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U.S. Department of Health and Human Services

Class 3 Device Recall BardPort M.R.I. Implanted Port

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  Class 3 Device Recall BardPort M.R.I. Implanted Port see related information
Date Initiated by Firm February 16, 2012
Date Posted March 01, 2012
Recall Status1 Terminated 3 on March 30, 2012
Recall Number Z-1133-2012
Recall Event ID 61185
510(K)Number K873213  
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Product BardPort M.R.I. Implanted Port with Attachable 6 Fr. ChronoFlex Open-Ended Single-Lumen Venous Catheter and Peel-Apart Introducer Kit. Subcutaneous implanted intravascular infusion port and catheter is used to provide repeated access to the vascular system for the delivery of medications, intravenous fluids, parenteral nutrition solutions, and blood products. They are also indicated for the withdrawal of blood samples.
Code Information Product Number: 0607173  Lot Numbers: RESF0856, RESH0067, RESH1150.
Recalling Firm/
Manufacturer		 Bard Access Systems
605 North 5600 West
Salt Lake City UT 84116-3738
For Additional Information Contact
801-595-0700
Manufacturer Reason
for Recall		 The end flap label on the kit incorrectly describes the product as "Bard Port" MRI DUAL Implanted Port instead of a "Bard Port MRI Implanted Port" as correctly indicated on the main label of the kit.
FDA Determined
Cause 2		 Labeling Change Control
Action A "Labeling Discrepancy Notification" letter was sent to US consignees via FED EX on February 16, 2012 and on February 20, 2012 for the foreign consignee explaining the labeling discrepancy and providing a visual example of the incorrect label. The customers were given the option of continuing to use the product with the understanding the end flap label was incorrect or they could return the affected products for replacement (Call 1-800-290-1689 to arrange a replacement).
Quantity in Commerce 545 units (Lot RESF0856 - 150 units; Lot RESH0067 - 295 units; Lot RESH1150 - 100 units)
Distribution Worldwide Distribution -- USA, including the states of CA, CT, FL, KS, IL, MI, MN, OH, OK, SD, TN, TX, VA, WA and the country of Belgium.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = LJT and Original Applicant = C.R. BARD, INC.
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