Recall Z-3190-2024— Merit Medical Systems, Inc.

Name: FDA recall Z-3190-2024
Creator: U.S. Food and Drug Administration
Published: 2024-08-12

Class II · Ongoing

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2024-08-12. It names one FDA 510(k) clearance: K070159. Product: Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F). Reason: 7F sheath introducers labeled as 7.5F.

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-08-12
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K070159 — PRELUDE SHEATH INTRODUCERMerit Medical Systems, Inc.·cleared 2007-06-21

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 Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)

Reason for recall

7F sheath introducers labeled as 7.5F

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