Devicor Medical Products Inc recalls Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified…

Recall date

February 28, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1512-2017

FDA classification

Class II

Brand / firm

Devicor Medical Products Inc

Sold / distributed

Worldwide Distribution - US including IA, IL, NY, OH, OK, PA, TN & WV. Internationally to Chile and Brazil

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance