ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge… — Class I medical device recall Z-1258-2021
Terminated recall by Smisson-Cartledge Biomedical, LLC, reported 2021-04-07, distributed nationwide. Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum
| Recall number | Z-1258-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smisson-Cartledge Biomedical, LLC, Macon, GA, United States |
| Recall initiated | 2021-02-18 |
| Classified | 2021-03-26 |
| Reported by FDA | 2021-04-07 |
| Terminated | 2024-04-26 |
| Distributed | Nationwide (US) |
| Quantity | 18,482 devices |
| UPC / GTIN / UDI-DI | 00857893006059 |
| Model numbers | PTC-1200 |
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 for recall
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1258-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.