FDA Issues Update on Recall of Fluid Warmers Due to Aluminum Contamination

September 17, 2021

The FDA has issued on update on Smiths Medical’s recall of its Normoflo irrigation fluid warmers and warming sets, deeming it a Class 1 recall because of the risk of serious injury or death.

The Aug. 6 recall was prompted by the potential for leaching of aluminum ions into the irrigation fluid in the warmers, which are used for warming blood, blood products and intravenous solutions before use during surgical procedures. The 520,163 affected products were manufactured between January 1994 and July 2021, and distributed from January 1994 until now.

Patients can be exposed to high levels of the metal when the aluminum-tainted fluid circulates through their bodies. However, there have been no reported injuries or deaths linked to the devices, the agency said.

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