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Bayer Healthcare recalls MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride
Recalled February 15, 2017 · FDA recall Z-0927-2017 · Bayer Healthcare
Hazard
Bayer has determined that all current Source Administration Sets (SAS) used with the Medrad Intego Pet Infusion System may produce particulates in radiopharmaceutical (RP) vials when the needle is inserted. · FDA Class II
Units
178,982 (86,172 units in U.S.)
Sold at
Nationwide Distribution
Description
Bayer has determined that all current Source Administration Sets (SAS) used with the Medrad Intego Pet Infusion System may produce particulates in radiopharmaceutical (RP) vials when the needle is inserted.
Product
MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. It is also intended to provide effective radiation shielding to medical personnel from Fluorine-18 radiation exposure during nuclear medicine diagnostic procedures.
Manufacturer(s)
Bayer Healthcare
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →