Device recall
Z-2091-2021: Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in…
FDA device recall · Class II · Dutch Ophthalmic USA, Inc.
Key facts
| Recall number (Z-number) | Z-2091-2021 |
|---|---|
| Recall event | 88153 |
| Product | Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06 |
| Product code | HMX |
| Recalling firm | Dutch Ophthalmic USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 5, 2021 |
| FEI number | 3007916166 |
At a glance
- None 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