Cook recalls Roadrunner PC Hydrophilic Wire Guide (RPN RPC-35-180) due to potential sterility compromise after 3-year storage. Affected units include specific lot numbers for vascular 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 a specific vascular wire guide used in medical procedures because it may not stay sterile after three years of storage. This could lead to infections if the device is used after the sterility period expires.
The device failed packaging tests that simulate three years of storage. This means the sterility of the device could be compromised over time, potentially causing infections if used after the expiration.
Healthcare professionals using the Roadrunner PC Hydrophilic Wire Guide for vascular procedures are most at risk. Patients receiving these devices during procedures may be affected if the device is not sterile.
Check for the reference part number RPC-35-180 and order number G07518 on the device packaging. Affected units include specific lot numbers: 14063361, 14087089, 14087092, 14117033, 14120926, 14120928, 14151216, 14151218, 14153159, 14158614, 14159695, 14159696.
Look for lot numbers on the packaging: 14063361, 14087089, 14087092, 14117033, 14120926, 14120928, 14151216, 14151218, 14153159, 14158614, 14159695, 14159696.
The device did not pass 3-year age acceleration testing, which means its sterility could be compromised over time.
Check the lot number on the packaging. If it matches the listed numbers, contact Cook for instructions.
The device may not be sterile after three years of storage, so it should not be used if the lot number is affected.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1709-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1709-2022 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.
