Deroyal Industries, Inc. Lafollette recalls DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set

Recall date

September 2, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2499-2021

FDA classification

Class I

Brand / firm

Deroyal Industries, Inc. Lafollette

Sold / distributed

US distribution in Florida and South Carolina.

Why it was recalled

DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming System which is recalled due to the potential for aluminum ions leaching into warming fluids.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set