Recall Z-1826-2015— Merit Medical Systems, Inc.

Name: FDA recall Z-1826-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-04

Class II · Terminated

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2015-06-04, terminated 2015-10-26. It names one FDA 510(k) clearance: K070159. Product: Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.. Reason: Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-06-04
Terminated: 2015-10-26
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

Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

Reason for recall

Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038.

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