Cook recalls C-Flex Double Pigtail Ureteral Stent Sets with specific product numbers due to risk of stiff wire guide tip 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 certain C-Flex Double Pigtail Ureteral Stent Sets because the wire guide might be loaded incorrectly into its holder. 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 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. The risk is specific to the way the wire guide is loaded and not present in all uses.
Healthcare professionals who use these stent sets during medical procedures are most at risk. Patients receiving these stents may also be affected if the incorrect loading occurs.
Check for product numbers G14364, G14365, G14367, NS7953136, NS8169661, NS8180857, NS8169662, NS8180858, NS8180859, or NS8180860 on the packaging or documentation.
Verify your stent set's product numbers match the recalled list: G14364, G14365, G14367, NS7953136, NS8169661, NS8180857, NS8169662, NS8180858, NS8180859, or NS8180860.
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.
Check for product numbers G14364, G14365, G14367, NS7953136, NS8169661, NS8180857, NS8169662, NS8180858, NS8180859, or NS8180860 on the packaging or documentation.
No immediate stop is required, but you should check your product numbers and contact Cook if you have the recalled model.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0973-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0973-2020 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.
