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Merit Medical Systems, Inc.: Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY

Medical DevicesSource: FDA (device) · Date: 2026-05-06

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Merit Medical Systems, Inc.
Product
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Reason / hazard
catheter may experience resistance when being advanced over the guidewire
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the state of CO.
Recall initiated
2026-04-02
Code info
All Lot Numbers/UDI: 00884450816509
Voluntary mandated
Voluntary: Firm initiated
City
South Jordan
State
UT
Country
United States
Event id
98637
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