Events

Recall of Device Recall GuardIVa Antimicrobial Hemostatic IV Dressing

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
    69683
  • Event Risk Class
    Class 2
  • Event Number
    Z-0493-2015
  • Event Initiated Date
    2014-11-03
  • Event Date Posted
    2014-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131344
  • 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
    Dressing, wound, drug - Product Code FRO
  • Reason
    Bard access systems is recalling guardiva (ref. no. fp23ad006) from lot asxht003 because they were non-sterile unit samples which potentially could be used clinically.
  • Action
    A customer letter was sent on 11/3/14 requesting immediate examination of inventory and to quarantine the products for return.

Device

Device Recall GuardIVa Antimicrobial Hemostatic IV Dressing
  • Model / Serial
    Product Code FP23AD006, Lot No.ASXHT003, Expiration Date Feb 2016
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    US Distribution to state of: TX, OK, LA, and AR.
  • Product Description
    GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.
  • 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