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 sizes with listed 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 a manufacturing defect may cause the securement flange to tear. This could lead to the tube becoming dislodged, potentially causing breathing difficulties or injury.
The securement flange in specific lots of these tubes may tear due to a manufacturing defect. If the flange tears, the tube could become dislodged, which might cause breathing difficulties or injury.
Patients using neonatal or pediatric tracheostomy tubes with the specific product codes and lot numbers listed in the recall. Healthcare providers and caregivers responsible for these patients are most at risk.
Check the product label for the tube size (2.5mm to 5.5mm AIRE-CUF) and the specific product code (e.g., 65SN025, 65SP025). Also, verify the lot numbers listed in the recall notice.
Look for the tube size (2.5mm to 5.5mm AIRE-CUF) and product code (e.g., 65SN025, 65SP025) on the tube.
If you have the affected tube, contact Smiths Medical directly for further instructions.
Neonatal and pediatric sizes: 2.5mm to 5.5mm AIRE-CUF tubes with specific product codes (e.g., 65SN025, 65SP025).
Check the product label for the tube size and product code, then compare with the listed lot numbers in the recall notice.
Contact Smiths Medical directly for further instructions on how to handle the affected tube.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2605-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2605-2024 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.
