BEUDAMED
    FDA Recall Terminated

    Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintree, MA 02184,(Cardiovascular Perioperative Autotransfusion)

    Recall: Z-0358-2008 · Initiated October 15, 2007

    Recall

    Recall Number
    Z-0358-2008
    Event Number
    45427
    Firm
    Haemonetics Corporation
    FEI Number
    1219343
    Product Code
    CAC
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    October 15, 2007
    Posted
    December 8, 2007
    Terminated
    March 19, 2012
    Address
    400 Wood Rd, Braintree, MA, 02184-2412

    Description

    Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintree, MA 02184,(Cardiovascular Perioperative Autotransfusion)

    Reason

    Labeling (additional) use instructions: to clarify proper position of cardioPAT device and post-op line to prevent fluid build up from patient's chest

    Action

    Haemonetics issued a Labeling suppplement to users via a Field Notification letter on October 15, 2007. Users are provide additional Directions for use for the Operator's Guide and Quick Reference Guide.

    Distribution

    Nationwide: USA including states of CA, CT, FL, IN, KY, MI, NC,NE, NH, PA, RI, SC,TX, and WA

    Quantity

    106 units