Smiths Medical recalls specific lots of Bivona Neonatal Tracheostomy Silicone Tubes due to a manufacturing defect that may cause the securement flange to tear. Affected tubes have specific sizes and 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 Neonatal 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 infants who require tracheostomies.
The securement flange on specific lots of these tubes can tear due to a manufacturing defect. If the flange tears, the tube may become dislodged from the tracheostomy site, which could cause serious injury or death for infants who rely on the tube for breathing.
Infants using tracheostomy tubes with the recalled model sizes (2.5mm to 4.0mm) and specific lot numbers are most at risk. Healthcare providers who use these tubes in neonatal care should check their inventory.
Check the product label for the tube size (2.5mm, 3.0mm, 3.5mm, or 4.0mm) and the lot number. The affected tubes have specific product codes (67NFPS25, 67NFPS30, 67NFPS35, 67NFPS40) and listed lot numbers.
Look for the tube size (2.5mm, 3.0mm, 3.5mm, or 4.0mm) and lot number on the tube packaging or label.
If your tube has a listed lot number from the affected ranges, stop using it immediately and contact Smiths Medical for instructions.
The affected tubes are neonatal tracheostomy tubes with sizes 2.5mm, 3.0mm, 3.5mm, or 4.0mm (product codes 67NFPS25, 67NFPS30, 67NFPS35, 67NFPS40) and specific lot numbers listed in the recall notice.
Check the product label for the tube size and lot number. If it matches the sizes and lot numbers listed in the recall (e.g., lot numbers starting with 3853382 for 2.5mm tubes), it is affected.
Stop using the tube immediately and contact Smiths Medical for instructions on replacement or repair. The recall does not include a remedy step for the user.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2609-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2609-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
