Recall Z-1133-2012 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Bard Access Systems
BardPort M.R.I. Implanted Port with Attachable 6 Fr. ChronoFlex Open-Ended Single-Lumen Venous Catheter and Peel-Apart Introducer Kit. Subcutaneous implanted intravascular infusion port and catheter is used to provide repeated access to the vascular system for the delivery of medications, intravenous fluids, parenteral nutrition solutions, and blood products. They are also indicated for the withdr
| Date | Mar 1, 2012 (initiated Feb 16, 2012) |
| Status | Terminated |
| Reason | The end flap label on the kit incorrectly describes the product as "Bard Port" MRI DUAL Implanted Port instead of a "Bard Port MRI Implanted Port" as correctly indicated on the main label of the kit. |
| Root cause | Labeling Change Control |
| Action | A "Labeling Discrepancy Notification" letter was sent to US consignees via FED EX on February 16, 2012 and on February 20, 2012 for the foreign consignee explaining the labeling discrepancy and providing a visual example of the incorrect label. The customers were given the option of continuing to use the product with the understanding the end flap label was incorrect or they could return the affected products for replacement (Call 1-800-290-1689 to arrange a replacement). |
| Quantity | 545 units (Lot RESF0856 - 150 units; Lot RESH0067 - 295 units; Lot RESH1150 - 100 units) |
| Distribution | Worldwide Distribution -- USA, including the states of CA, CT, FL, KS, IL, MI, MN, OH, OK, SD, TN, TX, VA, WA and the country of Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K873213 | HICKMAN PLASTIC SUBCUTANEOUS PORT C.R. Bard, Inc., Oct 27, 1987 |