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U.S. Department of Health and Human Services

Enforcement Report - Week of April 2, 2014

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Product Detail

Product Description PowerPort® Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070
Recall Number Z-1300-2014
Classification Class II
Code Info Lot Numbers: REXA1302, REXA1350, REXB1160
Product Distributed Qty 777
Reason For Recall Bard Access Systems, Inc. has notified customers of a labeling discrepancy involving PowerPort® Slim Implantable Port 1716000, 1716070 in which the label states that the implantable port contains silicone suture plugs, however approximately 23% of the units contained in the affected lots have a PowerPort® Slim titanium implantable port without silicone suture plugs.

Event Detail

Event Id 67567
Product Type Devices
Status Ongoing
Recalling Firm Bard Access Systems
City Salt Lake City
State UT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-27
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Nationwide Distribution in the states of: VA, WA, KY, IL, and IA.