Events

Recall of Device Recall Bard Access Marketing Brochures

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
    71757
  • Event Risk Class
    Class 2
  • Event Number
    Z-2808-2015
  • Event Initiated Date
    2015-07-20
  • Event Date Posted
    2015-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138973
  • 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
    Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
  • Reason
    Bard access systems is recalling marketing brochures for the powerpicc¿ and powerpicc¿ solo¿ catheters due to incorrect indication for use contained in the brochure.
  • Action
    Customer letter notification with reply form will be sent via Federal Express with delivery confirmation for US consignees on 7/20/15 informing them of the incorrect indication for use contained in the brochure.

Device

Device Recall Bard Access Marketing Brochures
  • Model / Serial
    The brochures were purchased from the vendor on 04/14/2015, Code S120667R0
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed to domestic and foreign conference attendees.
  • Product Description
    Marketing brochures for the PowerPICC and PowerPICC SOLO catheters
  • Manufacturer
    Bard Access Systems

Manufacturer

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