Events

Recall of BD QSyte Extension Set, Luer access extension

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
    53749
  • Event Risk Class
    Class 1
  • Event Number
    Z-0752-2010
  • Event Initiated Date
    2009-10-19
  • Event Date Posted
    2010-02-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86457
  • 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 administration set. - Product Code FPA
  • Reason
    Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
  • Action
    Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType;_ID=1&BusinessCode;=20001&d;=BD+Worldwide&s;=&dTitle;=&dc;=&dcTitle;=

Device

BD QSyte Extension Set, Luer access extension

Manufacturer

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