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-2562-2024
• 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: K04 (Custom Syringe Kit), REF: K05-00203M K05-00511J K05-00547J K05-00612Q K05-00819A K05-01030H K05-01274D K05-01646 K05-01688A K05-01717B K05-01880K K05-01890D K05-01945A K05-01954A K05-02247A K05-02436B K05-02507 K05-02511A K05-02954 K05-02982A To support various vascular or cardiac diagnostic and interventional procedures.
• Code Information: Catalog Number: K05-00203M UDI-DI code: 00884450138229 Lot Numbers: H2629466 H2645484 Catalog Number: K05-00511J UDI-DI code: 00884450271773 Lot Numbers: H2397984 H2412868 H2426797 H2446029 H2450196 H2482980 H2492350 H2511643 H2539331 H2549658 H2583385 H2594873 H2629250 H2654820 H2673730 H2697598 H2739498 H2756187 H2770202 H2801817 H2819960 H2834477 H2845285 H2890830 H2912779 H2925275 Catalog Number: K05-00547J UDI-DI code: 00884450312049 Lot Numbers: H2645495 Catalog Number: K05-00612Q UDI-DI code: 00884450138519 Lot Numbers: H2629467 Catalog Number: K05-00819A UDI-DI code: 00884450273470 Lot Numbers: H2639243 Catalog Number: K05-01030H UDI-DI code: 00884450394502 Lot Numbers: H2362663 H2385684 H2398244 H2443304 H2454819 H2503278 H2534002 H2584049 H2613765 H2639245 H2669271 H2713730 H2726182 H2739451 H2830115 H2845244 H2912708 H2925246 Catalog Number: K05-01274D UDI-DI code: 00884450160596 Lot Numbers: H2628681 H2659930 Catalog Number: K05-01646 UDI-DI code: 00884450139240 Lot Numbers: H2468170 H2610232 H2669236 H2761568 H2834483 Catalog Number: K05-01688A UDI-DI code: 00884450450260 Lot Numbers: H2383009 H2397922 H2412414 H2430164 H2451023 H2454910 H2542861 H2576902 H2619765 H2718026 H2821398 H2823953 H2844957 H2846857 H2895319 Catalog Number: K05-01717B UDI-DI code: 00884450139325 Lot Numbers: H2404146S1 H2410692 H2476492 H2495715 H2516725 H2520817 H2548562 H2557492 H2564607 H2576953 H2589882 H2613573 H2640670 H2650871 H2697189 H2736533 H2767978 H2787955 H2823896 H2844892 H2849102 H2854783 H2864807 H2869821 H2911094 H2920493 Catalog Number: K05-01880K UDI-DI code: 00884450250082 Lot Numbers: H2415380 H2415389 H2520099 H2521297 H2558149 H2581890 H2602338 H2626908 H2725829 H2758376 H2787928 H2796059 H2810014 H2828097 H2859867 H2864769 H2874962 H2885296 H2899952 H2915446 H2927509 Catalog Number: K05-01890D UDI-DI code: 00884450448465 Lot Numbers: H2420188 H2470760 H2557921 H2581894 H2602345 H2641626 H2871425 Catalog Number: K05-01945A UDI-DI code: 00884450190425 Lot Numbers: H2629623 Catalog Number: K05-01954A UDI-DI code: 00884450200643 Lot Numbers: H2629622 Catalog Number: K05-02247A UDI-DI code: 00884450141915 Lot Numbers: H2632850 Catalog Number: K05-02436B UDI-DI code: 00884450450253 Lot Numbers: H2393542 H2429834 H2450827 H2490409 H2495792 H2526835 H2542711 H2564295 H2581946 H2643007 H2674545 H2681527 H2687258 H2899223 Catalog Number: K05-02507 UDI-DI code: 00884450136850 Lot Numbers: H2348365 H2353310 H2369280 H2385672 H2390242 H2398231 H2412975 H2416155 H2427243 H2436679 H2443286 H2446096 H2450076 H2466702 H2511700 H2516470 H2522736 H2533989 H2553744 H2560064 H2564513 H2584038 H2618874 H2629469 H2639227 H2645485 H2659923 H2675984 H2693156 H2721337 H2733185 H2746808 H2751331 H2779140 H2819920 H2871550 H2880714 H2925260 Catalog Number: K05-02511A UDI-DI code: 00884450543115 Lot Numbers: H2739521 H2765683 H2901045 Catalog Number: K05-02954 UDI-DI code: 00884450298350 Lot Numbers: H2725969 Catalog Number: K05-02982A UDI-DI code: 00884450639511 Lot Numbers: H2382003 H2420219
• 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: 13,560 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.