Bioseal recalls trachea extenders with potential stress cracks causing breathing system leaks. Patients may not receive proper ventilation. Stop using immediately if you have the recalled model.
The reported stress crack in the port of the swivel elbow where the flip cap is inserted could result in leakage from the breathing system resulting in the prescribed ventilation not being delivered to the patient. These cracks could possibly leak if they reach a significant size and pose a serious heath risk to patient.
Bioseal is recalling trachea extenders that could develop cracks in the swivel elbow port. This might cause breathing system leaks, meaning patients don't get proper ventilation. If you have the recalled product, stop using it immediately.
The swivel elbow port can develop stress cracks that leak air from the breathing system. If the crack gets large enough, patients won't receive proper ventilation, which can be life-threatening.
Patients using the recalled trachea extenders for breathing support are at risk. Healthcare providers who use these extenders for tracheostomy or mask connections are most affected.
Check for the product name 'Bioseal Trachea Extender 1/pl 50pk/Cs' with lot numbers 400453, 400456, 400461, 400472, or 400476. The product was manufactured with a specific date and expiration date.
If you have the recalled trachea extenders, stop using them right away to prevent breathing system leaks.
Bioseal Trachea Extender 1/pl 50pk/Cs (REF TRAX01/50, Lot numbers 400453, 400456, 400461, 400472, 400476).
The swivel elbow port can develop stress cracks that cause breathing system leaks, potentially preventing proper ventilation for patients.
The recall record does not mention any remedy or fix for this issue.
We’ve drafted a message you can send Bioseal to request your refund or repair — edit it as you like.
Subject: Recall Z-2795-2020 — Bioseal Bioseal Hello, I own a Bioseal that is covered by recall Z-2795-2020 from Bioseal. 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.
