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Merit Medical Systems, Inc. recalls Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percuta
Recalled May 20, 2020 · FDA recall Z-1956-2020 · Merit Medical Systems
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. · FDA Class II
Units
15 kits
Sold at
US Nationwide distribution in the state of MI.
Description
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.
Product
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.
Manufacturer(s)
Merit Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →