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-2565-2024
• Recall Event ID: 94797
• Product Classification: Universal drainage tray - Product Code PPD
• Product: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10/K10-PI (Custom Waste Management Kit), REF: K10T-05815 K10T-05816 K10-04722C K10-03591KP K10-05530 K10-04291AP K10-04386CP K10T-05227 K10-05120P K10-03220AP K10-05251AP K10-04479P K10-01722QP K10-04931B K10-04429 K10-06012P K10-05043A K10-06066 K10-06011AP K10-06033AP K10-06086P K10-05222 K10T-00856B K10T-01343F K10T-03849G K10T-05668D K10T-05403 K10T-03958L K10T-05139 K10-05343 K10T-04662A K10-04800DP K10T-05428 K10T-04278C K10T-04942A K10T-04216G K10T-04110B K10-04201GP K10-01571C K10T-05261 K10-04183CP K10-00839FP K10-00785LP K10-00777BP K10-04413A K10-00592K K10-05097A K10-05774P K10-05636A K10-03327D K10-00814L K10-04360B K10-03383BP K10-01270T K10-04621 K10-05913P K10-05472 K10-04693D K10-03290D K10T-04335A K10-04426B K10-01700AP K12-05018 K10-05274AP K10-05511 K10T-04155C K10T-03903F K10T-04978H K10T-03997F K10-03364A K10-05833P K10-05097B K10-05700 K10-03184 K10-05457AP K10-05675 K10-03666B To support the withdrawal and collection of fluids from the body.
• Code Information: Catalog Number/UDI-DI code/Lot Numbers: K10-01722QP 00884450570340 H2410331 H2471342 H2480639 H2502357 H2513044 H2525139 H2543652 H2558245 H2564522 H2825008 H2831600 H2875331 H2915643 K10-03220AP 00884450174036 H2406448 H2408885 H2423250 H2428461 H2448942 H2500653 H2536816 H2567302 H2601107 H2623288 H2659637 H2665379 H2708979 H2721135 H2730471 H2760266 H2774855 H2794124 H2812819 H2829027 H2838364 H2843344 H2850151 H2868190 H2872165 H2905227 H2913401 K10-03591KP 00884450380635 H2391366 H2408970 H2441713 H2472906 H2482293 H2491990 H2496930 H2500665 H2518450 H2527822 H2551825 H2567305 H2627298 H2638378 H2645033 H2708977 H2716700 H2730479 H2751466 H2778878 H2784096 H2794135 H2808194 H2821498 H2918877 K10-04291AP 00884450176320 H2352552 H2401233 H2418439 H2431501 H2461658 H2475592 H2492022 H2511077 H2513895 H2518283 H2530047 H2538940 H2551884 H2563710 H2567356 H2641969 H2662164 H2679955 H2713607 H2728230 H2744412 H2785947 H2795948 H2809437 H2818171 H2832163 H2843600 H2866062 H2896827 H2912839 H2918929 K10-04386CP 00884450197523 H2384157 H2401236 H2423252 H2444355 H2470464 H2496947 H2522107 H2559517 H2573434 H2655272 H2659665 H2665397 H2708975 H2730487 H2744361 H2746709 H2755852 H2778887 H2834781 H2838372 H2844785 H2872168 H2882630 H2897046 H2913305 H2918921 K10-04429 00884450176795 H2418279 H2448704 H2468945 H2489657 H2505650 H2518225 H2585617 H2600807 H2642069 H2642462 H2665625 H2692001 H2703157 H2728629 H2735292 H2756121 H2776259 H2795556 H2814363 H2832784 H2845927 H2875164 H2913298 H2928657 K10-04479P 00884450177075 H2409371 H2475562 K10-04722C 00884450270431 H2429014 H2496323 H2520764 H2557465 H2589898 H2626879 H2666564 H2736535 H2777762 H2799974 H2828177 H2859884 H2864805 H2905908 K10-04931B 00884450393147 H2402920 H2469836 H2474257 H2476022 H2480793 H2494885 H2751615 H2782208 H2787882 H2800804 H2815006 H2824607 H2871355 K10-05043A 00884450202074 H2610631 H2627090 H2680755 H2728653 H2875168 H2928687 K10-05120P 00884450197202 H2399127 H2431312 H2498451 H2523383 H2527704 H2553771 H2576585 H2655265 H2669130 H2720156 H2757798 H2831587 H2837463 H2847025 H2867088 H2890107 H2915648 H2920730 K10-05222 00884450230824 H2839171 H2849535 K10-05251AP 00884450265499 H2408968 H2428471 H2448946 H2469092 H2475567 H2562411 H2567311 H2585822 H2627308 H2633766 H2655299 H2665378 H2675063 H2708968 H2744380 H2755857 H2774890 H2784101 H2789811 H2802599 H2829053 H2843351 H2877200 H2891663 H2928416 K10-05530 00884450284407 H2581869 K10-06011AP 00884450634516 H2752358 H2771050 H2818172 H2849571 H2866057 K10-06012P 00884450681107 H2464776 H2507506 H2507672 H2518503 H2576565 H2585848 H2641118 H2650735 H2707287 H2763420 H2900287 H2915472 K10-06033AP 00884450663707 H2780818 H2804119 H2816921 H2831647 H2837566 H2867095 H2890128 H2910148 K10-06066 00884450695524 H2744543 H2824018 H2869593 H2884336 H2912589 K10-06086P 00884450695111 H2804075 H2813661 H2831607 H2867102 K10T-05227 00884450619957 T2736090 T2842237 T2862543 T2899709 K10T-05815 00884450486061 T2143908 T2310781 T2323193 T2330789 T2340443 T2363413 T2363416 T2414967 T2427552 T2437298 T2474307 T2534990 T2534991 T2576721 T2580922S K10T-05816 00884450486115 T2198303 T2237161 T2238504 T2259632 T2259636 T2259646 T2323194 T2330794 T2330795 T2330796 T2363411 T2363412 T2363417 T2370536 T2399814 T2417139 T2427554 T2427562 T2456678 T2469555 T2474316 T2474987 T2474987S T2534987 T2534988 T2542105 T2553454 T2553455 T2553457 T2580725S T2590403 T2626099 K10-00592K 00884450235140 H2393452 H2420172 H2443412 H2451992 H2470701 H2476538 H2521149 H2521296 H2544998 H2577007 H2613404 H2642940 H2697212 H2707453 H2744182 H2763384 H2792508 H2846785 H2850808 H2864775 H2911026 K10-00777BP 00884450171356 H2382837 H2412350 H2412351 H2439664 H2454880 H2469915 H2496127 H2521359 H2532904 H2549693 H2564318 H2608724 H2630383 H2671723 H2676769 H2681498 H2729338 H2744246 H2782393 H2796088 H2800051 H2823930 H2828210 H2900295 H2908480 H2928030 K10-00785LP 00884450171363 H2354646 H2359761 H2381074 H2500634 H2576482 H2592743 H2633681 H2746688 H2829020 K10-00814L 00884450375211 H2391149 H2429178 H2429179 H2474142 H2519369 H2702874 H2709084 H2729408 H2865738 H2912314 H2932289 K10-00839FP 00884450171509 H2353207 H2442209 H2474355 H2559946 H2582189 H2666829 H2703436 H2730574 H2770405 H2777617 H2795425 H2819611 H2828354 H2847065 H2853704 H2859507 H2905308 K10-01270T 00884450320792 H2406427 H2413487 H2480743 H2519372 H2585454 H2596107 H2600560 H2615014 H2705266 H2717708 H2729411 H2753894 H2767717 H2781958 H2805418 H2824729 H2846005 H2879898 H2885139 K10-01571C 00884450172704 H2437814 H2469804 H2475959 H2519374 H2537897 H2562540 H2585455 H2591201 H2607153 H2705250 H2713444 H2738386 H2749188 H2767718 H2781960 H2800719 H2828298 H2865687 H2912221 H2927507 K10-01700AP 00884450172896 H2432646 H2475553 H2513924 H2518194 H2523106 H2546141 H2627293 H2633685 H2684906 H2755834 H2760262 H2789795 H2802581 H2834774 H2850144 H2896990 K10-03184 00884450173978 H2723085 K10-03290D 00884450174173 H2398057 H2429642 H2440121 H2470702 H2476533 H2497323 H2521293 H2552981 H2569338 H2593800 H2602335 H2626906 H2657735 H2736546 H2758364 H2767991 K10-03327D 00884450358474 H2399047 H2475961 H2490868 H2500928 H2642098 H2699127 H2763063 H2772973 H2781982 H2805423 H2814903 H2866206 H2916581 K10-03364A 00884450174302 H2767140 H2787066 H2825503 K10-03383BP 00884450174470 H2413766 H2431314 H2442065 H2451601 H2480561 H2531173 H2543647 H2559858 H2678789 H2690630 H2729477 H2746472 H2780753 H2802285 H2818310 H2847026 H2870440 H2895058 K10-03666B 00884450175088 H2823758 K10-04183CP 00884450176054 H2351711 H2354650 H2432649 H2469087 H2530021 H2556100 H2576500 H2596269 H2615644 H2669945 H2675061 H2680064 H2721140 H2746703 H2755848 H2765532 H2778883 H2798349 H2838371 H2844086 H2857414 H2882625 H2897043 H2905266 H2912943 H2928402 K10-04201GP 00884450431429 H2381217 H2405971 H2453053 H2474162 H2482360 H2488359 H2500676 H2516291 H2517062 H2544212 H2549177 H2551826 K10-04360B 00884450176511 H2402908 H2434453 H2454179 H2475964 H2500929 H2519386 H2537904 H2550456 H2562543 H2591207 H2625331 H2658559 H2709092 H2713458 H2724386 H2738402 H2743422 H2758297 H2767724 H2772976 H2781983 H2787737 H2796458 H2800724 H2814909 H2824736 H2837110 H2857775 H2885153 H2912269 H2916582 K10-04413A 00884450176740 H2386135 H2412595 H2417532 H2470430 H2575472 H2591208 H2607155 H2615025 H2642082 H2653570 H2705208 H2814913 H2866220 K10-04426B 00884450435441 H2413490 H2448841 H2475965 H2519387 H2537905 H2566457 H2630955 H2709095 K10-04621 00884450177457 H2406989 H2413470 H2444262 H2475966 H2511862 H2519388 H2684812 H2709283 H2713461 H2824738 H2837113 H2860555 H2871428 H2893756 H2915982 K10-04693D 00884450262481 H2407705 H2428330 H2464965 H2475323 H2518222 H2551727 H2596200 H2627088 H2703135 H2747760 H2787067 H2800132 H2814364 H2869637 K10-04800DP 00884450196021 H2488218 H2520856 H2595396 H2614413 H2641388 H2655270 H2690568 H2708832 H2720157 H2764416 H2777638 H2795332 H2809399 H2824993 H2838132 H2844551 H2859356 H2867094 H2880073 H2890106 H2910624 K10-05097A 00884450197073 H2386175 H2448851 H2519426 H2575499 H2607205 H2633708 H2654764 K10-05097B 00884450756508 H2685180 H2781343 H2837271 H2849973 H2866212 H2913308 K10-05274AP 00884450659519 H2587850 H2655380 H2666828 H2720256 H2745963 H2770428 H2780848 H2789392 H2813743 H2842017 H2875374 H2899222 H2905310 H2921244 K10-05343 00884450235560 H2529935 H2555969 H2592259 H2600916 H2675783 H2685118 H2703568 H2735167 H2762172 H2781243 H2795447 H2819538 H2881378 K10-05457AP 00884450312780 H2746387 H2764528 H2813694 H2831628 H2837542 H2841993 H2844694 H2867091 H2875345 H2890127 H2899252 K10-05472 00884450270639 H2409929 H2413270 H2498456 H2559869 H2641711 K10-05511 00884450283646 H2448561 K10-05636A 00884450394014 H2391156 H2397178 H2424068 H2448843 H2490871 H2585460 H2615031 H2749195 H2767728 K10-05675 00884450400944 H2753581 H2837273 K10-05700 00884450466759 H2744209 H2753582 H2791763 H2800136 H2814373 H2828011 H2837274 H2849975 H2875169 K10-05774P 00884450555910 H2402965 H2414102 H2500788 H2564127 H2592795 H2675065 H2684903 H2721147 H2739358 H2746717 H2770024 H2843360 H2868179 H2877212 H2913283 K10-05833P 00884450552957 H2751209 K10-05913P 00884450522356 H2418662 H2442106 H2453336 H2488235 H2498463 H2528155 H2547566 H2576600 H2581874 H2636097 K10T-00856B 00884450257630 T2131617 T2194472 T2239571 T2268933 T2310883 T2329171 T2360494 T2417861 T2465749 T2479569 T2505793 T2527123 T2587256 T2596741 T2652615 T2698965 T2712047 T2786089 T2805471 T2840601 T2842270 T2862040 T2898698 K10T-01343F 00884450238516 T2700152 T2712393 T2741709 T2775305 T2805997 T2848063 T2872006 T2885311 K10T-03849G 00884450201459 T2256824 T2299853 T2322984 T2333571 T2355740 T2387061 T2407485 T2429021 T2437094 T2499082 T2521173 T2527253 T2550792 T2572078 T2610045 T2655959 T2677529 T2701730 T2727027 T2761356 T2807112 T2832505 T2869837 T2910727 K10T-03903F 00884450257593 T2587257 T2625819 T2652624 T2708973 K10T-03958L 00884450414910 T2167604 T2261967 T2305936 T2322986 T2340254 T2370031 T2404523 T2429022 T2446367 T2470234 T2505381 T2509730 T2527260 T2536900 T2609506 T2670069 T2745524 T2760426 T2775349 T2830814 T2864822 T2899047 K10T-03997F 00884450447017 T2662074 K10T-04110B 00884450320624 T2363588 T2382425 T2457932 T2479583 T2498833 T2536906 T2581366 T2625820 T2677550 T2746584 T2752959 T2801981 T2863415 K10T-04155C 00884450267554 T2643976 K10T-04216G 00884450240878 T2360553 T2397204 T2412578 T2449689 T2494475 T2527503 T2550727 T2587447 T2627403 T2680829 T2713192 T2750452 T2758255 T2818275 T2862473 T2877074 T2918375 K10T-04278C 00884450318836 T2360557 T2397183 T2527527S T2550628 T2620405 T2747270 T2761384 T2816472 T2824136 T2928269 K10T-04335A 00884450413852 T2732959 T2762843 T2921111 K10T-04662A 00884450306109 T2283344 T2306126 T2330944 T2352352 T2371538 T2404616 T2489387 T2537750 T2543102 T2570353 T2609818 T2658520 T2682252 T2740099 T2773384 T2779965 T2792493 T2816379 T2843421 T2862488 T2906192 T2918402 K10T-04942A 00884450319659 T2351570 T2366382 T2397184 T2429120 T2443500 T2465880 T2499019 T2499664 T2515748 T2521872 T2527598 T2581434 T2595447 T2606462 T2643847 T2680804 T2773330 T2779967 T2816321 T2833110 T2902199 T2906195 T2927195 K10T-04978H 00884450501245 T2626084 T2709021 T2750457 T2816449 T2848391 T2849852 T2905868 K10T-05139 00884450388495 T2604766 K10T-05261 00884450320297 T2408189 T2417985 T2446370 T2479737 T2637165 T2736369 T2781930 T2821650 T2848452 T2870228 T2884484 T2898771 T2927200 K10T-05403 00884450247235 T2485404 T2527717 T2584669 T2670915 T2754726 T2833118 T2899048 K10T-05428 00884450264195 T2339967 T2371539 T2383202 T2404674 T2427545 T2434463 T2458517 T2516379 T2527722 T2578263 T2587584 T2609819 T2644043 T2680608 T2701830 T2718892 T2750466 T2775548 T2823560 T2827728 T2848575 T2862546 T2902677 T2906263 T2921192 K10T-05668D 00884450486702 T2256883 T2310963 T2333977 T2355746 T2399998 T2404953 T2429306 T2498021 T2499043 T2511779 T2550738 T2572042 T2606490 T2643781 T2670926 T2699281 T2738156 T2774643 T2775584 T2800622 T2827649 T2842495 T2862612 T2898777 T2902696 T2918477 K12-05018 00884450193778 H2428338 H2615366 H2753586 H2800139 H2857780
• 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: 138471
• 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.