FDA Device recall Z-2567-2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pressur…
- 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: K12T/12PI (Custom Pressur… 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-2567-2024 |
| 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: K12T/12PI (Custom Pressure Monitoring Kit), REF: K12-03846 K12-04185A K12-03447 K12M-02489 K12-10056 K12-02489A K12-02097B K12-12335 K12-12192P K12-12079P K12-04262BP K12-11132B K12-12382 K12-09098C K12-02112 K12-02111 K12-05576G K12-05805A K12T-10313C K12-11821P K12-01348D K12-11821 K12-11426 K12-06318 K12-12053 K12-03438 K12-07208A K12-12147 K12-09009 K12-10375 K12-08716 K12-11669AP K12-00657A K12-11131AP K12-10914 K12-07299P K12-05494 K12-00443A K12-08303 K12-06509A K12-10962 K12-11133 K12-06509B To support various vascular or cardiac diagnostic and interventional procedures.
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: K12-02097B 00884450191309 H2413516 H2430266 H2448853 H2474037 H2505248 H251815…Catalog Number/UDI-DI code/Lot Numbers: K12-02097B 00884450191309 H2413516 H2430266 H2448853 H2474037 H2505248 H2518159 H2540340 H2545409 H2575507 H2591235 H2744213 H2751673 H2846090 H2879948 H2912178 K12-02489A 00884450191422 H2407774 H2413469 H2520693 H2550452 H2566464 H2607157 H2705182 H2753896 H2758300 H2814926 H2850642 K12-03447 00884450192443 H2404130 H2408589 H2439003 H2451626 H2690274 H2757182 H2817430 H2846659 K12-03846 00884450144848 H2472033 H2494636 H2507902 H2536621 H2552837 H2557081 H2718140 H2810887 K12-04185A 00884450193143 H2398739 H2418369 H2557282 H2595087 H2635991 H2666462 H2690318 H2719739 H2775079 H2780258 H2792424 H2881789 H2916471 K12-04262BP 00884450250426 H2760748 H2784117 H2802626 H2829046 H2877237 H2897143 H2913395 K12-09098C 00884450816509 H2912500 H2912511 H2912512 H2912513 K12-10056 00884450383704 H2406238 H2418284 H2437885 H2469808 H2518359 H2529863 H2541614 H2555920 H2592114 H2659218 H2685221 H2709291 H2741843 H2767146 H2781349 H2795585 H2827702 |
|---|
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-2567-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.