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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: designed for Digital Mammography-Disposable skin markers for marking areas of concern or pain Lot Numbers: A004 Class II Digital Skin Mammography Marker separating from the backing of the spot material 6420 units Z-2112-2012
Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern Lot Numbers: A036, A037, A038, A039, A040, A041, A042, A044, A045, A046 Class II Digital Skin Mammography Marker separating from the backing of the spot material 267,332 units Z-2111-2012
Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern Lot Numbers: A015, A016, AO17, A018 Class II Digital Skin Mammography Marker separating from the backing of the spot material 32,640 units Z-2110-2012
Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern Lot Numbers: A020, A021, A022, A023, A024, AO25, A026 Class II Digital Skin Mammography Marker separating from the backing of the spot material 36,518 units Z-2109-2012
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