Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography
FDA Recall Z-1787-2014 · Posted 2014-06-13
Recalling FirmBeekley Corporation
Recall StatusTerminated
Product CodeMUE
Date Initiated2013-06-19
Date Terminated2014-06-16
Product Quantity81 boxes
Reason for Recall
Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots
Firm Action
Beekley sent an Urgent Medical Device Recall letters dated June 19, 2013 via FedEx with signature and tracking confirmation. The letter identified the affected product, problem and actions to be taken. Firm requests users to examine inventory, remove and return recalled product. For questions contact Chelsea Fuller, Regulatory Manager at 1-800-233-5539 x 491
Root Cause
Error in labeling
Distribution Pattern
Worldwide Distribution - USA in the states of CA, FL, MA, NC, NY, and PA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.