Cook Medical recalls Blue Rhino Percutaneous Tracheostomy Introducer Sets with expired expiration dates that exceed true shelf life. Affected lots may be unsafe for medical use.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Cook Medical is recalling certain Blue Rhino Percutaneous Tracheostomy Introducer Sets because their expiration dates exceed the actual shelf life. This could lead to unsafe medical use if the product is still in service.
The product's expiration dates are longer than the actual shelf life, which means the medical device may degrade over time and become unsafe for use. This could potentially lead to complications if the device fails during medical procedures.
Healthcare professionals and patients using the recalled tracheostomy sets. Those with the specific lot numbers listed in the recall are most at risk.
Check for the product name 'Blue Rhino Percutaneous Tracheostomy Introducer Set' with reference part number C-PTIS-100-FLEX-HC or C-PTIS-100-HC. Look for the specific lot numbers listed in the recall notice.
Identify the lot number on the product packaging or label to determine if it is affected.
The expiration dates on these tracheostomy sets exceed the true shelf life, which could lead to unsafe medical use if the product degrades over time.
Check the product's lot number against the list of affected lots provided in the recall notice.
The recall does not include a specific remedy, so contact Cook Medical directly for further instructions.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1781-2026 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-1781-2026 from Cook 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.