Events

Recall of DURACUF

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical Systems Information Technologies.

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
    26245
  • Event Risk Class
    Class 3
  • Event Number
    Z-1236-03
  • Event Initiated Date
    2000-10-24
  • Event Date Posted
    2003-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27368
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Incorrrect male connector attached to tubing preventing the correct connection of blood pressure cuff.
  • Action
    A Recall notification letter was mailed to all direct accounts on 10/24/2000 followed by a telephone call to each direct account. Distributors were not requested to subrecall because Critikon already knew the hospital accounts that had recieved product and they were notified via the 10/24/00 letter and phone call. Accounts were told to return product to Critikon for replacement.

Device

DURACUF
  • Model / Serial
    lot number 2290
  • Product Classification
    Cardiovascular Devices
  • Distribution
    Product was distributed to the firm''s related warehouse in Texas and then on to 20 distributors and 8 hospitals in the United States and also one international distributor in Japan.
  • Product Description
    Critikon brand Adult, DURA-CUF, product code 2790, used as an arm cuff in association with a blood pressure monitor.
  • Manufacturer
    GE Medical Systems Information Technologies

Manufacturer

GE Medical Systems Information Technologies
  • Manufacturer Address
    GE Medical Systems Information Technologies, 4502 Woodland Corporate Blvd., Tampa FL 33614
  • Source
    USFDA