Recall Z-1009-04 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
Cobe Cardiovascular, Inc
Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt
| Date | Jul 20, 2004 (initiated May 25, 2004) |
| Status | Terminated |
| Reason | Some Cardioplegia Delivery Sets, 4:1 w/shunt, were misassembled with 1:1 tubing sub-assemblies. This would provide 2 1/2x the desired cardioplegia. |
| Root cause | Other |
| Action | Customers were notified by telephone on 5/25/2004 and by letter on 6/3/2004. |
| Quantity | 216 sets |
| Distribution | AL, AZ, FL, KS, MN, MO, NV, TX, WI. Foreign distribution to Canada. |
| 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 |