Recall Z-2109-2012 ยท JAC System, X-Ray, Film Marking, Radiographic
Beekley Corporation
Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
| Date | Jul 31, 2012 (initiated Jul 9, 2012) |
| Status | Terminated |
| Reason | Digital Skin Mammography Marker separating from the backing of the spot material |
| Root cause | Unknown/Undetermined by firm |
| Action | Beekley Medical issued an Urgent Medical Device Recall letter dated July 9, 2012 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers were advised to contact Beekley Medical's Customer Service Team at 1-800-233-5539 to return affected lots for replacement. Customers were instructed to complete and return the attached reply form. |
| Quantity | 36,518 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.