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 of specific lots may tear due to a manufacturing defect. If the flange tears, the tracheostomy tube could become dislodged from the patient's airway, which is a serious risk for individuals who rely on this life-supporting device.
Patients using tracheostomy tubes, particularly neonatal and pediatric patients, are most at risk if they have the recalled lots. Healthcare providers who use these tubes in medical settings may also be affected.
Check the product label for the model 'TTS NEONATAL TRACH TUBE' with specific product codes: 67N025, 67N030, or 67N035. Look for the listed lot numbers in the recall notice.
Look for the model 'TTS NEONATAL TRACH TUBE' with product codes 67N025, 67N030, or 67N035 on the tube.
Reach out to Smiths Medical for assistance with the recall and to confirm if your specific tube is affected.
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 model and product codes listed in the recall notice. Contact Smiths Medical for further assistance.
Yes, specific lot numbers are listed in the recall notice for product codes 67N025, 67N030, and 67N035. Check the recall details for the exact lot numbers.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2606-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2606-2024 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.
