Bayer Healthcare recalls MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride…

Recall date

November 7, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0927-2017

FDA classification

Class II

Brand / firm

Bayer Healthcare

Sold / distributed

Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.