Cook recalls specific Roadrunner PC Hydrophilic Wire Guides for vascular procedures due to potential sterility compromise from inadequate packaging testing. Affected units include certain lot numbers and order numbers.
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 specific Roadrunner PC Hydrophilic Wire Guides used in vascular procedures because the packaging may not have passed sterility testing after 3 years of accelerated aging. This could lead to contamination during medical procedures.
The device packaging failed 3-year accelerated aging tests, which means the sterility of the device could be compromised over time. This could lead to contamination during medical procedures if the device is not properly sterilized.
Healthcare professionals using the Roadrunner PC Hydrophilic Wire Guide for vascular catheter procedures are most at risk. Patients receiving these devices during procedures may be affected if the device is not sterile.
Check for reference part number RPN:RLPC-35-180 and order number GPN:G07516. Affected units include specific lot numbers: 14103953, 14103956, 14143728, 14145412, 14145419, 14153927, 14156907, 14156908, 14156914, 14160996.
Verify the reference part number (RPN) and order number (GPN) on the device packaging.
The packaging failed 3-year accelerated aging tests, which could compromise the device's sterility over time.
The recall record does not specify a remedy, so check with Cook Incorporated for further instructions.
Yes, affected lot numbers include 14103953, 14103956, 14143728, 14145412, 14145419, 14153927, 14156907, 14156908, 14156914, and 14160996.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1708-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1708-2022 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.
