Cook recalls Heavy Duty PTFE Wire Guides due to risk of stiff wire tip entering patient during incorrect loading. Affected units have specific global product numbers.
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 Heavy Duty PTFE Wire Guides because they might be loaded incorrectly, causing the stiff tip to enter patients instead of the flexible tip. This could lead to injury during medical procedures.
The wire guide may be loaded incorrectly into the holder, causing the stiff tip to enter the patient. This happens because the stiff tip is more likely to cause injury than the flexible tip during medical procedures.
Medical professionals using these wire guides during procedures are most at risk. Patients could be injured if the stiff wire tip enters the body instead of the flexible tip.
Check for global product numbers G14323, G14260, or NS8481135 on the device. These are the specific models affected by the recall.
Look for global product numbers G14323, G14260, or NS8481135 on the device to confirm if it's affected.
The wire guide may be incorrectly loaded into the holder, causing the stiff tip to enter the patient instead of the flexible tip.
Check for global product numbers G14323, G14260, or NS8481135 on the device.
The recall record does not specify a remedy, so contact Cook Inc. 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-0961-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0961-2020 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.
