Class II

Medical Device Recall: Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 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

27 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1875-2024

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.

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