Smiths Medical ASD Inc.: Medical Device Recall in 2021 - (Recall #: Z-2376-2021)

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 Fluid Warmer Models H-1100 and H-1129

Product Classification:

Class I

Date Initiated: August 6, 2021

Date Posted: September 15, 2021

Recall Number: Z-2376-2021

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: 913

Code Information:

Model H-1100: Product Codes CON-H1100, H-1100, H-1100-ES-115V, H-1100-ES-230V, H-1100-FR-230V, H-1100-INT-230, H-1100-IT-230V, H-1100-NL-230V H-1100-SV-230V, H-1100-UK-230 Model H-1129: Product Code H-1129

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