Smiths Medical recalls Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tubes due to incorrect size labeling on the label, which could lead to improper fitting.
Label has the incorrect size for the tracheotomy tube.
Smiths Medical is recalling Bivona Mid-Range Aire-Cuf Adult Trache:ostomy Tubes because the label has the wrong size. This could cause improper fitting if the tube is used incorrectly.
The label has the incorrect size for the tracheotomy tube, which could lead to improper fitting if the tube is used. This might cause discomfort or complications but does not pose an immediate risk of serious injury.
Patients using tracheostomy tubes and healthcare providers who handle them are affected. The risk is low as the hazard is a labeling error, not a physical defect.
Check for the Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube with lot number 3952216. The product is intended for tracheotomized patients and may be reprocessed up to 10 times.
Verify the size on the label matches the intended tube size for your patient.
The label has the incorrect size for the tracheotomy tube, which could lead to improper fitting.
This is a labeling error, not a physical defect. The risk is low as it does not cause immediate injury.
Look for the Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube with lot number 3952216.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2946-2020 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2946-2020 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.
