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Merit Medical Systems, Inc. recalls Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
Recalled November 30, 2016 · FDA recall Z-0635-2017 · Merit Medical Systems
Hazard
Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier. · FDA Class II
Units
53 units
Sold at
Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.
Description
Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
Product
Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
Manufacturer(s)
Merit Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →