Merit Medical Systems, Inc.: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pressure Monitoring Kit), REF: K12-0384

Hazard

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.

Details from the source

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. 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. Quantity: 34197 kits Lot/code info: Catalog Number/UDI-DI code/Lot Numbers: K12-02097B 00884450191309 H2413516 H2430266 H2448853 H2474037 H2505248 H2518159 H2540340 H2545409 H2575507 H2591235 H2744213 H2751673 H2846090 H2879948 H2912178 K12-02489A 00884450191422 H2407774 H2413469 H2520693 H2550452 H2566464 H2607157 H2705182 H2753896 H2758300 H2814926 H2850642 K12-03447 00884450192443 H2404130 H2408589 H2439003 H2451626 H2690274 H2757182 H2817430 H2846659 K12-03846 00884450144848 H2472033 H2494636 H2507902 H2536621 H2552837 H2557081 H2718140 H2810887 K12-04185A 00884450193143 H2398739 H2418369 H2557282 H2595087 H2635991 H2666462 H2690318 H2719739 H2775079 H2780258 H2792424 H2881789 H2916471 K12-04262BP 00884450250426 H2760748 H2784117 H2802626 H2829046 H2877237 H2897143 H2913395 K12-09098C 00884450816509 H2912500 H2912511 H2912512 H2912513 K12-10056 00884450383704 H2406238 H2418284 H2437885 H2469808 H2518359 H2529863 H2541614 H2555920 H2592114 H2659218 H2685221 H2709291 H2741843 H2767146 H2781349 H2795585 H2827702 H2845945 H2866232 H2875176 H2898026 K12-11132B 00884450746530 H2756363 H2762177 H2781251 H2818304 H2832627 H2866135 H2884335 H2931204 K12-12079P 00884450652503 H2760347 H2770070 H2778943 H2798363 H2808227 H2825288 H2838422 H2857759 H2867574 H2897171 H2905369 H2913161 K12-12192P 00884450696118 H2879420 H2885386 K12-12335 00884450716328 H2562551 H2591862 H2607163 H2615042 H2649774 H2705172 H2751359 H2763152 H2772980 H2810502 H2866204 H2871433 H2912338 K12-12382 00884450767702 H2819681 K12M-02489 00884450

UPC codes

00884450191309, 00884450191422, 00884450192443, 00884450144848, 00884450193143, 00884450250426, 00884450816509, 00884450383704, 00884450746530, 00884450652503, 00884450696118, 00884450716328, 00884450767702, 00884450092873, 00884450190647, 00884450190722, 00884450190975, 00884450400517, 00884450400524, 00884450192412, 00884450194133, 00884450394816, 00884450391051, 00884450161821, 00884450546925, 00884450831151, 00884450234372, 00884450205051, 00884450259290, 00884450281611, 00884450278048, 00884450410257, 00884450443927, 00884450459850, 00884450554944, 00884450476055, 00884450500187, 00884450575956, 00884450567012, 00884450569801

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.