PlainRecalls
FDA Devices Critical Class I Terminated

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

Reported: April 7, 2021 Initiated: February 18, 2021 #Z-1260-2021

Product Description

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

Reason for Recall

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

Details

Units Affected
11768 devices
Distribution
Nationwide Distribution in US and international via 2 US distributors (VA and GA)
Location
Macon, GA

Frequently Asked Questions

What product 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. Recalled by Smisson-Cartledge Biomedical, LLC. Units affected: 11768 devices.
Why was this product recalled? ▼
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 7, 2021. Severity: Critical. Recall number: Z-1260-2021.

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