Cook recalls Roadrunner UniGlide Hydrophilic Wire Guide (HPW-35-150) due to potential sterility compromise from inadequate packaging testing. Affected units include specific lot numbers for vascular catheter procedures.
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 risky 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. This could lead to infections or complications during medical procedures if the device isn't properly sterile.
Healthcare professionals using this device for vascular catheter procedures during medical treatments. Patients receiving these procedures are at risk if the device isn't sterile.
Check for reference part number HPW-35-150 and order number G56149. Look for lot numbers: 14070921, 14108915, 14108916, 14129152, 14141997, 14170230.
Look for lot numbers on the device packaging: 14070921, 14108915, 14108916, 14129152, 14141997, 14170230.
The packaging didn't pass 3-year age acceleration testing, which could mean the device isn't sterile over time.
Check the lot number on the device packaging. If it matches the listed numbers, contact Cook for instructions.
The device may not be sterile due to packaging issues, so it's not safe for medical procedures without proper testing.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1710-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1710-2022 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.
