Merit Medical Systems, Inc.: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF

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: 168157 kits Lot/code info: Catalog Number/UDI-DI code/Lot Numbers: K09T-01138 00884450336007 T2363424 T2386670 T2408156 T2480761 T2550174 T2571631 T2635757 T2640323 T2734947 T2774657 T2805967 T2833068 T2843260 T2850761 T2873975 T2885243 T2906058 K09T-04484A 00884450566596 T2816450 T2832465 T2854450 T2871539 T2901668 K09T-04757F 00884450388396 T2385183 T2434454 T2495466 T2525635 T2556829 T2584607 T2597014 T2640329 T2675582 T2708063 T2805969 T2843261 T2885245 T2895071 T2916416 K09T-04835H 00884450270394 T2287853 T2315252 T2349573 T2360340 T2386004 T2390911 T2414694 T2434737 T2449763 T2494448 T2587504 T2635754 T2667679 T2680871 T2712317 T2738104 T2781020 T2807074 T2833069 T2846966 T2864503 T2876387 K09T-07256D 00884450603703 T2360341 T2442955 T2498994 T2512482 T2560718 T2662053 T2745275 T2753062 T2800989 T2816846 K09T-07588B 00884450264386 T2205472 T2241180 T2314951 T2329404 T2349817 T2385184 T2386005 T2399751 T2442956 T2466089 T2479716 T2515708 T2536603 T2556831 T2560719 T2587556 T2606272 T2623834 T2657321 T2662059 T2690340 T2718870 T2748986 T2779872 T2800990 T2816851 T2846968 T2864504 T2874066 T2881132 T2906059 K09T-07611K 00884450290392 T2596860 T2652491 T2699218 T2699221 T2708069 T2717940 T2738107 T2762257 T2800991 T2833071 T2849220 T2883795 T2886087 T2939092 K09T-07649K 00884450390627 T2305612 K09T-07649L 00884450644102 T2339957 T2366225 T2386671 T2407056 T2417965 T2456584 T2495473 T2525638 T2550175 T2571768 T2594494 T2606278 T2640321 T2676814 K09T-07649M 00884450763506 T2712330 T2800995 T2805971 T28

UPC codes

00884450336007, 00884450566596, 00884450388396, 00884450270394, 00884450603703, 00884450264386, 00884450290392, 00884450390627, 00884450644102, 00884450763506, 00884450390634, 00884450644119, 00884450783108, 00884450801956, 00884450388402, 00884450336328, 00884450305485, 00884450400142, 00884450806500, 00884450396100, 00884450273326, 00884450388426, 00884450229255, 00884450386798, 00884450603710, 00884450261262, 00884450624302, 00884450400883, 00884450297971, 00884450372333, 00884450658307, 00884450501573, 00884450538012, 00884450271834, 00884450747520, 00884450410738, 00884450408735, 00884450570104, 00884450571132, 00884450592670

Source

Official record: FDA (Device enforcement) ↗

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