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U.S. Department of Health and Human Services

Class 2 Device Recall OneTouch SureStep Pro

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 Class 2 Device Recall OneTouch SureStep Pro see related information
Date Posted July 17, 2010
Recall Status1 Terminated on December 08, 2010
Recall Number Z-2028-2010
Recall Event ID 54565
510(K)Number K023194 
Product Classification system, test, blood glucose, over the counter - Product Code NBW
Product OneTouch SureStep Pro Test strips, for use with the OneTouch SureStep Pro Blood Glucose Meters, in 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by LifeScan Puerto Rico

Medical device for quantitative measurement of glucose in whole blood for use in hospital and clinical settings. The product is also for use in quantitative measurement of glucose in venous, capillary, arterial and neonatal whole blood samples. This system can also be used by lay users at home.
Code Information Part Number 01079702, lot numbers 2960713004
2960714009
2960715009
2963504009
2963590009
2963591009
2963592009
2965254009
2965255009
2966650004
2966682009
2966967009
2967057009
2967292009
2967293009
2967849009
2967850009
2967851004
2968029009
2968058004
2968059009
2968060009
2968521008
2968522009
2968523009
2968907009
2969686009
2970097009
2970582009
2975839008
2975840009
2977745008
2977746008
2982027008
2982028008
2982029009
2982366009
2983580009
2984289008
2984956009
2985665008
2985721004
2986875004
2987194009
2987195004
2988277009
2988392009
2990530009
2990940009
2991535009
2992027010
2992293009
2992433011
2992544009
2992695010
2992815010
2992816011
2993127010
2993235010
2993294010
2993295011
2993425011
2993426010
2993599011
2993600011
2993739010
2993991011
2994157010
2994235011
2994236010
2994281004
2994317011
2994463010
2994650010
2994659010
2994704011
2994739010
2994811010
2994812009
2994938011
2998321010
2998322011
2998731011
2999850010
3000111010
3000377011
3000723011
3000724011
3002101010
3002236010
3002237010
3002359010
3003574010
3003632011
Recalling Firm/
Manufacturer
Lifescan Inc
1000 Gibraltar Dr
Milpitas CA 95035
For Additional Information Contact
408-942-5903
Manufacturer Reason
for Recall
Products may provide inaccurate results at readings over 400 mg/dL
FDA Determined
Cause 2
Other
Action The firm, Lifescan, Inc., issued two "Urgent Medical Device Recall" letters dated February 24, 2010 to all customers for the OneTouch SureStep Test Strips and the SureStep Pro Test Strips. The letters describes the product, problem and action to be taken by the customers. The customers were instructed to look at your test strip vials for the recalled lots and check the strips or if you have test strips from the lot, call LifeScan Customer Service at 800-574-6139 between 5 a.m. to 7 p.m. Pacific Time, seven days a week or visit www.SureStep.com. Replacement product will be shipped to you immediately at no charge. The customers were instructed to continue to test your blood glucose, while wafting for replacement. Also, the customers are asked to continue use of the meter with precautions if results over 400 units are observed. For more information, please visit www.SureStep.com or call our Healthcare Professional Line at 888-455-5627.
Quantity in Commerce 8,626,350
Distribution Worldwide distribution: USA and countries of Europe, Latin America and Asia.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NBW and Original Applicant = LIFESCAN, INC.
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