Z-2111-2012 Class II Terminated
FDA device recall Z-2111-2012 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: 267,332 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
- 267,332 units
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
Reason for Recall
Digital Skin Mammography Marker separating from the backing of the spot material
Distribution Pattern
US Nationwide Distribution
Code Information
Lot Numbers: A036, A037, A038, A039, A040, A041, A042, A044, A045, A046