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 |
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