Smiths Medical recalls specific lots of Bivona Tracheostomy Silicone Tubes due to a manufacturing defect that may cause securement flange tearing. Affected units have unique serial numbers and product codes.
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 patient's trachea, causing breathing difficulties or injury.
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: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF. Affected units have serial numbers including 3877658, 3901313, 3923737, and other numbers listed in the recall notice.
Look for the label 'TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF' on the tube.
Check if the tube's serial number matches the list of affected numbers provided in the recall notice.
The securement flange on specific lots may tear due to a manufacturing defect, which could cause the tube to become dislodged.
Check the product label and serial number against the list of affected units provided in the recall notice.
The recall notice does not specify a fix or remedy; affected units should be checked against the list and potentially discarded or returned.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2607-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2607-2024 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.
