FDA recall Z-1258-2021

Smisson-Cartledge Biomedical, LLC · Class I · device

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

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2021-02-18
Report date
2021-04-07
Termination date
2024-04-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Macon, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1258-2021