Smiths Medical recalls specific lots of Bivona Tracheostomy Silicone Tubes due to a manufacturing defect that may cause the securement flange to tear. Affected tubes include neonatal and pediatric models with certain 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 of specific lots may tear due to a manufacturing defect. If the flange tears, the tube could become dislodged from the tracheostomy site, which could cause serious injury or breathing difficulties.
Patients using tracheostomy tubes, particularly neonatal and pediatric patients, who own or use the recalled specific lots of Bivona tubes. Those with the listed product codes and lot numbers are most at risk.
Check the product code and lot numbers listed in the recall notice. The affected tubes include neonatal and pediatric models with specific product codes (e.g., 67SN025, 67SP025) and the listed lot numbers.
Identify the product code and lot numbers from the tube's label to see if it matches the recalled items listed in the notice.
Reach out to Smiths Medical for assistance with the recall if you have the affected tubes.
The securement flange of specific lots may tear due to a manufacturing defect, which could cause the tube to become dislodged from the tracheostomy site.
Neonatal and pediatric tracheostomy tubes with product codes 67SN025 through 67SP055 and the listed lot numbers.
Check the product code and lot numbers on the tube's label against the list provided in the recall notice.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2615-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2615-2024 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.
