Device recall
Z-1428-06: Cobe Optima XP Hollow Fiber Membrane Oxygenator, Non-Sterile, Catalog Number…
FDA device recall · Class II · Cobe Cardiovascular, Inc
Key facts
| Recall number (Z-number) | Z-1428-06 |
|---|---|
| Recall event | 35839 |
| Product | Cobe Optima XP Hollow Fiber Membrane Oxygenator, Non-Sterile, Catalog Number 436422974, COBE Cardiovascular, Inc.. (shipped International only for use in Heart/Lung packs) |
| Product code | DTZ |
| Recalling firm | Cobe Cardiovascular, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 8, 2011 |
| FEI number | 1718850 |
At a glance
- None 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