Device product
Beekley Medical 0-SPOT Mammography Skin Markers REF 652
Z-2309-2017
Product summary
- Event
- Event 77295
- Status
- Terminated
- Classification
- Class III
- Quantity
- 104 boxes (58/box)= 6,032 total units
- Official record key
device-enforcement:Z-2309-2017
Official wording
Reason: Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels
Code information: LOT 652.04251701
Distribution pattern: US Distribution to the states of : AR, CA GA, IL, TX, MN, NV, NY, WI., and Internationally to Canada.
Derived failure modes
-
Unknown
Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels