BEUDAMED
    FDA Recall Terminated

    Stat Profile Critical Care Xpress (CCX) Analyzer Catalog Number: 35942

    Recall: Z-0826-04 · Initiated March 30, 2004

    Recall

    Recall Number
    Z-0826-04
    Event Number
    28725
    Firm
    Nova Biomedical Corporation
    FEI Number
    1219029
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 30, 2004
    Posted
    July 20, 2004
    Terminated
    June 17, 2004
    Address
    200 Prospect St, Waltham, MA, 02453-3457

    Description

    Stat Profile Critical Care Xpress (CCX) Analyzer Catalog Number: 35942

    Reason

    Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems

    Action

    Nova Biomedical notified users by telephone on 3/31/04 and conducted follow-up by letter either by email or fax. On-site visit will be scheduled to replace the pump assembly.

    Distribution

    CA, IL, LA, MA ,NJ, NY, OH, PA, TX International: Italy ,England, Japan,Turkey., U.A.E., Greece, Thailand, Switzerland, Finland, Saudi Arabia, Italy, Mexico, Trinidad, Ireland, France, Cyprus, Czech Republic, ,Germany

    Quantity

    35 units