Device recall
Z-2648-2024: Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A…
FDA device recall · Class II · Alcon Research LLC
Key facts
| Recall number (Z-number) | Z-2648-2024 |
|---|---|
| Recall event | 94989 |
| Product | Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a… |
| Product code | LRO |
| Recalling firm | Alcon Research LLC |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1610287 |
At a glance
- None Linked 510(k)s
- 10–99 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