Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB SYSTEM KIT(ORANGE)PACK NAV, Abbott Item Number 70684-01, 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.
- Company
- Abbott Diabetes Care, Inc.
- Recall Initiated
- April 14, 2009
- Posted
- April 30, 2010
- Terminated
- March 31, 2011
- Recall Number
- Z-0820-2010
- Quantity
- 5,449 of total units
- Firm Location
- Alameda, CA
Reason for Recall
Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter.
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.
Lot / Code Info
Abbott Item #70684-01; Lot No. 01M0248; Kit Serial numbers BAAH220-80089, BAAH220-81000, Tx Serial Numbers AAAH187-80187, AAAH187-80845.
Root Cause
Process control
Action Taken
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.