Events

Recall of Device Recall PowerPICC SOLO 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
    71420
  • Event Risk Class
    Class 3
  • Event Number
    Z-2047-2015
  • Event Initiated Date
    2015-05-27
  • Event Date Posted
    2015-07-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137716
  • 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 powerpicc solo catheter kits due to incorrect expiration dates on the primary labeling.
  • Action
    BARD sent an Urgent Notification letter dated May 27, 2015, to all affected consignees via FedEx. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed that they may choose to return the affected product to Bard Access Systems or use with the understanding that the correct expiration date is November 2015 (2015-11). Customers with questions were instructed to call 1-800-290-1689. For questions regarding this recall call 801-522-5974.

Device

Device Recall PowerPICC SOLO Catheter
  • Model / Serial
    Lot No: REYK1763, Item No. 1194108D
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer || The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
  • 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