Recall Z-1874-2024— Merit Medical Systems, Inc.

Name: FDA recall Z-1874-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-14

Class II · Ongoing

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2024-03-14. It names one FDA 510(k) clearance: K211405. Product: Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY. Reason: Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-03-14
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K211405 — Prelude Guide SheathMerit Medical Systems, Inc.·cleared 2021-10-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.