FDA-Device2022-06-01Class II
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Devicor Medical Products Inc
Hazard
Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3.
Sold states
US Nationwide distribution in the states of DE, KY, NY, OH, WV.
Affected count
90 devices
Manufactured in
300 E Business Way Fl 5, Cincinnati, OH, United States
Products
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1124-2022Don't want to check this manually?
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