Smiths Medical ASD Inc.: Medical Device Recall in 2021 - (Recall #: Z-2377-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: August 6, 2021

Date Posted: September 15, 2021

Recall Number: Z-2377-2021

Event ID: 88455

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.

Status: Ongoing

Product Quantity: 519,250

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

Voluntary or Mandated:

Voluntary: Firm initiated