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Recall Observatory FDA recall evidence

Device product

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

Z-2377-2021

August 06, 2021

Class I

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 88455
Status
Ongoing
Classification
Class I
Quantity
519,250
Official record key
device-enforcement:Z-2377-2021

Official wording

Reason: 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.

Code information: 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

Distribution pattern: US Nationwide Distribution and PR OUS distribution in - Austria, Australia, Belgium, Switzerland, Canada, Germany, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Hungary, Ireland, Italy, Kuwait, Luxembourg, Netherlands, New Zealand, Panama, Poland, Portugal, Sweden, Turkey, Venezuela, South Africa

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.