FDA-Device2021-09-15Class I
NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
Smiths Medical ASD Inc.
Hazard
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.
Sold states
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
Affected count
519,250
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2377-2021Don't want to check this manually?
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