Recall Z-2309-2017 ยท JAC System, X-Ray, Film Marking, Radiographic
Beekley Corporation
Beekley Medical 0-SPOT Mammography Skin Markers REF 652
| Date | May 8, 2017 |
| Status | Terminated |
| Reason | Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels |
| Root cause | Employee error |
| Action | Beekley Medical issued letter dated May 8, 2017 advised user of the problem and to examine inventory and return product.C Accounts requested to complete response form . Questions: Quality Assurance & Regulatory Manager at 1-800-233-5539 x 434. |
| Quantity | 104 boxes (58/box)= 6,032 total units |
| Distribution | US Distribution to the states of : AR, CA GA, IL, TX, MN, NV, NY, WI., and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.