Recall Z-1578-2023— Merit Medical Systems, Inc.

Name: FDA recall Z-1578-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-21

Class II · Ongoing

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2023-03-21. It names one FDA 510(k) clearance: K070159. Product: COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units. Reason: Custom sheath Introducer contains incorrect needle size.

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-03-21
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

COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units

Reason for recall

Custom sheath Introducer contains incorrect needle size

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