Reported Aug 21, 2024 · Ongoing
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:…
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
- syringesK09/K09T (Custom Manifold Kit)
- REFTo support fluid administration into the body. To support various vascular or cardiac diagnostic and interventional procedures
119 of 119 codes
K09-00526LK09-00807AHK09-01467ADK09-01467AFK09-01514UK09-01734LK09-02040CK09-02683FK09-02804BK09-03844FK09-04088HK09-04088JK09-04863JK09-04946BK09-04998HK09-04998HPK09-05229JPK09-05342AK09-05375FK09-05939DK09-07759JK09-07789LK09-07789MK09-07828UK09-07828UPK09-07834CK09-07905GK09-08031DK09-08052QK09-08065JK09-08150RK09-08423GK09-08493KPK09-08847AK09-08875BK09-09051HK09-09184BK09-09403HPK09-09481AK09-09499BK09-09814K09-09900FK09-09902GK09-09902GPK09-09975K09-10060FK09-10062FK09-10210AK09-10210BK09-10286GK09-10300FK09-10315BK09-10432AK09-10444JK09-10475K09-10494CK09-10574DK09-10726K09-10736DK09-10788A
- Lot codes and dates
119 of 119 products
Products covered by this recall Model / number Barcodes Product as published K09-00807AH00884450742365Lot Numbers: H2349153 H2383516 H2406764 H2413970 H2423156 H2448659 H2520716 H2575100 H2615198 H2703317 H2744465 H2756069 H2786999 H2795483 H2832682 H2866202 H2875102 H2925662 UDI-DI code: 00884450742365 K09-01467AD00884450282441Lot Numbers: H2746426 H2796444 H2796457 H2811125 H2824906 H2834319 H2846603 H2849847 H2875232 H2898333 H2898334 UDI-DI code: 00884450282441 K09-01467AF00884450750575Lot Numbers: H2361544 H2382954 H2412363 H2430072 H2450925 H2498356 H2518811 H2520081 H2542786 H2586501 H2641143 H2687299 H2758479 UDI-DI code: 00884450750575 K09-01514U00884450392539Lot Numbers: H2663133 H2729165 H2782382 UDI-DI code:00884450392539 K09-01734L00884450585009Lot Numbers: H2369960 H2387656 H2425596 H2471303 H2506109 H2529512 H2564547 H2590002 H2616732 H2627662 H2666883 H2746432 H2770561 H2824896 H2841949 H2866790 H2897446 H2920615 UDI-DI code:00884450585009 K09-02040C00884450298312Lot Numbers: H2360817 H2387232 H2405472 H2442198 H2471391 H2488275 H2502884 H2528940 H2569420 H2587832 H2666928 H2676308 H2714908 H2740483 H2757855 H2780813 H2795414 H2809458 H2825037 H2837565 H2853628 H2890112 H2915671 UDI-DI code: 00884450298312 K09-02683F00884450204597Lot Numbers: H2512599 H2714847 UDI-DI code: 00884450204597 K09-02804B00884450283738Lot Numbers: H2487396 H2529031 H2559767 H2581856 H2595394 H2606455 H2676287 H2786364 H2841958 H2855547 UDI-DI code: 00884450283738 K09-03844F00884450205280Lot Numbers: H2746430 H2785501 H2804202 H2842009 H2890141 UDI-DI code: 00884450205280 K09-04088H00884450566374Lot Numbers: H2596165 UDI-DI code: 00884450566374 K09-04088J00884450743713Lot Numbers: H2426195 H2471388 H2473959 H2558086 H2581900 H2595432 H2615361 UDI-DI code: 00884450743713 K09-04863J00884450278642Lot Numbers: H2641900 H2691924 H2714049 H2722319 H2746454 H2825041 H2837221 H2899238 H2910128 UDI-DI code: 00884450278642 K09-04946B00884450464540Lot Numbers: H2405452 H2425982 H2431335 H2460807 H2480614 H2532106 H2569112 H2581867 H2606685 H2623838 H2648569 H2674453 H2715024 H2740801 H2749693 H2780765 H2818318 H2818319 H2847030 H2864031 H2910548 H2920663 UDI-DI code: 00884450464540 K09-04998H00884450680131Lot Numbers: H2642042 UDI-DI code:00884450680131 K09-04998HP00884450407349Lot Numbers: H2430236 UDI-DI code: 00884450407349 K09-05229JP00884450206676Lot Numbers: H2409016 H2428494 H2469111 H2524740 H2546174 H2565082S1 H2734104 H2740664 H2766411 H2775481 H2803916 H2823823 H2841931 H2874354 H2896100 H2928526 UDI-DI code: 00884450206676 K09-05342A00884450208649Lot Numbers: H2749821 H2764405 H2795137 H2824990 H2841954 H2863971 H2905112 UDI-DI code: 00884450208649 K09-05375F00884450223468Lot Numbers: H2413457 H2444223 H2474152 H2490841 H2508756 H2519305 H2545376 H2562513 H2585433 H2600537 H2642350 H2705154 H2709024 H2729368 H2749175 H2762973 H2776733 H2792236 H2800652 H2814845 H2833461 H2845963 H2866227 H2915961 H2927496 UDI-DI code: 00884450223468 K09-05939D00884450224823Lot Numbers: H2488306 H2835770 UDI-DI code: 00884450224823 K09-07759J00884450628515Lot Numbers: H2354795 H2381159 H2413459 H2434412 H2474054 H2475915 H2508758 H2550446 H2575409 H2600538 H2607144 H2630940 H2705169 H2744447 H2758271 H2762976 H2792240 H2819761 UDI-DI code: 00884450628515 - Amount recalled
- 188837 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.
Want the full recall guide?
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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