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 the securement flange may tear due to a manufacturing defect. This could lead to the tube becoming dislodged, which is a serious risk for patients using 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 breathing difficulties or other serious complications.
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: AIRE-CUF TRACHY TUBE 6.0MM, 7.0MM, or 8.0MM MID-RANGE. Look for the specific lot numbers listed in the recall notice.
Look for the model number and lot numbers on the tube label to determine if it is affected.
If the tube is in the affected lot numbers, stop using it immediately and contact Smiths Medical for instructions.
The recalled tubes are the Bivona Tracheostomy Silicone Tubes labeled as AIRE-CUF TRACHY TUBE 6.0MM, 7.0MM, or 8.0MM MID-RANGE with specific lot numbers listed in the recall notice.
Check the product label for the model number and compare it to the specific lot numbers listed in the recall notice.
If your tube is in the affected lot numbers, stop using it immediately and contact Smiths Medical for instructions on how to proceed.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2589-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2589-2024 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.
