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U.S. Department of Health and Human Services

Enforcement Report - Week of August 1, 2012

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Event Detail

Event ID 62432
Product Type Devices
Status Ongoing
Recalling Firm Beekley Corporation
City Bristol
State CT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-02
Initial Firm Notification of
Consignee or Public
Distribution Pattern International Distribution including Nationwide(USA), and the countries of Japan and Canada.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot Numbers: 107657, 108150, 108833 Class II Imaging artifact can occurr on mammogram result. 86,000 units Z-2080-2012