Recall Z-2615-2010 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
Terumo Cardiovascular Corporation
Cardiovascular Procedure Kit, (MP4 w/ Conducer Component Utilized), labeled in part ***RWJ Hospital***, Item # 71305-03
| Date | Sep 29, 2010 (initiated Jun 8, 2010) |
| Status | Terminated |
| Reason | Medical device vent port may be occluded and prevent delivery of priming fluid. |
| Root cause | Equipment maintenance |
| Action | Consignees were contacted on June 8, 2010, by phone, fax, email and priority mail to advise distributors and end-users of the potential occluded vent port defect and provide instructions for the replacement product recall. Consignees were mailed follow-up communications by priority overnight mail on June 9, 2010. |
| Quantity | 110 kits |
| Distribution | The products were distributed nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K900640 | MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU 3M Company, Apr 20, 1990 |