BardPort M.R.I. Implanted Port with Attachable 6 Fr. ChronoFlex Open-Ended Single-Lumen Venous Catheter and Peel-Apart I
FDA device recall Z-1133-2012 · posted 2012-03-01 · Terminated
Recall details
- Recalling firm
- Bard Access Systems
- Reason for recall
- 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.
- Action taken
- 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).
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- LJT
- Quantity affected
- 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.
- Date initiated
- 2012-02-16
- Date posted
- 2012-03-01
- 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 |
|---|---|---|
| HICKMAN PLASTIC SUBCUTANEOUS PORT (K873213) | C.R. Bard, Inc. | 1987-10-27 |