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 have specific 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 a manufacturing defect may cause the securement flange to tear. 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 from the tracheostomy site, which could cause serious injury or breathing difficulties.
Patients using tracheostomy tubes with the specific sizes and lot numbers listed in the recall are affected. Healthcare providers and caregivers who use these tubes are at the highest risk.
Check the product label for the size (4.0mm to 6.0mm) and the lot numbers listed in the recall. The product code (e.g., 67PFPS40) and UDI/DI numbers (e.g., 10351688518545) are also specific identifiers for affected tubes.
Look for the size (4.0mm to 6.0mm), product code (e.g., 67PFPS40), and lot numbers listed in the recall.
Reach out to Smiths Medical directly for assistance with the recall process.
Affected tubes are pediatric tracheostomy tubes with sizes 4.0mm to 6.0mm (product codes 67PFPS40 to 67PFPS60).
Check the product label for the size, product code (e.g., 67PFPS40), and lot numbers listed in the recall. Affected tubes have specific lot numbers for each size.
Contact Smiths Medical directly for assistance with the recall process. They will provide guidance on next steps.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2612-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2612-2024 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.
