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Bayer Medical Care, Inc. recalls Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affec
Recalled January 18, 2023 · FDA recall Z-0910-2023 · Bayer Medical Care
Hazard
Black specks may be present on the packaged needles · FDA Class II
Units
2840 units
Sold at
Worldwide distribution - US Nationwide distribution in the states of AZ, IN, MN, NY, OH, TX, VA and the country of China.
Description
Black specks may be present on the packaged needles
Product
Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (PET Positron Emission Tomography - nuclear medicine) diagnostic procedures.
Manufacturer(s)
Bayer Medical Care, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →