Smiths Medical recalls specific lots of Bivona Tracheostomy Silicone Tubes due to a manufacturing defect that may cause the securement flange to tear.
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 tracheostomy care.
The securement flange of specific lots may tear due to a manufacturing defect. If the flange tears, the tracheostomy tube could become dislodged, which could cause breathing difficulties or other serious complications for patients.
Patients using tracheostomy tubes, particularly neonatal and pediatric patients, are most at risk. Healthcare providers who use these tubes in medical settings may also be affected.
Check the product code and lot numbers listed in the recall notice. The affected tubes include specific sizes (2.5 to 5.5 uncuffed) for neonatal and pediatric patients, with detailed lot numbers provided in the recall.
Review the product code and lot numbers listed in the recall notice to determine if your tube is affected.
Smiths Medical has identified that the securement flange of specific lots may tear due to a manufacturing defect.
The affected tubes include specific sizes (2.5 to 5.5 uncuffed) for neonatal and pediatric patients, with detailed lot numbers provided in the recall notice.
Check the product code and lot numbers listed in the recall notice to determine if your tube is affected. If it is, contact Smiths Medical for further instructions.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2602-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2602-2024 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.
