Cook recalls Roadrunner PC Wire Guide (Nimble Floppy) devices with potential packaging seal breaches that could compromise sterility. Affected units include specific model numbers and expiration dates from June 2025 to December 2025.
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 Floppy) devices that may have a broken packaging seal, risking contamination. This could lead to infections if the devices are used in medical procedures.
The packaging seal may be completely breached, which could compromise the sterility of the devices. If the devices are used in medical procedures without being sterile, it could lead to infections.
Healthcare professionals using the Roadrunner PC Wire Guide for medical procedures are most at risk if the devices are used without proper sterility.
Check for the model number RFPC-35-145 G07914 on the device. Affected units were sold with specific expiration dates from June 2025 to December 2025.
Look for the model number RFPC-35-145 G07914 on the device packaging.
Cook Medical identified that devices from the affected lots may have a complete breach of the chevron seal of the packaging, which could compromise sterility.
If the devices are used in medical procedures without proper sterility, it could lead to infections.
Check for the model number RFPC-35-145 G07914 and expiration dates from June 2025 to December 2025.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1839-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1839-2022 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.
