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Devicor Medical Products Inc recalls Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identifie
Recalled March 29, 2017 · FDA recall Z-1512-2017 · Devicor Medical Products
Hazard
The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number. · FDA Class II
Units
320
Sold at
Worldwide Distribution - US including IA, IL, NY, OH, OK, PA, TN & WV. Internationally to Chile and Brazil
Description
The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.
Product
Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
Manufacturer(s)
Devicor Medical Products Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →