Prelude Short Sheath Introducer

Lot Numbers: H1041469, H1041473, H1036880, H1041464.

Cardiovascular Devices

2

No

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

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.

Injections / Infusions / Transfusions / Dialysis

Medical Device Safety Alert: Merit 7F Prelude Short Sheath Introducers

Lot number V686326.

Cardiovascular Devices

2

No

Worldwide Distribution -- USA, including states of CA, CO, GA, IL, MO, OK, and OR and countries of Austria, Belgium, Canada, Denmark, France, Germany, Hong Kong, Japan, Latvia, Lithuania, Netherlands, New Zealand, Spain, Sweden, and UK.

Prelude Short Sheath Introducer, Carolina Kidney and Endocrine - Declot tray, K12T-02693, Merit Medical Systems, Inc., South Jordan, Utah 84095. || 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. This 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.

Lot number V681838.

Cardiovascular Devices

2

No

Worldwide Distribution -- USA, including states of CA, CO, GA, IL, MO, OK, and OR and countries of Austria, Belgium, Canada, Denmark, France, Germany, Hong Kong, Japan, Latvia, Lithuania, Netherlands, New Zealand, Spain, Sweden, and UK.

Prelude Short Sheath Introducer, McAlester Regional Hospital - Fistulagram Pack, K12T-02894C, Merit Medical Systems, Inc., South Jordan, Utah 84095. || 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. This 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.