Warning
Merit Medical Systems Recalls Philips Bridge Prep Kit REF: K12-09098C Sterile EO
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-2004-2026Medical Device
Merit Medical Systems Recalls Philips Bridge Prep Kit REF: K12-09098C Sterile EO
Merit Medical Systems, Inc. · Class II — Moderate Risk
Product Description
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Reason for Recall
catheter may experience resistance when being advanced over the guidewire
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide distribution in the state of CO.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database