Recall Z-0045-2014— Merit Medical Systems, Inc.

Name: FDA recall Z-0045-2014
Creator: U.S. Food and Drug Administration
Published: 2013-09-13

Class II · Terminated

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2013-09-13, terminated 2014-01-03. It names one FDA 510(k) clearance: K943739. Product: Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.. Reason: 4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-09-13
Terminated: 2014-01-03
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K943739 — SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETERMallinckrodt Medical·cleared 1994-11-15

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 Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.

Reason for recall

4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.

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