Reported Apr 5, 2017 · Terminated
7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage:…
Merit Medical Systems, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416
Is this the product you have?
- 7F Prelude¿ Short Sheath Introducer
- Catalog Numbers
K15-00070K15-00170PSS-7F-4-035MTPSS-7F-4MT
- Produc UsageThe 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
- Lot codes and dates
- Lot Numbers
H1041469H1041473H1036880H1041464
- Lot Numbers
- Amount recalled
- 1,265 total
Where it was sold
- Nationwide
- VA
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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