Cook recalls specific Roadrunner Hydrophilic PC Wire Guides due to potential risk of stiff wire tip entering patient instead of flexible tip during medical procedures.
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Cook is recalling certain Roadrunner Hydrophilic PC Wire Guides because they might be loaded incorrectly into the holder. This could cause the stiff tip to enter the patient instead of the flexible tip during medical procedures, potentially causing injury.
The wire guide may be incorrectly loaded into the holder, causing the stiff tip to enter the patient instead of the flexible tip. This could lead to injury during medical procedures if the device is used improperly.
Medical professionals using these specific wire guides for procedures. Patients undergoing procedures with these devices are at risk if the wire is inserted incorrectly.
Check for the Global Product Numbers listed in the recall notice: 7853231 through 8474910. These are specific models of Cook's Roadrunner Hydrophilic PC Wire Guides.
Verify your wire guide has one of the listed Global Product Numbers: 7853231 through 8474910.
The wire guide may be incorrectly loaded into the holder, causing the stiff tip to enter the patient instead of the flexible tip during medical procedures.
Check for the Global Product Numbers listed: 7853231 through 8474910.
The recall does not specify a remedy, so contact Cook directly for guidance.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0963-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0963-2020 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.