Recall Z-1497-2017— Merit Medical Systems, Inc.

Name: FDA recall Z-1497-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-16

Class I · Terminated

Class I FDA medical device recall by Merit Medical Systems, Inc., initiated 2017-02-16, terminated 2017-08-08. It names one FDA 510(k) clearance: K082063. Product: 7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude¿ Short 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. The device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.. Reason: Merit Medical Systems, Inc. announces a voluntary field action for sheaths included with the 7F Prelude¿ Short Sheath Introducers because the sheath marker tips may detach during use..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class I
Status: Terminated
Initiated: 2017-02-16
Terminated: 2017-08-08
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K082063 — PRELUDE SHORT SHEATH INTRODUCERMerit Medical Systems, Inc.·cleared 2008-10-15

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

7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude¿ Short 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. The device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.

Reason for recall

Merit Medical Systems, Inc. announces a voluntary field action for sheaths included with the 7F Prelude¿ Short Sheath Introducers because the sheath marker tips may detach during use.

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