FDA-Device2020-05-20Class II
Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.
Merit Medical Systems, Inc.
Hazard
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.
Sold states
US Nationwide distribution in the state of MI.
Affected count
15 kits
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1956-2020Don't want to check this manually?
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