FDA recall Z-1874-2024

Merit Medical Systems, Inc. · Class II · device

Product

Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY

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.

Key facts

Status
Ongoing
Initiation date
2024-03-14
Report date
2024-05-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
South Jordan, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1874-2024