Events

Recall of Device Recall Sterile needle guide kit

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

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
    30396
  • Event Risk Class
    Class 2
  • Event Number
    Z-0715-05
  • Event Initiated Date
    2004-11-03
  • Event Date Posted
    2005-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-04-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35803
  • 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
    Transducer, Ultrasonic, Diagnostic - Product Code ITX
  • Reason
    Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile.
  • Action
    All domestic consignees were notified by letter on 10/04/2004. All foreign consignees were notified by letter on 10/15/04.

Device

Device Recall Sterile needle guide kit
  • Model / Serial
    Product Code 9001C0214. Lot numbers: 61187, 61233, 61258, 61302, 61332, 63189, 63220, 63245, 63270, 63339, 63360, 63398, 63401, 63402, 63422, 63451, 63515, 63521, 63538, 63564, 63612, 63615, 63666, 63729, 63766, 63783, 63830, 63862, 63925, 63957, 63973, 64042, 64094, 64108, 64148, 64182, 64218, 64229, 64258, 64261, 64268, 64378, 64419, 64420, 64440, 64460, 64493.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Foreign distribution to: Austria; Bahrain, Belgium, Bermuda, Brazil, Canada, Greece, Hong Kong, Italy, Japan, Kuwait, Malaysia, Mexico, Norway, Oman, Pakistan, Portugal, Qatar, Saudi Arabia, Switzerland, Turkey, United Arab Emirates, United Kingdom.
  • Product Description
    Site-Rite Sterile Needle Guide Kit - 20 gauge
  • Manufacturer
    Bard Access Systems, Inc

Manufacturer

Bard Access Systems, Inc
  • Manufacturer Address
    Bard Access Systems, Inc, 5425 Amelia Earhart Dr, Salt Lake City UT 84116-3713
  • Source
    USFDA