FDA recall Z-2376-2021

Smiths Medical ASD Inc. · Class I · device

Product

NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129

Reason for recall

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2021-08-06
Report date
2021-09-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2376-2021