Class 2 Device Recall Bella Blankets

• Date Initiated by Firm: July 02, 2012
• Create Date: June 26, 2015
• Recall Status: Terminated on July 09, 2013
• Recall Number: Z-2080-2012
• Recall Event ID: 62432
• 510(K)Number: K073262
• Product Classification: System, x-ray, mammographic - Product Code IZH
• Product: Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging receptor plate.
• Code Information: Lot Numbers: 107657, 108150, 108833
• Recalling Firm/ Manufacturer: Beekley Corporation; 1 Prestige Ln; Bristol CT 06010-7468
• For Additional Information Contact: 800-233-5539
• Manufacturer Reason for Recall: Imaging artifact can occur on mammogram result
• FDA Determined Cause: Nonconforming Material/Component
• Action: Beekley Medical issued "Urgent: Medical Device Recall" notifications dated June 29, 2012 that were sent via certified mail USPS on July 2, 2012. The product issue was was described and customers were provided the recommended actions. Customer Service number is 1-800-233-5539.
• Quantity in Commerce: 86,000 units
• Distribution: International Distribution including Nationwide(USA), and the countries of Japan and Canada.
• 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.

• 510(K) Database: 510(K)s with Product Code = IZH