Z-1497-2017 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 5, 2017
- Initiation Date
- February 16, 2017
- Termination Date
- August 8, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,265 total
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.
Distribution Pattern
Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.
Code Information
Lot Numbers: H1041469, H1041473, H1036880, H1041464.