Cook recalls Roadrunner PC Hydrophilic Wire Guides with potential packaging breaches that could compromise sterility. Affected items include specific part numbers and expiration dates. Consumers should check their product details to determine if they are affected.
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 certain Roadrunner PC Hydrophilic Wire Guides due to a possible breach in the packaging seal. This could mean the devices are no longer sterile, which is critical for medical use. If you have these devices, you should stop using them until you can confirm they are safe.
The packaging seal may be completely breached, which could compromise the sterility of the devices. This is a concern because medical devices must be sterile to prevent infections during surgery.
Medical professionals who use these devices for procedures may be affected. Patients using these devices during surgery are at risk if the devices are not sterile.
Check for part numbers RPC-035145-0-5, RPC-035145-5, or RPC-038145-0-5 with specific expiration dates listed in the recall notice. The devices were sold between June 2025 and July 2025.
Review the part numbers and expiration dates on your device to see if it matches the affected items listed in the recall.
Cook identified that some devices may have a complete breach in the packaging seal, which could compromise sterility.
Check the part numbers and expiration dates to see if your device is affected. If it is, stop using it until you can confirm it's safe.
Yes, affected devices have expiration dates from June 2025 through July 2025, as listed in the recall notice.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1837-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1837-2022 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.
