Smisson-Cartledge Biomedical, LLC Recall 86808
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
Smisson-Cartledge Biomedical, LLC Recall 86808 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1259-2021 |
| Event ID | 86808 |
| Event 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 |
| Product Type | Devices |
| Distribution | Nationwide Distribution in US and international via 2 US distributors (VA and GA) |
| Quantity | 7118 devices |
| Recall Reason | Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids. |
| Device Classification | 20210407 |
| Device Code Info | Model DNC-1200, GTIN # (01) 00857893006073, all serial numbers |
| Center Classification Date | 20210326 |
| Recall Initiation Date | 20210218 |
| Recalling Firm | Smisson-Cartledge Biomedical, LLC |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Similar To |