Device product
NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
Z-2376-2021
Product summary
- Event
- Event 88455
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 913
- Official record key
device-enforcement:Z-2376-2021
Official wording
Reason: 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.
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
Derived failure modes
-
Unknown
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.