Events

Recall of Device Recall VersaSafe Extension Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CareFusion 303, 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
    66758
  • Event Risk Class
    Class 2
  • Event Number
    Z-0435-2014
  • Event Initiated Date
    2013-11-08
  • Event Date Posted
    2013-12-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123294
  • 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
    Intravascular Adminstration Set - Product Code FPA
  • Reason
    Carefusion is recalling the versasafe extension intravascular administration set because it may have excessive adhesive which will prevent the male spin collar to operate as intended.
  • Action
    A customer letter and a distributor letter will be distributed on 11/8/13 to all customers who purchased the VersaSafe Extension Set, Model 21000M-07, Lot Number 13066550. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return to CareFusion the enclosed, pre-addressed and postage paid, Recall Response Card.

Device

Device Recall VersaSafe Extension Set

Manufacturer

CareFusion 303, Inc.
  • Manufacturer Address
    CareFusion 303, Inc., 10020 Pacific Mesa Blvd, San Diego CA 92121-4386
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA