Class 2 Device Recall Beekley Medical SPOTS

• Date Initiated by Firm: July 09, 2012
• Date Posted: July 31, 2012
• Recall Status: Terminated on July 09, 2013
• Recall Number: Z-2111-2012
• Recall Event ID: 62526
• Product Classification: System, x-ray, film marking, radiographic - Product Code JAC
• Product: Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
• Code Information: Lot Numbers: A036, A037, A038, A039, A040, A041, A042, A044, A045, A046
• FEI Number: 3000204334
• Recalling Firm/ Manufacturer: Beekley Corporation; 1 Prestige Ln; Bristol CT 06010-7468
• For Additional Information Contact: 800-233-5539
• Manufacturer Reason for Recall: Digital Skin Mammography Marker separating from the backing of the spot material
• FDA Determined 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 in Commerce: 267,332 units
• Distribution: US Nationwide Distribution
• 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.