Freestyle Navigator Continuous Glucose Monitor System, Clinical Transmitter, Abbott Item Number: PRT 03831-091, 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.
FDA Recall Z-1461-2010 · Posted 2010-04-30
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Recalling FirmAbbott Diabetes Care, Inc.
Recall StatusTerminated
Product CodeMDS
Date Initiated2009-04-14
Date Terminated2011-03-31
Product Quantity5,449 of total units
Reason for Recall
Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter.
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution -- United States (OH, FL, NJ, CA, MS, MN, MA, and NY), France, Australia, the Netherlands, Sweden, the UK, Israel, Ireland and Germany.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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