Cook recalls Roadrunner UniGlide Hydrophilic Wire Guide (RPN HPWA-18-80) due to potential sterility compromise after 3-year storage. Affected units were sold with specific lot numbers.
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 due to a risk that the device's sterility could be compromised after 3 years of storage. This affects medical devices used in vascular catheter procedures. The recall is based on packaging testing results that did not meet 3-year age acceleration standards.
The device's packaging failed 3-year age acceleration testing, which means the sterility of the device could be compromised over time. This risk is related to the device's storage conditions and not immediate use.
Healthcare professionals using the Roadrunner UniGlide Hydrophilic Wire Guide for vascular catheter procedures are most at risk. The recall applies to specific lot numbers produced between July 2014 and August 2014.
Check for the reference part number HPWA-18-80 and order number G56162 on the device packaging. Affected units have lot numbers 14070920 or 14174878.
Look for reference part number HPWA-18-80 and order number G56162 on the device packaging.
The device's sterility could be compromised after 3 years of storage due to packaging testing not meeting 3-year age acceleration standards.
Check for reference part number HPWA-18-80 and order number G56162 on the device packaging. Affected units have lot numbers 14070920 or 14174878.
The recall does not require immediate discontinuation; it is based on potential sterility issues after 3 years of storage.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1712-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1712-2022 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.
