Devices

Contour, Contour TS Blood Glucose Test Strips and Bonus Packs

Model / Serial
9545C, 9677, 9678, 9679, 9680, 7151G, 7190, 7183, 9615, 7393, 9591, 9591A 9579, 1802, 6181, 7070A, 9725, 9507C, and 9578. Contour 125 Count Bonus Pack (includes 2-50 Count and 1-25 Count Vials) the following lot numbers:DW0AC3B32A, DW0AC3B32C, DW0BC3B31A, DW0BC3B31B, DW0BC3D05B, DW0CC3B31A, DW0CC3B31B, DW0GC3B31C, DW0GC3B31D, DW0GC3B31F, DW0HC3B32A, DW9MC3B32D, DW9MC3B32E, DW9MC3B33A, and DW9MC3B33B.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution and Puerto Rico
Product Description
Contour, Contour TS Blood Glucose Test Strips and Bonus Packs || Intended for self-testing by people with diabetes and healthcare professionals to monitor glucose concentrations in whole blood
Manufacturer
Bayer Healthcare, LLC
1 Event
- Recall of Contour, Contour TS Blood Glucose Test Strips and Bonus Packs

Manufacturer

Bayer Healthcare, LLC

Manufacturer Address
Bayer Healthcare, LLC, 430 S Beiger Street, Mishawaka IN 46544-3207
Manufacturer Parent Company (2017)
Bayer AG
Source
USFDA

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