Recall Z-2742-2018— Merit Medical Systems, Inc.

Name: FDA recall Z-2742-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-02

Class II · Terminated

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2018-02-02, terminated 2020-11-30. It names one FDA 510(k) clearance: K173601. Product: 1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.. Reason: Supplier manufacturing defect with the syringe plunger tip..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-02-02
Terminated: 2020-11-30
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K173601 — Merit SyringeMerit Medical Systems, Inc.·cleared 2018-01-31

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

1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.

Reason for recall

Supplier manufacturing defect with the syringe plunger tip.

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