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 the securement flange may tear due to a manufacturing defect. This could lead to the tube becoming dislodged, which is a serious risk for patients 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 breathing difficulties.
Patients using tracheostomy tubes and caregivers who have the specific model and lot numbers listed in the recall. Those with the Bivona Neonatal/Pediatric or Adult Tracheostomy products affected by the manufacturing defect are most at risk.
Check the product label for the model (4.0mm to 6.0mm FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE) and the lot numbers listed in the recall. The specific lot numbers are provided in the recall notice for each model.
Look for the model number (4.0mm to 6.0mm FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE) and lot numbers on the tube.
If the product matches the recalled model and lot numbers, contact Smiths Medical for further instructions.
The securement flange on specific lots of these tubes may tear due to a manufacturing defect.
Check the product label for the model (4.0mm to 6.0mm FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE) and the lot numbers listed in the recall notice.
No, but if your tube matches the recalled model and lot numbers, contact Smiths Medical for further instructions.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2598-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2598-2024 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.
