FDA-Device2024-05-29Class II
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
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-1874-2024More Merit Medical Systems, Inc. recalls
- FDA-Device2026-04-01Merit Medical CentrosFLO Hemodialysis Catheters recalled for sheath splitting defect
- FDA-Device2026-04-01Merit Medical ProGuide Chronic Dialysis Catheters recalled for sheath introducer design defect
- FDA-Device2026-04-01Merit Medical Systems 16F splittable sheath introducer recalled for design defect causing failure to split
- FDA-Device2026-04-01Merit Medical BioFlo DuraMax Catheter recalled for design defect in sheath introducer
- FDA-Device2026-04-01Merit Medical DuraMax hemodialysis catheter recalled for sheath introducer design defect
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