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Blue Ortho recalls Instructions For Use document of the GPS Trackers.
Recalled November 4, 2020 · FDA recall Z-0288-2021 · Blue Ortho
Hazard
Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational documents. · FDA Class II
Units
3471 units
Sold at
Domestic Distribution Only: CA, CO, SC and WI.
Description
Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational documents.
Product
Instructions For Use document of the GPS Trackers.
Manufacturer(s)
Blue Ortho
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →