Bard Access Systems
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
| Date | Sep 8, 2011 (initiated Aug 30, 2011) |
| Status | Terminated |
| Reason | Implanted port has discrepant product information on package labeling. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050310 | BARDPORT TITANIUM PORTS Bard Access Systems, Inc., Apr 18, 2005 |