Class II — Zyno Medical LLC
| Recalling firm | Zyno Medical LLC. |
|---|---|
| Registered facility | Zyno Medical LLC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump |
| Product | Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient. |
| Quantity | 2589 units |
| Distribution | Nationwide Distribution. |
| Initiated | 2011-06-13 |
| Classified | 2013-03-29 |
| Terminated | 2016-07-25 |
| Recall number | Z-1024-2013 |
| 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 — Zyno Medical LLC (Z-1024-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64448/
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