Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09/K09T (Custom Manifold Kit), REF: K09-00526L K09-00807AH K09-01467AD K09-01467AF K09-01514U K09-01734L K09-02040C K09-02683F K09-02804B K09-03844F K09-04088H K09-04088J K09-04863J K09-04946B K09-04998H K09-04998HP K09-05229JP K09-05342A K09-05375F K09-05939D K09-07759J K09-07789L K09-07789M K09-07828U K09-07828UP K09-07834C K09-07905G K09-08031D K09-08052Q K09-08065J K09-08150R K09-08423G K09-08493KP K09-08847A K09-08875B K09-09051H K09-09184B K09-09403HP K09-09481A K09-09499B K09-09814 K09-09900F K09-09902G K09-09902GP K09-09975 K09-10060F K09-10062F K09-10210A K09-10210B K09-10286G K09-10300F K09-10315B K09-10432A K09-10444J K09-10475 K09-10494C K09-10574D K09-10726 K09-10736D K09-10788A K09-10811 K09-10829B K09-10830C K09-10929 K09-10994D K09-11024DP K09-11076C K09-11107D K09-11149B K09-11196 K09-11207DP K09-11259G K09-11259GP K09-11444B K09-11482D K09-11607B K09-11646C K09-11913C K09-12030AP K09-12245A K09-12304A K09-12304B K09-12359B K09-12396FP K09-12404 K09-12556B K09-12615 K09-12698 K09-12698A K09-12699 K09-12699A K09-12699B K09-12704A K09-12867A K09-12899A K09-12939B K09-12939C K09-13082C K09-13171 K09-13228A K09-13337BP K09-13420 K09-13507CP K09-13617P K09-13659AP K09-13660 K09-13767 K09-13880 K09-13882 K09-13882A K09-13933 K09-14000 K09-14000A K09-14047 K09-14096 K09-14196 K09-14219 K09-14220 K09T-13643 To support fluid administration into the body. To support various vascular or cardiac diagnostic and interventional procedures.

Detalles del retiro

Fabricante

Merit Medical Systems, Inc.

Distribuidor

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.

Lote

Catalog Number: K09-00526L UDI-DI code: 00884450410110 Lot Numbers: H2349153 H2383516 H2406764 H2413970 H2423156 H2448659 H2520716 H2575100 H2615198 H2703317 H2744465 H2756069 H2786999 H2795483 H2832682 H2866202 H2875102 H2925662 Catalog Number: K09-00807AH UDI-DI code: 00884450742365 Lot Numbers: H2746426 H2796444 H2796457 H2811125 H2824906 H2834319 H2846603 H2849847 H2875232 H2898333 H2898334 Catalog Number: K09-01467AD UDI-DI code: 00884450282441 Lot Numbers: H2361544 H2382954 H2412363 H2430072 H2450925 H2498356 H2518811 H2520081 H2542786 H2586501 H2641143 H2687299 H2758479 Catalog Number: K09-01467AF UDI-DI code: 00884450750575 Lot Numbers: H2663133 H2729165 H2782382 Catalog Number: K09-01514U UDI-DI code:00884450392539 Lot Numbers: H2369960 H2387656 H2425596 H2471303 H2506109 H2529512 H2564547 H2590002 H2616732 H2627662 H2666883 H2746432 H2770561 H2824896 H2841949 H2866790 H2897446 H2920615 Catalog Number: K09-01734L UDI-DI code:00884450585009 Lot Numbers: H2360817 H2387232 H2405472 H2442198 H2471391 H2488275 H2502884 H2528940 H2569420 H2587832 H2666928 H2676308 H2714908 H2740483 H2757855 H2780813 H2795414 H2809458 H2825037 H2837565 H2853628 H2890112 H2915671 Catalog Number: K09-02040C UDI-DI code: 00884450298312 Lot Numbers: H2512599 H2714847 Catalog Number: K09-02683F UDI-DI code: 00884450204597 Lot Numbers: H2487396 H2529031 H2559767 H2581856 H2595394 H2606455 H2676287 H2786364 H2841958 H2855547 Catalog Number: K09-02804B UDI-DI code: 00884450283738 Lot Numbers: H2746430 H2785501 H2804202 H2842009 H2890141 Catalog Number: K09-03844F UDI-DI code: 00884450205280 Lot Numbers: H2596165 Catalog Number: K09-04088H UDI-DI code: 00884450566374 Lot Numbers: H2426195 H2471388 H2473959 H2558086 H2581900 H2595432 H2615361 Catalog Number: K09-04088J UDI-DI code: 00884450743713 Lot Numbers: H2641900 H2691924 H2714049 H2722319 H2746454 H2825041 H2837221 H2899238 H2910128 Catalog Number: K09-04863J UDI-DI code: 00884450278642 Lot Numbers: H2405452 H2425982 H2431335 H2460807 H2480614 H2532106 H2569112 H2581867 H2606685 H2623838 H2648569 H2674453 H2715024 H2740801 H2749693 H2780765 H2818318 H2818319 H2847030 H2864031 H2910548 H2920663 Catalog Number: K09-04946B UDI-DI code: 00884450464540 Lot Numbers: H2642042 Catalog Number: K09-04998H UDI-DI code:00884450680131 Lot Numbers: H2430236 Catalog Number: K09-04998HP UDI-DI code: 00884450407349 Lot Numbers: H2409016 H2428494 H2469111 H2524740 H2546174 H2565082S1 H2734104 H2740664 H2766411 H2775481 H2803916 H2823823 H2841931 H2874354 H2896100 H2928526 Catalog Number: K09-05229JP UDI-DI code: 00884450206676 Lot Numbers: H2749821 H2764405 H2795137 H2824990 H2841954 H2863971 H2905112 Catalog Number: K09-05342A UDI-DI code: 00884450208649 Lot 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 Catalog Number: K09-05375F UDI-DI code: 00884450223468 Lot Numbers: H2488306 H2835770 Catalog Number: K09-05939D UDI-DI code: 00884450224823 Lot Numbers: H2354795 H2381159 H2413459 H2434412 H2474054 H2475915 H2508758 H2550446 H2575409 H2600538 H2607144 H2630940 H2705169 H2744447 H2758271 H2762976 H2792240 H2819761 Catalog Number: K09-07759J UDI-DI code: 00884450628515 Lot Numbers: H2379532 H2387653 H2434868 H2471448 H2478110 H2520513 H2521340 H2539588 H2599403 H2640836 H2642292 H2687906 H2824846 H2833805 H2867113 H2920598 Catalog Number: K09-07789L UDI-DI code: 00884450573709 Lot Numbers: H2397265 H2413521 Catalog Number: K09-07789M UDI-DI code: 00884450680506 Lot Numbers: H2437839 H2448861 H2497890 H2520583 H2558117 H2565065S1 H2566492 H2596153 H2642183 H2685412 H2708246 H2758678 H2792401 H2814997 H2833726 H2846103 H2866069 H2885248 H2899257 Catalog Number: K09-07828U UDI-DI code: 00884450207369 Lot Numbers: H2398381 H2476400 H2496135 H2520086 H2687302 H2725977 Catalog Number: K09-07828UP UDI-DI code: 00

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States