Device recall
Z-0730-04: Vision Hollow Fiber Oxygenator with GBS Coating
FDA device recall · Class II · Gish Biomedical Inc
Key facts
| Recall number (Z-number) | Z-0730-04 |
|---|---|
| Recall event | 28525 |
| Product | Vision Hollow Fiber Oxygenator with GBS Coating |
| Product code | DTZ |
| Recalling firm | Gish Biomedical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 4, 2005 |
| 510(k) numbers | K023381 |
| FEI number | 2021836 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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