Merit Medical Systems, Inc.: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF: K05-00203M K05-00511J K05-

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: 13,560 kits Lot/code info: Catalog Number: K05-00203M UDI-DI code: 00884450138229 Lot Numbers: H2629466 H2645484 Catalog Number: K05-00511J UDI-DI code: 00884450271773 Lot 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 Catalog Number: K05-00547J UDI-DI code: 00884450312049 Lot Numbers: H2645495 Catalog Number: K05-00612Q UDI-DI code: 00884450138519 Lot Numbers: H2629467 Catalog Number: K05-00819A UDI-DI code: 00884450273470 Lot Numbers: H2639243 Catalog Number: K05-01030H UDI-DI code: 00884450394502 Lot Numbers: H2362663 H2385684 H2398244 H2443304 H2454819 H2503278 H2534002 H2584049 H2613765 H2639245 H2669271 H2713730 H2726182 H2739451 H2830115 H2845244 H2912708 H2925246 Catalog Number: K05-01274D UDI-DI code: 00884450160596 Lot Numbers: H2628681 H2659930 Catalog Number: K05-01646 UDI-DI code: 00884450139240 Lot Numbers: H2468170 H2610232 H2669236 H2761568 H2834483 Catalog Number: K05-01688A UDI-DI code: 00884450450260 Lot Numbers: H2383009 H2397922 H2412414 H2430164 H2451023 H2454910 H2542861 H2576902 H2619765 H2718026 H2821398 H2823953 H2844957 H2846857 H2895319 Catalog Number: K05-01717B UDI-DI code: 00884450139325 Lot Numbers: H2404146S1 H2410692 H2476492 H2495715 H2516725 H2520817 H2548562 H2557492 H2564607 H2576953 H2589882 H2613573 H2640670 H2650871 H2697189 H2736533 H2767978 H2787955 H2823896 H2844892

UPC codes

00884450138229, 00884450271773, 00884450312049, 00884450138519, 00884450273470, 00884450394502, 00884450160596, 00884450139240, 00884450450260, 00884450139325, 00884450250082, 00884450448465, 00884450190425, 00884450200643, 00884450141915, 00884450450253, 00884450136850, 00884450543115, 00884450298350, 00884450639511

Source

Official record: FDA (Device enforcement) ↗

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