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U.S. Department of Health and Human Services

Class 2 Device Recall PowerPort Slim Implantable Port

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 Class 2 Device Recall PowerPort Slim Implantable Portsee related information
Date Initiated by FirmFebruary 27, 2014
Date PostedMarch 27, 2014
Recall Status1 Terminated 3 on September 05, 2014
Recall NumberZ-1300-2014
Recall Event ID 67567
Product Classification Intravascular, subcutaneous implanted catheter - Product Code LJT
ProductPowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070
Code Information Lot Numbers: REXA1302, REXA1350, REXB1160
FEI Number 3006260740
Recalling Firm/
Manufacturer		 Bard Access Systems
605 North 5600 West
Salt Lake City UT 84116-3738
For Additional Information ContactCarlos Arriscorreta, Ph.D.
801-522-5706
Manufacturer Reason
for Recall		Labeling discrepancy.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.
FDA Determined
Cause 2		Packaging
ActionNotified by Urgent Customer Notification Letter date February 13, 2014, customers were asked to immediately examine their inventory and identify any product subject to this notification. In addition, if they have further distributed this product, please identify customers and notify them at once of this notification. Customers may include a copy of this letter in your notification to customers. Customers may choose to use the involved product with the understanding that the kit may contain a PowerPort Slim implantable port without suture plugs, or may return the applicable product for replacement or credit.
Quantity in Commerce777
DistributionUS Nationwide distribution including WA, KY, IL, and IA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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