Cook recalls Sof-Flex Double Pigtail Ureteral Stent Sets with specific product numbers due to risk of stiff wire guide tip entering patient during insertion.
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 Sof-Flex Double Pigtail Ureteral Stent Sets with certain product numbers because the wire guide might be loaded incorrectly. This could cause the stiff tip of the wire guide to enter the patient instead of the flexible tip, potentially causing injury.
The wire guide may be incorrectly loaded into the wire guide holder, causing the stiff tip to enter the patient instead of the flexible tip. This could lead to injury during the stent insertion procedure.
Patients undergoing ureteral stent procedures who use the recalled Sof-Flex Double Pigtail Ureteral Stent Sets with the listed product numbers are affected. Medical professionals performing these procedures are most at risk.
Check the product numbers on the packaging: G15076, G14906, G14840, G14865, G17128, or the corresponding NS numbers listed in the recall notice.
Verify the product numbers on the packaging to confirm if the stent set is recalled.
The recall indicates a potential risk of injury if the wire guide is loaded incorrectly. Do not use the recalled product until the remedy is applied.
The recall does not specify a remedy, so contact Cook directly for guidance on safe use or alternatives.
Check the product numbers listed: G15076, G14906, G14840, G14865, G17128, or the corresponding NS numbers.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0975-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0975-2020 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.
