Device recall
Z-1425-06: Cobe Optima XP Hollow Fiber Membrane Oxygenator, Sterile, (Custom Heart/Lung…
FDA device recall · Class II · Cobe Cardiovascular, Inc
Key facts
| Recall number (Z-number) | Z-1425-06 |
|---|---|
| Recall event | 35839 |
| Product | Cobe Optima XP Hollow Fiber Membrane Oxygenator, Sterile, (Custom Heart/Lung Packs), Catalog Numbers: 028901008, 032794001, 067129002, 067149006, 067174002, 067188002, 067212004, 067221009, 067236004, 067260001, 067296002, 067351006, 067354002, 067388004, 067434005, 067442001, 067447010, 067452001… |
| Product code | DTZ |
| Recalling firm | Cobe Cardiovascular, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 8, 2011 |
| 510(k) numbers | K926467, K974812 |
| FEI number | 1718850 |
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