Events

Recall of Device Recall Continuous flush device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson Medical 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
    33316
  • Event Risk Class
    Class 2
  • Event Number
    Z-0075-06
  • Event Initiated Date
    2005-07-01
  • Event Date Posted
    2005-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41699
  • 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, Continuous Flush - Product Code KRA
  • Reason
    Device could permit an over-infusion of iv solutions during pressure monitoring procedures.
  • Action
    Consignees were notified by letter on 8/22/2005 and told to immediately locate and quarantine all affected product for return to BD. Customer Recall Response Card was to completed and returned. For questions concerning the recall, call 800-453-4538 between 8AM and 5PM MST.

Device

Device Recall Continuous flush device
  • Model / Serial
    Part Number 687566. Lot Number 302520
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including PR. VA facilities in OH, WA, NV and NY. No military or foreign distribution by US firm..
  • Product Description
    CRITIFLO(tm) FLUSH KIT
  • Manufacturer
    Becton Dickinson Medical Systems

Manufacturer

Becton Dickinson Medical Systems
  • Manufacturer Address
    Becton Dickinson Medical Systems, 9450 S State St, Sandy UT 84070-3213
  • Source
    USFDA