Cook recalls intraoperative stent sets due to missing warning about stent knotting. Affected models include 4.0 Fr and 4.7 Fr versions with specific catalog numbers. No immediate action needed but check for the product.
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 certain intraoperative stent sets because the instructions didn't warn about stent knotting. This could lead to complications during surgery if the stent becomes knotted. Affected products have specific model numbers and catalog codes.
The stent set instructions did not include a warning about stent knotting. If the stent knots during surgery, it could cause complications like blockages or require additional procedures. This is a procedural risk rather than a direct hazard to the patient.
Surgical teams using the Cook Salle Intraoperative Pyeloplasty Stent Set during procedures are most at risk. Patients receiving this stent set during surgery may be affected if knotting occurs.
Check for product model numbers 4.0 Fr (SIPSF-040018-56-6 G18168 or SIPSF-040018-59 G32773) or 4.7 Fr (SIPSF-050018-59 G32774). The recall covers all lot codes of these specific stent sets.
Identify the model number on the stent set packaging or label to confirm if it matches the recalled versions (4.0 Fr or 4.7 Fr).
The recall states the instructions did not warn about stent knotting, which could cause complications during surgery. However, the hazard is not described as causing immediate injury.
The recall does not specify a stop-use action, so you can continue using it if it's not the recalled model.
The official notice does not provide a remedy, so no action is required beyond checking the model number.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1370-2019 — Cook Cook Hello, I own a Cook that is covered by recall Z-1370-2019 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.
