RECOMMENDATION: Customers were instructed to stop using all units of the Flexishield Mini Catalog Number F5300 in their inventory and return them to the company. It is recommended that health care professionals inform the patient about the likelihood of post-operative tungsten particles in the breast and continue the imaging recommended in your clinical protocol for the full 5 years, unless otherwise directed by the patient’s treatment team. For the recalled lot numbers and additional recommendations please see the Recall Notice.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
