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 units have unique serial numbers and product codes.
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 a manufacturing defect may cause the securement flange to tear. This could lead to the tube becoming dislodged, which is dangerous for infants and children who require tracheostomies.
The securement flange on specific lots of these tubes may tear due to a manufacturing defect. If the flange tears, the tube could become dislodged, potentially causing breathing difficulties or injury.
Infants and children using tracheostomy tubes are most at risk. Parents and caregivers of patients with tracheostomies should check if their tube is affected.
Check the product label for 'NEONATAL TRACH TUBE' and the specific product codes: 60N030, 60N035, or 60N040. Look for the listed serial numbers in the recall notice.
Look for the product label indicating 'NEONATAL TRACH TUBE' and the specific product codes: 60N030, 60N035, or 60N040.
If you have the affected tube, contact Smiths Medical directly for further instructions on how to handle the product.
Smiths Medical identified that the securement flange of specific lots may tear due to a manufacturing defect, which could lead to the tube becoming dislodged.
Check the product label for the specific product codes and serial numbers listed in the recall notice. Contact Smiths Medical for further instructions.
If the securement flange tears, the tube could become dislodged, potentially causing breathing difficulties or injury for patients who require tracheostomies.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2591-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2591-2024 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.
