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 product codes 67P025-67P055.
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 on specific lots of these tubes may tear due to a manufacturing defect. If the flange tears, the tube could become dislodged, which could cause breathing difficulties or other complications for patients who rely on tracheostomies.
Patients using tracheostomy tubes, particularly those with pediatric or adult tracheostomies, are most at risk. Owners of the specific product codes and lot numbers listed in the recall are affected.
Check the product label for the specific product codes (67P025 to 67P055) and lot numbers listed in the recall. The tubes are labeled as 'TTS PEDIATRIC TRACH TUBE' and are manufactured by Smiths Medical.
Look for the product code (67P025-67P055) and lot numbers listed in the recall to determine if your tube is affected.
Reach out to Smiths Medical for guidance on whether your specific tube is affected and what steps to take.
The securement flange on specific lots of these tubes may tear due to a manufacturing defect, which could lead to the tube becoming dislodged.
Check the product label for the specific product codes and lot numbers listed in the recall. If affected, contact Smiths Medical for guidance.
The recall is for a potential tear in the securement flange, which could cause dislodgement. However, the remedy does not specify an immediate stop-use action, so use caution.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2610-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2610-2024 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.
