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
Z-1259-2021
Product summary
- Event
- Event 86808
- Status
- Terminated
- Classification
- Class I
- Quantity
- 7118 devices
- Official record key
device-enforcement:Z-1259-2021
Official wording
Reason: Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
Code information: Model DNC-1200, GTIN # (01) 00857893006073, all serial numbers
Distribution pattern: Nationwide Distribution in US and international via 2 US distributors (VA and GA)
Derived failure modes
-
Unknown
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.