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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 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
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 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 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
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