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U.S. Department of Health and Human Services

Enforcement Report - Week of August 1, 2012

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Product Detail

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

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 Letter
Distribution Pattern International Distribution including Nationwide(USA), and the countries of Japan and Canada.