Drug recall
Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a…
FDA recall event 64448 · Class II · Zyno Medical LLC
Key facts
| Event ID | 64448 |
|---|---|
| Recall numbers | Z-1024-2013 |
| Recalling firm | Zyno Medical LLC |
| Product type | Devices |
| Products | Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump |
| Initiation date | Jun 13, 2011 |
| Report date | Apr 10, 2013 |
| Termination date | Jul 25, 2016 |
| City | Natick |
| State | MA |
| Country | United States |
| FEI number | 3006575795 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: