Cook recalls Roadrunner PC Hydrophilic Wire Guides (RPN RFPC-35-180) 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 certain Roadrunner PC Hydrophilic Wire Guides used in vascular procedures because packaging testing failed to meet standards. This could mean the devices aren't sterile, which is dangerous during medical procedures.
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 other complications during medical procedures if the device isn't properly sterilized.
Healthcare professionals using these devices for vascular catheter procedures are most at risk. Patients receiving these devices during medical treatments could be affected if the product isn't sterile.
Check for reference part number RFPC-35-180 and order number G07937 on the device. Affected units include specific lot numbers: 14145420, 14145424, 14156909, 14156912, 14156916, 14164348, 14173577.
Look for reference part number RFPC-35-180 and order number G07937 on the device.
The packaging didn't pass 3-year age acceleration testing, which could mean the device isn't sterile over time.
The recall record doesn't specify a remedy, so contact Cook directly for guidance.
Affected lot numbers are 14145420, 14145424, 14156909, 14156912, 14156916, 14164348, 14173577.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1706-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1706-2022 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.
