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Smisson-Cartledge Biomedical, LLC recalls ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion S
Recalled April 7, 2021 · FDA recall Z-1259-2021 · Smisson-Cartledge Biomedical
Hazard
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids. · FDA Class I
Units
7118 devices
Sold at
Nationwide Distribution in US and international via 2 US distributors (VA and GA)
Description
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
Product
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
Manufacturer(s)
Smisson-Cartledge Biomedical, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →