Cook recalls urethral dilator sets with potential risk of stiff wire guide entering patient during use. Affected models include 8401849, 84049:45, 8404946, 8417702, 8404946X. Stop using immediately if you own these models.
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 urethral dilator sets that could have a stiff wire guide tip inserted into patients instead of the flexible tip. This risk could cause injury during medical procedures if the device is used incorrectly.
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 if the device is used improperly.
Healthcare professionals and patients using the urethral dilator sets. Those with the specific model numbers listed are most at risk.
Check for model numbers: 8401849, 8404945, 8404946, 8417702, or 8404946X. These models were sold globally under Cook Inc.
If you own the affected model numbers, stop using the urethral dilator set immediately.
The affected models are 8401849, 8404945, 8404946, 8417702, and 8404946X.
The wire guide may be incorrectly loaded into the holder, leading to the stiff tip being introduced into the patient instead of the flexible tip.
Check the model number on your urethral dilator set; affected models include 8401849, 8404945, 8404946, 8417702, or 8404946X.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0971-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0971-2020 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.
