Bayer Medical Care, Inc. recalls Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affect…
- Recall date
- November 30, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0910-2023
- FDA classification
- Class II
- Brand / firm
- Bayer Medical Care, Inc.
- Sold / distributed
- Worldwide distribution - US Nationwide distribution in the states of AZ, IN, MN, NY, OH, TX, VA and the country of China.
Why it was recalled
Black specks may be present on the packaged needles
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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