Device recall
Z-0575-06: The GISH Vision Blood Cardioplegia System with GBS coating (a non-leaching…
FDA device recall · Class II · Gish Biomedical Inc
Key facts
| Recall number (Z-number) | Z-0575-06 |
|---|---|
| Recall event | 34220 |
| Product | The GISH Vision Blood Cardioplegia System with GBS coating (a non-leaching heparin coating) (product desgination VBCXGBS) consists of an extracorporeal heat exhanger and fluid administration set. The heat exchanger consists of a one piece, stainless steel bellows-configured heat exchanger as the… |
| Product code | DTZ |
| Recalling firm | Gish Biomedical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 21, 2007 |
| 510(k) numbers | K040355 |
| 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