Smiths Medical recalls specific lots of Bivona Tracheostomy Silicone Tubes due to a manufacturing defect that may cause the securement flange to tear. Affected products include PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS and other sizes with listed product codes 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 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 patients who require tracheostomies.
The securement flange on specific lots of the Bivona Tracheostomy Tubes may tear due to a manufacturing defect. If the flange tears, the tube could become dislodged from the tracheostomy site, potentially causing breathing difficulties or other complications.
Patients using tracheostomy tubes and healthcare providers who handle these tubes are most at risk. The recall affects specific product sizes and lot numbers used in neonatal, pediatric, and adult care.
Check the product label for the model: PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, 5.0MM FLEXTEND PLUS, or 5.5MM FLEXTEND PLUS. Look for the specific product codes (60PFP40, 60PFP45, 60PFP50, 60PFP55) and the listed lot numbers in the recall notice.
Look for the model number and product code on the tube label to determine if it is affected by this recall.
Reach out to Smiths Medical for assistance with the recall process if you have the affected product.
The affected models are PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS (product code 60PFP40), 5.0MM FLEXTEND PLUS (60PFP50), and 5.5MM FLEXTEND PLUS (60PFP55).
Check the product label for the model and product code, then compare the lot numbers listed in the recall notice to determine if your tube is affected.
Contact Smiths Medical directly for guidance on the next steps, as the recall does not include a specific remedy or return process.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2596-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2596-2024 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.
