Recall Z-1490-06 ยท CAC Apparatus, Autotransfusion
Cobe Cardiovascular, Inc
Cobe STAT PAC, Autotransfusion Set (Made with Compact Wash Sets), Cobe Product Codes: AS4C12, AS4C22, ASCBC12C, ASCBC22C, ASCBFC22C. 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
| K982650 | AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS) Dideco S.P.A., Dec 16, 1998 |