Z-1133-2012

BardPort M.R.I. Implanted Port with Attachable 6 Fr. ChronoFlex Open-Ended Single-Lumen Venous Catheter and...

Name: Z-1133-2012 BardPort M.R.I. Implanted Port with Attachable 6 Fr. ChronoFlex Open-Ended Single-Lumen Venous Catheter and...
Creator: Bard Access Systems
Published: 2012-02-16
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2012-02-16 / Terminated / root cause: labeling and UDI

FDA source

Bard Access Systems began a recall of BardPort M.R.I. Implanted Port with Attachable 6 Fr. ChronoFlex Open-Ended Single-Lumen Venous Catheter and Peel-Apart Introducer Kit. Subcutaneous implanted... on 2012-02-16. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1133-2012
Status: Terminated
Initiated: 2012-02-16
Posted: 2012-03-01
Terminated: 2012-03-30
Recalling firm: Bard Access Systems, Inc.
Product: 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 withdrawal of blood samples.
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Product Number: 0607173 Lot Numbers: RESF0856, RESH0067, RESH1150.

Product code LJT

K873213Class IIHickman Plastic Subcutaneous PortC.R. Bard, Inc. / cleared 1987-10-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)