Cook recalls Roadrunner UniGlide Hydrophilic Wire Guide (RPN HPWS-35-150) due to potential sterility compromise from inadequate packaging testing. Affected units 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 due to potential sterility issues from packaging that didn't pass 3-year testing. This could lead to infections if used in medical procedures.
The packaging didn't pass 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. Patients receiving procedures with this device may be at risk if sterility is compromised.
Look for the reference part number HPWS-35-150 or order number G56152 on the device. Units were sold between 2014 and 2015 with lot numbers starting with 14118842.
Look for reference part number HPWS-35-150 or order number G56152 on the device packaging.
The recall states the packaging may not have met sterility testing standards, but the device itself is not inherently dangerous if used correctly.
Check for reference part number HPWS-35-150 or order number G56152 on the device. Units were sold between 2014 and 2015 with lot numbers starting with 14118842.
The recall does not specify a remedy, so 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-1717-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1717-2022 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.
