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 dangerous for patients using 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 could cause breathing difficulties or other complications for patients.
Patients using tracheostomy tubes with the specific product codes 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 codes (e.g., PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF) and the lot numbers listed in the recall. The specific product codes and lot numbers are detailed in the recall notice.
Look for the model code and lot numbers on the product label to determine if it is in the recalled range.
Reach out to Smiths Medical for assistance with the recall if you have the product in question.
The securement flange of specific lots may tear due to a manufacturing defect.
The affected models are PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF (65P025), 3.0MM AIRE-CUF (65P030), 3.5mm AIRE-CUF (65P035), 4.0MM AIRE-CUF (65P040), 4.5MM AIRE-CUF (65P045), 5.0MM AIRE-CUF (65P050), and 5.5MM AIRE-CUF (65P055).
Check the product label for the model code and lot numbers listed in the 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-2604-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2604-2024 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.
