Smisson-Cartledge Biomedical product recalled over fire hazard

Recall date

February 18, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Smisson-Cartledge Biomedical, LLC recalls ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion Sys…

Recall number

Z-1258-2021

FDA classification

Class I

Brand / firm

Smisson-Cartledge Biomedical, LLC

Sold / distributed

Nationwide Distribution in US and international via 2 US distributors (VA and GA)

Why it was recalled

Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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