| Class 2 Device Recall Freestyle Navigator Continuous Glucose Monitor System |  |
Date Initiated by Firm | April 14, 2009 |
Date Posted | April 30, 2010 |
Recall Status1 |
Terminated 3 on March 31, 2011 |
Recall Number | Z-1445-2010 |
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, ABB Warranty Kit Xmitter Nav, Abbott Item Number 70791-01, 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. |
Code Information |
Abbott Item # 70791-01; with multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01M1928, 01M1978, 01M2038, 01M2178, 01M2528, and 01M3258. Kit Serial numbers beginning with: AAAH 090 or AAAH 139 or AAAH 158 or AAAH 187 or AAAH 195 or AAAH 268 or AAAH283 and followed by a five (5 )digit number. Tx Serial numbers beginning with: AAAH 090 or AAAH 139 or AAAH 158 or AAAH 187 or AAAH 195 or AAAH 268 or AAAH 283 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
|
|
|
|