Cook recalls Roadrunner PC Wire Guide devices with potential packaging seal breaches that could compromise sterility. Affected units include specific lot numbers from June 2025. Consumers should contact Cook for details.
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 Guide devices that may have packaging seals that are completely broken. This could mean the devices are no longer sterile, which is dangerous for medical use.
The packaging seal may be completely broken, which could compromise the sterility of the device. If the device is not sterile, it could cause infections or other complications during medical procedures.
Medical professionals using the Roadrunner PC Wire Guide device for procedures are most at risk. Patients receiving these devices could be affected if the device is not sterile.
Check for the part number RLPC-35-145 with lot numbers 14828631, 14828643, or 14828644 from June 7, 2025. The device is sold under the brand name Cook.
Look for the part number RLPC-35-145 and lot numbers 14828631, 14828643, or 14828644 from June 7, 2025.
Cook identified that some devices may have a complete breach of the chevron seal, which could compromise sterility.
Check for the part number RLPC-35-145 with lot numbers 14828631, 14828643, or 14828644 from June 7, 2025.
The recall record does not specify a remedy, so contact Cook directly for instructions.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1840-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1840-2022 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.
