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Recall Observatory FDA recall evidence

Device product

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

Z-2376-2021

August 06, 2021

Class I

Product summary

Firm
Smiths Medical ASD Inc.
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

    reason.no_named_rule · v1.0.0

    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.

Field note

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