BEUDAMED
    FDA Recall Terminated

    Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, Replacement Kit, Transmitter, Abbott Item Number 70791-02, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.

    Recall: Z-1446-2010 · Initiated April 14, 2009

    Recall

    Recall Number
    Z-1446-2010
    Event Number
    52635
    Firm
    Abbott Diabetes Care, Inc.
    FEI Number
    3002803444
    Product Code
    MDS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 14, 2009
    Posted
    April 30, 2010
    Terminated
    March 31, 2011
    Address
    1360 South Loop Road, Alameda, CA, 94502-7000

    Description

    Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, Replacement Kit, Transmitter, Abbott Item Number 70791-02, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.

    Reason

    Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter.

    Action

    Notification letters were issued to FreeStyle Navigator customers via certified mail and notification was posted on the Abbott Diabetes Care's Website. Customers were notified of the potential issue and actions to take: 1) if moisture is observed in the FreeStyle Navigator transmitter now or at any time, discontinue use of the transmitter and call Abbott Diabetes Care Customer Care at 1-800-418-6427 and 2) if a loss of connection is encountered or if your results are not reliable or are inconsistent with how you feel, consult your User's Guide for troubleshooting guidelines. If the issue is not resolved, call Abbott Diabetes Care Customer Care at 1-800-418-6421. For outside-of-US accounts, the firm's regional offices will distribute notices to identified customers in the appropriate language.

    Distribution

    Worldwide Distribution -- United States (OH, FL, NJ, CA, MS, MN, MA, and NY), France, Australia, the Netherlands, Sweden, the UK, Israel, Ireland and Germany.

    Quantity

    5,449 of total units