Class II — Cardinal Health 200, LLC
| Recalling firm | Cardinal Health 200, LLC |
|---|---|
| Registered facility | View this company's 35 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical® supplied finished kits. Merit Medical® supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical® kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device. |
| Product | Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1; 3) Neurological Tray, Catalog Number SAN29NRCC2; 4) Neurological Tray, Catalog Number SAN29NRCC3; 5) Neurological Tray, Catalog Number SAN29NRCCA; 6) Neurological Tray, Catalog Number SANV1NIYH2; 7) Neurological Tray, Catalog Number SANV1NIYH3; 8) Neurological Tray, Catalog Number SANV1NIYH4; 9) Neurological Tray, Catalog Number SANV1NIYH5; 10) Neurological Tray, Catalog Number SANV1NIYH6; 11) Neurological Tray, Catalog Number SANV1NIYH7; 12) Neur… |
| Quantity | 13487 units |
| Distribution | Nationwide |
| Initiated | 2024-05-29 |
| Classified | 2024-07-10 |
| Recall number | Z-2330-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cardinal Health 200, LLC (Z-2330-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94763/
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