DeRoyal recalls procedure packs with Smiths Medical NORMOFLO Irrigation Warming Sets due to potential aluminum ions leaching into warming fluids. Affected units include specific lot numbers from 2021-2025.
DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming System which is recalled due to the potential for aluminum ions leaching into warming fluids.
DeRoyal is recalling procedure packs containing Smiths Medical NORMOFLO Irrigation Warming Sets because aluminum ions may leach into warming fluids. This could pose a health risk if the fluid is used for medical purposes.
The warming system may leach aluminum ions into irrigation fluids. Aluminum ions can be harmful if absorbed through the body, especially during medical procedures where fluids are used directly.
Patients using DeRoyal procedure packs with Smiths Medical NORMOFLO Irrigation Warming Sets are most at risk. Healthcare providers who use these packs for medical irrigation may also be affected.
Check for DeRoyal Procedure Packs labeled with Smiths Medical NORMOFLO Irrigation Warming Sets. Affected units have specific lot numbers listed in the recall notice, such as Lot 46459298 through Lot 54367035.
Look for DeRoyal Procedure Packs with Smiths Medical NORMOFLO Irrigation Warming Sets and check the lot numbers listed in the recall notice.
The DeRoyal procedure packs contain Smiths Medical NORMOFLO Irrigation Warming Sets that may leach aluminum ions into warming fluids, which could pose a health risk.
Check the product labels for the specific lot numbers listed in the recall notice. If you have an affected lot, stop using it and contact DeRoyal for further instructions.
Aluminum ions leaching into warming fluids could be harmful if absorbed through the body, especially during medical procedures.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-2499-2021 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-2499-2021 from DeRoyal. 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.
