Cook recalls Universa Firm Ureteral Stents with specific product numbers due to risk of stiff wire guide tip entering patients 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 certain Universa Firm Ureteral Stents because the wire guide might be loaded incorrectly into the holder. This could cause the stiff tip of the wire guide to enter the patient instead of the flexible tip during medical procedures. Affected patients should contact Cook for guidance.
The wire guide may be incorrectly loaded into the holder, causing the stiff tip to enter the patient instead of the flexible tip. This could lead to unintended tissue damage during ureteral procedures.
Healthcare professionals using the stents for medical procedures are most at risk. Patients who have received the recalled stents should contact Cook for instructions.
Check for product numbers listed in the recall: G49864 through G49877, G49879, G49881, G49882, G49887, G49888, and other specific serial numbers provided in the recall notice.
Verify if your stent has any of the listed product numbers: G49864 through G49877, G49879, G49881, G49882, G49887, G49888, and other specific serial numbers.
The wire guide may be incorrectly loaded into the holder, causing the stiff tip to enter the patient instead of the flexible tip during medical procedures.
Check for product numbers listed in the recall: G49864 through G49877, G49879, G49881, G49882, G49887, G49888, and other specific serial numbers provided in the recall notice.
Contact Cook directly for guidance on next steps as the recall remedy is not specified in the notice.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0977-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0977-2020 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.
