Cook recalls Roadrunner UniGlide Hydrophilic Wire Guide (RPN HPWA-18-150) due to potential sterility compromise from packaging testing failures. Affected units sold from 2014-2015.
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 a medical device used for vascular catheter procedures because its packaging may not have maintained sterility after long-term testing. This could lead to infections if the device is used without proper sterilization.
The device's packaging failed 3-year age acceleration testing, which means the sterility of the device could be compromised over time. This could lead to infections if the device is used without proper sterilization.
Healthcare professionals using the Roadrunner UniGlide Hydrophilic Wire Guide for vascular procedures may be affected. Patients receiving these devices during procedures are at risk if the device is not sterile.
Check for reference part number HPWA-18-150 or order number G56161 on the device. Units were sold between 2014 and 2015 with lot numbers 14095646 and 14174879.
Look for reference part number HPWA-18-150 or order number G56161 on the device packaging.
The recall states the packaging may not have maintained sterility after long-term testing, so it is not recommended for use until the recall is addressed.
Check for reference part number HPWA-18-150 or order number G56161 on the device. Units were sold between 2014 and 2015 with lot numbers 14095646 and 14174879.
The recall does not specify a remedy, so contact Cook Incorporated for guidance on next steps.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1711-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1711-2022 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.
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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.
