Smiths Medical recalls NORMOFLO Irrigation Warming sets (models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700) due to potential aluminum leaching with blood products and longer use. Consumers should check their product codes.
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 NORMOFLO Irrigation Warming administration sets (models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700) because using them with certain blood products or longer durations may cause harmful aluminum levels. This could pose health risks if the sets are used incorrectly.
Aluminum leaching can occur when the sets are used with certain blood products or solutions at lower flow rates for extended periods. This may lead to harmful aluminum levels in the body, though the risk is not immediate or severe.
Healthcare professionals and patients using these irrigation sets for blood products or prolonged medical treatments. Those with specific medical conditions requiring long-term use may be at higher risk.
Check the product code on the set: IR-40, IR-500, IR-600, IRI-600, IRI-600B, or IR-700. These models were sold with specific product codes listed in the recall notice.
Look for the product code on the set: IR-40, IR-500, IR-600, IRI-600, IRI-600B, or IR-700.
The recall is due to potential aluminum leaching when using these sets with certain blood products or solutions at lower flow rates for longer durations.
Check the product code on the set: IR-40, IR-500, IR-600, IRI-600, IRI-600B, or IR-700.
The recall does not require immediate discontinuation; however, users should check their product code and follow the provided steps.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2377-2021 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2377-2021 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.
