Recall Z-1259-2021— Smisson-Cartledge Biomedical, LLC
Class I · Terminated
Class I FDA medical device recall by Smisson-Cartledge Biomedical, LLC, initiated 2021-02-18, terminated 2024-04-26. It names one FDA 510(k) clearance: K052055. 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: Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids..
- Recalling firm
- Smisson-Cartledge Biomedical, LLC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2021-02-18
- Terminated
- 2024-04-26
- Firm location
- Macon, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.