FDA Device recall Z-2579-2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (A…
- FDA Device
- Class II
- ongoing
- Published 2024-08-21
On 2024-08-21 the FDA classified a Class II recall of Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (A… by Merit Medical Systems, citing 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 m….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2579-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-11 |
| Published | 2024-08-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K05-02166B K05T-00380C K05T-01674B K05T-01863 K05T-01941C K05T-01955 K05T-02138 K05T-02159 K05T-02272G K05T-02272H K05T-02515A K05T-02533 K05T-02728 K05T-02733C K05T-03153 K05T-03201 K09T-00318D K09T-07304G K09T-07627L K09T-07627M K09T-08747 K09T-08774F K09T-08952 K09T-09037J K09T-09358 K09T-09576J K09T-09760C K09T-09978A K09T-10485L K09T-10728H K09T-10728J K09T-11022C K09T-11022D K09T-11379F K09T-11430B K09T-11478A K09T-11738D K09T-11798 K09T-11875B K09T-12020B K09T-12020C K09T-12200 K09T-12538F K09T-12538G K09T-12883B K09T-12883C K09T-12942B K09T-12942C K09T-12942D K09T-12942F K09T-12970B K09T-13293 K09T-13293A K09T-13294 K09T-13294A K09T-13384B K09T-13384C K09T-13444B K09T-13459A K09T-13459B K09T-13681A K09T-13740 K09T-13927 K09T-13927A K09T-13949 K09T-13972 K09T-14025 K09T-14028B K09T-14035 K09T-14072 K09T-14218 K10T-01528G K10T-01528H K10T-03769F K10T-04233J K10T-04941B K10T-05595A K10T-05611B K10T-05680B K10T-06085 K10T-06085A K10T-06101 K10T-12092 K10T-12092A K12-05727F K12T-01737D K12T-01816A K12T-01996K K12T-02064 K12T-02285F K12T-02667A K12T-02703C K12T-02703F K12T-02911F K12T-02911G K12T-02940 K12T-03196 K12T-03312 K12T-03724F K12T-03933C K12T-03975A K12T-03979C K12T-04085 K12T-04270A K12T-04271B K12T-04348A K12T-04383G K12T-04707 K12T-04926G K12T-05302D K12T-05303D K12T-05303F K12T-05327D K12T-05432F K12T-05432G K12T-05627 K12T-05849C K12T-05849D K12T-05849F K12T-05850B K12T-05850C K12T-05903B K12T-05968D K12T-05974A K12T-05996M K12T-05996N K12T-06043 K12T-06313B K12T-06412A K12T-06431A K12T-06436 K12T-06694A K12T-06821 K12T-06826 K12T-06839A K12T-07986C K12T-08071C K12T-08071D K12T-08072D K12T-08072F K12T-08166D K12T-08703 K12T-08964F K12T-09013F K12T-09237A K12T-09292A K12T-09338D K12T-09456B K12T-09840B K12T-10464 K12T-10514A K12T-10515 K12T-10515A K12T-10516 K12T-10562 K12T-10583A K12T-10586A K12T-10649 K12T-10664A K12T-10881B K12T-11049 K12T-11151 K12T-11586 K12T-11626B K12T-11626C K12T-11680 K12T-11684 K12T-11826 K12T-11853P K12T-11857B K12T-11880 K12T-11880A K12T-11880B K12T-11901 K12T-11903 K12T-11910 K12T-11923 K12T-11923A K12T-11924A K12T-11925A K12T-11943B K12T-11943C K12T-11984 K12T-11985 K12T-11996 K12T-12017 K12T-12091 K12T-12138 K12T-12149 K12T-12153 K12T-12155 K12T-12155A K12T-12155B K12T-12157 K12T-12157A K12T-12157B K12T-12224 K12T-12224A K12T-12224B K12T-12230 K12T-12242 K12T-12242A K12T-12244 K12T-12285A K12T-12291 K12T-12291A K12T-12323 K12T-12331A K12T-12397 K12T-12403 K12T-12406 K12T-12406A K12T-12407 K12T-12419 K12T-12448 K12T-12448A K12T-12494 K12T-11210 K12T-12321 K20T-00002 K20T-00004A K20T-00012 K20T-00016A K20T-00019 K20T-00027 K20T-00031 K20T-00035 K12T-02045 K12T-02909 K12T-03993A K12T-06280 K12T-09329A K12T-09368A K12T-10157 K12T-12095 K05T-01920F K09T-10485M K09T-14028 K09T-14028A K10-04922C K10T-00554J K10T-00554L K10T-00861D K10T-01428A K10T-01785L K10T-02735D K10T-03122A K10T-03348K K10T-03627F K10T-03627G K10T-03627H K10T-03776F K10T-03776G K10T-03784 K10T-03810A K10T-03810B K10T-03979M K10T-04060G K10T-04113Q K10T-04113R K10T-04160R K10T-04163H K10T-04199C K10T-04200C K10T-04256H K10T-04338G K10T-04415K K10T-04463D K10T-04500B K10T-04578B K10T-04655B K10T-04718F K10T-04723B K10T-04744D K10T-04774D K10T-04775 K10T-04780 K10T-04806A K10T-04844N K10T-04861B K10T-04862 K10T-04892 K10T-04983B K10T-04986F K10T-05012G K10T-05012H K10T-05081F K10T-05082G K10T-05165A K10T-05197B K10T-05219 K10T-05272C K10T-05307B K10T-05308B K10T-05365A K10T-05366B K10T-05367 K10T-05397 K10T-05451N K10T-05451R K10T-05462 K10T-05493B K10T-05504C K10T-05518 K10T-05531 K10T-05541C K10T-05541D K10T-05592B K10T-05593C K10T-05612 K10T-05651B K10T-05655 K10T-05662 K10T-05665A K10T-05666 K10T-05666A K10T-05667F K10T-05667G K10T-05667H K10T-05670B K10T-05711A K10T-05711B K10T-05746A K10T-05747A K10T-05797 K10T-05812A K10T-05817 K10T-05819
Reason
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.
Identifiers
| code_info | Catalog Number/UDI-DI code/Lot Numbers: TKITS-CI K05-02166B 00884450499597 T2199559 T2241078 T2282965 T2314787 T2449229…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 T25 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2579-2024%22
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