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 of the tube.
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 breathing difficulties or other serious complications for patients.
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 are at the highest risk.
Check the product label for the model and size (4.0mm to 6.0mm TTS FLEXTEND PLUS V FLANGE). Look for the specific lot numbers listed in the recall notice for each model size.
Look for the model and size (4.0mm to 6.0mm TTS FLEXTEND PLUS V FLANGE) and lot numbers on the tube.
If the tube matches the recalled model and lot numbers, contact Smiths Medical for further instructions.
The recall includes pediatric tracheostomy tubes with sizes 4.0mm to 6.0mm TTS FLEXTEND PLUS V FLANGE, each with specific lot numbers listed in the notice.
Check the product label for the model and size (4.0mm to 6.0mm TTS FLEXTEND PLUS V FLANGE) and compare the lot numbers to those listed in the recall notice.
If your tube matches the recalled model and lot numbers, contact Smiths Medical for further instructions. They may provide 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-2611-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2611-2024 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.
