RUSCH Endotracheal Tubes with specific REF numbers and lot numbers may have a cuff that inflates while pilot balloon remains flat. This could cause airway issues during medical procedures. Affected units include models with REF numbers a) through k) and listed lot numbers.
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
Teleflex Medical Europe Ltd recalls specific RUSCH Endotracheal Tubes that may inflate their cuff while the pilot balloon stays flat. This risk could lead to airway problems during medical procedures if the tube is used improperly.
The cuff can inflate while the pilot balloon remains flat, which may cause the tube to not seal properly in the airway. This could lead to air leaks or inadequate ventilation during medical procedures.
Healthcare professionals and medical facilities using the recalled tubes for intubation procedures. Patients undergoing surgery or medical treatments with these tubes are at risk if the tube fails to seal properly.
Check the product's REF numbers (a) through k) and corresponding lot numbers listed in the recall notice. The tubes have a Murphy Eye design with high volume, low pressure cuff.
Identify the REF number and lot numbers from the product label to determine if it's affected.
If the pilot balloon remains flat while the cuff inflates, stop using the tube immediately.
The affected tubes have REF numbers a) through k) with specific lot numbers listed in the recall notice.
Check the product's REF number and lot numbers against the list provided in the recall notice.
If the pilot balloon remains flat while the cuff inflates, stop using the tube immediately. Contact Teleflex Medical Europe Ltd for further instructions.
We’ve drafted a message you can send RUSCH to request your refund or repair — edit it as you like.
Subject: Recall Z-2322-2021 — RUSCH RUSCH Hello, I own a RUSCH that is covered by recall Z-2322-2021 from RUSCH. 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.