Z-2376-2021 Class I Ongoing

Recalled by Smiths Medical ASD Inc. — Minneapolis, MN

Recall Details

Product Type
Devices
Report Date
September 15, 2021
Initiation Date
August 6, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
913

Product Description

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 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

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