Smiths Medical ASD Inc. Recall 88455
Description: NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
Smiths Medical ASD Inc. Recall 88455 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2376-2021 |
| Event ID | 88455 |
| Event Description | NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 |
| 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 | 913 |
| 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 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 Date | 20210903 |
| Recall Initiation Date | 20210806 |
| Recalling Firm | Smiths Medical ASD Inc. |
| Initial Notification | Letter |
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