Recall Z-0949-2017— Merit Medical Systems, Inc.

Name: FDA recall Z-0949-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-01

Class II · Terminated

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2016-12-01, terminated 2017-04-18. It names one FDA 510(k) clearance: K140543. Product: PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires. Reason: Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner diameter and therefore will not allow passage of an 0.021 (0.53 mm) guide wire..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-12-01
Terminated: 2017-04-18
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K140543 — PRELUDEEASE HYDROPHILIC SHEATH INTRODUCERMerit Medical Systems, Inc.·cleared 2014-10-16

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

PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires

Reason for recall

Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner diameter and therefore will not allow passage of an 0.021 (0.53 mm) guide wire.

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