FDA Device recall Z-2563-2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Mana…
- 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: K08-PI (Custom Fluid Mana… 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-2563-2024 |
| 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: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
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: K08-02042 UDI-DI code: 00884450179994 Lot Numbers: H2791360 H2825591 H2832445 H2855331 H2874529 H289734…Catalog Number: K08-02042 UDI-DI code: 00884450179994 Lot Numbers: H2791360 H2825591 H2832445 H2855331 H2874529 H2897347 Catalog Number: K08-02948 UDI-DI code: 00884450250846 Lot Numbers: H2409549 H2421264 H2454187 H2471302 H2555399 H2560081 H2590001 H2608380 H2616367 H2641745 H2689450 H2718414 H2778302 H2824898 H2835712 H2849743 H2866799 H2875231 H2880035 Catalog Number: K08-03026 UDI-DI code: 00884450280416 Lot Numbers: H2414033 H2437895 H2474035 H2489683 H2518365 H2583262 H2584710 H2596210 H2836476 H2864917 H2881380 H2906069 H2912967 Catalog Number: K08-03119 UDI-DI code: 00884450333716 Lot Numbers: H2424087 H2465222 H2500943 H2519412 H2519413 H2708309 H2744000 H2806045 H2837641 H2846068 H2865870 H2872906 H2879960 H2912192 |
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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-2563-2024%22
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