Cobe STAT PAC, Autotransfusion Set (Made with Compact Wash Sets), Cobe Product Codes: AS4C12, AS4C22, ASCBC12C, ASCBC22C
FDA device recall Z-1490-06 · posted 2006-09-09 · Terminated
Recall details
- Recalling firm
- Cobe Cardiovascular, Inc
- Reason for recall
- Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.
- Action taken
- Consignees were notified by telephone and e-mail on 08/04/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- CAC
- Quantity affected
- 8,964 wash sets, 1,518 Stat pacs-Recalls Z-1488-1491-06
- Distribution
- Nationwide, including VA facilities in CA and OH
- Date initiated
- 2006-08-04
- Date posted
- 2006-09-09
- Date terminated
- 2011-12-28
- 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 |
|---|---|---|
| AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS) (K982650) | Dideco S.P.A. | 1998-12-16 |