FDA-Device2024-05-29Class II
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Merit Medical Systems, Inc.
Hazard
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
Sold states
Worldwide - US Nationwide distribution in the state of CA and the countries of New Zealand and Canada.
Affected count
18 units
Manufactured in
1600 W Merit Pkwy, South Jordan, UT, United States
Products
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1874-2024Don't want to check this manually?
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