Merit Medical Systems, Inc.: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09/K09T (Custom Manifold Kit), REF: K09-00526L K09-00807

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: 188837 kits Lot/code info: 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: H2746

UPC codes

00884450410110, 00884450742365, 00884450282441, 00884450750575, 00884450392539, 00884450585009, 00884450298312, 00884450204597, 00884450283738, 00884450205280, 00884450566374, 00884450743713, 00884450278642, 00884450464540, 00884450680131, 00884450407349, 00884450206676, 00884450208649, 00884450223468, 00884450224823, 00884450628515, 00884450573709, 00884450680506, 00884450207369, 00884450299005, 00884450209035, 00884450398883, 00884450209073, 00884450334256, 00884450307700, 00884450625149, 00884450213919, 00884450276860, 00884450254172, 00884450564707, 00884450169773, 00884450209479, 00884450486740, 00884450214770, 00884450214794

Source

Official record: FDA (Device enforcement) ↗

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