557 T2532120 T2570326 T2608879 T2626232 T2679155 T2752202 T2791366 T2830812 T2904810 K12T-06033C 00884450356821 T2380321 T2552693 T2560408 T2587631 T2611542 T2710250 T2716734 T2777468 T2800763 T2814337 T2832384 T2851125 T2883799 T2928229 K12T-06211B 00884450354711 T2422372 T2445623 T2505116 T2532300 T2571635 T2609883 T2644137 T2679173 T2712996 T2736412 T2756084 T2786078 T2806292 T2882708 T2904827 K12T-06250 00884450354797 T2238159 K12T-06282 00884450160817 T2371879 T2409217 T2489567 T2519311 T2527059 T2580048 T2697361 T2741637 T2819387 T2851133 K12T-06374D 00884450570357 T2385099 T2422413 T2459226 T2532306 T2570256 T2596954 T2656069 T2690322 T2736260 T2804776 T2830037 K12T-06416A 00884450355046 T2232765 T2431680 T2485384 T2568711 K12T-06561A 00884450207000 T2329249 T2422954 T2465726 T2557907 K12T-06640C 00884450243251 T2329484 T2485380 T2550384 T2580090 T2680666 T2713000 T2746752 T2823657 K12T-06732A 00884450309193 T2632144 K12T-06783B 00884450355190 T2206927 T2235660 T2297962 T2312071 T2393079 T2417245 T2442973 T2469346 T2532378 T2552697 T2560796 T2609902 T2644143 T2704829 T2736416 T2784324 T2816470 T2830076 T2876323 K12T-06819C 00884450388594 T2550389 T2596244 T2609903 T2610665 T2644145 T2662204 T2713003 T2714802 T2748394 T2776740 T2787638 T2803443 T2819855 T2823659 T2845734 T2851137 T2900328 T2900329 K12T-06979B 00884450286661 T2407257 T2445800 T2505304 T2546243 T2550662 T2568730 T2582612 T2627332 T2643867 T2684403 T2753172 T2814329 T2838972 T2851143 K12T-07003A 00884450299111 T2206930 T2240580 T2262043 T2304690 T2314852 T2347978 T2396533 T2417910 T2439326 T2465799 T2505838 T2532454 T2568732 T2587327 T2656073 T2699016 T2762773 T2804925 T2805675 T2903826 K12T-07008G 00884450501580 T2435094 T2479987 T2543251 T2580974 T2611539 T2632199 T2671820 T2742905 T2777536 T2821670 T2904994 K12T-07088 00884450199480 T2262044 T2325700 T2445821 T2487164 T2487165 T2569654 T2643387 T2729339 T2762774 T2804926 T2819554 T2859044 K12T-07266A 00884450294413 T2261979 T2314773 T2406773 T2449220 T2546276 T2587236 T2625755 T2712019 T2805396 T2849478 K12T-07305 00884450351529 T2169370 T2306180 T2409279 T2476700 T2571637 T2662209 T2894202 K12T-07556C 00884450630327 T2299526 T2315027 T2337374 T2402607 T2431728 T2466028 T2489598 T2532514 T2568773 T2587647 T2632269 T2672075 T2773328 T2806844 T2845762 T2866951 T2915841 K12T-07614A 00884450309308 T2390018 T2407154 T2410169 T2532515 T2560820 T2632270 T2662212 T2748538 T2777556 T2791462 T2819791 T2851152 T2903828 K12T-07729A 00884450242230 T2281690 T2312131 T2326459 T2409291 T2431732 T2487376 T2540403 T2542192 T2550402 T2582678 T2597094 T2620393 T2642481 T2662214 T2718966 T2780115 T2806848 T2871321 T2878097 T2905960 T2915843 K12T-07845B 00884450292686 T2306074 T2310754 T2316766 T2316774 T2402613 T2457281 T2505823 T2508211 T2684484 T2699023 T2699024 T2752334 T2758651 T2762788 T2788896 T2805717 T2824485 T2845767 K12T-07893B 00884450482483 T2306183 T2366330 T2418046 T2488282 T2499649 T2662217 T2680671 T2736427 T2823666 T2905093 K12T-08003 00884450246252 T2329492 T2411629 T2587651 T2609918 T2635703 K12T-08565A 00884450279120 T2372630 T2457278 T2533244 T2545124 T2582688 T2599882 T2644161 T2704868 T2777576 T2814957 T2830382 T2859137 T2905158 K12T-08614B 00884450282397 T2584755 T2713015 K12T-08727B 00884450398661 T2246211 T2315034 T2387565 T2417454 T2447483 T2479833 T2543103 T2570370 T2587655 T2679690 T2736432 T2753178 T2806857 T2823672 T2903801 K12T-08801 00884450272688 T2571645 T2691099 K12T-08867 00884450274323 T2231298 K12T-09267D 00884450679319 T2431225 T2533310 T2572076 T2713227 T2840612 K12T-09337A 00884450360071 T2410201 T2418049 T2434526 T2479836 T2550428 T2605775 T2670972 T2704900 T2762037 T2815074 T2859816 T2907246 T2912515 K12T-09438A 00884450480861 T2869460 K12T-09523A 00884450383490 T2366339 T2407182 T2432256 T2509374 K12T-09595 00884450311189 T2164826 T2223529 T2269035 T2315043 T2332534 T2372678 T2418052 T2449520 T2463823 T2471517 T2547112 T2558267 T2587676 T2644263 T2693128 T2718982 T2780131 T2823677 T2866984 T2907301 T2915865 K12T-09685 00884450352380 T2409474 T2534386 T2609937 T2753182 T2764500 T2859160 K12T-09875 00884450329474 T2644271 T2701090 T2718986 T2787645 T2802422 T2820542 T2900345 K12T-09880A 00884450387870 T2759327 K12T-09889 00884450355923 T2232816 T2269103 T2315241 T2372683 T2418162 T2492449 T2583507 T2643817 T2721283 T2804974 T2859821 T2928271 K12T-09974A 00884450624913 T2753185 T2832405 T2879288 K12T-10167A 00884450795736 T2823501 T2870501 T2893596 K12T-10287 00884450398470 T2216993 T2431387 T2441503 T2534082 T2645393 T2777723 K12T-10338H 00884450632208 T2615306S K12T-10409 00884450399705 T2596990 T2705024 T2718845 T2753027 T2840454 K12T-10733 00884450419748 T2194562 T2316724 T2385145 T2417937 T2446644 T2490001 T2550121 T2570219 T2656616 T2693470 T2744141 T2779846 T2821665 T2849533 K12T-11467 00884450491720 T2366352 T2410205 T2418077 T2449532 T2485055 T2550581 T2583873 T2634286 T2662267 T2697043 T2697044 T2759104 T2816448 T2860507 T2900387 K12T-11524A 00884450601105 T2315069 T2358232 T2366354 T2434564 T2466026 T2471610 T2535678 T2560896 T2626306 T2662269 T2701132 T2719023 T2738034 T2780160 T2879799 T2908343 K12T-12152A 00884450733103 T2596903 K12T-12456 00884450794319 T2806980 T2903865 K22C-00001 00884450410844 T2538579 K22C-00001A 00884450443255 T2223542 T2232656 T2246239 T2299542 T2315077 T2329630 T2340035 T2367921 T2385416 T2407223 T2433228 T2448640 T2449543 T2479264 T2488290 T2538561 T2538568 T2560914 T2611912 T2644376 T2680768 T2713145 T2719248 T2738066 T2793877 T2825152 T2832448 T2876369 T2908907 K22C-00034 00884450412664 T2212048 T2443684 T2489925 T2571719 K22C-00035 00884450412695 T2403701 T2430290 T2565094 T2611005 T2753058 T2815881 T2841622 K22C-00042 00884450429853 T2283432 T2310762 T2316876 T2329631 T2366371 T2418087 T2434583 T2528424 T2545444 T2626480 T2644378 T2680770 T2774825 T2841627 T2887731 T2903795 T2929174 K22C-00043 00884450433133 T2248289 T2310580 T2387835 T2397230 K22C-00052 00884450445440 T2281678 T2283193 T2350825 T2385167 T2397088 T2434350 T2479676 T2548734 T2553489 T2605774 T2634626 T2643538 T2707335 T2753059 T2805919 T2832134 T2876224 K22C-00053A 00884450621028 T2681492 T2713155 T2778755 T2780182 K22C-00054A 00884450453445 T2780183 T2891592 K22C-00056 00884450438428 T2256529 T2329382 T2377583 T2407037 T2434353 T2466411 T2605754 T2643539 T2680494 K22C-00058A 00884450465271 T2258142 T2281679 T2355564 T2393191 T2407038 T2448642 T2489354 T2559696 T2583968 T2609638 T2697237 T2745091 T2832135 T2876227 K22C-00059 00884450457665 T2626491 T2657100 T2680771 T2697239 T2745092 T2762922 T2806990 T2861393 K22C-00062A 00884450522967 T2249249 T2385989 T2815884 T2917469 K22C-00064A 00884450568927 T2193750 T2208760 T2246002 T2299023 T2316880 T2349563 T2362889 T2377589 T2403710 T2433229 T2436921 T2437739 T2479266 T2498819 T2527133 T2531692 T2559698 T2656027 T2715230 T2736117 T2757433 T2778757 T2792385 T2792388 T2841457 T2865494 T2899731 T2939494 K22C-00069 00884450676301 T2431279 T2535806 T2609998 T2644380 T2662319 T2762221 K22C-00069A 00884450790755 T2832561 T2854496 K22C-00070 00884450678602 T2432171 T2535631 T2548740 T2570265 T2587399 T2625984 T2643540 T2701633 T2805920 T2823531 T2907226 T2926530 K22C-11010 00884450454480 T2231602 T2287828 T2312909 T2385168 T2424127 T2446806 T2470363 T2498879 T2643541
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 W Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact
801-253-1600
Manufacturer Reason
for Recall		Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
FDA Determined
Cause 2		No Marketing Application
ActionOn 06/11/2024, the firm sent an "URGENT MEDICAL DEVICE RECALL NOTICE" Letter to customers informing them that specific Merit Medical convenience kits contain plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. These syringes lack the appropriate/sufficient FDA market authorization. In addition, Merit Medical posted the Urgent Medical Device Recall letter and complete list of affected products/kits on their website at https://www.merit.com/products/documents/product-notices/. Customer are instructed to: 1. Immediately determine if any of the products identified in the attached Customer Response Form (CRF) are within their facility, quarantine them, and discontinue use and distribution. 2. Ensure that appropriate personnel within their organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, ensure this notice is immediately shared with them. Additional distribution details may be required by health authorities. 4. Follow the attached instructions for placing the recall labels on the products containing Jiangsu Shenli syringes, which inform the users to not use the affected syringes. If additional recall labels are needed, contact Customer Service at (801) 208-4381. Product may be returned to inventory once properly over-labeled. 5.At the point of use, the Jiangsu Shenli syringes are to be discarded. Photographs of Jiangsu Shenli syringes are enclosed to assist in identification. 6.Post this URGENT MEDICAL DEVICE RECALL NOTICE and Jiangsu Shenli Syringe photographs on or near the affected products. 7.If replacement syringes are needed, contact Customer Service at (801) 208-4381 for recommended syringe suppliers. For questions contact Merit Sales Representative or Merit Customer Service at 801-208-4381, Hours: 6 am to 6 pm MST Mon.-Fri.
Quantity in Commerce103369 kits
DistributionU.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, 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, WY.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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