Recall Z-1069-05 ยท CAC Apparatus, Autotransfusion
Cobe Cardiovascular, Inc
ASY Brat 2 Procedure Set, for blood recovery & autotransfusion.
| Date | Aug 3, 2005 (initiated Jun 22, 2005) |
| Status | Terminated |
| Reason | Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product. |
| Root cause | Other |
| Action | Domestic customers were notified by overnight letter beginning 6/22/2005.Foreign consignees were notified by e-mail on 6/16-17/2005 |
| Quantity | 1002 units |
| Distribution | Nationwide, including VA facilities in PA and WA. No other military or government consignees. Foreign distribution to Australia, Canada, Italy and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K933625 | BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM Cobe Cardiovascular, Inc., Dec 29, 1993 |