FDA Device recall Z-2376-2021
NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
- FDA Device
- Class I
- ongoing
- Published 2021-09-15
On 2021-09-15 the FDA classified a Class I recall of NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 by Smiths Medical Asd, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2376-2021 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-08-06 |
| Published | 2021-09-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Smiths Medical Asd |
| Distribution | US |
Product
NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
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.
Identifiers
| 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-I…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2376-2021%22
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