Smiths Medical recalls specific lots of Bivona Tracheostomy Silicone Tubes due to a manufacturing defect that may cause the securement flange to tear. Affected products include certain sizes 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 serious for patients who rely on tracheostomies.
The securement flange of specific lots may tear during normal use due to a manufacturing defect. If the flange tears, the tracheostomy tube could become dislodged, potentially causing breathing difficulties or other complications.
Healthcare professionals and patients using tracheostomy tubes who own the recalled products are most at risk. The defect affects specific sizes and lot numbers.
Check the product label for the model: TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF or 8.0MM TIGHT TO SHAFT CUFF. Look for the listed lot numbers in the description.
Look for the model number and lot numbers on the product label to determine if it is affected.
If your product is listed in the affected lot numbers, stop using it immediately and contact Smiths Medical for a replacement.
The securement flange of specific lots may tear due to a manufacturing defect.
Affected lot numbers include those listed in the product description, such as 3774400 through 4394645.
Check the product label for the model number and compare it to the listed lot numbers 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-2588-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2588-2024 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.
