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 lots of Bivona neonatal tracheostomy tubes because a manufacturing defect may cause the securement flange to tear. This could lead to the tube becoming dislodged, which is a serious risk for infants.
The securement flange of specific lots may tear due to a manufacturing defect. If the flange tears, the tracheostomy tube could become dislodged, which is a serious risk for infants who rely on this tube for breathing.
Infants using the recalled Bivona neonatal tracheostomy tubes are most at risk. Healthcare providers who have the specific lot numbers listed in the recall are also affected.
Check the product label for the model '2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO'. Look for lot numbers: 3853440, 3874312, 3891526, 3904670, 3923733, 3946227, 3952384, 3965919, 3991145, 4015537, 4035730, 4095917, 4119108, 4134019, 4156630, 4173731, 4179354, 4327881, 4334986, 4351236, 4374430, 4388157, 4395780.
Look for the model '2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO' and the specific lot numbers listed in the recall.
If you have the recalled lot numbers, stop using the tube immediately to prevent potential dislodgement.
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.
Stop using the tube immediately and contact Smiths Medical for instructions on replacement or return.
Yes, check for lot numbers: 3853440, 3874312, 3891526, 3904670, 3923733, 3946227, 3952384, 3965919, 3991145, 4015537, 4035730, 4095917, 4119108, 4134019, 4156630, 4173731, 4179354, 4327881, 4334986, 4351236, 4374430, 4388157, 4395780.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2593-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2593-2024 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.
