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Smiths Medical ASD Inc. Recall 88455

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

Smiths Medical ASD Inc. Recall 88455 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2376-2021
Event ID88455
Event DescriptionNORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
Product TypeDevices
DistributionUS 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
Recall ReasonThere is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.
Device Classification20210915
Device Code InfoModel 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
Center Classification Date20210903
Recall Initiation Date20210806
Recalling FirmSmiths Medical ASD Inc.
Initial Notification Letter
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