Cook recalls Roadrunner UniGlide Hydrophilic Wire Guide (RPN HPWA-35-150) due to potential sterility compromise from inadequate packaging testing. Affected units include specific lot numbers sold between 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 its Roadrunner UniGlide Hydrophilic Wire Guide catheter guide due to potential sterility issues from packaging that didn't pass 3-year testing. This could lead to infections if the device is used without proper sterility.
The packaging didn't meet standards for 3-year accelerated testing, which could mean the device isn't sterile when it should be. This might cause infections during medical procedures if the device is used without proper sterility.
Healthcare professionals using this device for vascular catheter procedures during medical treatments. Patients receiving procedures with this device are at risk of infection if the device isn't sterile.
Check for reference part number HPWA-35-150 and order number G56173 on the device. Look for specific lot numbers listed in the recall notice (e.g., 14070910, 14070913, etc.) that were sold between 2014 and 2015.
Look for the lot numbers listed in the recall (e.g., 14070910, 14070913) on the device packaging or label.
The recall states the device may not be sterile due to packaging testing issues, so it should not be used until the manufacturer confirms it's safe.
Check the lot number against the list provided in the recall. If it matches, stop using it and contact Cook for instructions.
The recall does not mention a replacement option; the remedy is null, so you should contact Cook directly for guidance.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1713-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1713-2022 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.
