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-2567-2024
• Recall Event ID: 94797
• Product Classification: Angiography/angioplasty kit - Product Code OEQ
• Product: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pressure Monitoring Kit), REF: K12-03846 K12-04185A K12-03447 K12M-02489 K12-10056 K12-02489A K12-02097B K12-12335 K12-12192P K12-12079P K12-04262BP K12-11132B K12-12382 K12-09098C K12-02112 K12-02111 K12-05576G K12-05805A K12T-10313C K12-11821P K12-01348D K12-11821 K12-11426 K12-06318 K12-12053 K12-03438 K12-07208A K12-12147 K12-09009 K12-10375 K12-08716 K12-11669AP K12-00657A K12-11131AP K12-10914 K12-07299P K12-05494 K12-00443A K12-08303 K12-06509A K12-10962 K12-11133 K12-06509B To support various vascular or cardiac diagnostic and interventional procedures.
• Code Information: Catalog Number/UDI-DI code/Lot Numbers: K12-02097B 00884450191309 H2413516 H2430266 H2448853 H2474037 H2505248 H2518159 H2540340 H2545409 H2575507 H2591235 H2744213 H2751673 H2846090 H2879948 H2912178 K12-02489A 00884450191422 H2407774 H2413469 H2520693 H2550452 H2566464 H2607157 H2705182 H2753896 H2758300 H2814926 H2850642 K12-03447 00884450192443 H2404130 H2408589 H2439003 H2451626 H2690274 H2757182 H2817430 H2846659 K12-03846 00884450144848 H2472033 H2494636 H2507902 H2536621 H2552837 H2557081 H2718140 H2810887 K12-04185A 00884450193143 H2398739 H2418369 H2557282 H2595087 H2635991 H2666462 H2690318 H2719739 H2775079 H2780258 H2792424 H2881789 H2916471 K12-04262BP 00884450250426 H2760748 H2784117 H2802626 H2829046 H2877237 H2897143 H2913395 K12-09098C 00884450816509 H2912500 H2912511 H2912512 H2912513 K12-10056 00884450383704 H2406238 H2418284 H2437885 H2469808 H2518359 H2529863 H2541614 H2555920 H2592114 H2659218 H2685221 H2709291 H2741843 H2767146 H2781349 H2795585 H2827702 H2845945 H2866232 H2875176 H2898026 K12-11132B 00884450746530 H2756363 H2762177 H2781251 H2818304 H2832627 H2866135 H2884335 H2931204 K12-12079P 00884450652503 H2760347 H2770070 H2778943 H2798363 H2808227 H2825288 H2838422 H2857759 H2867574 H2897171 H2905369 H2913161 K12-12192P 00884450696118 H2879420 H2885386 K12-12335 00884450716328 H2562551 H2591862 H2607163 H2615042 H2649774 H2705172 H2751359 H2763152 H2772980 H2810502 H2866204 H2871433 H2912338 K12-12382 00884450767702 H2819681 K12M-02489 00884450092873 H2405222 H2520692 H2800145 K12-00443A 00884450190647 H2757679 H2778135 H2796711 H2866277 H2905075 H2915547 H2926391 K12-00657A 00884450190722 H2535655 H2795577 H2810190 K12-01348D 00884450190975 H2383033 H2418832 H2436858 H2451479 H2495639 H2516727 H2520753 H2550062 H2557408 H2599531 H2729229 H2782335 H2836580 H2879389 K12-02111 00884450400517 T2616733 T2653219 T2709061 T2752964 T2821654 T2862633 T2899120 T2932790 K12-02112 00884450400524 T2587406 T2596839 T2653221 T2688030 T2718647 T2733013 T2775588 T2802964 T2827652 T2842314 T2899023 K12-03438 00884450192412 H2418283 H2489665 H2572196 H2659563 H2675954 H2747768 H2866235 H2881466 K12-05494 00884450194133 H2764836 H2817505 H2828814 H2844859 K12-05576G 00884450394816 T2489238 T2489238S T2498868 T2616734 T2625824 T2740284 T2758288 T2779743 T2792619 T2816292 T2849694 T2906286 K12-05805A 00884450391051 T2232844 T2290430 T2329711 T2360690 T2427593 T2458542 T2499085 T2511362 T2555156 T2587519 T2627492 T2670933 T2699182 T2738197 T2802974 T2849863 T2902775 T2919721 K12-06318 00884450161821 H2399243 H2405752 H2421061 H2440852 H2473607 H2495222 H2518737 H2518738 H2553249 H2629602 H2652655 H2685033 H2704237 H2714593 H2736618 H2756210 H2782550 H2792325 H2820346 H2848446 H2869766 H2873395 H2897239 K12-06509A 00884450546925 H2760798 H2760799 H2799936 H2827918 H2832624 H2845494 H2881391 K12-06509B 00884450831151 H2925180 H2925184 K12-07208A 00884450234372 H2423209 H2428435 H2476040 H2585526 H2625403 H2654836 H2705056 H2824534 H2833789 H2885273 K12-07299P 00884450205051 H2765572 H2770055 H2774920 H2789836 H2808226 H2834790 H2838415 H2850204 H2882653 H2891703 H2897156 H2913008 K12-08303 00884450259290 H2765793 H2786648 H2795405 H2825027 H2837539 H2859419 H2890129 H2899255 H2915703 K12-08716 00884450281611 H2489883 H2512815 H2529971 H2575336 H2585770 H2615571 H2849684 K12-09009 00884450278048 H2625375 H2741745 H2743438 H2749202 H2758304 H2767731 H2866221 H2904508 H2927568 K12-10375 00884450410257 H2740385 H2757742 H2783289 H2796737 H2824894 H2849850 K12-10914 00884450443927 H2757139 H2763456 H2788121 H2796775 H2803156 K12-10962 00884450459850 H2757850 H2844695 H2859430 H2915384 K12-11131AP 00884450554944 H2760338 H2770059 H2787186 H2794192 H2812899 H2838417 H2850211 H2866043 H2886332 H2897168 K12-11133 00884450476055 H2787945 H2817450 H2844021 K12-11426 00884450500187 H2396335 H2414054 H2418341 H2448761 H2465110 H2494088 H2518207 H2541674 H2575288 H2585737 H2600923 H2606522 H2685059 H2741742 H2762178 H2791589 H2827919 K12-11669AP 00884450575956 H2493003 H2525138 H2567746 H2606696 H2614537 H2648576 H2655286 H2690603 H2714879 H2720165 H2764453 H2780779 H2825009 H2831601 H2841971 H2905224 K12-11821 00884450567012 H2390923 K12-11821P 00884450569801 H2386248 H2406446 H2414114 H2423279 H2633830 H2665313 H2669960 H2680037 H2713967 H2774923 H2838420 H2850214 H2866256 H2918807 K12-12053 00884450613108 H2408722 H2421065 H2440872 H2447205 H2477642 H2497438 H2509096 H2518743 H2539421 H2547208 H2564387 H2589607 H2616609 H2626428 H2652660 H2673425 H2685041 H2704238 H2743356 H2756216 H2770510 H2792316 H2810898 H2828819 H2833610 H2855826 H2866849 H2880085 H2907333 H2926243 H2931778 K12-12147 00884450644706 H2457285 H2475865 H2518744 H2518745 H2589613 H2601419 H2616349 H2626437 H2640599 H2658613 H2685045 H2704239 H2743357 H2756219 H2782555 H2828820 H2844895 H2855828 H2860747 H2866850 H2897241 K12T-10313C 00884450558911 T2310434 T2367456 T2534496 T2547548 T2587736 T2693219 T2816291 T2879933
• 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: 34197 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.