Recall Z-1408-2013— Merit Medical Systems, Inc.

Name: FDA recall Z-1408-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-02

Class II · Terminated

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2013-05-02, terminated 2013-07-22. It names one FDA 510(k) clearance: K943739. Product: Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.. Reason: Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-05-02
Terminated: 2013-07-22
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 Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.

Reason for recall

Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape.

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