Recall Z-1491-06 ยท CAC Apparatus, Autotransfusion
Cobe Cardiovascular, Inc
Cobe STAT PAC Autotransfusion Set (made with Electa Wash Set), Cobe Product Codes: ASCBFE22, ASCBE22, AS9E55, AS9E22, AS9E12, AS4E55, AS4E22, AS4E17. Cobe Cardiovascular Inc.
| Date | Sep 9, 2006 (initiated Aug 4, 2006) |
| Status | Terminated |
| Reason | Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood. |
| Root cause | Other |
| Action | Consignees were notified by telephone and e-mail on 08/04/2006. |
| Quantity | 8,964 wash sets, 1,518 Stat pacs-Recalls Z-1488-1491-06 |
| Distribution | Nationwide, including VA facilities in CA and OH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020647 | DIDECO ELECTA Dideco S.P.A., Sep 5, 2002 |