Class 3 Device Recall Beekley Spots Light Image OSpots

• Date Initiated by Firm: June 19, 2013
• Date Posted: June 13, 2014
• Recall Status: Terminated on June 16, 2014
• Recall Number: Z-1787-2014
• Recall Event ID: 65483
• Product Classification: Full field digital,system,x-ray,mammographic - Product Code MUE
• Product: Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography
• Code Information: Lot Number: 252.04261301
• Recalling Firm/ Manufacturer: Beekley Corporation; 1 Prestige Ln; Bristol CT 06010-7468
• For Additional Information Contact: 800-233-5539
• Manufacturer Reason for Recall: Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots
• FDA Determined Cause: Error in labeling
• 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
• Quantity in Commerce: 81 boxes
• Distribution: Worldwide Distribution - USA in the states of CA, FL, MA, NC, NY, and PA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.