BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0174-06 · Initiated July 22, 2005

    Recall

    Recall Number
    Z-0174-06
    Event Number
    32844
    Firm
    Haemonetics Corporation
    FEI Number
    1219343
    Product Code
    CAC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 22, 2005
    Posted
    November 23, 2005
    Terminated
    May 24, 2012
    Address
    400 Wood Rd, Braintree, MA, 02184-2412

    Description

    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

    Reason

    Blood clotting of patient post operative while on the cardioPAT Cardiovascular Perioperative Autotransfusion System

    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.

    Distribution

    CA, MN, NE, TX

    Quantity

    4 machines and 486 disposables