FDASeptember 2, 2021device

DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

deroyal industries inc lafollettederoyalderoyal industries

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set — Recall Details · AllClear