Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor Recalled by Smisson-Cartledge Biomedical, LLC Due to Customers are being notified of results from a...
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 Smisson-Cartledge Biomedical, LLC directly.
Affected Products
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures
Quantity: 18482 devices
Why Was This Recalled?
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Smisson-Cartledge Biomedical, LLC
Smisson-Cartledge Biomedical, LLC has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report