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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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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
Distribution Pattern US Distribution including the states of CO, VA, and MS.

Product Detail

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