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FDAApril 22, 2019device

Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G32773 4.7 Fr SIPSF-050018-59 G32774

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.

What to do

FDA enforcement status: Terminated

Brands named

cook

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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