Smiths Medical recalls specific lots of BLUgriggs Percutaneous Dilation Tracheotomy Trays with BLUselect tubes due to potential pilot balloon disconnection during use. Affected items have listed item numbers and lot numbers.
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 certain tracheotomy trays and tubes that may disconnect the pilot balloon from the inflation line, which could lead to breathing difficulties. This defect affects specific product models and lots sold in the U.S.
The manufacturing defect can cause the pilot balloon to disconnect from the tracheostomy inflation line in specific lots. This may lead to breathing difficulties if the balloon fails to maintain the airway opening during medical procedures.
Patients and healthcare providers using the recalled tracheotomy trays and tubes in the U.S. are most at risk if the pilot balloon disconnects during medical procedures.
Check for the listed item numbers (e.g., 101/540/080) and lot numbers (e.g., 3943992) on the product packaging. The products are labeled as Smiths Medical Portex BLUgriggs Percutaneous Dilation Tracheotomy Trays with BLUselect tubes.
Look for the item number and lot number on the product packaging to confirm if it is affected.
The products have a manufacturing defect that can cause the pilot balloon to disconnect from the tracheostomy inflation line in specific lots.
The affected products include specific item numbers and lot numbers listed in the recall notice, such as item number 101/540/080 with lot number 3943992.
No, but you should check the product details to confirm if your item is affected. The recall does not require immediate discontinuation but requires verification.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-3087-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-3087-2024 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.
