—#153619

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.

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K082063
Affected lot / code info: Lot Numbers: H1041469, H1041473, H1036880, H1041464.

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

Consignees notified on 2/16/17 to immediately stop using or distributing the affected lots and return them to Merit. For any questions, please contact your Merit Sales Representative or Merit Customer Service at 801.208.4381.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 W Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern: Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.

Timeline

Recall initiated: 2017-02-16
Posted by FDA: 2017-03-24
Terminated: 2017-08-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153619. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.