Reported Jul 1, 2015 · Terminated
Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath…
Merit Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 West Merit Parkway · South Jordan, UT · 84095
Is this the product you have?
- Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude 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.
- Lot codes and dates
Catalo Number PR0-6F-11-038Lot Number H767887
- Amount recalled
- 1,445
Where it was sold
Why it was recalled
Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038.
This product could cause temporary or reversible health problems — stop using it.
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