Reported May 29, 2019 · Terminated
Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr -…
Cook Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Inc. · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
- Cook Salle Intraoperative Pyeloplasty
- Stent Set PRODUCT/CATALOG NUMBER/GPN4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G32773 4.7 Fr SIPSF-050018-59 G32774
- Lot codes and dates
- All lot codes
- Amount recalled
- 3711
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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