Recall Z-0265-06 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Cobe Cardiovascular, Inc
Custom heart lung perfusion packs
| Date | Dec 2, 2005 (initiated Oct 6, 2005) |
| Status | Terminated |
| Reason | One way valve in the heart lung pack assembly may be missing. |
| Root cause | Other |
| Action | Consignees notified by letter on 10/06/2005. |
| Quantity | 21,512 units |
| Distribution | Nation wide, including VA facilities in FL, NM, & CO and military facilities in CA, VA, & WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.