Various 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.

Recall details

Manufacturer

Merit Medical Systems, Inc.

Distributor

U.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.

Lot

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

Risk classification

Class II

Area (FDA)

device

Country

United States