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U.S. Department of Health and Human Services

Class 2 Device Recall Bella Blankets

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  Class 2 Device Recall Bella Blankets see related information
Date Initiated by Firm July 02, 2012
Create Date June 26, 2015
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = BEEKLEY CORP.
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