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 pediatric and adult tracheostomy tubes with sizes 3.0mm to 5.5mm.
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 of 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 model and lot numbers listed in the recall are affected. Healthcare providers and caregivers who use these tubes for medical purposes are at risk if they have the recalled items.
Check the product label for the size (3.0mm to 5.5mm) and the lot numbers listed in the recall. The specific product codes and lot numbers are detailed in the official recall notice.
Look for the product size (3.0mm to 5.5mm) and the lot numbers listed in the recall notice to determine if your tube is affected.
If you have the affected tube, contact Smiths Medical directly for instructions on how to safely replace it.
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.
The affected tubes are pediatric and adult tracheostomy tubes with sizes 3.0mm to 5.5mm, as listed in the recall notice.
Check the product label for the size (3.0mm to 5.5mm) and the lot numbers listed in the recall notice. The specific product codes and lot numbers are detailed in the official 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-2601-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2601-2024 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.
