FDA (Devices) recall action 82795
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Cook Inc. is recalling Kwart RetroInject and Salle Intraoperative Pyeloplasty Stent Sets because the instructions for use did not include a warning for stent knotting.
Cook Inc. is recalling Kwart Retro-Inject Ureteral Stent Sets because the instructions for use did not include a warning for stent knotting.