Z-3173-2011

BardPort Titanium Implanted Port. Bard Access Systems. Assembled in Mexico. A totally implantable vascular...

Name: Z-3173-2011 BardPort Titanium Implanted Port. Bard Access Systems. Assembled in Mexico. A totally implantable vascular...
Creator: Bard Access Systems
Published: 2011-08-30
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2011-08-30 / Terminated / root cause: labeling and UDI

FDA source

Bard Access Systems began a recall of BardPort Titanium Implanted Port. Bard Access Systems. Assembled in Mexico. A totally implantable vascular access device designed to provide long term repeated... on 2011-08-30. The reason FDA records is "Implanted port has discrepant product information on package labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3173-2011
Status: Terminated
Initiated: 2011-08-30
Posted: 2011-09-08
Terminated: 2012-03-30
Recalling firm: Bard Access Systems, Inc.
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
Reason for recall: Implanted port has discrepant product information on package labeling.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Prod Number: 0602290. Lot Numbers: RESF1061, RESI0209, RESI0672, RESI1072, RESK0055, RESK0806, RETA0584, RETC0929, RETF0739, RETH0830.

K050310Class IIBardport Titanium PortsBard Access Systems, Inc. / cleared 2005-04-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)