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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2377-2021 |
| Event ID | 88455 |
| Event Description | NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700 |
| Product Type | Devices |
| Distribution | 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 |
| Quantity | 519,250 |
| Recall 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. |
| Device Classification | 20210915 |
| Device Code Info | Model 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 Date | 20210903 |
| Recall Initiation Date | 20210806 |
| Recalling Firm | Smiths Medical ASD Inc. |
| Initial Notification | Letter |
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