Cobe STAT PAC Autotransfusion Set (made with Electa Wash Set), Cobe Product Codes: ASCBFE22, ASCBE22, AS9E55, AS9E22, AS
FDA device recall Z-1491-06 · 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 |
|---|---|---|
| DIDECO ELECTA (K020647) | Dideco S.P.A. | 2002-09-05 |