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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Product Detail

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.
Recall Number Z-1408-2013
Classification Class II
Code Info Lot Numbers: 1662386, 1662390, 1662385, 1662387, 1662391
Product Distributed Qty 1,465
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.

Event Detail

Event Id 65150
Product Type Devices
Status Ongoing
Recalling Firm Merit Medical Systems, Inc.
City South Jordan
State UT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-02
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern USA Nationwide Distribution.