FDA Device recall Z-2576-2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Safety Paracentesis Proce…
- 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: Safety Paracentesis Proce… 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-2576-2024 |
| 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: Safety Paracentesis Procedure Tray (Paracentesis Tray kit), REF: SPPT-100/D SPPT-5F-10/D SPPT-5F-10L/B SPPT-5F-10S SPPT-5F-12PL SPPT-5F-17PL SPPT-5F-7/D SPPT-5F-7L/B SPPT-5F-7S SPPT-6F-10L SPPT-6F-10S SPPT-6F-10S SPPT-6F-12PL SPPT-6F-17PL SPPT-8F-10L SPPT-8F-12PL TAPS-100 TAPS-5F-10LT TAPS-5F-10T TAPS-5F-12PLT TAPS-5F-17PLT TAPS-5F-7LT TAPS-5F-7T TAPS-6F-10LT The Safety Paracentesis Procedure Tray is intended for drainage of fluid and specimen collection for diagnostic purposes or to remove excess fluid collections.
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: SPPT-100/D 00884450038659 T2382100 T2382102 T2748984 T2871502 T2666406 T276292…Catalog Number/UDI-DI code/Lot Numbers: SPPT-100/D 00884450038659 T2382100 T2382102 T2748984 T2871502 T2666406 T2762926 T2824322 T2704382 T2863414 T2801600 T2382101 T2385423 T2407226 T2433246 T2717925 T2847798 T2433245 T2434587 T2438449 T2805260 T2587798 T2464348 T2479913 T2884261 T2498906 T2526998 T2530735 T2655953 T2931511 T2597132 T2565099 T2626508 T2657109 T2644387 SPPT-5F-10/D 00884450038673 T2351182 T2351183 T2367928 T2379511 T2379512 T2385424 T2398514 T2489934 T2498907 T2514802 T2753259 T2801601 T2730270 T2884264 T2879873 T2687139 T2779057 T2710244 T2861406 T2730271 T2823733 T2847801 T2704399 T2863441 T2662329 T2379513 T2424134 T2433247 T2464349 T2713162 T2805262 T2832456 T2805261 T2762927 T2433248 T2434588 T2438450 T2587799 T2472514 T2477549 T2900575 T2479284 T2622995S T2520450 T2520451 T2529637 T2626510 T2543014 T2583979 T2560921 T2610008 T2550617 T2655948 T2597133 T2587800 T2611991 T2657110 T2644390 SPPT-5F-10L/B 00884450038680 T2351188 T2365762 T2379520 T2388791 T2388793 |
|---|
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-2576-2024%22
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