Medical Device Safety and Recalls: Bayer Recalls Medrad Intego PET Infusion System Source Administration Sets due to Particulates Generated in Vial

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Bayer Recalls Medrad Intego PET Infusion System Source Administration Sets due to Particulates Generated in Vial

Bayer has determined 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.  For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm536548.htm

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