Smiths Medical recalls portex BLUperc Percutaneous Dilation Procedural Trays with BLUselect tracheostomy tubes due to potential pilot balloon disconnection in specific lots. Affected items include various sizes and lot numbers listed in the recall notice.
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 portex BLUperc Percutaneous Dilation Procedural Trays with BLUselect tracheostomy tubes because of a manufacturing defect that could cause the pilot balloon to disconnect from the tracheostomy inflation line. This risk exists in specific lots of the products listed in the recall notice.
The manufacturing defect in specific lots of the BLUselect tracheostomy tubes can cause the pilot balloon to disconnect from the tracheostomy inflation line during use. This disconnection could lead to the tube becoming dislodged or the patient losing proper airway support.
Healthcare professionals and patients who use these tracheostomy tubes during medical procedures are most at risk. The affected items include specific product sizes and lot numbers listed in the recall notice.
Check the product label for the item number (e.g., 101/561/070) and lot number (e.g., 3887555) listed in the recall notice. The affected products include specific sizes and lot numbers for BLUselect tracheostomy tubes and related procedural trays.
Look for the item number (e.g., 101/561/070) and lot number (e.g., 3887555) on the product label to determine if it is affected.
The hazard is a potential disconnection of the pilot balloon from the tracheostomy inflation line in specific lots due to a manufacturing defect.
Affected products include BLUperc Percutaneous Dilation Procedural Trays with BLUselect tracheostomy tubes of specific sizes (7.0 mm, 8.0 mm, 9.0 mm) and lot numbers listed in the recall notice.
Check the product label for the item number and lot number. If it matches the affected items listed, stop using it and contact Smiths Medical for further 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-3088-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-3088-2024 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.
