Cook recalls PTFE Wire Guides with Global Product Numbers 638813, 635413-10, etc. due to potential incorrect insertion into patients 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 PTFE Wire Guides that may be incorrectly loaded into the wire guide holder. This could lead to the stiff tip of the wire guide being inserted into the patient instead of the flexible tip, which poses a risk of injury during medical procedures.
The wire guide may be loaded incorrectly into the holder, causing the stiff tip to enter the patient instead of the flexible tip. This could lead to injury during medical procedures as the stiff tip might cause damage to tissues or blood vessels.
Medical professionals using these wire guides during procedures are most at risk. Patients receiving the wire guide during surgery may be affected if the device is incorrectly inserted.
Check for Global Product Numbers listed: 638813, 635413-10, 7832498, 7832499, 7832500, 7925385, 7925387, 7930517, 8090868, 8287793, 8287794, 8287799, 8400121, 8548813, 8548815, NS8548814, 7760235, 7881599, 8062433, 8074027, 8290383, 8290384, 8404559, 8404562, 7999663, 8077582, 8077583, 8065959, 8073949, 8074014, 8074015.
Look for the listed Global Product Numbers on the device to confirm if it is recalled.
The wire guide may be incorrectly loaded into the holder, causing the stiff tip to enter the patient instead of the flexible tip, which could lead to injury during medical procedures.
Check for the listed Global Product Numbers: 638813, 635413-10, 7832498, 7832499, 7832500, 7925385, 7925387, 7930517, 8090868, 8287793, 8287794, 8287799, 8400121, 8548813, 8548815, NS8548814, 7760235, 7881599, 8062433, 8074027, 8290383, 8290384, 8404559, 8404562, 7999663, 8077582, 8077583, 8065959, 8073949, 8074014, 8074015.
The recall record does not specify a remedy, so contact Cook Inc. for guidance on next steps.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0962-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0962-2020 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.
