Events

Recall of Device Recall Pressure monitoring kit

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
    32610
  • Event Risk Class
    Class 2
  • Event Number
    Z-1557-05
  • Event Initiated Date
    2005-07-01
  • Event Date Posted
    2005-09-21
  • 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=40430
  • 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
    System, Measurement, Blood-Pressure, Non-Invasive - Product Code DXN
  • Reason
    Actuating tab may detach from the stopcock body, allowing fluid leak.
  • Action
    Consignees were notified by phone and fax on 07/01/2004.

Device

Device Recall Pressure monitoring kit
  • Model / Serial
    Part Number 682000, Lot Numbers: 407104, 407387
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including VA facilities in NY, SD, IL, OH and military facilities in GA, NC and Guam. Foreign distribution to Japan.
  • Product Description
    BD DTX Plus, 60'' complete single-line pressure monitoring 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