Smiths Medical recalls specific lots of Bivona Tracheostomy Silicone Tubes due to a manufacturing defect that may cause the securement flange to tear. Affected products include 3.0mm, 3.5mm, and 4.0mm FLEXTEND NEO STRAIGHT TRACH TUBES with listed product codes and lot numbers.
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Smiths Medical is recalling specific lots of Bivona Tracheostomy Silicone Tubes because the securement flange may tear due to a manufacturing defect. This could lead to the tube becoming dislodged, which is dangerous for patients who require tracheostomies.
The securement flange on specific lots of these tubes may tear due to a manufacturing defect. If the flange tears, the tube could become dislodged from the tracheostomy site, which could cause breathing difficulties or other complications for patients.
Patients using tracheostomy tubes and healthcare providers who handle these tubes are most at risk. The affected products are specific sizes (3.0mm, 3.5mm, and 4.0mm) and lots as listed in the recall.
Check the product label for the size (3.0mm, 3.5mm, or 4.0mm FLEXTEND NEO STRAIGHT TRACH TUBE) and the lot numbers listed in the recall. The product codes are 60NFPS30, 60NFPS35, and 60NFPS40.
Look for the size (3.0mm, 3.5mm, or 4.0mm FLEXTEND NEO STRAIGHT TRACH TUBE) and the lot numbers listed in the recall.
The securement flange may tear due to a manufacturing defect, which could cause the tube to become dislodged.
Affected sizes are 3.0mm (lot numbers 3853441-4196272), 3.5mm (lot numbers 3853442-4196273), and 4.0mm (lot numbers 3853443-4197613).
No, but you should check if your tubes are affected and contact Smiths Medical if you have them.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2594-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2594-2024 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.
