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-2564-2024
• 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: K09/K09T (Custom Manifold Kit), REF: K09-00526L K09-00807AH K09-01467AD K09-01467AF K09-01514U K09-01734L K09-02040C K09-02683F K09-02804B K09-03844F K09-04088H K09-04088J K09-04863J K09-04946B K09-04998H K09-04998HP K09-05229JP K09-05342A K09-05375F K09-05939D K09-07759J K09-07789L K09-07789M K09-07828U K09-07828UP K09-07834C K09-07905G K09-08031D K09-08052Q K09-08065J K09-08150R K09-08423G K09-08493KP K09-08847A K09-08875B K09-09051H K09-09184B K09-09403HP K09-09481A K09-09499B K09-09814 K09-09900F K09-09902G K09-09902GP K09-09975 K09-10060F K09-10062F K09-10210A K09-10210B K09-10286G K09-10300F K09-10315B K09-10432A K09-10444J K09-10475 K09-10494C K09-10574D K09-10726 K09-10736D K09-10788A K09-10811 K09-10829B K09-10830C K09-10929 K09-10994D K09-11024DP K09-11076C K09-11107D K09-11149B K09-11196 K09-11207DP K09-11259G K09-11259GP K09-11444B K09-11482D K09-11607B K09-11646C K09-11913C K09-12030AP K09-12245A K09-12304A K09-12304B K09-12359B K09-12396FP K09-12404 K09-12556B K09-12615 K09-12698 K09-12698A K09-12699 K09-12699A K09-12699B K09-12704A K09-12867A K09-12899A K09-12939B K09-12939C K09-13082C K09-13171 K09-13228A K09-13337BP K09-13420 K09-13507CP K09-13617P K09-13659AP K09-13660 K09-13767 K09-13880 K09-13882 K09-13882A K09-13933 K09-14000 K09-14000A K09-14047 K09-14096 K09-14196 K09-14219 K09-14220 K09T-13643 To support fluid administration into the body. To support various vascular or cardiac diagnostic and interventional procedures.
• Code Information: Catalog Number: K09-00526L UDI-DI code: 00884450410110 Lot Numbers: H2349153 H2383516 H2406764 H2413970 H2423156 H2448659 H2520716 H2575100 H2615198 H2703317 H2744465 H2756069 H2786999 H2795483 H2832682 H2866202 H2875102 H2925662 Catalog Number: K09-00807AH UDI-DI code: 00884450742365 Lot Numbers: H2746426 H2796444 H2796457 H2811125 H2824906 H2834319 H2846603 H2849847 H2875232 H2898333 H2898334 Catalog Number: K09-01467AD UDI-DI code: 00884450282441 Lot Numbers: H2361544 H2382954 H2412363 H2430072 H2450925 H2498356 H2518811 H2520081 H2542786 H2586501 H2641143 H2687299 H2758479 Catalog Number: K09-01467AF UDI-DI code: 00884450750575 Lot Numbers: H2663133 H2729165 H2782382 Catalog Number: K09-01514U UDI-DI code:00884450392539 Lot Numbers: H2369960 H2387656 H2425596 H2471303 H2506109 H2529512 H2564547 H2590002 H2616732 H2627662 H2666883 H2746432 H2770561 H2824896 H2841949 H2866790 H2897446 H2920615 Catalog Number: K09-01734L UDI-DI code:00884450585009 Lot Numbers: H2360817 H2387232 H2405472 H2442198 H2471391 H2488275 H2502884 H2528940 H2569420 H2587832 H2666928 H2676308 H2714908 H2740483 H2757855 H2780813 H2795414 H2809458 H2825037 H2837565 H2853628 H2890112 H2915671 Catalog Number: K09-02040C UDI-DI code: 00884450298312 Lot Numbers: H2512599 H2714847 Catalog Number: K09-02683F UDI-DI code: 00884450204597 Lot Numbers: H2487396 H2529031 H2559767 H2581856 H2595394 H2606455 H2676287 H2786364 H2841958 H2855547 Catalog Number: K09-02804B UDI-DI code: 00884450283738 Lot Numbers: H2746430 H2785501 H2804202 H2842009 H2890141 Catalog Number: K09-03844F UDI-DI code: 00884450205280 Lot Numbers: H2596165 Catalog Number: K09-04088H UDI-DI code: 00884450566374 Lot Numbers: H2426195 H2471388 H2473959 H2558086 H2581900 H2595432 H2615361 Catalog Number: K09-04088J UDI-DI code: 00884450743713 Lot Numbers: H2641900 H2691924 H2714049 H2722319 H2746454 H2825041 H2837221 H2899238 H2910128 Catalog Number: K09-04863J UDI-DI code: 00884450278642 Lot Numbers: H2405452 H2425982 H2431335 H2460807 H2480614 H2532106 H2569112 H2581867 H2606685 H2623838 H2648569 H2674453 H2715024 H2740801 H2749693 H2780765 H2818318 H2818319 H2847030 H2864031 H2910548 H2920663 Catalog Number: K09-04946B UDI-DI code: 00884450464540 Lot Numbers: H2642042 Catalog Number: K09-04998H UDI-DI code:00884450680131 Lot Numbers: H2430236 Catalog Number: K09-04998HP UDI-DI code: 00884450407349 Lot Numbers: H2409016 H2428494 H2469111 H2524740 H2546174 H2565082S1 H2734104 H2740664 H2766411 H2775481 H2803916 H2823823 H2841931 H2874354 H2896100 H2928526 Catalog Number: K09-05229JP UDI-DI code: 00884450206676 Lot Numbers: H2749821 H2764405 H2795137 H2824990 H2841954 H2863971 H2905112 Catalog Number: K09-05342A UDI-DI code: 00884450208649 Lot Numbers: H2413457 H2444223 H2474152 H2490841 H2508756 H2519305 H2545376 H2562513 H2585433 H2600537 H2642350 H2705154 H2709024 H2729368 H2749175 H2762973 H2776733 H2792236 H2800652 H2814845 H2833461 H2845963 H2866227 H2915961 H2927496 Catalog Number: K09-05375F UDI-DI code: 00884450223468 Lot Numbers: H2488306 H2835770 Catalog Number: K09-05939D UDI-DI code: 00884450224823 Lot Numbers: H2354795 H2381159 H2413459 H2434412 H2474054 H2475915 H2508758 H2550446 H2575409 H2600538 H2607144 H2630940 H2705169 H2744447 H2758271 H2762976 H2792240 H2819761 Catalog Number: K09-07759J UDI-DI code: 00884450628515 Lot Numbers: H2379532 H2387653 H2434868 H2471448 H2478110 H2520513 H2521340 H2539588 H2599403 H2640836 H2642292 H2687906 H2824846 H2833805 H2867113 H2920598 Catalog Number: K09-07789L UDI-DI code: 00884450573709 Lot Numbers: H2397265 H2413521 Catalog Number: K09-07789M UDI-DI code: 00884450680506 Lot Numbers: H2437839 H2448861 H2497890 H2520583 H2558117 H2565065S1 H2566492 H2596153 H2642183 H2685412 H2708246 H2758678 H2792401 H2814997 H2833726 H2846103 H2866069 H2885248 H2899257 Catalog Number: K09-07828U UDI-DI code: 00884450207369 Lot Numbers: H2398381 H2476400 H2496135 H2520086 H2687302 H2725977 Catalog Number: K09-07828UP UDI-DI code: 00884450299005 Lot Numbers: H2398380 H2412364 H2418719 H2430073 H2450929 H2476399 H2496134 H2527501 H2549705 H2557541 H2581987 H2586498 H2602705 H2626751 H2656809 H2671733 H2684453 H2693359 H2715287 H2763495 H2782384 H2804870 H2819132 H2821845 H2843973 H2854815 H2859913 H2879430 H2885390 H2901814 Catalog Number: K09-07834C UDI-DI code: 00884450209035 Lot Numbers: H2393352 H2408686 H2453224 H2488198 H2520848 H2539283 H2576576 H2601760 H2621100 H2666916 H2676281 H2740690 H2749606 H2780746 H2824989 H2841953 H2859346 H2890059 Catalog Number: K09-07905G UDI-DI code: 00884450398883 Lot Numbers: H2393373 H2434148 H2474571 H2488230 H2513034 H2532111 H2547551 H2587768 H2606690 H2641718 H2659700 H2681375 H2740390 H2795360 H2880252 Catalog Number: K09-08031D UDI-DI code: 00884450209073 Lot Numbers: H2413504 H2430271 H2469783 H2494696 H2519417 H2545402 H2585471 H2591222 H2600569 H2645326 H2685428 H2751545 H2792379 H2846071 H2850715 H2885221 H2912189 H2929578 Catalog Number: K09-08052Q UDI-DI code: 00884450334256 Lot Numbers: H2356024 H2369603 H2381990 H2409897 H2418734 H2442168 H2462882 H2520919 H2537621 H2547601 H2559166 H2559935 H2595422 H2652467 H2666873 H2726944 H2749120 H2749122 H2749123 H2780809 H2789329 H2813695 H2841994 H2853616 H2875339 H2890114 H2910131 Catalog Number: K09-08065J UDI-DI code: 00884450307700 Lot Numbers: H2347421 H2367047 H2388006 Catalog Number: K09-08150R UDI-DI code: 00884450625149 Lot Numbers: H2471450 H2476097 H2498497 H2529511 H2559983 H2641723 H2746422 H2770424 H2789391 H2804219 H2816942 H2859499 H2890144 H2915710 H2926591 Catalog Number: K09-08423G UDI-DI code: 00884450213919 Lot Numbers: H2451524 H2496241 H2576946 H2593400 H2697200 H2725761 H2849101 H2915458 Catalog Number: K09-08493KP UDI-DI code: 00884450276860 Lot Numbers: H2412255 H2439633 H2532894 H2562889 H2569232 H2592406 H2602617 H2619264 Catalog Number: K09-08847A UDI-DI code: 00884450254172 Lot Numbers: H2676867 H2718404 Catalog Number: K09-08875B UDI-DI code: 00884450564707 Lot Numbers: H2447079 H2525122 H2641701 H2667085 H2804116 Catalog Number: K09-09051H UDI-DI code: 00884450169773 Lot Numbers: H2471421 H2474377 H2480752 H2532711 H2666871 H2746487 H2757875 H2780831 H2804196 H2813738 H2847068 H2873191 H2880223 H2906182 H2915712 Catalog Number: K09-09184B UDI-DI code: 00884450209479 Lot Numbers: H2390285 H2398101 H2412190 H2429010 H2440019 H2451529 H2451673 H2460433 H2476484 H2496331 H2501782 H2509256 H2520762 H2544202 H2557463 H2565441 H2576947 H2593402 H2602349 H2619386 H2626854 H2641352 H2676857 H2869819 H2874999 H2889669 H2911084 H2920490 Catalog Number: K09-09403HP UDI-DI code: 00884450486740 Lot Numbers: H2749717 H2757815 H2770326 H2786374 H2795367 H2831595 H2880050 H2890063 Catalog Number: K09-09481A UDI-DI code: 00884450214770 Lot Numbers: H2354844 H2370975 H2397267 H2424096 H2430262 H2508975 H2540346 H2566494 H2591241 H2600583 H2630971 H2654806 H2658630 H2680861 H2729937 H2767954 H2792408 H2806164 H2819986 H2828953 H2850737 H2866132 H2871345 H2879991 H2929681 Catalog Number: K09-09499B UDI-DI code: 00884450214794 Lot Numbers: H2381976 H2405321 H2418641 H2446733 H2474568 H2512330 H2520853 H2547479 H2595389 H2614402 H2629219 H2666866 H2676285 H2713985 H2740377 H2764411 H2780751 H2803993 H2831580 H2847023 H2890064 Catalog Number: K09-09814 UDI-DI code: 00884450215258 Lot Numbers: H2438008 H2606525 H2627174 H2649877 Catalog Number: K09-09900F UDI-DI code: 00884450550304 Lot Numbers: H2361545 H2367024 H2397842 H2418657 H2429846 H2439645 H2450863 H2496256 H2521372 H2558419 H2564300 H2573959 H2589897 H2602667 H2608718 H2619298 H2641101 H2729347 H2900324 H2911151 Catalog Number: K09-09902G UDI-DI code:00884450199497 Lot Numbers: H2367288 H2434574 H2714092 H2819618 Catalog Number: K09-09902GP UDI-DI code: 00884450225509 Lot Numbers: H2384769 H2400690 H2406480 H2419357 H2480746 H2506090 H2532707 H2569166 H2576723 H2740523 H2770409 H2787669 H2795430 H2813732 Catalog Number: K09-09975 UDI-DI code: 00884450227152 Lot Numbers: H2398797 H2475249 H2480024 H2747723 Catalog Number: K09-10060F UDI-DI code: 00884450199817 Lot Numbers: H2387220 H2408702 H2426184 H2442162 H2474639 H2487476 H2488262 H2532168 H2641733 H2667077 H2722249 H2740787 H2757842 H2780803 H2809448 H2831627 H2835536 H2837535 Catalog Number: K09-10062F UDI-DI code: 00884450258736 Lot Numbers: H2367042 H2382952 H2394414 H2397878 H2418715 H2430071 H2439675 H2464189 H2469939 H2490481 H2496132 H2500557 H2520079 H2520103 H2557540 H2582995 H2589885 H2612344 H2641142 H2693373 H2758490 H2782387 H2823926 H2841767 H2859915 H2875044 H2900293 Catalog Number: K09-10210A UDI-DI code: 00884450227404 Lot Numbers: H2389293 H2394402 H2397874 H2412352 H2418705 H2430061 H2439668 H2439669 H2450901 H2454881 H2476395 H2480731 H2490455 H2496128 H2500547 H2520065 H2520101 H2542768 H2557536 H2564320 H2569259 H2576634 H2594080 H2602692 H2603377 H2608728 H2612339 H2626745 H2626746 H2640668 H2641138 H2650751 H2663144 H2671726 H2687294 H2717944 H2758491 H2800041 Catalog Number: K09-10210B UDI-DI code: 00884450790731 Lot Numbers: H2808197 H2808201 H2813057 H2825050 H2842022 H2890149 H2910127 Catalog Number: K09-10286G UDI-DI code: 00884450572313 Lot Numbers: H2397843 H2418663 H2441779 H2510033 H2510034 H2542742 H2542743 H2569249 H2573960 H2614698 H2614775 H2641108 H2676779 H2701896 H2749383 H2758446 H2794933 H2823921 H2836597 H2854807 H2864894 H2905931 H2911152 H2920518 Catalog Number: K09-10300F UDI-DI code: 00884450621356 Lot Numbers: H2451653 H2451683 H2476488 H2496325 H2552833 H2565444 H2576950 H2582085 H2593408 H2626881 H2641355 H2725762 H2729014 H2767982 H2799977 H2814254 H2828175 H2836581 H2844891 H2854779 H2889676 H2899997 H2915459 Catalog Number: K09-10315B UDI-DI code: 00884450210017 Lot Numbers: H2406598 H2421161 H2440950 H2461487 H2471090 H2512356 H2599404 H2608319 H2627600 H2718395 H2757681 H2770542 Catalog Number: K09-10432A UDI-DI code: 00884450216590 Lot Numbers: H2585547 Catalog Number: K09-10444J UDI-DI code: 00884450540534 Lot Numbers: H2393387 H2405418 H2418744 H2420393 H2473593 H2473921 H2502889 H2520929 H2523472 H2559719 H2567730 H2581896 H2595423 H2615355 H2659761 H2714925 H2740828 H2753531 Catalog Number: K09-10475 UDI-DI code: 00884450224045 Lot Numbers: H2359867 H2434434 H2762982 H2879883 Catalog Number: K09-10494C UDI-DI code: 00884450750087 Lot Numbers: H2752403 H2770554 H2796720 H2875209 H2890040 H2905039 Catalog Number: K09-10574D UDI-DI code: 00884450273753 Lot Numbers: H2357365 H2367014 H2382869 H2382870 H2397959 H2412252 H2439630 H2439631 H2450808 H2469972 H2470758 H2476249 H2490404 H2510681 H2519993 H2542703 H2564290 H2569231 H2581941 H2608677 H2650689 H2650690 H2671713 H2687253 H2717893 H2736570 H2763408 H2782351 H2792530 H2828183 H2841750 H2854788 H2864812 H2869826 H2885367 H2889687 H2905909 H2915464 H2927604 Catalog Number: K09-10726 UDI-DI code: 00884450216866 Lot Numbers: H2757793 H2789161 H2837453 Catalog Number: K09-10736D UDI-DI code: 00884450624500 Lot Numbers: H2350713 H2381987 H2409953 H2431360 H2442130 H2474643 H2509836 H2520881 H2543653 H2559926 H2631423 Catalog Number: K09-10788A UDI-DI code: 00884450559963 Lot Numbers: H2369351 H2387652 H2409538 H2421237 H2471294 H2512353 Catalog Number: K09-10811 UDI-DI code: 00884450557716 Lot Numbers: H2356093 H2379951 H2406488 H2421298 H2436923 H2440967 H2471308 H2502997 H2525135 H2555403 H2578855 H2666884 H2714927 H2867112 Catalog Number: K09-10829B UDI-DI code: 00884450457917 Lot Numbers: H2393002 H2414040 H2443213 H2518372 H2536698 H2555947 H2575227 H2642119 H2659290 Catalog Number: K09-10830C UDI-DI code: 00884450210499 Lot Numbers: H2428294 H2489561 H2518331 H2575114 Catalog Number: K09-10929 UDI-DI code: 00884450217405 Lot Numbers: H2407687 H2432447 H2454272 H2475251 H2500493 H2529823 H2561933 H2592015 H2627014 H2630698 H2642132 H2649811 H2670835 H2675978 H2709341 H2723108 H2751032 H2753528 H2762291 H2771800 H2810123 H2832688 H2845902 H2875107 H2897827 H2918270 H2928681 Catalog Number: K09-10994D UDI-DI code: 00884450681152 Lot Numbers: H2751606 H2806061 H2837645 H2846075 H2850717 H2855751 H2866120 H2879966 Catalog Number: K09-11024DP UDI-DI code: 00884450262726 Lot Numbers: H2387198 H2413770 H2460764 H2488227 H2520830 H2583327 H2621133 H2653189 H2655274 H2676289 H2722100 H2743926 H2780763 H2813645 H2847029 H2859359 H2863998 H2890071 H2920682 Catalog Number: K09-11076C UDI-DI code: 00884450282410 Lot Numbers: H2745424 H2763296 H2833774 H2871335 Catalog Number: K09-11107D UDI-DI code: 00884450647103 Lot Numbers: H2399232 Catalog Number: K09-11149B UDI-DI code: 00884450549704 Lot Numbers: H2360513 H2382896 H2418656 H2450861 H2470766 H2476281 H2496277 H2500510 H2520032 H2603466 H2619297 H2641809 H2650721 Catalog Number: K09-11196 UDI-DI code: 00884450218082 Lot Numbers: H2359707 H2381003 H2414043 H2448741 H2474049 H2480103 H2518373 H2536699 H2551744 H2555948 H2600866 H2630752 H2649859 H2659267 H2665498 H2751651 H2751656 H2762130 H2781198 H2819491 H2832489 H2845472 H2866096 H2881356 Catalog Number: K09-11207DP UDI-DI code: 00884450224281 Lot Numbers: H2359229 H2406868 H2474265 H2518282 H2556087 H2585788 H2605796 H2630822 H2645018 H2659655 H2751112 H2812795 H2866049 H2867490 H2896918 Catalog Number: K09-11259G UDI-DI code: 00884450750933 Lot Numbers: H2758542 H2782425 H2840940 H2885430 H2915502 Catalog Number: K09-11259GP UDI-DI code: 00884450770740 Lot Numbers: H2796087 H2800045 H2809498 H2819135 Catalog Number: K09-11444B UDI-DI code: 00884450249994 Lot Numbers: H2387235 H2442241 H2487375 H2523476 H2532715 H2587844 H2615569 H2666885 H2740793 H2780835 H2804200 H2819620 H2853709 H2915355 H2932752 Catalog Number: K09-11482D UDI-DI code: 00884450334089 Lot Numbers: H2360602 H2387199 H2393370 H2413772 H2425986 H2446876 H2474651 H2488229 H2520863 H2543650 H2559873 H2595402 H2606689 H2659699 H2666909 H2713997 H2746403 H2774630 H2809410 Catalog Number: K09-11607B UDI-DI code: 00884450265451 Lot Numbers: H2409657 Catalog Number: K09-11646C UDI-DI code: 00884450210864 Lot Numbers: H2364084 H2391416 H2407700 H2423152 H2474140 H2500498 H2546015 H2567145 H2585556 H2627016 H2665582 H2685243 H2751517 H2860569 H2884403 Catalog Number: K09-11913C UDI-DI code: 00884450544488 Lot Numbers: H2387651 H2409536 H2471424 H2506105 H2520527 H2529745 Catalog Number: K09-12030AP UDI-DI code: 00884450632314 Lot Numbers: H2757856 H2780816 H2804118 H2831644 H2842002 H2867061 H2880114 H2910138 H2926565 H2933143 Catalog Number: K09-12245A UDI-DI code: 00884450261576 Lot Numbers: H2505776 H2523568 H2779968 Catalog Number: K09-12304A UDI-DI code: 00884450555750 Lot Numbers: H2454270 H2471307 H2506113 H2514525 H2544423 H2560083 H2578853 H2590004 H2608457 Catalog Number: K09-12304B UDI-DI code: 00884450743300 Lot Numbers: H2640829 H2702833 H2714919 H2770563 H2796743 H2835778 H2849848 H2866801 H2890049 H2910095 H2915560 H2920617 Catalog Number: K09-12359B UDI-DI code: 00884450273586 Lot Numbers: H2523510 H2615216 Catalog Number: K09-12396FP UDI-DI code: 00884450638736 Lot Numbers: H2360505 H2383032 H2418585 H2429836 H2439636 H2469988 H2490412 H2581950 H2592418 H2667624 H2676798 H2707272 H2749380 H2754014 H2792534 H2799992 H2814261 H2823906 H2828184 H2835136 H2841751 H2846814 H2864816 H2895264 H2905910 H2926208 H2933006 Catalog Number: K09-12404 UDI-DI code: 00884450258248 Lot Numbers: H2360546 H2382951 H2388004 H2418714 H2454885 H2464188 H2469938 H2480739 H2500553 H2520078 H2542782 H2557539 H2569263 H2602702 H2701886 H2749398 H2782390 H2800047 H2841769 H2854818 H2869868 H2889717 H2920545 Catalog Number: K09-12556B UDI-DI code: 00884450292679 Lot Numbers: H2520739 H2575311 H2617749S1 Catalog Number: K09-12615 UDI-DI code: 00884450290583 Lot Numbers: H2381996 H2399227 H2434608 H2453439 H2474393 H2493073 H2513076 H2528957 H2558248 H2569171 H2591932 H2608202 H2629346 H2666892 H2714934 H2740794 H2757880 H2789382 H2804209 H2819622 H2837614 H2847071 H2876247 H2890157 H2910104 Catalog Number: K09-12698 UDI-DI code: 00884450286579 Lot Numbers: H2356023 H2387224 H2477451 H2496748 H2506084 H2520912 H2576667 H2666951 H2714891 H2757846 H2837540 H2865612 Catalog Number: K09-12698A UDI-DI code: 00884450820858 Lot Numbers: H2890177 Catalog Number: K09-12699 UDI-DI code: 00884450298985 Lot Numbers: H2414045 H2437915 H2475377 H2509009 H2523550 H2569476 H2575229 Catalog Number: K09-12699A UDI-DI code: 00884450750551 Lot Numbers: H2666940 H2745973 Catalog Number: K09-12699B UDI-DI code: 00884450812587 Lot Numbers: H2850573 H2868386 Catalog Number: K09-12704A UDI-DI code: 00884450293072 Lot Numbers: H2367556 H2379948 H2392946 H2440958 H2454149 H2498353 H2539645 H2613546 H2641685 H2676870 H2718406 H2744318 H2757707 H2770548 H2809534 H2824866 H2833764 H2849844 H2875212 H2905048 Catalog Number: K09-12867A UDI-DI code: 00884450333723 Lot Numbers: H2791694 Catalog Number: K09-12899A UDI-DI code: 00884450584101 Lot Numbers: H2372599 H2473518 H2480643 H2488248 H2614539 H2666923 H2714964 H2804062 H2835783 H2853419 H2880059 H2915611 H2920697 Catalog Number: K09-12939B UDI-DI code: 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H2399172 H2418666 H2434227 H2471341 H2488236 H2493001 H2520873 H2572185 H2601392 H2617009 H2641408 H2659705 H2714837 H2714838 H2764448 H2780771 H2786377 H2804059 H2825006 H2838172 H2844559 H2867100 H2880062 H2890079 H2905176 Catalog Number: K09-13420 UDI-DI code: 00884450481073 Lot Numbers: H2434618 H2493078 H2567728 H2804212 Catalog Number: K09-13507CP UDI-DI code: 00884450634127 Lot Numbers: H2745953 H2764499 H2780782 H2818325 H2844562 H2853425 H2867097 H2875302 H2905191 H2910592 Catalog Number: K09-13617P UDI-DI code: 00884450621134 Lot Numbers: H2746377 H2761524 Catalog Number: K09-13659AP UDI-DI code: 00884450587508 Lot Numbers: H2749817 H2759126 H2770399 Catalog Number: K09-13660 UDI-DI code: 00884450558102 Lot Numbers: H2386167 H2413493 H2444246 H2448836 H2519357 H2537889 H2596113 H2709059 H2713404 H2753890 H2763003 H2776753 H2845999 H2879893 H2885127 H2912334 Catalog Number: K09-13767 UDI-DI code: 00884450603307 Lot Numbers: H2641154 H2642946 H2773381 H2804874 H2846834 H2869869 H2889718 H2915481 Catalog Number: K09-13880 UDI-DI code: 00884450732700 Lot Numbers: H2604628 H2641722 H2666966 H2796739 H2811122 H2821392 H2834318 H2880040 H2890051 H2915561 H2920619 Catalog Number: K09-13882 UDI-DI code: 00884450659700 Lot Numbers: H2370740 Catalog Number: K09-13882A UDI-DI code: 00884450720325 Lot Numbers: H2559933 H2752306 H2780792 H2831609 H2880069 H2905203 Catalog Number: K09-13933 UDI-DI code: 00884450666708 Lot Numbers: H2394993 H2408701 Catalog Number: K09-14000 UDI-DI code: 00884450749913 Lot Numbers: H2792573 Catalog Number: K09-14000A UDI-DI code: 00884450785102 Lot Numbers: H2800118 H2814953 H2854844 H2875095 Catalog Number: K09-14047 UDI-DI code: 00884450743317 Lot Numbers: H2749842 H2757828 H2825022 H2859396 H2895090 H2922539 Catalog Number: K09-14096 UDI-DI code: 00884450741993 Lot Numbers: H2625857 H2650759 H2758506 H2782391 H2823929 H2828209 H2841770 H2869870 H2885396 H2905939 H2915482 Catalog Number: K09-14196 UDI-DI code: 00884450806302 Lot Numbers: H2838189 Catalog Number: K09-14219 UDI-DI code: 00884450812709 Lot Numbers: H2850576 H2868384 H2920719 Catalog Number: K09-14220 UDI-DI code: 00884450813393 Lot Numbers: H2850578 H2868383 Catalog Number: K09T-13643 UDI-DI code: 00884450540329 Lot Numbers: T2428999 T2449676 T2466104 T2490332 T2550721 T2556890 T2606429 T2667831 T2697369 T2699398 T2699399 T2723025 T2753441 T2807106 T2842475 T2879925 T2895213 T2918330
• 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: 188837 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.