September 16, 2021

FDA: Class I recall of Normoflo irrigation fluid warmers, warming sets

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA) on September 15 identified the recall of Smiths Medical Normoflo irrigation fluid warmers and warming sets as Class I, the most serious.

The recall was initiated because of the potential for aluminum ions leaching into warmed fluids, potentially exposing patients to high levels of aluminum. Toxic levels of aluminum may cause serious adverse events including death.

The fluid warming systems are used to warm blood, blood products, and IV solutions during trauma surgery; to rewarm patients after surgery; and for irrigation in urologic surgical procedures.

Distribution dates are January 1994 to present. To date, there have been no complaints, injuries, or deaths related to this issue, the FDA says.

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