Recall Z-0002-2017— Merit Medical Systems, Inc.

Name: FDA recall Z-0002-2017
Creator: U.S. Food and Drug Administration
Published: 2016-08-25

Class II · Terminated

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2016-08-25, terminated 2016-12-01. It names one FDA 510(k) clearance: K122321. Product: Merit Inflation Syringe Kit. Catalog Number KOS-02857. Reason: Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-08-25
Terminated: 2016-12-01
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K122321 — BASIXCONPAK ANALOG INFLATION SYRINGEMerit Medical Ireland, Ltd.·cleared 2012-12-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Merit Inflation Syringe Kit. Catalog Number KOS-02857

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.