Device recall
Z-0195-2016: Custom Pak 9319-27. Single-use medical devices and accessories designed by…
FDA device recall · Class II · Alcon Research, Ltd.
Key facts
| Recall number (Z-number) | Z-0195-2016 |
|---|---|
| Recall event | 72363 |
| Product | Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure. |
| Product code | LRO |
| Recalling firm | Alcon Research, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 24, 2016 |
| 510(k) numbers | K880961 |
| FEI number | 1610287 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1,000+ 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