Smiths Medical recalls specific lots of Bivona Tracheostomy Silicone Tubes due to a manufacturing defect that may cause the securement flange to tear. Affected units include neonatal and pediatric tracheostomy tubes with listed lot numbers.
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, posing a risk to patients who require tracheostomy care.
The securement flange on specific lots of these tubes may tear due to a manufacturing defect. This could cause the tube to become dislodged from the patient's trachea, potentially leading to breathing difficulties or other complications.
Healthcare providers using neonatal or pediatric tracheostomy tubes with the listed lot numbers are most at risk. Patients with tracheostomies who use these tubes could experience dislodgement if the securement flange tears.
Check the lot numbers on the tube: 3853476, 3868313, 3911441, 3952404, 3965318, 3991202, 4006287, 4006294, 4097838, 4125826, 4148013, 4185431, 4206833, 4221354, 4238779, 4331627, 4345039, 4348774, 4383653, 4400691. These tubes are labeled as neonatal tracheostomy tubes with product code 60N025.
Look for the lot numbers listed: 3853476, 3868313, 3911441, 3952404, 3965318, 3991202, 4006287, 4006294, 4097838, 4125826, 4148013, 4185431, 4206833, 4221354, 4238779, 4331627, 4345039, 4348774, 4383653, 4400691.
Smiths Medical identified that the securement flange of specific lots may tear due to a manufacturing defect, which could cause the tube to become dislodged.
Check the lot number on the tube. If it matches the listed numbers, stop using it and contact Smiths Medical for further instructions.
Yes, if the securement flange tears, the tube could become dislodged, potentially causing breathing difficulties or other complications.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2590-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2590-2024 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.
