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 various sizes (2.5mm to 5.5mm) with listed 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 on specific lots of these tubes may tear due to a manufacturing defect. If the flange tears, the tube could become dislodged, potentially causing breathing difficulties or other complications for patients who rely on tracheostomies.
Patients using tracheostomy tubes and healthcare providers who handle these tubes are most at risk. The affected products are used in neonatal, pediatric, and adult care settings.
Check the product label for the size (2.5mm to 5.5mm) and the lot numbers listed above. The affected tubes have specific UDI/DI codes and product codes as detailed in the recall notice.
Look for the product label that lists the size (2.5mm to 5.5mm) and the specific lot numbers provided in the recall notice.
If you have the affected product, contact Smiths Medical directly for further instructions or to arrange a replacement.
The affected tubes are sizes 2.5mm to 5.5mm (PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS through 5.5MM STANDARD FLEXTEND PLUS).
Check the product label for the size and the specific lot numbers listed in the recall notice. Affected tubes have the UDI/DI codes and product codes mentioned in the record.
No, but you should check if your tubes are affected and contact Smiths Medical if you have the listed lot numbers to ensure safety.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2599-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2599-2024 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.
