Recall Z-0649-2017— Merit Medical Systems, Inc.

Name: FDA recall Z-0649-2017
Creator: U.S. Food and Drug Administration
Published: 2016-08-12

Class II · Terminated

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2016-08-12, terminated 2017-05-09. It names one FDA 510(k) clearance: K915678. Product: Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.. Reason: Merit Medical Systems, Inc. announces a voluntary field action for Fluid Administration Sets due to a molding defect in the drip chamber..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-08-12
Terminated: 2017-05-09
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K915678 — MERIT ADMINISTRATION SETMerit Medical Systems, Inc.·cleared 1992-07-30

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

Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.

Reason for recall

Merit Medical Systems, Inc. announces a voluntary field action for Fluid Administration Sets due to a molding defect in the drip chamber.

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