Smiths Medical recalls specific lots of Bivona neonatal tracheostomy 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 models of neonatal tracheostomy 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 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 breathing difficulties or other complications for infants.
Infants using tracheostomy tubes who own or use the recalled Bivona neonatal tracheostomy tubes (models 2.5FLEXTEND PLUS to 4.0FLEXTEND PLUS) are most at risk. Healthcare providers and caregivers should check if their tubes match the listed serial numbers.
Check the product label for the model name (NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS to 4.0FLEXTEND PLUS) and the serial number. The specific serial numbers are listed in the recall notice for each model.
Look for the model name and serial number on the tube to determine if it is in the recalled list.
If the tube is recalled, inform your healthcare provider immediately to discuss replacement options.
The recalled models are NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS (serial numbers 3939632, 3942500, etc.), 3.0FLEXTEND PLUS (serial numbers 3868231, 3877660, etc.), 3.5FLEXTEND PLUS (serial numbers 3840087, 3853439, etc.), and 4.0FLEXTEND PLUS (serial numbers 3840062, 3877647, etc.).
Check the tube label for the model and serial number. If it matches the recalled list, contact your healthcare provider to discuss replacement options immediately.
The recall states the securement flange may tear, which could lead to tube dislodgement. This poses a risk of breathing difficulties for infants, but the remedy does not specify immediate stop-use 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-2592-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2592-2024 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.
