FDA-Device2016-10-12Class II

Merit Inflation Syringe Kit. Catalog Number KOS-02857

Merit Medical Systems, Inc.
Hazard

Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.

Sold states
One consignee located in CA. No Canadian, other foreign or VA/govt/military consignees.
Affected count
1,297 total units
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
Merit Inflation Syringe Kit. Catalog Number KOS-02857

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0002-2017

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