Device recall
Z-0134-2026: Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product…
FDA device recall · Class II · Iantrek Inc.
Key facts
| Recall number (Z-number) | Z-0134-2026 |
|---|---|
| Recall event | 97640 |
| Product | Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis device is a manual surgical instrument used for the ab-interno construction or modification of a cyclodialysis, followed by delivery of viscous materials… |
| Product code | HMX |
| Recalling firm | Iantrek Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3017891009 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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