Various Merit Medical convenience kits that contain recalled Jiangsu… — Class II medical device recall Z-2569-2024
Ongoing recall by Merit Medical Systems, Inc., reported 2024-08-21, distributed nationwide. Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. L
| Recall number | Z-2569-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2024-06-11 |
| Classified | 2024-08-12 |
| Reported by FDA | 2024-08-21 |
| Distributed | Nationwide (US) |
| Quantity | 72,115 kits |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 00884450015278, 00884450015285, 00884450052297, 00884450054017, 00884450727911, 00884450727928 |
| Lot numbers | PC101/B, PC201/B, PC801, PC801/A, PC802, PC802/A, T2158130, T2169450, T2185313, T2199673, T2202175, T2208175, T2208176, T2208910, T2208911, T2223544, T2223545, T2223546, T2232658, T2232659, T2241254, T2246241, T2246244, T2248296, T2262305, T2269052, T2269053, T2269054, T2278244, T2292460, T2298721, T2299544, T2299545, T2299546, T2303828, T2303868, T2303870, T2306252, T2306254, T2310770 and 168 more |
| Model numbers | PC101/B, PC801, PC801/A, PC802, PC802/A |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2569-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.