Smiths Medical is recalling the Normoflo irrigation fluid warmer and warmer sets due to the potential for aluminum ions leaching into warmed fluids.
The recall has been designated as a Class I recall — the most serious kind — by the FDA.
According to an FDA notice, when fluid circulates through a patient’s body, the patient can be exposed to high levels of aluminum. That exposure may not be easily recognized and could lead to serious adverse events, including death. No complaints, injuries or reports of death have been received to date.
The recall covers the Normoflo irrigation fluid warmer and Normoflo irrigation warming set. The company initiated the recall on Aug. 6, 2021, for devices manufactured between January 1994 and July 2021 and distributed between January 1994 and the present day. To date, Smiths Medical has recalled 520,163 devices in the U.S.
Normoflo fluid warming systems warm blood, blood products and intravenous solutions before use, as the uses for them include when more blood is needed for patients suffering from blood loss due to trauma or surgery, as well as for rewarding patients after surgery to prevent hypothermia and for irrigation in urology procedures.
On Aug. 13, Smiths Medical notified customers of the recall and told users to identify any affected devices in their possession and ensure that all users or potential users of the affected devices are made aware of the recall.
Smiths Medical did not immediately respond to request for comment on the recall. This story may be updated.