Recall Z-0960-03 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
Cobe Cardiovascular, Inc
Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt.
| Date | Jul 2, 2003 (initiated May 9, 2003) |
| Status | Terminated |
| Reason | Tubing set included in Cardioplegia Delivery System was 4:1 instead of the labeled 8:1 size. |
| Root cause | Other |
| Action | All consignees were contacted by telephone on 05/09/2003, followed by a letter. |
| Quantity | 60 units |
| Distribution | MN, NE, OK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934847 | NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS Sorin Biomedical, Inc., Apr 15, 1994 |