Events

Recall of BARD Access Systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by C.R. 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
    38621
  • Event Risk Class
    Class 2
  • Event Number
    Z-1229-2007
  • Event Initiated Date
    2007-08-10
  • Event Date Posted
    2007-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=54054
  • 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
    Stainless steel guidewire - Product Code MPB
  • Reason
    Metal guidewires used in hemodialysis catheters may have been reverse loaded within the dispenser. potential exists for the stiff end of the guidewire to be inserted into the patient instead of the flexible end.
  • Action
    Consignees were notified by letter on 08/10/2007 and asked to remove and return all unused affected product to Bard.

Device

BARD Access Systems
  • Model / Serial
    Product Code 5583705, Lot Numbers: 22FMA202, 22IMO531, 22KMO573, 22DN2914, 22FN5232, 22GN5835, 22GN5878, 22HN6574, 22BO6078, 22BO6163, 22FO6086, 22GO6026, 22HO6101, 22IO6111, 22KO6124, 22CP6268, 22EP6831, REPG0035, REPG0643, REPH0954, REPK0058, REPK0729, REPL0298, REQB0030, REQB0224, REQD0200, REQF0429, REQF0736, REQJ0282, REQK0875, RERC0052, RERD0719.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, Latin America, and Europe (Austria, Belgium, Finland, France, Germany, Great Britain, Holland, Italy, Norway, Spain, and Sweden).
  • Product Description
    Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems, Hemodialysis Catheter, Salt Lake City, UT 84116.
  • Manufacturer
    C.R. Bard Access Systems, Inc

Manufacturer

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