Radiation shielding devices made with radionuclide-contaminated lead by about 19 firms -- FDA notice.
This article was originally published in The Gray Sheet
Executive Summary
MANUFACTURER ASSURANCE OF LEAD PURITY FOR RADIATION SHIELDS will be reviewed by FDA during quality system inspections, the agency says. FDA is asking inspectors to determine if manufacturers have taken steps to ensure the purity of lead used in devices after discovering that about 19 companies inadvertently produced radiation shielding devices with lead contaminated with naturally occurring radionuclides.