Smiths Medical recalls specific lots of Bivona neonatal tracheostomy tubes due to a manufacturing defect that may cause the securement flange to tear, potentially leading to airway complications.
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 models of neonatal tracheostomy tubes because a manufacturing defect could cause the securement flange to tear. This poses a risk of airway complications if the tube becomes dislodged.
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, potentially causing airway complications for infants.
Healthcare providers using neonatal tracheostomy tubes with specific model numbers and serial numbers listed in the recall. Infants requiring tracheostomy care are most at risk.
Check the product label for the model number (2.5mm, 3.0mm, 3.5mm, or 4.0mm TTS FLEXTEND V FLANGE) and the serial numbers listed in the recall. The product code (67NFP25, 67NFP30, 67NFP35, or 67NFP40) and specific serial numbers are also listed.
Look for the model number (2.5mm, 3.0mm, 3.5mm, or 4.0mm TTS FLEXTEND V FLANGE) and the serial numbers provided in the recall.
Reach out to Smiths Medical ASD, Inc. for further assistance or to confirm if your specific tube is affected.
Neonatal tracheostomy tubes with model numbers 2.5mm, 3.0mm, 3.5mm, or 4.0mm TTS FLEXTEND V FLANGE and specific serial numbers listed in the recall.
Check the product label for the model number and serial numbers. Contact Smiths Medical ASD, Inc. for further assistance or to confirm if your tube is affected.
The securement flange may tear, potentially causing the tube to become dislodged and leading to airway complications. However, the recall does not specify that this has caused injuries.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2608-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2608-2024 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.
