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U.S. Department of Health and Human Services

Class 2 Device Recall Freestyle Navigator Continuous Glucose Monitor System

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  Class 2 Device Recall Freestyle Navigator Continuous Glucose Monitor System see related information
Date Initiated by Firm April 14, 2009
Date Posted April 30, 2010
Recall Status1 Terminated 3 on March 31, 2011
Recall Number Z-1452-2010
Recall Event ID 52635
PMA Number P050020 
Product Classification Continuous glucose monitor - Product Code MDS
Product Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System, Business 1, MMOL. Abbott Item Number 70966-02, 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.
Code Information Abbott Item # 70966-02 with multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01M0748 or 01M0858 or 01M1548 or 01M2628 or 01M2188. Kit Serial numbers beginning with: BAAH 207 or BAAH 220 or BAAH 223 or BAAH 243 or BAAH 275 or BAAH 290 or BAAH 299 or BAAH 341 and followed by a five (5 )digit number. Tx Serial numbers beginning with: AAAH187 or AAAH 212 or AAAH 221 or AAAH 239 or AAAH 296 and followed by a five (5) digit number. 
Recalling Firm/
Manufacturer		 Abbott Diabetes Care, Inc.
1360 South Loop Road
Alameda CA 94502-7000
For Additional Information Contact
510-749-5400
Manufacturer Reason
for Recall		 Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter.
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 5,449 of total units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MDS and Original Applicant = Abbott Laboratories
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