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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott brand FreeStyle Navigator

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  Class 2 Device Recall Abbott brand FreeStyle Navigator see related information
Date Initiated by Firm November 01, 2008
Date Posted May 20, 2009
Recall Status1 Terminated 3 on June 03, 2009
Recall Number Z-1196-2009
Recall Event ID 50202
PMA Number P050020 
Product Classification Sensor, glucose, invasive - Product Code MDS
Product Abbott brand FreeStyle Navigator, Receiver Warranty Kit, Blood Glucose Monitoring System, Part Number: 70789-01.

The product is manufactured by Benchmark Electronics, 3535 Technology Drive NW, Rochester, MN and distributed by Abbott Diabetes Care, 1360 South Loop Road, Alameda, CA.
Code Information Lot Number: 01M2278; Serial Numbers: BAAH223-80915 and BAAH223-80182.
Recalling Firm/
Manufacturer		 Abbott Diabetes Care, Inc.
1360 S Loop Rd
Alameda CA 94502-7000
For Additional Information Contact Tina Mazurkiewicz
510-749-5400
Manufacturer Reason
for Recall		 The product has the Units of Measure set to mmol/L rather than mg/dL. The blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
FDA Determined
Cause 2		 Packaging process control
Action The Consignees of the affected FreeStyle Navigator Receiver Kit was contacted via telephone, Federal Express or an Abbott representative beginning on November 1, 2008. Contact Customer Service at 1-866-597-5520 with further questions.
Quantity in Commerce 2 units
Distribution US Distribution to states of NY and AZ.
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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