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# Smisson-Cartledge’s Class 1 Recall of Infusion System IV Sets
- URL: https://www.fdaweb.com/smisson-cartledges-class-1-recall-of-infusion-system-iv-sets/
- Published: 2021-04-12T12:00:00.000Z
- Updated: 2026-09-14T16:54:25.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149091

Smisson-Cartledge Biomedical has recalled (Class 1) its ThermaCor 1200 Rapid Thermal Infusion System Disposable Sets because a cassette that warms fluids directly with an aluminum plate may leak aluminum into the fluids and expose patients to high levels of the metal. The recall is specific to the disposable cassette portion of the device, not to the full pump, a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/smisson-cartledge-biomedical-llc-recalls-thermacor-1200-disposable-sets-risk-patient-contact?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. Use of the affected product could cause increase exposure to aluminum ions, which could cause serious patient harm such as bone or muscle pain and weakness, anemia, seizures, or coma, it says. There have been no complaints, reports of injuries, or deaths related to the device issue, according to the company.

The disposable sets are part of the infusion system that is used for fluid or bolus delivery. The system comprises a footswitch for hands-free fluid control, a fluid delivery device, and a single-use disposable set with supply lines that can be used with intravenous bags or surgical equipment, the company says.