FDA Recall
Terminated
Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: designed for Digital Mammography-Disposable skin markers for marking areas of concern or pain
Recall: Z-2112-2012
·
Initiated July 9, 2012
Recall
- Recall Number
- Z-2112-2012
- Event Number
- 62526
- Firm
- Beekley Corporation
- FEI Number
- 3000204334
- Product Code
- JAC
- Status
- Terminated
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- July 9, 2012
- Posted
- July 31, 2012
- Terminated
- July 9, 2013
- Address
- 1 Prestige Ln, Bristol, CT, 06010-7468
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
Digital Skin Mammography Marker separating from the backing of the spot material
Action
Beekley Medical issued an Urgent Medical Device Recall letter dated July 9, 2012 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers were advised to contact Beekley Medical's Customer Service Team at 1-800-233-5539 to return affected lots for replacement. Customers were instructed to complete and return the attached reply form.
Distribution
US Nationwide Distribution
Quantity
6420 units