Bayer notified the FDA that all Source Administration Sets used with the Medrad Intego PET Infusion System may produce a particulate matter in the medicine vials. The particulates may be created when the tip of the needle pushes through the rubber top of the vial. If this occurs, the particulate matter could enter into the patient and cause serious adverse health consequences including infection, damage of tissue, and death. FDA recommends that facilities immediately discontinue the use and quarantine any unused affected product. Facilities should contact Bayer Customer Care for instructions on returning the recalled product. Read the FDA recall notice.