Recalling firm
Merit Medical Systems, Inc.
Product type
Device
Status
Ongoing
Report date
2026-05-06
Distribution
US Nationwide distribution in the state of CO.
Firm state
UT
Initiated by
Voluntary: Firm initiated
Reason for recall
catheter may experience resistance when being advanced over the guidewire
Product description
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Code / lot info
All Lot Numbers/UDI: 00884450024140
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.