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
This recall has been terminated (originally issued September 8, 2011).
- Company
- Bard Access Systems
- Recall Initiated
- August 30, 2011
- Posted
- September 8, 2011
- Terminated
- March 30, 2012
- Recall Number
- Z-3173-2011
- Quantity
- 1375 units
- Firm Location
- West Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Implanted port has discrepant product information on package labeling.
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.
Lot / Code Info
Prod Number: 0602290. Lot Numbers: RESF1061, RESI0209, RESI0672, RESI1072, RESK0055, RESK0806, RETA0584, RETC0929, RETF0739, RETH0830.
Root Cause
Labeling Change Control
Action Taken
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.