Z-2112-2012 Class II Terminated
FDA device recall Z-2112-2012 was initiated by Beekley Corporation on July 9, 2012 and is designated Class II. Reason for recall: Digital Skin Mammography Marker separating from the backing of the spot material The recall status is terminated (terminated July 9, 2013). Affected quantity: 6420 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 8, 2012
- Initiation Date
- July 9, 2012
- Termination Date
- July 9, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6420 units
Product Description
Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: designed for Digital Mammography-Disposable skin markers for marking areas of concern or pain
Reason for Recall
Digital Skin Mammography Marker separating from the backing of the spot material
Distribution Pattern
US Nationwide Distribution
Code Information
Lot Numbers: A004