Reported May 20, 2020 · Terminated
Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the…
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 W Merit Pkwy · South Jordan, UT · 84095-2416
Is this the product you have?
- Custom Sheath Introducer
- Kit REF K21-00031 - Product Usageintended use is to provide access and facilitate the percutaneous introduction of various devices into vein
- Lot codes and dates
- Catalog NumberK21-00031
- Lot NumberH1583914
- UDI00884450426357
- Amount recalled
- 15 kits
Where it was sold
- Nationwide
- MI
Why it was recalled
labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism.
This product could cause temporary or reversible health problems — stop using it.
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