Z-1525-2010

PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable 6F Chronoflex Polyurethane Open-ended...

Name: Z-1525-2010 PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable 6F Chronoflex Polyurethane Open-ended...
Creator: Bard Access Systems
Published: 2010-03-18
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2010-03-18 / Terminated / root cause: packaging

FDA source

Bard Access Systems began a recall of PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable 6F Chronoflex Polyurethane Open-ended Single -Lumen Venous Catheter, BARD Access... on 2010-03-18. The reason FDA records is "8F PowerPort stems were mixed with 6F PowerPorts and packaged". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1525-2010
Status: Terminated
Initiated: 2010-03-18
Posted: 2010-04-29
Terminated: 2010-10-01
Recalling firm: Bard Access Systems, Inc.
Product: PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable 6F Chronoflex Polyurethane Open-ended Single -Lumen Venous Catheter, BARD Access Systems Assembled in Mexico Indicated for patient therapies requiring repeated access to the vascular system for the infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and blood sample withdrawals.
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: 8F PowerPort stems were mixed with 6F PowerPorts and packaged.
Root cause tag: packaging
FDA root cause: Mixed-up of materials/components
Action: The firm, Bard Access Systems, Inc. (BAS) sent a "URGENT: Powerport isp M.R.I with 6F Chronoflex Catheter RECALL" letter dated March 18, 2010, to the customers. The letter describes the product, problem and actions to be taken by customers. The customers were instructed to immediately examine their inventory and quarantine all products subject to this recall and notify any customers they may have distributed the product to; DO NOT USE THIS PRODUCT OR FURTHER DISTRIBUTE ANY OF THE IMPLICATED LOTS; remove and return the affected lots to BAS, and complete and Fax the Reply Form and Inventory Reconciliation Form, if unable to Fax call and report information. Only unused products, in its original packaging, should be returned to BAS. Should you have any questions or require assistance in this matter, please contact BAS Customer Service by calling our toll-free number 1-800-290-1689.
Quantity in commerce: 200 units total (100 units of each lot, see code information)
Distribution: Nationwide distribution: AZ, CA, DC, FL, MA, MD, NC, NE, NV, NY, PA and SC.
Product codes and lots: REF#1806061 2 lots: Lot # RETE0854 and RETG1016

Product code LJT

K072549Class IITitanium Powerport Isp Implanted Port with 6 Fr Chronoflex Polyurethane CatheterC.R. Bard, Inc. / cleared 2007-11-14

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)