Events

Recall of Device Recall Introducer catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson Infusion Therapy.

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
    30864
  • Event Risk Class
    Class 2
  • Event Number
    Z-0628-05
  • Event Initiated Date
    2005-01-10
  • Event Date Posted
    2005-03-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-04-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36728
  • 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
    Introducer, Catheter - Product Code DYB
  • Reason
    Various procedure trays and kits may have an insufficient seal, thus compromising sterility.
  • Action
    Customers were contacted by telephone and by letters dated 01/10/05.

Device

Device Recall Introducer catheter
  • Model / Serial
    Ref. No. 680124, Lot No''s. 406462 and 311197
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic distribution: WI. International distribution: Puerto Rico, Virgin Islands. There were no military or VA facilities.
  • Product Description
    BD Exacta 8.5 Fr Percutaneous Sheath Introducer Tray
  • Manufacturer
    Becton Dickinson Infusion Therapy

Manufacturer

Becton Dickinson Infusion Therapy
  • Manufacturer Address
    Becton Dickinson Infusion Therapy, 9450 S State St, Sandy UT 84070
  • Source
    USFDA