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Terminated

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

FDA Recall Z-3173-2011 · Posted 2011-09-08

Recalling FirmBard Access Systems
Recall StatusTerminated
Date Initiated2011-08-30
Date Terminated2012-03-30
Product Quantity1375 units

Reason for Recall

Implanted port has discrepant product information on package labeling.

Firm 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.

Root Cause

Labeling Change Control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050310BARDPORT TITANIUM PORTSBard Access Systems, Inc. · 2005-04-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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