Device recall
Z-0519-06: The GISH Vision Hollow Fiber Oxygenator with GBS coating (a non-leaching heparin…
FDA device recall · Class II · Gish Biomedical Inc
Key facts
| Recall number (Z-number) | Z-0519-06 |
|---|---|
| Recall event | 34215 |
| Product | The GISH Vision Hollow Fiber Oxygenator with GBS coating (a non-leaching heparin coating) is a sterile, non-pyrogenic, single use, disposable, extracorporeal device designed to be used in an extracorporeal blood circuit to control exchange of gases. It is intended for the supply of oxygen to, and… |
| Product code | DTZ |
| Recalling firm | Gish Biomedical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 21, 2007 |
| 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