Cook recalls Roadrunner UniGlide Hydrophilic Wire Guide (RPN HPWA-35-80) due to potential sterility compromise from packaging testing failure. Affected units sold with lot numbers starting 14156569.
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 devices because the packaging may not have properly protected the sterile product during testing. This could lead to infection risks if the device is used without being sterile.
The packaging failed to meet 3-year age acceleration testing standards, which could compromise the device's sterility. This means the device might not be sterile when used in medical procedures, potentially causing infections.
Healthcare professionals using the device for vascular catheter procedures are most at risk. Patients receiving the device during procedures may be affected if the device is not sterile.
Check for reference part number HPWA-35-80 and order number G56172. Lot numbers start with 14156569. The device is used for vascular catheter positioning in medical procedures.
Look for lot numbers starting with 14156569 on the packaging or device label.
The recall indicates potential sterility issues, so it is not safe to use without checking the lot number and following the recall steps.
Check the lot number starting with 14156569 and contact Cook for further instructions.
Affected devices have reference part number HPWA-35-80 and order number G56172 with lot numbers starting with 14156569.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1714-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1714-2022 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.
