Smiths Medical recalls NORMOFLO Irrigation Fluid Warmers H-1100 and H-1129 due to potential aluminum leaching with blood products and longer use. Affected users should contact for remedy.
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.
Smiths Medical is recalling two models of irrigation fluid warmers because they might leak harmful levels of aluminum when used with blood products or for extended periods. This could pose a health risk to users.
Using these warmers at low flow rates with blood products or for extended periods can cause harmful aluminum levels to build up in the fluid. This may lead to health issues if the fluid is administered to patients.
Healthcare professionals and patients using these warmers with blood products or for long durations are most at risk. The recall affects specific models sold in the U.S.
Check for product codes like CON-H1100, H-1100, or H-1129 on the device. These models were sold in the U.S. and are used for irrigation fluid warming.
Look for model codes such as CON-H1100, H-1100, or H-1129 on the device.
The recall is due to potential aluminum leaching when using lower flow rates with blood products and longer durations.
The official recall notice does not specify a remedy, so contact Smiths Medical for further instructions.
Yes, using the warmer at low flow rates with blood products or for extended periods can cause harmful aluminum levels.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2376-2021 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2376-2021 from Smiths Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
