Smiths Medical recalls specific lots of Bivona Tracheostomy Silicone Tubes due to a manufacturing defect that may cause the securement flange to tear, potentially leading to dislodgement.
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 a manufacturing defect may cause the securement flange to tear. This could lead to the tube becoming dislodged, which is a serious risk for patients who require tracheostomy care.
The securement flange on certain lots of these tubes may tear due to a manufacturing defect. If the flange tears, the tube could become dislodged from the patient's airway, which is a serious medical risk.
Patients using tracheostomy tubes and caregivers who handle these medical devices are most at risk. The recall affects specific model numbers and serial numbers listed in the official notice.
Check for the product label: '6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE'. The specific serial numbers listed in the recall notice include 3853449, 3880705, and other numbers provided in the official record.
Look for the label '6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE' on the tube.
Confirm if your tube's serial number matches the list of affected numbers provided in the recall notice.
Smiths Medical identified that the securement flange of specific lots may tear due to a manufacturing defect, which could lead to tube dislodgement.
Check the product label and serial number against the list provided in the recall notice to determine if it's affected.
The recall does not specify a fix; affected units should be checked and potentially replaced if they match the listed serial numbers.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2597-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2597-2024 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.
