FDA: Class I recall of DeRoyal procedure packs containing Smiths Medical Normoflo irrigation warming sets

Editor's Note

The Food and Drug Administration (FDA), on October 6, identified the recall by Deroyal Industries of its procedure packs containing Smiths Medical Normoflo irrigation warming sets as Class I, the most serious.

The recall was initiated because of the possibility of harmful levels of aluminum leaching into the fluid path of the warmers.

Fluid warming devises are used to provide blood to trauma or surgery patients, rewarm patients after surgery, and to irrigate during urology procedures.

Distribution dates were November 29, 2017, to July 21, 2021.