FDA Device recall Z-2569-2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC (Pericardiocentesis Tr…
- 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: PC (Pericardiocentesis Tr… 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-2569-2024 |
| 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: PC (Pericardiocentesis Tray - Fluid drainage tray), REF: PC101/B PC801 PC801/A PC802 PC802/A The Pericardiocentesis Kit is intended to withdraw fluid from the pericardial sac (membrane surrounding the heart) to evaluate the fluid for diagnostic purposes or to remove excess fluid causing compression of the heart.
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: PC101/B 00884450015278 T2158130 T2169450 T2199673 T2208910 T2223544 T2232658 T…Catalog Number/UDI-DI code/Lot Numbers: PC101/B 00884450015278 T2158130 T2169450 T2199673 T2208910 T2223544 T2232658 T2241254 T2246241 T2248296 T2269052 T2278244 T2298721 T2299544 T2303828 T2303868 T2303870 T2312911 T2315079 T2329632 T2340038 T2351178 T2366374 T2382095 T2382096 T2398873 T2403711 T2431280 T2431281 T2434584 T2446766 T2464347 T2467230 T2477524 T2489926 T2513657 T2514888 T2518078 T2519083 T2550611 T2565097 T2566133 T2581123 T2587792 T2597130 T2610002 T2611975 T2611988 T2617249 T2632088 T2638072 T2652386 T2652389 T2652395 T2652396 T2657105 T2662320 T2680774 T2680775 T2687130 T2687131 T2713157 T2719249 T2738068 T2762224 T2781710 T2783882 T2786106 T2801582 T2802364 T2816169 T2818676 T2821641 T2823720 T2823722 T2829990 T2829992 T2838973 T2847768 T2850599 T2850884 T2854426 T2854427 T2867188 T2868244 T2876373 T2900566 T2900613 T2912473 T2912528 T2919513 T2932986 T2940181 PC201/B 00884450015285 T2185313 T2202175 T2208175 T2223545 T2269053 T2299545 T2315080 T2329634 T2362892 T23 |
|---|
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-2569-2024%22
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