Cobe CML Duo Flat Sheet Membrane Oxygenator/Reservoir, sterile, (Standalone systems). Catalog Numbers: 050226400, 050422
FDA device recall Z-1423-06 · posted 2006-08-24 · Terminated
Recall details
- Recalling firm
- Cobe Cardiovascular, Inc
- Reason for recall
- Cooling and rewarming time is extended. Efficiency of the heat exchangers is reduced because many of the folds that are critical to heat exchange on the blood side of the units were blocked with a metalic material, thus decreasing the surface area needed for proper heat transfer.
- Action taken
- Consignees were notified by letter on 06/26/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTZ
- Quantity affected
- 474 units (Domestic)
- Distribution
- Worldwide distribution --- USA including VA facilities in CO, GA, MO and countries of Australia, Canada, Italy, and Japan
- Date initiated
- 2006-06-26
- Date posted
- 2006-08-24
- Date terminated
- 2011-08-08
- Location
- Arvada, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR (K000255) | Cobe Cardiovascular, Inc. | 2000-04-25 |
| COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR (K963518) | Cobe Cardiovascular, Inc. | 1997-12-08 |