Cook recalls Universa Soft Ureteral Stent Sets (UFH-526) due to incorrect outer box labeling that may confuse with Firm Stent Sets. This could lead to improper use.
Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa Firm Ureteral Stent Set ;pouch label reflects the packaged product.
Cook is recalling their Universa Soft Ureteral Stent Sets (model UFH-526) because the outer boxes are labeled incorrectly as Firm Stent Sets instead of Soft. This risk could cause improper medical use if healthcare providers mix up the stent types.
The stent sets are incorrectly labeled in the outer packaging as 'Firm' instead of 'Soft'. This could lead to healthcare providers using the wrong type of stent, which might not function properly for urinary drainage.
Healthcare providers who use these stents for temporary urinary drainage may be affected. Patients using the stents are not directly at risk from this labeling error.
Check for the model number UFH-526 on the stent set. The outer box should say 'Soft Ureteral Stent Set' not 'Firm Ureteral Stent Set'.
Look for the model number UFH-526 on the stent set and verify the outer box label says 'Soft Ureteral Stent Set'.
The outer boxes are incorrectly labeled as 'Firm Ureteral Stent Set' instead of 'Soft Ureteral Stent Set', which could lead to using the wrong stent type.
No, this is a labeling issue that does not require stopping use. Healthcare providers should check the label before use.
Check the packaging label to confirm it says 'Soft Ureteral Stent Set'. If labeled incorrectly, contact Cook for guidance.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-2971-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-2971-2020 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.
