Device recall
Z-0506-2025: Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The…
FDA device recall · Class II · Zyno Medical LLC
Key facts
| Recall number (Z-number) | Z-0506-2025 |
|---|---|
| Recall event | 95601 |
| Product | Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified healthcare… |
| Product code | FRN |
| Recalling firm | Zyno Medical LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K100705, K130690 |
| FEI number | 3006575795 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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