Cook recalls Bander Ureteral Diversion Open-End Stent Sets (Global Product Nos G14822-G1: 8011030-8629475) due to risk of stiff wire guide entering patient during use.
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 Bander Ureteral Diversion Open-End Stent Sets because the wire guide might be loaded incorrectly, causing the stiff tip to enter the patient instead of the flexible tip. This could lead to injury during medical procedures.
The wire guide's stiff tip could enter the patient's body instead of the flexible tip during insertion, potentially causing tissue damage or injury. This happens when the wire guide is loaded incorrectly into the holder.
Medical professionals using the stent sets for urinary diversion procedures are most at risk. Patients receiving these devices during surgery may be affected if the stent is incorrectly placed.
Check for the product numbers listed: 8011030, 8033568, 8063430, 8063431, 8150491, 8417631, 8417632, 8587162, 8587163, 8590532, 8590533, 7990830, 8003084, 8033571, 8063428, 8590520, 8590522, 8629475, NS8629473. The product is sold globally under the brand Cook.
Verify your stent set's product number against the list: 8011030, 8033568, 8063430, 8063431, 8150491, 8417631, 8417632, 8587162, 8587163, 8590532, 8590533, 7990830, 8003084, 8033571, 8063428, 8590520, 8590522, 8629475, NS8629473.
The wire guide may be incorrectly loaded into the holder, causing the stiff tip to enter the patient instead of the flexible tip during use.
Check your product number against the list provided. If it matches, stop using it and contact Cook for further instructions.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0972-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0972-2020 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.
