BardPort Titanium Implanted Port. Bard Access Systems. Assembled in Mexico. A totally implantable vascular access device
FDA device recall Z-3173-2011 · posted 2011-09-08 · Terminated
Recall details
- Recalling firm
- Bard Access Systems
- Reason for recall
- Implanted port has discrepant product information on package labeling.
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Quantity affected
- 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
- Date initiated
- 2011-08-30
- Date posted
- 2011-09-08
- Date terminated
- 2012-03-30
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BARDPORT TITANIUM PORTS (K050310) | Bard Access Systems, Inc. | 2005-04-18 |