ThermaCor Infusion Set Recall Due To High Levels of Aluminum Exposure

Federal health regulators are warning about a risk of problems with nearly 40,000 ThermaCor infusion sets, which may exposure patients to high levels of aluminum during use and cause serious side effects, including coma.

The FDA announced a ThermaCor 1200 Disposable Sets recall on April 12, citing the risk of patient contact with aluminum during use of the infusion set. Although no reports of injury or death have been linked to the devices, the action was categorized as a Class I medical device recall, suggesting continued use poses a serious risk of injury or death.

The disposable infusion sets are part of the ThermaCor 1200 Rapid Thermal Infusion System, which is used for fluid or bolus delivery. The system is comprised of a foot switch for hands-free fluid control, a fluid delivery device, and a single-use disposable set with supply lines which can be used with intravenous (IV) bags or surgical equipment.

The infusion sets are being recalled because the cassette that warms fluids directly with an aluminum plate may leak into the fluids and expose patients to high levels of the metal. Exposure to high levels of aluminum ions could cause serious harm to patients. Side effects of exposure to high levels of aluminum include bone or muscle pain and weakness, anemia, seizures, or coma.

The recall includes ThermaCor 1200 Disposable Sets, models PTC-1200, DNC-1200, and PNC-1200 distributed from 2006 to present. The recall is specific to the disposable cassette portion of the device, not the full pump.

Smisson-Cartledge Biomedical first warned about the problem in an Urgent Medical Device Correction Notification sent to distributors and customers in February. The company recommended limiting the use of balanced electrolyte solutions to less than six hours. It also warned that lower flow rates, increased temperatures, certain fluids, and longer durations may lead to higher aluminum levels during use. Some patients face an increased risk, including neonates, infants, pregnant mothers, and the elderly. Similarly, patients with poor renal function or on dialysis face an increased risk.

Customers can contact Smisson-Cartledge Biomedical by phone at 478-330-6203 or online at info@thermacor1200.com regarding the recall.

Side effects or problems related to use of ThermaCor infusion sets should be reported to the FDA’s MedWatch Adverse Event Reporting Program.