Cook recalls Roadrunner UniGlide Hydrophilic Wire Guide (RPN HPWAS-35-80) due to potential sterility compromise from inadequate packaging testing.
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Cook is recalling its Roadrunner UniGlide Hydrophilic Wire Guide catheter guide due to packaging testing issues that could compromise sterility. This means the device might not be sterile when used, risking infection during medical procedures.
The device's packaging failed 3-year age acceleration testing, which could mean the sterility of the device is compromised over time. This increases the risk of infection during medical procedures if the device is not properly sterile.
Healthcare professionals using this device for vascular catheter procedures are affected. Patients undergoing procedures with this device face the risk of infection if the device is not sterile.
Check for reference part number HPWAS-35-80 or order number G56175 on the device packaging. The lot numbers 14174876, 14174880, NS14104906, NS14173970, and NS14173971 are also associated with this recall.
Look for reference part number HPWAS-35-80 or order number G56175 on the device packaging.
The product did not meet packaging testing criteria, which could compromise sterility over time.
There is a risk of infection if the device is not sterile due to potential packaging failure.
Check for reference part number HPWAS-35-80 or order number G56175 on the packaging, or lot numbers 14174876, 14174880, NS14104906, NS14173970, and NS14173971.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1716-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1716-2022 from Cook. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
