Device recall
Z-0523-2025: Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number…
FDA device recall · Class III · Zyno Medical LLC
Key facts
| Recall number (Z-number) | Z-0523-2025 |
|---|---|
| Recall event | 95635 |
| Product | Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: 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 physician or other certified healthcare… |
| Product code | FRN |
| Recalling firm | Zyno Medical LLC |
| Recall class | Class III |
| 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