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-2576-2024
• Recall Event ID: 94797
• Product Classification: Paracentesis tray - Product Code PYC
• Product: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Safety Paracentesis Procedure Tray (Paracentesis Tray kit), REF: SPPT-100/D SPPT-5F-10/D SPPT-5F-10L/B SPPT-5F-10S SPPT-5F-12PL SPPT-5F-17PL SPPT-5F-7/D SPPT-5F-7L/B SPPT-5F-7S SPPT-6F-10L SPPT-6F-10S SPPT-6F-10S SPPT-6F-12PL SPPT-6F-17PL SPPT-8F-10L SPPT-8F-12PL TAPS-100 TAPS-5F-10LT TAPS-5F-10T TAPS-5F-12PLT TAPS-5F-17PLT TAPS-5F-7LT TAPS-5F-7T TAPS-6F-10LT The Safety Paracentesis Procedure Tray is intended for drainage of fluid and specimen collection for diagnostic purposes or to remove excess fluid collections.
• Code Information: Catalog Number/UDI-DI code/Lot Numbers: SPPT-100/D 00884450038659 T2382100 T2382102 T2748984 T2871502 T2666406 T2762926 T2824322 T2704382 T2863414 T2801600 T2382101 T2385423 T2407226 T2433246 T2717925 T2847798 T2433245 T2434587 T2438449 T2805260 T2587798 T2464348 T2479913 T2884261 T2498906 T2526998 T2530735 T2655953 T2931511 T2597132 T2565099 T2626508 T2657109 T2644387 SPPT-5F-10/D 00884450038673 T2351182 T2351183 T2367928 T2379511 T2379512 T2385424 T2398514 T2489934 T2498907 T2514802 T2753259 T2801601 T2730270 T2884264 T2879873 T2687139 T2779057 T2710244 T2861406 T2730271 T2823733 T2847801 T2704399 T2863441 T2662329 T2379513 T2424134 T2433247 T2464349 T2713162 T2805262 T2832456 T2805261 T2762927 T2433248 T2434588 T2438450 T2587799 T2472514 T2477549 T2900575 T2479284 T2622995S T2520450 T2520451 T2529637 T2626510 T2543014 T2583979 T2560921 T2610008 T2550617 T2655948 T2597133 T2587800 T2611991 T2657110 T2644390 SPPT-5F-10L/B 00884450038680 T2351188 T2365762 T2379520 T2388791 T2388793 T2680782 T2385425 T2713163 T2805263 T2779058 T2687141 T2863432 T2762928 T2823734 T2715257 T2867194 T2738091 T2852110 T2407228 T2422529 T2433254 T2489936 T2847803 T2779059 T2805264 T2433253 T2434589 T2448645 T2472525 T2479286 T2900576 T2900577 T2876381 T2885492 T2519031 T2519032 T2530734 T2626511 T2926546 T2550618 T2581125 T2587801 T2610010 T2916397 T2570319 T2657113 T2597134 T2612001 T2644391 T2655944 SPPT-5F-10S 00884450038697 T2351191 T2379524 T2385426 T2385427 T2581126 T2779063 T2871508 T2863417 T2762929 T2730272 T2814937 T2704392 T2407229 T2431282 T2503414 T2801602 T2847809 T2597135 T2626512 T2433255 T2448646 T2587802 T2472533 T2498909 T2655943 T2662331 T2464351 T2471637 T2943986 T2900578 T2543040 T2530736 T2612004 SPPT-5F-12PL 00884450277522 T2319777 T2368460 T2379527 T2438156 T2666491 SPPT-5F-17PL 00884450277546 T2385066 T2438155 T2662274 T2449563 SPPT-5F-7/D 00884450038703 T2351200 T2365767 T2384431 T2385430 T2762930 T2753262 T2704381 T2730273 T2379529 T2407234 T2422515 T2433256 T2503416 T2805292 T2847811 T2433257 T2466066 T2479289 T2498910 T2854442 T2639144 T2587803 T2626514 T2560922 T2660539 SPPT-5F-7L/B 00884450038710 T2762931 T2394395 T2353607 T2365772 T2379531 T2382113 T2680784 T2704397 T2730275 T2738092 T2900581 T2863440 T2823736 T2852163 T2713165 T2753263 T2403749 T2418097 T2433258 T2498911 T2805293 T2587804 T2801603 T2867195 T2433259 T2434591 T2448647 T2472573 T2479291 T2900580 T2503555 T2884271 T2530737 T2657117 T2581127 T2933550 T2543006 T2581129 T2612007 T2610013 T2639145 T2670040 SPPT-5F-7S 00884450038727 T2560924 T2385699 T2398572 T2753264 T2704387 T2738093 T2610014 T2407235 T2433262 T2867196 T2780197 T2847812 T2438461 T2636646 T2655958 T2466022 T2479293 T2527002 T2587805 T2912446 SPPT-6F-10L 00884450277560 T2928291 SPPT-6F-10S 00884450277577 T2719257 T2655851 SPPT-6F-12PL 00884450277584 T2389562 T2666121 T2431283 T2704402 SPPT-6F-12PS 00884450277591 T2704428 SPPT-6F-17PL 00884450277607 T2438157 SPPT-8F-10L 00884450277645 T2340050 T2365801 T2670041 T2610015 T2530907 T2587806 T2379536 T2407236 T2469351 T2495435 T2527005 T2527006 T2704427 T2779065 T2719258 T2805324 T2847814 SPPT-8F-12PL 00884450277669 T2867197 T2766169 T2823737 T2710256 T2802562 T2871509 T2859151 TAPS-100 00884450038734 T2379537 T2385432 T2780199 T2704383 T2738095 T2730276 T2823738 T2863411 T2394396 T2394396S T2407237 T2418101 T2498913 T2805327 T2433263 T2464352 T2472587 T2527008 T2657216 T2586465 T2626516 T2884273 T2543029 T2587807 T2639146 TAPS-5F-10LT 00884450038741 T2489939 T2523240 T2523242 T2526967 T2550619 T2560925 T2543030 T2574187 T2581130 T2587808 T2587809 T2674794 T2597136 T2597137 T2639157 T2662335 T2730277 T2626517 T2704391 T2753266 T2779066 T2644396 T2762932 T2871512 T2900587 T2719266 T2832457 T2823739 T2687146 T2738096 T2655951 T2713167 T2805329 T2814938 T2801748 T2657218 T2847817 T2869841 T2855428 T2876383 T2939875 T2885495 T2943546 T2925561 T2916403 TAPS-5F-10T 00884450038758 T2477572 T2489945 T2489946 T2526968 T2527009 T2542370 T2526969 T2543031 T2550620 T2584574 T2597138S T2587810 T2588953 T2597138 T2610016 T2687149 T2814940 T2900588 T2762933 T2644401 T2869850 T2655950 T2707349 T2730278 T2753268 T2657227 T2869838 T2823740 T2779068 T2847823 T2805330 T2879882 T2861413 T2925562 TAPS-5F-12PLT 00884450277737 T2489947 T2498944 T2644403 T2601813 T2655936 T2610017 T2570347 T2527010 T2805332 T2710243 T2710255 T2814941 T2818677 T2832459 T2854447 T2867200 T2920424 TAPS-5F-17PLT 00884450277751 T2570343 T2539964 T2644405 T2587811 T2697253 TAPS-5F-7LT 00884450038765 T2503569 T2543034 T2586466 T2597140 T2612085S T2655960 T2626521 T2884282 T2859181 T2707365 T2762934 T2719267 T2832460 T2801751 T2921077 T2916407 TAPS-5F-7T 00884450038772 T2503571 T2530988 T2560927 T2581131 T2597141S T2597141 T2713168 T2687153 T2638243 T2762935 T2814942 T2753269 T2655961 T2916408 T2854448 TAPS-6F-10LT 00884450277775 T2543035 T2587812 T2612086 T2623038 T2655826 T2823742 T2674854 T2779070 T2655827 T2713170 T2839074 T2738097 T2801757 T2859148 T2861424 T2919527 TAPS-6F-10T 00884450277782 T2527013 T2624657 T2591150 T2626525 T2657254 T2704429 T2852200 T2814943 T2779071 T2710242 T2933774 TAPS-6F-12PLT 00884450277799 T2489956 T2498939 T2525411 T2560928 T2626526 T2662337 T2612087 T2525410 T2730279 T2655937 T2707415 T2680790 T2814944 T2805335 T2876384 T2855447 TAPS-6F-12PT 00884450277805 T2501701 T2639080 T2612088 T2666120 T2900593 T2662338 T2853505 T2738098 T2713171 T2846633 T2801761 T2939879 TAPS-6F-17PLT 00884450277812 T2704430 TAPS-6F-7T 00884450277843 T2511831 T2584573 T2587813 TAPS-8F-10LT 00884450277850 T2666569 T2662340 T2832461 T2707366 T2928290 T2910071 TAPS-8F-10T 00884450277867 T2543036 T2494488 T2662341 T2666122 T2687162 T2704386 T2867202 T2809724 T2900595 TAPS-8F-12PLT 00884450277874 T2556800 T2533088 T2623003 T2687163 T2655949 T2626531 T2910072 T2753272 T2704388 T2713173 TAPS-8F-12PT 00884450277881 T2713174 TAPS-8F-17PLT 00884450277898 T2527049 T2570344 T2597142 T2636647 T2587816 T2697258 T2713176 T2861427 T2666123 T2916412 TAPS-8F-17PT 00884450277904 T2753274 T2710258 T2739243
• 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: 317115 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.