Cook recalls Roadrunner PC Wire Guide (Nimble) devices with potential packaging seal breaches that could compromise sterility. Affected units include specific lot numbers from July 2025. Consumers should check their device's lot code and 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 (Nimble) devices that may have a broken packaging seal, risking contamination and loss of sterility. This could lead to infections or other complications if the device is used without proper sterility.
The packaging seal may be completely breached, which could compromise the sterility of the device. If the device is not sterile, it might cause infections or other complications during medical procedures.
Medical device users who own the Roadrunner PC Wire Guide (Nimble) with specific lot numbers from July 2025 are affected. Patients and healthcare providers using these devices for procedures are most at risk.
Check the device's lot number on the packaging, which starts with 14831437 through 14840309. The expiration date is listed as July 7, 2025, for these specific lots.
Look for the lot number on the packaging, which ranges from 14831437 to 14840309.
The packaging seal may be breached, potentially compromising sterility and increasing infection risk during medical procedures.
Check the lot number on the packaging; affected units have lot numbers from 14831437 to 14840309 with an expiration date of July 7, 2025.
The recall does not specify a remedy, so contact Cook directly for further instructions.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1838-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1838-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
