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FDA (Device enforcement)Recalled 2024-06-11class ii

Merit Medical Systems, Inc.: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22C (Vein Tray Angiography kit), REF: K09T-11796F K12T-0

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: 103369 kits Lot/code info: Catalog Number/UDI-DI code/Lot Numbers: K09T-11796F 00884450503508 T2636554 K12T-01558G 00884450352670 T2329177 T2350727 T2371542 T2406796 T2430055 T2485419 T2540319 T2558850 T2574369 T2596749 T2637263 T2659470 T2716683 K12T-01558H 00884450782934 T2779744 T2823401 T2865508 T2909943 K12T-01822 00884450048849 T2329672 T2351649 T2366410 T2418145 T2479954 T2525431 T2544260 T2571995 T2635756 T2670966 T2716684 T2721174 T2738158 T2753461 T2781018 T2827635 K12T-01852L 00884450390641 T2627432 K12T-02006J 00884450410912 T2803003 T2866385 T2872131 K12T-02054 00884450048917 T2311048 T2323911 T2380682 T2383287 T2395389 T2427758 T2449372 T2464344 T2550262 T2609831 T2626139 T2697324 T2718897 T2753113 T2806098 T2832182 T2844200 T2866387 T2885324 K12T-02091G 00884450265925 T2458700 T2545242 T2587424 T2715273 T2736377 T2753117 T2780031 T2821698 T2888650 T2918566 K12T-02102B 00884450352861 T2597046 T2637278 T2662098 T2697333 T2751272 T2844211 K12T-02309 00884450055007 T2222971 T2331208 T2339980 T2405330 T2528876 T2560752 T2606584 T2697350 T2761529 T2821644 T2902935 K12T-02392A 00884450242926 T2144921 T2218464 T2244482 T2262003 T2296102 T2314800 T2339899 T2360807 T2416467 T2465735 T2509991 T2587265 T2637343 T2702608 T2776001 T2803012 T2821648 T2899061 K12T-02416 00884450238684 T2232553 K12T-02510N 00884450558522 T2616294 T2644061 T2776005 T2816289 T2886448 K12T-02725G 00884450278260 T2194607 T2303611 T2351004 T2408869 K12T-02725H 00884450679500 T2489997 T2587462 T2614079 T2655947 T2700183 T27132

UPC codes

00884450503508, 00884450352670, 00884450782934, 00884450048849, 00884450390641, 00884450410912, 00884450048917, 00884450265925, 00884450352861, 00884450055007, 00884450242926, 00884450238684, 00884450558522, 00884450278260, 00884450679500, 00884450242209, 00884450049211, 00884450518328, 00884450518533, 00884450339459, 00884450353073, 00884450267486, 00884450353134, 00884450339749, 00884450340004, 00884450275887, 00884450389379, 00884450311929, 00884450389416, 00884450632130, 00884450340394, 00884450282175, 00884450285442, 00884450340622, 00884450340639, 00884450389508, 00884450782941, 00884450341070, 00884450277096, 00884450801710

Source

Official record: FDA (Device enforcement)

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

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