DeRoyal’s Procedure Packs Recalled Due to Aluminum Leaching Risk

The FDA issued an update on DeRoyal Industries’ Sept. 2 recall of its DeRoyal Procedure Packs containing Smiths Medical’s Normoflo irrigation warming set, deeming it a Class I recall because of the risk of serious injury or death.

The company issued the recall because the potential for harmful levels of aluminum leaching into the fluid path through the warming sets that are used in combination with fluid warming devices. The 2,856 affected products were distributed from Nov. 29, 2017, to July 21, 2021.

The FDA said that no injuries or deaths have been reported so far in connection with the recalled products.