Smiths Medical recalls specific lots of Bivona Tracheostomy Silicone Tubes due to a manufacturing defect that may cause the securement flange to tear, potentially leading to dislodgement.
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, which is a serious risk for patients who require tracheostomies.
The securement flange of specific lots may tear due to a manufacturing defect. If the flange tears, the tracheostomy tube could become dislodged, which can cause serious injury or death.
Patients with tracheostomies using the specific Bivona Tracheostomy Silicone Tubes listed in the recall. Healthcare providers who use these tubes for pediatric patients are most at risk.
Check the product code and lot numbers listed in the recall. The affected tubes are labeled as Pediatric Tracheostomy Tubes with specific sizes (2.5mm to 5.5mm) and have UDI/DI numbers starting with 10351688518590 to 10351688518651.
Immediately stop using the affected Bivona Tracheostomy Silicone Tubes if you have them.
The affected tubes are Pediatric Tracheostomy Tubes with sizes 2.5mm to 5.5mm (Product Codes 67PFS25 to 67PFS55) and specific lot numbers listed in the recall.
Check the product code and lot numbers on your tube. Affected tubes have UDI/DI numbers starting with 10351688518590 to 10351688518651 and specific lot numbers listed in the recall.
Immediately stop using the affected tube and contact Smiths Medical for a replacement or other remedy.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2613-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2613-2024 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.
