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 a manufacturing defect may cause the securement flange to tear. This could lead to the tube becoming dislodged, which is dangerous for patients who require tracheostomy support.
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 patient's trachea, causing breathing difficulties or other serious complications.
Patients using neonatal or pediatric tracheostomy tubes with the specific lot numbers listed in the recall are affected. Healthcare providers and caregivers responsible for these patients are at the highest risk.
Check the product label for the specific product codes (65N025, 65N030, 65N035, 65N040) and lot numbers listed in the recall notice. The tubes are labeled as Neonatal Tracheostomy Tubes.
Look for the product code (65N025, 65N030, 65N035, or 65N040) and lot numbers on the tube label to determine if it is affected.
If the tube is affected, contact your healthcare provider for guidance on whether to stop using it and what steps to take next.
The recalled tubes are Neonatal Tracheostomy Tubes with product codes 65N025, 65N030, 65N035, and 65N040, and specific lot numbers listed in the recall notice.
Smiths Medical identified that 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. If it is affected, contact your healthcare provider for guidance on next steps.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2603-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2603-2024 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.
