medical Class I Updated 2021-09-15

Smiths Medical ASD Inc. recalls NORMOFLO Irrigation Warming administration set (disposable),

Recalled Product

NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700


Hazard / Issue

There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model IR-40: Product Code IR-40 Model IR-500: Product Code IR-500 Model IR-600: Product Code IR-600 Model IRI-600: Product Code IRI-600 Model IRI-600B: Product Code IRI-600B Model IR-700: Product Code IR-700
View official government recall

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