Smiths Medical recalls specific BLUselect tracheostomy tubes (6.0-10.0 sizes) due to potential pilot balloon disconnection. Affected items have unique item numbers and lot numbers listed in the recall. Stop using immediately if you own one of these models.
There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a manufacturing defect.
Smiths Medical is recalling specific models of BLUselect tracheostomy tubes (sizes 6.0 to 10.0) because of a manufacturing defect that could cause the pilot balloon to disconnect from the inflation line. This poses a risk of airway obstruction if the tube becomes dislodged during use. Affected items have unique item numbers and lot numbers listed in the recall notice.
The manufacturing defect in the pilot balloon connection could cause it to disconnect from the tracheostomy inflation line during use. This might lead to airway obstruction if the tube becomes dislodged, which could be serious for patients who rely on this life-support device.
Patients using tracheostomy tubes with the specific models listed in the recall are most at risk. Healthcare providers who use these tubes in medical settings may also be affected.
Check the item number on the tube label (e.g., 101/800/060CZ) and the lot number (e.g., 3895097) to see if it matches the affected items listed in the recall. The tubes come in sizes 6.0 to 10.0 with specific features like cuff type (cuffed) and whether they have a fenestrated design.
Look for the item number (e.g., 101/800/060CZ) and lot number (e.g., 3895097) on the tube label to determine if it's affected.
If your tube matches the affected item numbers and lot numbers, stop using it right away to prevent potential airway obstruction.
Reach out to Smiths Medical for instructions on how to replace the tube with a safe alternative.
The recall affects BLUselect tracheostomy tubes with sizes 6.0 to 10.0, including specific item numbers and lot numbers listed in the notice. Examples include item numbers 101/800/060CZ with lot numbers 3895097, 3925835, and others.
Check the item number (e.g., 101/800/060CZ) and lot number (e.g., 3895097) on the tube label. If it matches any of the listed item numbers and lot numbers, your tube is affected.
Stop using the tube immediately and contact Smiths Medical for instructions on how to replace it with a safe alternative.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-3086-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-3086-2024 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.
