Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PET Infusion Pump Recalled by Bayer Healthcare Due to The Source Administration Sets (SAS) used with the...
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
PET Infusion Pump
Quantity: 165,127 (79,714 units in U.S.)
Why Was This Recalled?
The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure testing specifications in an occlusion situation when the product is more than one year past manufacturing date.
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