FDA-Device2017-06-14Class III

Beekley Medical 0-SPOT Mammography Skin Markers REF 652

Beekley Corporation
Hazard

Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels

Sold states
US Distribution to the states of : AR, CA GA, IL, TX, MN, NV, NY, WI., and Internationally to Canada.
Affected count
104 boxes (58/box)= 6,032 total units
Manufactured in
1 Prestige Ln, N/A, Bristol, CT, United States
Products
Beekley Medical 0-SPOT Mammography Skin Markers REF 652

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2309-2017

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