Smiths Medical recalls tracheostomy tubes with non-sterile labeling. Devices sold as sterile but not actually sterile pose infection risks. Consumers should check model numbers and contact Smiths Medical for details.
Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
Smiths Medical is recalling certain tracheostomy tubes because they are labeled as sterile but are not actually sterile. This could lead to infections if used without proper sterilization.
The tubes are labeled as sterile but are not sold as sterile. This means they could become contaminated and cause infections if used without proper sterilization procedures.
Healthcare professionals and patients using tracheostomy tubes may be affected. Those with tracheostomies are at higher risk due to potential infection.
Check for model numbers: CMZ3241N (DS009716), ST16EN80NSC194N (DS009794), and other listed part numbers. These tubes were sold with the label 'Sterile' but are not actually sterile.
Look for model numbers listed in the recall notice to confirm if your tubes are affected.
The tubes are labeled as sterile but are not actually sterile, so they may pose an infection risk if used without proper sterilization.
Check for model numbers like CMZ3241N (DS009716) or ST16EN80NSC194N (DS009794) listed in the recall notice.
Contact Smiths Medical directly to confirm if your tubes are affected and get guidance on next 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-2114-2018 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2114-2018 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.
