FDA (Devices) recall action 98637
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
catheter may experience resistance when being advanced over the guidewire
The agency’s own wording, quoted from the enforcement report.
Merit Medical Systems is recalling the Philips Bridge Prep Kit (Lot K12-09098B) because the catheter may experience resistance when being advanced over the guidewire.
Merit Medical Systems is recalling the Philips Bridge Prep Kit (REF K12-09098C) because the catheter may experience resistance when advanced over the guidewire, potentially affecting proper device function.
Merit Medical Systems, Inc. is recalling the Philips Bridge Prep Kit (Ref K12-09098C) because the catheter may experience resistance when being advanced over the guidewire during use.