Events

Recall of Device Recall Peripherally inserted central catheter.

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
    31670
  • Event Risk Class
    Class 2
  • Event Number
    Z-0285-06
  • Event Initiated Date
    2005-03-25
  • Event Date Posted
    2005-12-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38327
  • 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
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
  • Reason
    Aspiration (blood return) could not be achieved on some l-cath 16 gauge catheters.
  • Action
    Consignees were notified via telephone and fax letter, beginning 04/25/2005.

Device

Device Recall Peripherally inserted central catheter.
  • Model / Serial
    REF 384426
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    AL, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, NJ, OH, OK, PA, TN, TX, WA. No Government or military consignees. Foreign distribution to Australia, Canada, Japan.
  • Product Description
    16 G / 5F Dual Lumen L-Cath Basic Kit with Introsyte
  • 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