Smiths Medical recalls pediatric tracheostomy tubes with incorrect neck flange size. This may cause breathing issues if used improperly. Affected units include model 60HA30, lot 37941: 3.5mm ID plate instead of 3.0mm.
One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.
Smiths Medical is recalling pediatric tracheostomy tubes that were packaged with a 3.5mm neck flange plate instead of the correct 3.0mm size. Using these tubes could cause breathing problems if the tube is too large for the child's airway.
The tubes were packaged with a 3.5mm neck flange plate instead of the correct 3.0mm size. This larger size could make the tube too tight or too loose in the child's airway, potentially causing breathing difficulties or blockages.
Parents or caregivers of children with tracheostomies who use these tubes are most at risk. Children with tracheostomies require precise tube sizing to avoid breathing complications.
Check for model number 60HA30 and lot number 3794165 on the tube packaging. The affected tubes have a 3.5mm ID adjustable neck flange plate instead of the 3.0mm size.
Verify the neck flange plate size on the tube; it should be 3.0mm, not 3.5mm.
The tubes were packaged with a 3.5mm neck flange plate instead of the correct 3.0mm size. This larger size could cause breathing problems if the tube is too tight or too loose in the child's airway.
Check the neck flange plate size on the tube. If it's 3.5mm instead of 3.0mm, stop using it and contact Smiths Medical for guidance.
The recall record does not mention a specific remedy or fix. You should check the tube size and contact Smiths Medical if you have the affected model.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2485-2020 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2485-2020 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.
