NORMOFLO Irrigation Fluid Warmer recall
NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
Why was NORMOFLO Irrigation Fluid Warmer recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 913
- 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
- Recall date
- September 15, 2021
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)