Devices

Device Recall OneTouch SureStep Pro

Model / Serial
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
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA and countries of Europe, Latin America and Asia.
Product Description
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.
Manufacturer
Lifescan Inc
1 Event
- Recall of Device Recall OneTouch SureStep Pro

Manufacturer

Lifescan Inc

Manufacturer Address
Lifescan Inc, 1000 Gibraltar Dr, Milpitas CA 95035
Manufacturer Parent Company (2017)
Johnson & Johnson
Source
USFDA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)