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Devicor Medical Products Inc recalls HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Recalled June 1, 2022 · FDA recall Z-1124-2022 · Devicor Medical Products
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. · FDA Class II
Units
90 devices
Sold at
US Nationwide distribution in the states of DE, KY, NY, OH, WV.
Description
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.
Product
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Manufacturer(s)
Devicor Medical Products Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →