FDAFDA · Food and drugs·Recall number Z-2579-2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K05-02166B K05T-00380C K05T-01674B K05T-01863 K05T-01941C K05T-01955 K05T-02138 K05T-02159 K05T-02272G K05T-02272H K05T-02515A K05T-02533 K05T-02728 K05T-02733C K05T-03153 K05T-03201 K09T-00318D K09T-07304G K09T-07627L K09T-07627M K09T-08747 K09T-08774F K09T-08952 K09T-09037J K09T-09358 K09T-09576J K09T-09760C K09T-09978A K09T-10485L K09T-10728H K09T-10728J K09T-11022C K09T-11022D K09T-11379F K09T-11430B K09T-11478A K09T-11738D K09T-11798 K09T-11875B K09T-12020B K09T-12020C K09T-12200 K09T-12538F K09T-12538G K09T-12883B K09T-12883C K09T-12942B K09T-12942C K09T-12942D K09T-12942F K09T-12970B K09T-13293 K09T-13293A K09T-13294 K09T-13294A K09T-13384B K09T-13384C K09T-13444B K09T-13459A K09T-13459B K09T-13681A K09T-13740 K09T-13927 K09T-13927A K09T-13949 K09T-13972 K09T-14025 K09T-14028B K09T-14035 K09T-14072 K09T-14218 K10T-01528G K10T-01528H K10T-03769F K10T-04233J K10T-04941B K10T-05595A K10T-05611B K10T-05680B K10T-06085 K10T-06085A K10T-06101 K10T-12092 K10T-12092A K12-05727F K12T-01737D K12T-01816A K12T-01996K K12T-02064 K12T-02285F K12T-02667A K12T-02703C K12T-02703F K12T-02911F K12T-02911G K12T-02940 K12T-03196 K12T-03312 K12T-03724F K12T-03933C K12T-03975A K12T-03979C K12T-04085 K12T-04270A K12T-04271B K12T-04348A K12T-04383G K12T-04707 K12T-04926G K12T-05302D K12T-05303D K12T-05303F K12T-05327D K12T-05432F K12T-05432G K12T-05627 K12T-05849C K12T-05849D K12T-05849F K12T-05850B K12T-05850C K12T-05903B K12T-05968D K12T-05974A K12T-05996M K12T-05996N K12T-06043 K12T-06313B K12T-06412A K12T-06431A K12T-06436 K12T-06694A K12T-06821 K12T-06826 K12T-06839A K12T-07986C K12T-08071C K12T-08071D K12T-08072D K12T-08072F K12T-08166D K12T-08703 K12T-08964F K12T-09013F K12T-09237A K12T-09292A K12T-09338D K12T-09456B K12T-09840B K12T-10464 K12T-10514A K12T-10515 K12T-10515A K12T-10516 K12T-10562 K12T-10583A K12T-10586A K12T-10649 K12T-10664A K12T-10881B K12T-11049 K12T-11151 K12T-11586 K12T-11626B K12T-11626C K12T-11680 K12T-11684 K12T-11826 K12T-11853P K12T-11857B K12T-11880 K12T-11880A K12T-11880B K12T-11901 K12T-11903 K12T-11910 K12T-11923 K12T-11923A K12T-11924A K12T-11925A K12T-11943B K12T-11943C K12T-11984 K12T-11985 K12T-11996 K12T-12017 K12T-12091 K12T-12138 K12T-12149 K12T-12153 K12T-12155 K12T-12155A K12T-12155B K12T-12157 K12T-12157A K12T-12157B K12T-12224 K12T-12224A K12T-12224B K12T-12230 K12T-12242 K12T-12242A K12T-12244 K12T-12285A K12T-12291 K12T-12291A K12T-12323 K12T-12331A K12T-12397 K12T-12403 K12T-12406 K12T-12406A K12T-12407 K12T-12419 K12T-12448 K12T-12448A K12T-12494 K12T-11210 K12T-12321 K20T-00002 K20T-00004A K20T-00012 K20T-00016A K20T-00019 K20T-00027 K20T-00031 K20T-00035 K12T-02045 K12T-02909 K12T-03993A K12T-06280 K12T-09329A K12T-09368A K12T-10157 K12T-12095 K05T-01920F K09T-10485M K09T-14028 K09T-14028A K10-04922C K10T-00554J K10T-00554L K10T-00861D K10T-01428A K10T-01785L K10T-02735D K10T-03122A K10T-03348K K10T-03627F K10T-03627G K10T-03627H K10T-03776F K10T-03776G K10T-03784 K10T-03810A K10T-03810B K10T-03979M K10T-04060G K10T-04113Q K10T-04113R K10T-04160R K10T-04163H K10T-04199C K10T-04200C K10T-04256H K10T-04338G K10T-04415K K10T-04463D K10T-04500B K10T-04578B K10T-04655B K10T-04718F K10T-04723B K10T-04744D K10T-04774D K10T-04775 K10T-04780 K10T-04806A K10T-04844N K10T-04861B K10T-04862 K10T-04892 K10T-04983B K10T-04986F K10T-05012G K10T-05012H K10T-05081F K10T-05082G K10T-05165A K10T-05197B K10T-05219 K10T-05272C K10T-05307B K10T-05308B K10T-05365A K10T-05366B K10T-05367 K10T-05397 K10T-05451N K10T-05451R K10T-05462 K10T-05493B K10T-05504C K10T-05518 K10T-05531 K10T-05541C K10T-05541D K10T-05592B K10T-05593C K10T-05612 K10T-05651B K10T-05655 K10T-05662 K10T-05665A K10T-05666 K10T-05666A K10T-05667F K10T-05667G K10T-05667H K10T-05670B K10T-05711A K10T-05711B K10T-05746A K10T-05747A K10T-05797 K10T-05812A K10T-05817 K10T-05819
Published August 21, 2024 · Recall initiated: June 11, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
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: TKITS-CI K05-02166B 00884450499597 T2199559 T2241078 T2282965 T2314787 T2449229 T2350723 T2408151 T2865497 T2490391 T2434206 T2495447 T2549930 T2587249 T2542280 T2718618 T2643306 T2687167 T2762714 T2779728 T2805456 T2823368 T2853484 K05T-00380C 00884450286999 T2428876 T2445382 T2465777 T2505820 T2614851 T2479555 T2560483 T2587250 T2636525 T2697344 T2730359 T2916415 T2745227 T2779731 T2792255 T2805457 T2842259 T2865498 K05T-01674B 00884450140796 T2390906 T2425906 T2453860 T2823388 T2800974 T2774647 T2853488 T2899143 K05T-01863 00884450315347 T2317007 T2397063S T2366145 T2425907 T2470012 T2587251 T2505851 T2533799 T2525473 T2623832 T2625813 T2718633 T2762715 T2805459 T2823390 T2863782 T2910718 K05T-01941C 00884450235386 T2363422 T2390908 T2428877 T2466078 T2495453 T2548913 T2597012 T2584604 T2687170 T2652469 T2627880 T2712308 T2779868 T2753061 T2899028 T2866724 T2816242 K05T-01955 00884450140826 T2345281 T2399661 T2464322 T2470005 T2386001 T2587403 T2765333 T2643557 T2719601 T2823391 T2861459 K05T-02138 00884450140833 T2313700 T2349568 T2363423 T2386669 T2621412 T2479311 T2533804 T2549003 T2745251 T2726918 T2716870 K05T-02159 00884450140840 T2397995 T2561788 T2417859 T2434208 T2509792 T2801089 T2762716 T2549931 T2625814 T2675576 T2893877 K05T-02272G 00884450684023 T2708057 T2448644 T2479556 T2549932 T2525579 T2536595 T2643308 T2587252 T2596738 T2675577 T2726919 T2774653 T2759596 T2810448 T2843256 T2800975 K05T-02272H 00884450814710 T2871522 T2898650 K05T-02515A 00884450255797 T2246086 T2295357 T2317021 T2355732 T2708058 T2434420 T2436222 T2464320 T2479677 T2498901 T2550150 T2584606 T2602771 T2596837 T2774655 T2643558 T2800976 T2667623 T2682131 T2849520 T2842263 T2823393 T2895062 T2898651 K05T-02533 00884450255803 T2470008 T2390909 T2417860 T2509879 T2525626 T2698958 T2620280 T2876922 T2718634 T2849216 T2809725 T2909932 T2899055 K05T-02728 00884450235768 T2232330 T2300859 T2310997 T2333495 T2310972 T2360346 T2386002 T2697318 T2436240 T2457782 T2495460 T2505739 T2536598 T2549933 T2587253 T2647453 T2643309 T2667633 T2834062 T2762718 T2736188 T2864486 T2901664 T2918188 K05T-02728 00884450235768 T2232330 T2300859 T2310997 T2333495 T2310972 T2360346 T2386002 T2697318 T2436240 T2457782 T2495460 T2505739 T2536598 T2549933 T2587253 T2647453 T2643309 T2667633 T2834062 T2762718 T2736188 T2864486 T2901664 T2918188 K05T-02728 00884450235768 T2232330 T2300859 T2310997 T2333495 T2310972 T2360346 T2386002 T2697318 T2436240 T2457782 T2495460 T2505739 T2536598 T2549933 T2587253 T2647453 T2643309 T2667633 T2834062 T2762718 T2736188 T2864486 T2901664 T2918188 K05T-02733C 00884450410813 T2223646 T2495463 T2315211 T2342954 T2322340 T2333496 T2536600 T2397194 T2407260 T2418130 T2428881 T2449669 T2697342 T2587431 T2623833 T2627379 T2676794 T2738103 T2708061 T2773344 T2818284 T2823759 T2876928 T2898652 T2931544 K05T-03153 00884450463796 T2407053 T2408155 T2442952 T2479713 T2542359 T2788780 T2587555 T2675580 T2748985 T2850760 T2816275 K05T-03201 00884450547915 T2327701 T2349571 T2625815 T2390910 T2470017 T2489182 T2533261 T2762719 T2549934 T2718635 T2690357 T2656028 T2823394 K09T-00318D 00884450388389 T2300861 T2329688 T2349572 T2370009 T2386003 T2403812 T2442953 T2495464 T2550789 T2521167 T2521168 T2680870 K09T-07304G 00884450671948 T2400947 T2407054 T2479715 T2447477 T2525636 T2541147 T2635779 T2676810 T2662054 T2708067 T2781718 T2833070 T2861463 K09T-07627L 00884450336151 T2428888 T2436257 T2457838 T2495467 T2550678 T2627380 T2572024 T2517476 T2652496 T2738109 T2676813 T2643765 T2699225 T2800993 T2587432 K09T-07627M 00884450794616 T2807076 T2816853 T2871586 T2933811 T2832466 K09T-08747 00884450411582 T2448462 T2299466 T2322585 T2417966 T2329405 T2360363 T2646157 T2382188 T2386672 T2403854 T2864506 T2434457 T2471545 T2849271 T2781172 T2697320 T2909806 T2560720 T2538556 T2585644 T2657322 T2587557 T2781183 T2748988 T2712889 T2779900 T2811085 K09T-08774F 00884450242957 T2700125 T2700174 T27211
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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