Events

Recall of Device Recall TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bard Access Systems.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55175
  • Event Risk Class
    Class 2
  • Event Number
    Z-1525-2010
  • Event Initiated Date
    2010-03-18
  • Event Date Posted
    2010-04-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90222
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
  • Reason
    8f powerport stems were mixed with 6f powerports and packaged.
  • 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.

Device

Device Recall TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER
  • Model / Serial
    REF#1806061 2 lots: Lot # RETE0854 and RETG1016
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution: AZ, CA, DC, FL, MA, MD, NC, NE, NV, NY, PA and SC.
  • Product Description
    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.
  • Manufacturer
    Bard Access Systems

Manufacturer

Bard Access Systems
  • Manufacturer Address
    Bard Access Systems, 605 North 5600 West, Salt Lake City UT 84116-3738
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA