Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: designed for Digital Mamm...
FDA Device Recall #Z-2112-2012 — Class II — July 9, 2012
Recall Summary
| Recall Number | Z-2112-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 9, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Beekley Corporation |
| Location | Bristol, CT |
| Product Type | Devices |
| 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
Lot / Code Information
Lot Numbers: A004
Other Recalls from Beekley Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2831-2018 | Class II | S-SPOT REF 777, 777S Adhere to skin for mar... | Jun 13, 2018 |
| Z-2832-2018 | Class II | TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 7... | Jun 13, 2018 |
| Z-2830-2018 | Class II | O-SPOT REF 791, 791S Adhere to skin for mar... | Jun 13, 2018 |
| Z-2309-2017 | Class III | Beekley Medical 0-SPOT Mammography Skin Markers... | May 8, 2017 |
| Z-1787-2014 | Class III | Beekley Spots Light Image O-Spots for Mammograp... | Jun 19, 2013 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.