Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medrad Source Administration Sets Recalled by Bayer Healthcare Due to The firm's investigation of the Medrad Intego indicates...
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 Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.
Quantity: 198,598
Why Was This Recalled?
The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tubing is out of specification and may result in the system failing to position the dose correctly during extraction, potentially leading to a low measurement of the extracted dose or to a higher dose being extracted. The occluded SAS tubing may impair the priming function and prompt an RP prime fail
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