Smiths Medical recalls pediatric tracheostomy tubes with specific sizes and lot numbers due to a manufacturing defect that may cause the securement flange to tear.
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 pediatric tracheostomy tubes (2.5mm to 5.5mm) with specific product codes and lot numbers because the securement flange may tear due to a manufacturing defect. This could lead to the tube becoming dislodged or causing injury.
The securement flange of specific lots of these tubes may tear due to a manufacturing defect. If the flange tears, the tube could become dislodged, potentially causing injury or breathing difficulties.
Parents or caregivers of children using pediatric tracheostomy tubes with the specific sizes and lot numbers listed in the recall. Children with tracheostomies are most at risk.
Check the product code (67PFSS25 to 67PFSS55) and lot numbers listed in the recall. The tubes are pediatric tracheostomy tubes with sizes ranging from 2.5mm to 5.5mm.
Identify the product code (67PFSS25 to 67PFSS55) and lot numbers listed in the recall to determine if your tube is affected.
Smiths Medical identified that the securement flange of specific lots of these tubes may tear due to a manufacturing defect.
Check the product code and lot numbers to see if your tube is affected. If it is, stop using it and contact Smiths Medical for further instructions.
If the securement flange tears, the tube could become dislodged, potentially causing breathing difficulties or injury.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2614-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2614-2024 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.
