Device recall
Z-2252-2021: The device is a 25-gauge infusion line that is part of 25-gauge surgical pack…
FDA device recall · Class II · Dutch Ophthalmic USA, Inc.
Key facts
| Recall number (Z-number) | Z-2252-2021 |
|---|---|
| Recall event | 88162 |
| Product | The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201. |
| Product code | HQC |
| Recalling firm | Dutch Ophthalmic USA, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K190875 |
| FEI number | 3007916166 |
At a glance
- 1–9 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