Drug recall
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal…
FDA recall event 86808 · Class I · Smisson-Cartledge Biomedical, LLC
Key facts
| Event ID | 86808 |
|---|---|
| Recall numbers | Z-1258-2021, Z-1259-2021, Z-1260-2021 |
| Recalling firm | Smisson-Cartledge Biomedical, LLC |
| Product type | Devices |
| Products | 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… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Feb 18, 2021 |
| Report date | Apr 7, 2021 |
| Termination date | Apr 26, 2024 |
| City | Macon |
| State | GA |
| Country | United States |
| FEI number | 3006158088 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: