Cook recalls Roadrunner PC Hydrophilic Wire Guide (RPN RFSPC-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 its Roadrunner PC Hydrophilic Wire Guide devices because packaging testing failed to meet 3-year age acceleration standards. This could mean the devices are no longer sterile, which is dangerous during vascular procedures.
The device's packaging did not pass 3-year age acceleration testing, which means the sterility of the device could be compromised over time. This poses a risk of infection or contamination during vascular procedures.
Healthcare professionals using the Roadrunner PC Hydrophilic Wire Guide for vascular catheter procedures are most at risk. Patients undergoing these procedures may be affected if the device is not sterile.
Check for reference part number RFSPC-35-180 and order number G09608 on the device. Affected units include specific lot numbers: 14071906, 14091204, 14134663, 14134667, 14134669, 14134670, 14134673, 14134676, 14143872, 14143873, 14160997, 14184102, NS14143735, NS14152903.
Look for lot numbers on the device: 14071906, 14091204, 14134663, 14134667, 14134669, 14134670, 14134673, 14134676, 14143872, 14143873, 14160997, 14184102, NS14143735, NS14152903.
The device did not meet packaging testing standards for 3-year age acceleration, which could compromise sterility over time.
Check the lot number on the device. If it matches the affected numbers listed, contact Cook for guidance.
The recall record does not specify a remedy; affected devices should be checked and contacted for further instructions.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1707-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1707-2022 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.
