BEUDAMED
    FDA Recall Terminated

    Martel Printer The Martel Printer is an accessory to the i-STAT Portable clinical Analyzer (model 300). The i-STAT Analyzer is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in i-STAT test cartridges. These tests include Hematocrit, glucose, blood urea nitrogen, sodium, potassium, chloride, ionized calcium, blood gases (oxygen, carbon dioxide, and pH), Creatinine, lactate and activated clotting time.

    Recall: Z-1133-2010 · Initiated November 6, 2009

    Recall

    Recall Number
    Z-1133-2010
    Event Number
    53674
    Firm
    Abbott Point of Care Inc.
    FEI Number
    2245578
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    November 6, 2009
    Posted
    March 15, 2010
    Terminated
    September 14, 2011
    Address
    400 College Rd E, Princeton, NJ, 08540-6607

    Description

    Martel Printer The Martel Printer is an accessory to the i-STAT Portable clinical Analyzer (model 300). The i-STAT Analyzer is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in i-STAT test cartridges. These tests include Hematocrit, glucose, blood urea nitrogen, sodium, potassium, chloride, ionized calcium, blood gases (oxygen, carbon dioxide, and pH), Creatinine, lactate and activated clotting time.

    Reason

    Some Martel Printers used with the i-STAT 1 system have the potential of being damaged due to the use or rechargeable battery packs that do not contain a fuse.

    Action

    An "Urgent Recall Notice" dated October 2009 was sent to customers. The notice described the product, problem and action to be taken by the customers. The customers are requested to remove the printers from use, if they have a Martel printer with the specified serial numbers, that do not have a battery door for access to the rechargeable battery pack. The customers are ask to turn in to Abbott Point of Care or a designated repair facility, all affected Martel printers for battery pack replacement. Abbott will return the Martel printers to your facility at no charge. The customers are ask to please follow the instructions on the enclosed customer reply cared. If in doubt regarding identification of the affected Martel printers, contact Abbott Point of Care Technical Support. If you have any questions regarding this information or if removing the affected Martel printers from use will negatively impact patient care, please contact Abbott Point of Care Technical Support at 800-366-8020, option 1 or your Abbott Point of Care representative.

    Distribution

    Worldwide distribution

    Quantity

    6432 printers (1208 have already been returned and repaired or scrapped)