RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set (REFs 504550-504590) recalled due to risk of cuff inflation while pilot balloon remains flat. Check lot numbers for affected units.
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
Teleflex Medical Europe Ltd is recalling RUSCH Flexi-Set Cuffed Endotracheal Tubes and Stylet Sets with specific reference numbers and lot numbers. The tubes could inflate the cuff while the pilot balloon stays flat, potentially causing breathing issues during medical procedures.
The endotracheal tube cuff may inflate while the pilot balloon remains flat. This can cause improper airway sealing during medical procedures, potentially leading to breathing difficulties or inadequate ventilation.
Healthcare professionals using these tubes for intubation procedures are most at risk. Patients receiving intubation care with affected units may experience breathing difficulties.
Check the reference numbers (504550-504590) and lot numbers listed in the recall notice. Affected units have specific lot numbers provided in the recall details.
Identify the reference number and lot number on the tube packaging to determine if it is affected.
The endotracheal tube cuff could inflate while the pilot balloon remains flat, potentially causing breathing issues during medical procedures.
Reference numbers 504550, 504555, 504560, 504565, 504570, 504575, 504580, 504585, and 504590.
Check the reference number and lot number on the tube packaging against the list provided in the recall notice.
We’ve drafted a message you can send RUSCH to request your refund or repair — edit it as you like.
Subject: Recall Z-2320-2021 — RUSCH RUSCH Hello, I own a RUSCH that is covered by recall Z-2320-2021 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.
