Device recall
Z-1024-2013: Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids…
FDA device recall · Class II · Zyno Medical LLC
Key facts
| Recall number (Z-number) | Z-1024-2013 |
|---|---|
| Recall event | 64448 |
| Product | Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient. |
| Product code | OPP |
| Recalling firm | Zyno Medical LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 25, 2016 |
| 510(k) numbers | K071545, K100705 |
| FEI number | 3006575795 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database