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Smiths Medical ASD Inc. Recall 88455

Description: NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700

Smiths Medical ASD Inc. Recall 88455 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2377-2021
Event ID88455
Event DescriptionNORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
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
Quantity519,250
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 IR-40: Product Code IR-40 Model IR-500: Product Code IR-500 Model IR-600: Product Code IR-600 Model IRI-600: Product Code IRI-600 Model IRI-600B: Product Code IRI-600B Model IR-700: Product Code IR-700
Center Classification Date20210903
Recall Initiation Date20210806
Recalling FirmSmiths Medical ASD Inc.
Initial Notification Letter
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