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U.S. Department of Health and Human Services

Class 3 Device Recall BardPort Titanium Implanted Port.

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  Class 3 Device Recall BardPort Titanium Implanted Port. see related information
Date Initiated by Firm August 30, 2011
Date Posted September 08, 2011
Recall Status1 Terminated 3 on March 30, 2012
Recall Number Z-3173-2011
Recall Event ID 59830
510(K)Number K050310  
Product BardPort Titanium Implanted Port.
Bard Access Systems.
Assembled in Mexico.

A totally implantable vascular access device designed to provide long term repeated access to the vascular system
Code Information Prod Number: 0602290. Lot Numbers: RESF1061, RESI0209, RESI0672, RESI1072, RESK0055, RESK0806, RETA0584, RETC0929, RETF0739, RETH0830.
Recalling Firm/
Manufacturer		 Bard Access Systems
605 North 5600 West
Salt Lake City UT 84116-3738
For Additional Information Contact
801-522-5614
Manufacturer Reason
for Recall		 Implanted port has discrepant product information on package labeling.
FDA Determined
Cause 2		 Labeling Change Control
Action Bard Access System, Inc. sent a "Label Discrepancy Notification dated August 30, 2011 to all affected customers. The letter included affected product and informed them of the labeling discrepancy. Customers could either use the device or return it to Bard for replacement. For information on this recall call (801) 595-5568.
Quantity in Commerce 1375 units
Distribution Worldwide Distribution: Nationwide Distribution including the states of; AL, AR, AZ, CA, CT, DC, FL, GA, HI, IL, KY, LA, MA, MD, MI, MO, NJ, NV, NY, OK, PA, RI, SC, TN, TX, UT, VA, WI, and WV; and the countries of Canada and Belgium.
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 = and Original Applicant = BARD ACCESS SYSTEMS, INC.
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