Cook recalls Roadrunner PC Wire Guides with potential packaging seal breaches that could compromise sterility. Affected units include specific lot numbers and expiration dates from July 2025. Consumers should check their product details and contact Cook for guidance.
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Cook is recalling Roadrunner PC Wire Guides that may have a broken packaging seal, which could mean the medical devices are no longer sterile. This recall affects specific lot numbers and expiration dates from July 2025. Using these devices could lead to infections or other health risks if the seal was compromised.
The packaging seal breach could compromise the sterility of the medical devices. If the seal is broken, the devices might not be sterile when used, increasing the risk of infections or other health issues.
Medical professionals and patients using the Roadrunner PC Wire Guides with specific lot numbers and expiration dates from July 2025 are most at risk. The recall targets devices that may have packaging seal breaches.
Check for the Roadrunner PC Wire Guide with part numbers RPC-35-145 G06979 or RPC-35-80 G09534. Affected units have specific lot numbers and expiration dates from July 2025.
Look for the part numbers RPC-35-145 G06979 or RPC-35-80 G09534 on the device packaging.
Cook identified that some Roadrunner PC Wire Guides may have a complete breach of the chevron seal, which could compromise the sterility of the devices.
Check the product details for the specific part numbers and expiration dates. Contact Cook for further guidance if you have the affected units.
Yes, a broken packaging seal could mean the devices are no longer sterile, increasing the risk of infections or other health issues.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1841-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1841-2022 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.
