Class 2 Device Recall Merit Medical

• Date Initiated by Firm: June 11, 2024
• Date Posted: August 12, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2578-2024
• Recall Event ID: 94797
• Product Classification: Cardiovascular procedure kit - Product Code OEZ
• Product: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K09T-01138 K09T-04484A K09T-04757F K09T-04835H K09T-07256D K09T-07588B K09T-07611K K09T-07649K K09T-07649L K09T-07649M K09T-09035H K09T-09035J K09T-09035M K09T-09035N K09T-09107K K09T-09319C K09T-09599Q K09T-09672H K09T-09672J K09T-09843AP K09T-10192B K09T-10405A K09T-10449 K09T-10542G K09T-10790D K09T-10899C K09T-11052F K09T-11266B K09T-11305F K09T-11372G K09T-11496A K09T-11541B K09T-11831C K09T-11940A K09T-11940B K09T-12050D K09T-12292B K09T-12558D K09T-12624B K09T-13050F K09T-13097B K09T-13097C K09T-13232 K09T-13257 K09T-13335B K09T-13362A K09T-13362B K09T-13468A K09T-13469A K09T-13521C K09T-13595A K09T-13666 K09T-13801 K09T-14072A K09T-14106 K10T-03350C K10T-04039F K10T-04245G K10T-04385G K10T-04448M K10T-04486D K10T-04486F K10T-04741 K10T-04845G K10T-05008B K10T-05199B K10T-05342D K10T-05468F K10T-05581B K10T-05602A K10T-05745B K10T-05991A K10T-06073 K12T-01749D K12T-02061A K12T-02061B K12T-02162B K12T-02460F K12T-03044G K12T-03327G K12T-03723C K12T-03975B K12T-04229H K12T-04312T K12T-04323G K12T-04324D K12T-04849C K12T-04997F K12T-05302H K12T-05302J K12T-05396D K12T-05519C K12T-05524F K12T-05674D K12T-05741 K12T-05741A K12T-06472 K12T-06693C K12T-06823D K12T-06823F K12T-06899 K12T-07098 K12T-07204A K12T-07351C K12T-07543F K12T-07543G K12T-07545B K12T-07703A K12T-07822F K12T-07918C K12T-08368B K12T-08769B K12T-08980 K12T-09026A K12T-09129H K12T-09195A K12T-09350 K12T-09354 K12T-09526B K12T-09586 K12T-09722 K12T-09890A K12T-09922C K12T-10006 K12T-10006A K12T-10006B K12T-10006C K12T-10024 K12T-10092A K12T-10121A K12T-10235A K12T-10262A K12T-10293D K12T-10311 K12T-10316A K12T-10489B K12T-10489C K12T-10584A K12T-10653 K12T-10660D K12T-10778C K12T-10978A K12T-10996B K12T-11004A K12T-11069 K12T-11091 K12T-11098B K12T-11116B K12T-11124 K12T-11229A K12T-11326A K12T-11405B K12T-11471B K12T-11514A K12T-11615A K12T-11626A K12T-11672 K12T-11759 K12T-12078 K12T-12078B K12T-12200A K12T-12275 K12T-12276 K12T-12278 K12T-12405 K12T-12466 K12T-12499 K17T-00008 K17T-00010B K17T-00013 To support fluid administration into the body and physiological pressure monitoring. To support various vascular or cardiac diagnostic and interventional procedures
• Code Information: Catalog Number/UDI-DI code/Lot Numbers: K09T-01138 00884450336007 T2363424 T2386670 T2408156 T2480761 T2550174 T2571631 T2635757 T2640323 T2734947 T2774657 T2805967 T2833068 T2843260 T2850761 T2873975 T2885243 T2906058 K09T-04484A 00884450566596 T2816450 T2832465 T2854450 T2871539 T2901668 K09T-04757F 00884450388396 T2385183 T2434454 T2495466 T2525635 T2556829 T2584607 T2597014 T2640329 T2675582 T2708063 T2805969 T2843261 T2885245 T2895071 T2916416 K09T-04835H 00884450270394 T2287853 T2315252 T2349573 T2360340 T2386004 T2390911 T2414694 T2434737 T2449763 T2494448 T2587504 T2635754 T2667679 T2680871 T2712317 T2738104 T2781020 T2807074 T2833069 T2846966 T2864503 T2876387 K09T-07256D 00884450603703 T2360341 T2442955 T2498994 T2512482 T2560718 T2662053 T2745275 T2753062 T2800989 T2816846 K09T-07588B 00884450264386 T2205472 T2241180 T2314951 T2329404 T2349817 T2385184 T2386005 T2399751 T2442956 T2466089 T2479716 T2515708 T2536603 T2556831 T2560719 T2587556 T2606272 T2623834 T2657321 T2662059 T2690340 T2718870 T2748986 T2779872 T2800990 T2816851 T2846968 T2864504 T2874066 T2881132 T2906059 K09T-07611K 00884450290392 T2596860 T2652491 T2699218 T2699221 T2708069 T2717940 T2738107 T2762257 T2800991 T2833071 T2849220 T2883795 T2886087 T2939092 K09T-07649K 00884450390627 T2305612 K09T-07649L 00884450644102 T2339957 T2366225 T2386671 T2407056 T2417965 T2456584 T2495473 T2525638 T2550175 T2571768 T2594494 T2606278 T2640321 T2676814 K09T-07649M 00884450763506 T2712330 T2800995 T2805971 T2829278 T2846972 T2895076 T2913241 T2918196 K09T-09035H 00884450390634 T2305169 K09T-09035J 00884450644119 T2407057 T2417968 T2449348 T2456585 T2495474 T2525665 T2550176 T2587558 T2614918 T2640322 T2662061 T2676826 T2739363 K09T-09035M 00884450783108 T2774709 T2801082 K09T-09035N 00884450801956 T2832138 T2845195 T2850766 T2883742 T2886099 T2936006 K09T-09107K 00884450388402 T2333502 T2428903 T2457858 T2495482 T2551032 T2584608 T2643751 T2807078 K09T-09319C 00884450336328 T2333503 T2406792 T2426303 T2442997 T2479557 T2495485 T2525667 T2542381 T2570205 T2667684 T2676839 T2697309 T2726942 T2750320 T2779735 T2800998 T2805468 T2824416 T2899053 K09T-09599Q 00884450305485 T2657331 K09T-09672H 00884450400142 T2262333 T2322586 T2349973 T2370013 T2382254 T2390913 T2418132 T2428904 T2454371 T2471274 T2499030 T2525672 T2536622 T2550679 T2587433 T2606292 T2636536 T2676303 T2680820 T2708087 T2738112 T2786079 T2801005 T2823766 T2831465 K09T-09672J 00884450806500 T2843279 T2885516 T2898660 K09T-09843AP 00884450396100 T2634757 K09T-10192B 00884450273326 T2606293 T2647494 T2657421 T2667760 K09T-10405A 00884450388426 T2435072 T2449671 T2495513 K09T-10449 00884450229255 T2269725 T2298788 T2320198 T2354640 T2484242 T2501039 T2571619 T2581479 T2627904 T2679655 T2712890 T2734943 T2781721 T2805975 T2810457 T2824612 T2918261 K09T-10542G 00884450386798 T2327703 T2385009 T2572026 T2596862 T2682149 T2699228 T2764349 T2789920 T2792298 T2864577 T2876388 K09T-10790D 00884450603710 T2397998 T2407058 T2446365 T2466116 T2491596 T2538587 T2571762 T2597021 T2619221 T2633111 T2676861 T2700131 T2736359 T2779938 T2805976 T2847942 T2866729 T2895720 T2901758 K09T-10899C 00884450261262 T2256693 T2327704 T2366465 T2397999 T2418184 T2495532 T2499083 T2528610 T2572079 T2643754 T2699197 T2712368 T2792307 T2847943 T2854453 T2876389 T2895202 K09T-11052F 00884450624302 T2366390 T2443045 T2443049 T2473866 T2499065 T2531651 T2566151 T2599040 T2627386 T2650516 T2697340 T2721146 T2761341 T2781022 T2807093 T2840610 T2847945 T2864582 T2916421 K09T-11266B 00884450400883 T2435084 T2499032 T2550685 T2554945 T2584613 T2614985 T2635783 T2667765 T2700133 T2712373 T2833078 T2899814 K09T-11305F 00884450297971 T2307586 T2333520 T2366391 T2389983 T2428911 T2432410 T2474025 T2480890 T2525700 T2525703 T2550687 T2576051 T2587438 T2636553 T2657501 T2676882 T2699967 T2712374 T2748993 T2781023 T2804759 T2833079 T2847946 T2876391 T2906107 K09T-11372G 00884450372333 T2480900 T2506600 T2536629 T2581320 T2606314 T2699169 T2766980 K09T-11496A 00884450658307 T2367270 T2404513 T2436016 T2436056 T2446736 T2474270 T2474271 T2489362 T2525719 T2566155 T2587562 T2597022 T2621657 T2643840 T2643841 T2643955 T2700134 T2736361 T2792309 T2802363 T2821673 T2828941 T2861637 T2877008 T2877011 T2901790 K09T-11541B 00884450501573 T2299771 T2333521 T2360397 T2399791 T2443059 T2525726 T2540032 T2561863 T2587440 T2615034 T2652525 T2667774 T2701716 T2733148 T2734952 T2762263 T2792311 T2816438 T2823773 T2842472 T2847957 T2898995 K09T-11831C 00884450538012 T2233977 T2301004 T2308773 T2330885 T2370016 T2406793 T2489184 T2520012 T2520012S T2543072 T2570254 T2596739 T2602899 T2625816 T2657587 T2697337 T2736190 T2762721 T2800812 T2816483 T2826108 T2871660 T2898969 K09T-11940A 00884450271834 T2299469 T2466260 T2525740 K09T-11940B 00884450747520 T2759124 K09T-12050D 00884450410738 T2417972 T2428927 T2457873 T2511582 T2525742 T2561872 T2597024 T2636564 T2667776 T2700138 T2708155 T2823536 T2824589 T2874176 T2899094 T2919405 K09T-12292B 00884450408735 T2275682 T2310877 T2313747 T2366231 T2370019 T2414779 T2436532 T2489372 T2495552 T2531647 T2550182 K09T-12558D 00884450570104 T2246166 T2313748 T2322850 T2349146 T2386022 T2426491 T2449353 T2498991 T2550183 T2606419 T2643958 T2667818 T2700141 T2701718 T2746562 T2781174 T2816452 T2843378 T2850770 T2903861 T2910068 K09T-12624B 00884450571132 T2652571 K09T-13050F 00884450592670 T2241181 T2291335 T2322853 T2363573 T2382390 T2417973 T2449354 T2495602 T2520402 T2521610 T2542504 T2626068 T2652592 T2658303 T2677439 T2697327 T2753074 T2765368 T2804977 T2810460 T2823538 T2850784 T2918319 K09T-13097B 00884450525609 T2550693 T2556889 T2587442 T2647601 T2676926 T2766472 T2807102 K09T-13097C 00884450801703 T2823540 T2898993 K09T-13232 00884450451045 T2350042 T2562888 T2636578 T2651327 T2716023 T2832578 T2873226 K09T-13257 00884450454473 T2329408 T2520362 T2536815 T2560723 T2708162 T2805981 K09T-13335B 00884450630303 T2407065 T2466058 T2489378 T2542577 T2550188 T2636580 T2658306 T2676938 T2734258 T2781182 K09T-13362A 00884450486771 T2262339 T2360420 K09T-13362B 00884450640128 T2314788 T2427532 T2823395 T2842267 T2899102 K09T-13468A 00884450522103 T2496484 T2708954 K09T-13469A 00884450533109 T2327706 T2366393 T2428991 T2457893 T2525939S T2543084 T2615167 T2652604 T2700145 T2712381 T2738118 K09T-13521C 00884450586136 T2329410 T2350942 T2377796 T2417974 T2449356 T2489116 T2490328 T2516490 T2587567 T2615174 T2640337 T2697317 T2774796 T2779943 K09T-13595A 00884450561102 T2340067 T2370022 T2386033 T2408837 T2435085 T2466009 T2489117 T2489117S T2536863 T2543992 T2578864 T2615176 T2636583 T2676942 T2697368 K09T-13666 00884450557709 T2241182 T2278117 T2313751 T2366237 T2414797 T2457895 T2536866 T2566217 T2587568 T2636584 T2662071 T2750438 T2775000 T2792414 T2805989 T2843389 T2895215 T2898695 K09T-13801 00884450709702 T2540582 T2587569 T2636585 T2662072 T2805991 T2823545 K09T-14072A 00884450790939 T2842479 T2887235 T2926868 T2929478 K09T-14106 00884450746523 T2658313 T2661297 T2832148 T2848026 T2871959 T2890781 T2898982 K10T-03350C 00884450388471 T2622665 T2643310 T2894194 K10T-04039F 00884450267400 T2248493 T2299854 T2315255 T2333576 T2360519 T2426596 T2792473 T2840603 K10T-04245G 00884450455524 T2146383 T2217680 T2268993 T2295584 T2306525 T2313755 T2329417 T2350955 T2360555 T2399851 T2399854 T2439257 T2474213 T2516018 T2536363 T2577080 T2587578 T2622510 T2643979 T2697310 T2753078 T2779953 T2779955 T2800720 T2810484 T2823555 T2866742 T2901990 T2918296 T2927177 K10T-04385G 00884450390948 T2636624 K10T-04448M 00884450400852 T2266445 T2288418 T2306124 T2343674 T2345489 T2366239 T2398005 T2408839 T2417980 T2446368 T2466069 T2489383 T2498963 T2519306 T2536918 T2550217 T2560735 T2584662 T2609812 T2636627 T2658519 T2677556 T2701754 T2712897 T2727040 T2740097 T2779961 T2788932 T2806016 T2853502 T2876254 T2898985 K10T-04486D 00884450442883 T2278118 T2313767 T2350957 T2360564 T2404587 T2417981 T2457351 T2527538 T2531643 T2560736 T2597031 T2635769 T2764415 T2775478 T2832152 K10T-04486F 00884450794302 T2823558 T2866743 T2885313 T2899887 T2918401 K10T-04741 00884450319369 T2539998 K10T-04845G 00884450454077 T2278319 T2306367 T2345515 T2345517 T2360581 T2383168 T2407270 T2429111 T2435089 T2443498 T2456517 T2473871 T2499039 T2527572 T2587451 T2616582 T2627411 T2699253 T2699260 T2712419 T2738141 T2833109 T2842489 T2912464 K10T-05008B 00884450363768 T2429156 T2449363 T2485374 T2498957 T2527606 T2550223 T2626086 T2666112 T2701790 T2736368 T2789665 T2802870 T2832164 T2848436 K10T-05199B 00884450455531 T2232543 T2246170 T2295614 T2313783 T2407071 T2443504 T2458451 T2489389 T2550227 T2597033 T2626088 T2662082 T2697360 T2718890 T2792502 T2833112 T2850806 K10T-05342D 00884450495780 T2314965 T2339966 T2385206 T2479740 T2560739 T2581442 T2697331 T2775546 T2806065 T2862544 T2899890 K10T-05468F 00884450584538 T2644045 T2657334 K10T-05581B 00884450542514 T2290391 T2370534 T2412581 T2527729 T2597036 T2773368 T2816402 T2902680 K10T-05602A 00884450388525 T2269088 T2329670 T2351646 T2397211 T2443577 T2497067 T2499026 T2531668 T2577222 T2596872 T2621517 T2670922 T2709043 T2738155 T2754777 T2764066 T2840631 T2873227 T2902684 K10T-05745B 00884450499573 T2256889 T2314969 T2414962 T2458538 T2479747 T2550248 T2561908 T2597039 T2644049 T2677677 T2779989 T2802944 T2833139 T2848598 T2899106 K10T-05991A 00884450619902 T2266481 T2339972 T2407078 T2498125 T2581497 T2637215 T2709056 T2801100 T2830833 T2874295 T2918492 K10T-06073 00884450676912 T2437006 T2443508 T2776688 T2840772 T2928284 K12T-01749D 00884450337493 T2849225 T2899060 T2902780 K12T-02061A 00884450337844 T2269001 T2329441 T2415928 T2437737 T2498655 K12T-02061B 00884450721278 T2555169 T2560750 T2591136 T2644059 T2677759 T2773352 T2817159 T2875230 K12T-02162B 00884450048986 T2570270 T2587425 T2627315 T2677760 T2697328 T2780033 T2823616 T2900191 K12T-02460F 00884450388969 T2128177 T2169198 T2225628 T2278126 T2314974 T2346091 T2385231 T2407081 T2443689 T2479750 T2503572 T2524654 T2585638 T2609838 T2677838 T2712907 T2727084 T2816334 T2850848 T2895679 T2921250 K12T-03044G 00884450585115 T2214901 T2241194 T2283366 T2306142 T2339983 T2371560 T2406221 T2417997 T2458768 T2489446 T2489453 T2519014 T2519015 T2543129 T2571761 T2597050 T2626193 T2653289 T2677861 T2729008 T2762872 T2790677 T2816287 T2850895 T2895853 T2900197 K12T-03327G 00884450238950 T2241325 T2283495 T2315230 T2334447 T2357823 T2371561 T2408267 T2418148 T2437821 T2471150 T2492439 T2529661 T2545188 T2581674 T2596882 T2627437 T2659933 T2680841 T2697353 T2712496 T2747367 T2781049 T2821704 T2842520 T2879932 T2906837 T2918628 K12T-03723C 00884450389423 T2241201 T2385277 T2418000 T2503584 T2529728 T2555766 T2597056 T2710696 T2794209 T2823628 K12T-03975B 00884450767726 T2728059 T2850920 T2898975 K12T-04229H 00884450312995 T2262327 T2300691 T2324292 T2329375 T2361334 T2401035 T2414125 T2421993 T2465921 T2499022 T2530822 T2557758 T2563095 T2585688 T2627319 T2697326 T2728111 T2736391 T2781177 T2785562 T2823634 T2844819 T2876297 T2919441 K12T-04312T 00884450685907 T2627440 T2650605 T2719607 K12T-04323G 00884450532720 T2582267 T2631380 T2635531 T2703944 K12T-04324D 00884450411049 T2668820 T2680633 T2680633S T2710752 T2734946S K12T-04849C 00884450372326 T2361517 T2407115 T2422260 T2483723 T2526991 T2545400 T2560762 T2585785 T2619388 T2644083 T2679024 T2704223 T2722033 T2764682 T2776306 T2816476 T2850991 T2872257 T2898879 K12T-04997F 00884450343487 T2531050 T2550336 T2587611 T2710787 T2747755 T2806230 T2852296 K12T-05302H 00884450631706 T2349212 T2385973 T2401814 T2434492 T2449470 K12T-05302J 00884450696903 T2531089 T2550343 T2571776 T2607544 T2626219 T2660520 T2704298 T2762884 T2811801 T2830694 T2897090 T2907032 K12T-05396D 00884450463451 T2545964 T2555950 T2609863 T2662187 T2736404 T2776862 T2820401 T2851061 T2872265 T2893604 T2899136 T2900212 K12T-05519C 00884450333785 T2221441 T2245319 T2280356 T2314837 T2350755 T2366180 T2387241 T2406930 T2434257 T2465835 T2479641 T2531820 T2532770 T2557849 T2587301 T2611001 T2643375 T2671716 T2728171 T2735061 T2776869 T2803923 T2828847 T2858599 T2888281 T2904701 K12T-05524F 00884450457047 T2385294 T2407123 T2437378 T2568629 T2587622 T2609867 T2638081 T2680649 T2806250 T2848047 T2858600 T2869389 T2887604 T2900216 K12T-05674D 00884450363751 T2241212 T2262165 T2304150 T2329473 T2355810 T2390521 T2407128 T2438705 T2479809 T2514687 T2538681 T2560778 T2597816 T2609872 T2660531 T2666532 T2700040 T2712955 T2729192 T2762260 T2795240 T2834918 T2851099 T2897658 K12T-05741 00884450345849 T2232254 T2291426 T2314768 T2324623 T2392979 T2401918 T2431467 T2459207 T2475933 T2493327 T2545986 T2557861 T2587229 T2609512 T2679117 K12T-05741A 00884450771907 T2728212 T2734139 T2779705 T2803957 T2842249 T2869392 T2904738 K12T-06472 00884450202050 T2211054 K12T-06693C 00884450647707 T2347923 T2366311 T2396510 T2434513 T2486134 T2550385 T2552387 T2640148 T2681637 T2714799 T2897697 T2904946 K12T-06823D 00884450388563 T2476675 T2557919 T2597084 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• 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: No Marketing Application
• Action: On 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 Commerce: 168157 kits
• Distribution: 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.
• Total Product Life Cycle: TPLC 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.