Recall Z-0174-06 ยท CAC Apparatus, Autotransfusion
Haemonetics Corporation
cardioPAT Cardiovascular Perioperative Autotransfusion System, Model: LN 2050-110-E and Disposables: cardioPAT Replacement RBC Bags, LN 00270 cardioPAT Replacement Waste Bags, LN 00271 cardioPAT Replacement Intraoperative Suction Set, LN 00272 cardioPAT Replacement Postoperative Suction Set, LN 00273 cardioPAT cardiovascular Perioperative Autotransfusion System Disposable Set, LN 00274 cardioPA
| Date | Nov 23, 2005 (initiated Jul 22, 2005) |
| Status | Terminated |
| Reason | Blood clotting of patient post operative while on the cardioPAT Cardiovascular Perioperative Autotransfusion System |
| Root cause | Other |
| Action | Haemonetics issued a recall notification via Certified Mail on 7/22/05 to four user sites requesting return of the machine and all disposables received. |
| Quantity | 4 machines and 486 disposables |
| Distribution | CA, MN, NE, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043127 | HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM Haemonetics Corp., Jan 4, 2005 |