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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: 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: 1,753,625 kits Lot/code info: Catalog Number/UDI-DI code/Lot Numbers: TKITS-CI K05-02166B 00884450499597 T2199559 T2241078 T2282965 T2314787 T2449229 T2350723 T2408151 T2865497 T2490391 T2434206 T2495447 T2549930 T2587249 T2542280 T2718618 T2643306 T2687167 T2762714 T2779728 T2805456 T2823368 T2853484 K05T-00380C 00884450286999 T2428876 T2445382 T2465777 T2505820 T2614851 T2479555 T2560483 T2587250 T2636525 T2697344 T2730359 T2916415 T2745227 T2779731 T2792255 T2805457 T2842259 T2865498 K05T-01674B 00884450140796 T2390906 T2425906 T2453860 T2823388 T2800974 T2774647 T2853488 T2899143 K05T-01863 00884450315347 T2317007 T2397063S T2366145 T2425907 T2470012 T2587251 T2505851 T2533799 T2525473 T2623832 T2625813 T2718633 T2762715 T2805459 T2823390 T2863782 T2910718 K05T-01941C 00884450235386 T2363422 T2390908 T2428877 T2466078 T2495453 T2548913 T2597012 T2584604 T2687170 T2652469 T2627880 T2712308 T2779868 T2753061 T2899028 T2866724 T2816242 K05T-01955 00884450140826 T2345281 T2399661 T2464322 T2470005 T2386001 T2587403 T2765333 T2643557 T2719601 T2823391 T2861459 K05T-02138 00884450140833 T2313700 T2349568 T2363423 T2386669 T2621412 T2479311 T2533804 T2549003 T2745251 T2726918 T2716870 K05T-02159 00884450140840 T2397995 T2561788 T2417859 T2434208 T2509792 T2801089 T2762716 T2549931 T2625814 T2675576 T2893877 K05T-02272G 00884450684023 T2708057 T2448644 T2479556 T2549932 T2525579 T2536595 T2643308 T2587252 T2596738 T2675577 T2726919 T2774653 T2759596 T2810448 T2843256 T2800975 K05T-02272H 00884450814710 T28715

UPC codes

00884450499597, 00884450286999, 00884450140796, 00884450315347, 00884450235386, 00884450140826, 00884450140833, 00884450140840, 00884450684023, 00884450814710, 00884450255797, 00884450255803, 00884450235768, 00884450410813, 00884450463796, 00884450547915, 00884450388389, 00884450671948, 00884450336151, 00884450794616, 00884450411582, 00884450242957, 00884450048139, 00884450268575, 00884450048160, 00884450264942, 00884450356883, 00884450387733, 00884450479346, 00884450486290, 00884450821503, 00884450388440, 00884450777909, 00884450290682, 00884450332191, 00884450229446, 00884450571903, 00884450391945, 00884450337035, 00884450337066

Source

Official record: FDA (Device enforcement)

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

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