Normoflo (blood heating devices and infusion solutions)

2021: Recall 0.5 million defective blood heating devices and infusion solutions

In mid-September 2021, Smiths Medical announced the recall of 0.5 million warmers and Normoflo irrigation liquid kits due to the possibility of aluminum ions entering heated liquids.

The U.S. Food and Drug Administration (FDA) has defined this recall as a Grade I recall, meaning the closest attention from the executive department.

According to the FDA notification, when fluid circulates in the patient's body, it may be exposed to high levels of aluminum. This exposure can be difficult to recognize and can lead to serious collateral events, including fatality. As of September 15, 2021, there were no complaints, injuries or reports of death.

Smiths Medical recalls 0.5 million defective blood heating devices and Normoflo infusion solutions

The review applies to the Normoflo irrigation liquid heater and the liquid heating kit itself. Smiths Medical began recall on August 6, 2021 for devices manufactured from January 1994 to July 2021 and distributed from January 1994 to September 16, 2021.

As of September 16, 2021, Smiths Medical recalled 520,000 devices in the United States, according to the FDA. Normoflo fluid heating systems heat blood, blood products and intravenous solutions before use. They are used when more blood is required for patients suffering from blood loss as a result of injury or surgery, as well as for heating patients after surgery to prevent hypothermia and for irrigation in urological procedures.

On August 13, 2021, Smiths Medical notified customers of the recall and asked users to identify all affected devices at their disposal and ensure that all users or potential users of affected devices are informed of the recall.^[1]

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