Events

Recall of Device Recall PowerPort Slim Implantable Port

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
    67567
  • Event Risk Class
    Class 2
  • Event Number
    Z-1300-2014
  • Event Initiated Date
    2014-02-27
  • Event Date Posted
    2014-03-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125727
  • 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
    Intravascular, subcutaneous implanted catheter - Product Code LJT
  • Reason
    Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, however approximately 23% of the units contained in the affected lots have a powerport slim titanium implantable port without silicone suture plugs.
  • Action
    Notified by Urgent Customer Notification Letter date February 13, 2014, customers were asked to immediately examine their inventory and identify any product subject to this notification. In addition, if they have further distributed this product, please identify customers and notify them at once of this notification. Customers may include a copy of this letter in your notification to customers. Customers may choose to use the involved product with the understanding that the kit may contain a PowerPort¿ Slim implantable port without suture plugs, or may return the applicable product for replacement or credit.

Device

Device Recall PowerPort Slim Implantable Port
  • Model / Serial
    Lot Numbers: REXA1302, REXA1350, REXB1160
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide distribution including WA, KY, IL, and IA.
  • Product Description
    PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070
  • 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