Class II
Medical Device Recall: Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Merit Medical Systems, Inc. · March 14, 2024
Reason for Recall
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
Distribution
Worldwide - US Nationwide distribution in the state of CA and the countries of New Zealand and Canada.
States Affected
NATIONWIDE
Quantity Affected
18 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1874-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.