FDA-Device2016-11-30Class II
Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
Merit Medical Systems, Inc.
Hazard
Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
Sold states
Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.
Affected count
53 units
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0635-2017Don't want to check this manually?
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