Device recall
Z-1702-2015: The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use…
FDA device recall · Class II · Alcon Research, Ltd.
Key facts
| Recall number (Z-number) | Z-1702-2015 |
|---|---|
| Recall event | 71156 |
| Product | The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove. |
| 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