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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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Product Detail

Product Description Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
Recall Number Z-0045-2014
Classification Class II
Code Info Part Number/Lot Number: 7560-43/I663860, 7560-43/I663861, 7560-G3/I664519 and 7560-G3/I666388.
Product Distributed Qty 200
Reason For Recall 4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.

Event Detail

Event Id 66400
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 2013-09-13
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Distribution including the states of CO, VA, and MS.