Smiths Medical recalls specific lots of Bivona pediatric tracheostomy tubes due to a risk of securement flange tearing from manufacturing defects. Affected units may cause injury during use.
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 pediatric tracheostomy tubes because the securement flange may tear due to a manufacturing defect. This could lead to injury if the tube becomes dislodged during use.
The securement flange on specific lots of the tubes can tear due to a manufacturing defect. If the flange tears, the tube may become dislodged, potentially causing injury to the patient.
Parents and caregivers of infants using the recalled tracheostomy tubes are most at risk. Healthcare providers who use these tubes in neonatal care may also be affected.
Check for the product code 60PFSS25 and lot numbers listed: 3868303, 3894869, 3949045, 3991182, 3997819, 4038948, 4075236, 4086044, 4148027, 4163850, 4185425, 4223732, 4234640, 4327882, 4352790, 4362855, 4389906.
Verify the product code 60PFSS25 and lot numbers listed in the recall notice to confirm if your tube is affected.
Reach out to Smiths Medical directly for further assistance or to confirm if your specific tube is part of the recall.
Smiths Medical identified that the securement flange of specific lots may tear due to a manufacturing defect, which could lead to injury if the tube becomes dislodged.
Check the product code and lot numbers listed in the recall notice to see if your tube is affected. If it is, contact Smiths Medical for further instructions.
Yes, if the securement flange tears, the tube may become dislodged, potentially causing injury to the patient.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2600-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2600-2024 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.
