Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MEDRAD Intego PET Infusion System - Pump Intended to deliver Recalled by Bayer Healthcare Due to Bayer has determined that all current Source Administration...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Bayer Healthcare directly.
Affected Products
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.
Quantity: 178,982 (86,172 units in U.S.)
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Bayer Healthcare
Bayer Healthcare has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report