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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Product Detail

Product Description Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
Recall Number Z-2111-2012
Classification Class II
Code Info Lot Numbers: A036, A037, A038, A039, A040, A041, A042, A044, A045, A046
Product Distributed Qty 267,332 units
Reason For Recall Digital Skin Mammography Marker separating from the backing of the spot material

Event Detail

Event Id 62526
Product Type Devices
Status Ongoing
Recalling Firm Beekley Corporation
City Bristol
State CT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-09
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Nationwide Distribution