Reported Aug 21, 2024 · Ongoing
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04…
Merit Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416
Is this the product you have?
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd
- syringesK04 (Custom Syringe Kit)
- REFTo support various vascular or cardiac diagnostic and interventional procedures
K05-00203MK05-00511JK05-00547JK05-00612QK05-00819AK05-01030HK05-01274DK05-01646K05-01688AK05-01717BK05-01880KK05-01890DK05-01945AK05-01954AK05-02247AK05-02436BK05-02507K05-02511AK05-02954K05-02982A
- Lot codes and dates
20 of 20 products
Products covered by this recall Model / number Barcodes Product as published K05-00511J00884450271773Lot Numbers: H2629466 H2645484 UDI-DI code: 00884450271773 K05-00547J00884450312049Lot 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 UDI-DI code: 00884450312049 K05-00612Q00884450138519Lot Numbers: H2645495 UDI-DI code: 00884450138519 K05-00819A00884450273470Lot Numbers: H2629467 UDI-DI code: 00884450273470 K05-01030H00884450394502Lot Numbers: H2639243 UDI-DI code: 00884450394502 K05-01274D00884450160596Lot Numbers: H2362663 H2385684 H2398244 H2443304 H2454819 H2503278 H2534002 H2584049 H2613765 H2639245 H2669271 H2713730 H2726182 H2739451 H2830115 H2845244 H2912708 H2925246 UDI-DI code: 00884450160596 K05-0164600884450139240Lot Numbers: H2628681 H2659930 UDI-DI code: 00884450139240 K05-01688A00884450450260Lot Numbers: H2468170 H2610232 H2669236 H2761568 H2834483 UDI-DI code: 00884450450260 K05-01717B00884450139325Lot Numbers: H2383009 H2397922 H2412414 H2430164 H2451023 H2454910 H2542861 H2576902 H2619765 H2718026 H2821398 H2823953 H2844957 H2846857 H2895319 UDI-DI code: 00884450139325 K05-01880K00884450250082Lot 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 UDI-DI code: 00884450250082 K05-01890D00884450448465Lot Numbers: H2415380 H2415389 H2520099 H2521297 H2558149 H2581890 H2602338 H2626908 H2725829 H2758376 H2787928 H2796059 H2810014 H2828097 H2859867 H2864769 H2874962 H2885296 H2899952 H2915446 H2927509 UDI-DI code: 00884450448465 K05-01945A00884450190425Lot Numbers: H2420188 H2470760 H2557921 H2581894 H2602345 H2641626 H2871425 UDI-DI code: 00884450190425 K05-01954A00884450200643Lot Numbers: H2629623 UDI-DI code: 00884450200643 K05-02247A00884450141915Lot Numbers: H2629622 UDI-DI code: 00884450141915 K05-02436B00884450450253Lot Numbers: H2632850 UDI-DI code: 00884450450253 K05-0250700884450136850Lot Numbers: H2393542 H2429834 H2450827 H2490409 H2495792 H2526835 H2542711 H2564295 H2581946 H2643007 H2674545 H2681527 H2687258 H2899223 UDI-DI code: 00884450136850 K05-02511A00884450543115Lot 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 UDI-DI code: 00884450543115 K05-0295400884450298350Lot Numbers: H2739521 H2765683 H2901045 UDI-DI code: 00884450298350 K05-02982A00884450639511Lot Numbers: H2725969 UDI-DI code: 00884450639511 — Lot Numbers: H2382003 H2420219 - Amount recalled
- 13,560 kits
This recall covers 23 products
The agency filed one notice per product. You are reading one of them; the other 22 are below.
10 more are in the archive.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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