Recall Z-0631-2017— Merit Medical Systems, Inc.

Name: FDA recall Z-0631-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-23

Class II · Terminated

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2016-09-23, terminated 2017-03-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Fluid Management Set. Catalog Number K08-MP5159A. Reason: Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-09-23
Terminated: 2017-03-27
Firm location: South Jordan, UT, United States

Product description

Fluid Management Set. Catalog Number K08-MP5159A

Reason for recall

Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.

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