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 cardioPAT Replacement One-Way Valve Assembly LN 00275
FDA Recall Z-0174-06 · Posted 2005-11-23
Recalling FirmHaemonetics Corporation
Recall StatusTerminated
Product CodeCAC
Date Initiated2005-07-22
Date Terminated2012-05-24
Product Quantity4 machines and 486 disposables
Reason for Recall
Blood clotting of patient post operative while on the cardioPAT Cardiovascular Perioperative Autotransfusion System
Firm 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.
Root Cause
Other
Distribution Pattern
CA, MN, NE, TX
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.