Cook recalls specific ureteral stent sets due to missing warning for stent knotting. Affected models include 4.7 Fr, 6.0 Fr, and 7.0 Fr sizes with certain lot codes. No action is required as the hazard is not severe enough to warrant immediate stop use.
Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.
Cook is recalling specific ureteral stent sets that lack a warning about stent knotting. This could potentially cause complications during medical procedures, but the recall does not require immediate action.
The stent sets do not include a warning about knotting, which could lead to complications during medical procedures. Knotting might cause blockages or require additional interventions if not detected.
Medical professionals using the Cook Kwart RetroInject stent sets for urological procedures are most at risk. Patients receiving these stents during surgery may also be affected.
Check for product labels with sizes 4.7 Fr, 6.0 Fr, or 7.0 Fr and lot codes listed in the recall notice. The sets have an AQ Hydrophilic Coating and specific catalog numbers.
Look for the product size (4.7 Fr, 6.0 Fr, or 7.0 Fr) and lot code on the stent set packaging.
No, the recall does not require immediate action as the hazard is not severe enough to warrant stopping use.
The recall does not require any action as the hazard is not severe enough to warrant immediate stop use.
Yes, the affected models include 4.7 Fr, 6.0 Fr, and 7.0 Fr sizes with specific lot codes and catalog numbers.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1369-2019 — Cook Cook Hello, I own a Cook that is covered by recall Z-1369-2019 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.
