FDA Enforcement
Class III
Terminated
Beekley Medical 0-SPOT Mammography Skin Markers REF 652
Recall: Z-2309-2017
·
Reported June 14, 2017
Enforcement
- Recall Number
- Z-2309-2017
- Event ID
- 77295
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Beekley Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 14, 2017
- Initiation Date
- May 8, 2017
- Classification Date
- June 7, 2017
- Termination Date
- June 20, 2017
- Address
- 1 Prestige Ln, N/A, Bristol, CT, 06010-7468, United States
Description
Beekley Medical 0-SPOT Mammography Skin Markers REF 652
Reason
Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels
Code Info
LOT 652.04251701
Distribution
US Distribution to the states of : AR, CA GA, IL, TX, MN, NV, NY, WI., and Internationally to Canada.
Quantity
104 boxes (58/box)= 6,032 total units