Device recall
Z-2585-2017: OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide…
FDA device recall · Class II · Cook Inc.
Key facts
| Recall number (Z-number) | Z-2585-2017 |
|---|---|
| Recall event | 77307 |
| Product | OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the Odyssey 30 Holmium Laser System for fragmentation of urinary calculi and soft tissue applications including incision/excision, ablation, and coagulation |
| Product code | GEX |
| Recalling firm | Cook Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 26, 2019 |
| 510(k) numbers | K073496 |
| FEI number | 1820334 |
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