Merit Medical Systems, Inc. recalls Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY

Recalled May 29, 2024 · FDA recall Z-1875-2024 · Merit Medical Systems

Hazard

Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. · FDA Class II

Units

27 units

Sold at

Worldwide - US Nationwide distribution in the state of CA and the countries of New Zealand and Canada.

Description

Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.

Product

Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY

Manufacturer(s)

Merit Medical Systems, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →