Class I — Smisson-Cartledge Biomedical, LLC
| Recalling firm | SMISSON-CARTLEDGE BIOMEDICAL LLC |
|---|---|
| Registered facility | SMISSON-CARTLEDGE BIOMEDICAL LLC (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids. |
| 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 |
| Quantity | 11768 devices |
| Distribution | Nationwide Distribution in US and international via 2 US distributors (VA and GA) |
| Initiated | 2021-02-18 |
| Classified | 2021-03-26 |
| Terminated | 2024-04-26 |
| Recall number | Z-1260-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Smisson-Cartledge Biomedical, LLC (Z-1260-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86808/
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