# FDA recall Z-1258-2021

> **Smisson-Cartledge Biomedical, LLC** · Class I · device recall initiated 2021-02-18.

## 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.

## Distribution

Nationwide Distribution in US and international via 2 US distributors (VA and GA)

## Key facts

- **Recall number:** Z-1258-2021
- **Recalling firm:** Smisson-Cartledge Biomedical, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-18
- **Report date:** 2021-04-07
- **Termination date:** 2024-04-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Macon, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1258-2021

## Citation

> AI Analytics. FDA recall Z-1258-2021. Retrieved 2026-07-30 from https://api.ai-analytics.org/recall/Z-1258-2021. Source: US FDA. Licensed CC0.

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