Smiths Medical recalls specific lots of Bivona Tracheostomy Silicone Tubes (2.5mm to 5.5mm uncuffed) 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 (2.5mm to 5.5mm uncuffed) because the securement flange may tear due to a manufacturing defect. This could lead to the tube becoming dislodged, which is dangerous for patients using 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 tracheostomy stoma, causing breathing difficulties or other complications.
Patients using tracheostomies with the recalled Bivona Tracheostomy Silicone Tubes are at risk. Healthcare providers who use these tubes in medical settings should check if their equipment is affected.
Check the product label for the tube size (2.5mm to 5.5mm uncuffed) and the lot numbers listed in the recall notice. The specific product codes and lot numbers are detailed in the recall record.
Look for the product code (e.g., 60P025) and lot numbers listed in the recall notice to determine if your tube is affected.
If you have the recalled tube, contact Smiths Medical directly for instructions on how to return or replace it.
Smiths Medical identified that the securement flange of specific lots of these tubes may tear due to a manufacturing defect.
The affected tubes are 2.5mm to 5.5mm uncuffed, with specific product codes and lot numbers listed in the recall notice.
Check the product label for the tube size and compare the lot numbers to 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-2595-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2595-2024 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.
