Cook recalls Roadrunner UniGlide Hydrophilic Wire Guide (RPN HPWS-35-80) 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 devices because packaging testing failed, which could mean the devices aren't sterile. This is serious for medical procedures where sterility is critical.
The packaging didn't pass 3-year age acceleration testing, which means the device might not stay sterile over time. In medical procedures, even a small risk of contamination could cause serious infections or complications.
Healthcare professionals using this device for vascular catheter procedures during diagnostic or interventional treatments. Patients undergoing these procedures are at risk if the device isn't sterile.
Check for reference part number HPWS-35-80 and order number G56151 on the device packaging. Units were sold between 2014 and 2015 with lot numbers starting with 14156572.
Immediately stop using the device if it has the reference part number HPWS-35-80 and order number G56151.
The packaging didn't pass 3-year age acceleration testing, which could mean the device isn't sterile over time.
Immediately stop using it and contact Cook for further instructions.
Yes, lot numbers starting with 14156572 were sold between 2014 and 2015.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1718-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1718-2022 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.
