Events

Recall of Device Recall BD Angiocath Autoguard shielded IV catheter

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

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
    73691
  • Event Risk Class
    Class 2
  • Event Number
    Z-1690-2016
  • Event Initiated Date
    2016-03-18
  • Event Date Posted
    2016-05-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144761
  • 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,short-term less than 30 days - Product Code FOZ
  • Reason
    The device may have a defect in the catheter. in some instances this defect could result in catheter separation or breakage.
  • Action
    BD isssued an urgent voluntary product recall lettter/recall response card on 3/18/2016.

Device

Device Recall BD Angiocath Autoguard shielded IV catheter
  • Model / Serial
    Catalog Number 381720 - 24 G x 0.75 in. BD Angiocath" Autoguard" shielded IV catheter (0.7 mm x 19 mm) made of FEP polymer.   3121951 3143801 3190895 3254585 3303872 4051735 4133600 4177944 4219570 4289603 4317642 5063833 5106687 5125665 5230884 5300771     24 G x 0.56 in. BD Angiocath-N" Autoguard" shielded IV catheter (0.7 mm x 14 mm) made of FEP polymer  3045792 3106688 3289840 4059581 4203557 5002915 5063827 5125565 5300772
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    1) 24 G x 0.75 in. BD Angiocath" Autoguard" shielded IV || catheter (0.7 mm x 19 mm) made of FEP polymer || catalog number 381700 || 2) 24 G x 0.56 in. BD Angiocath-N" Autoguard" shielded || IV catheter (0.7 mm x 14 mm) made of FEP polymer || catalog number 381720
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • Manufacturer Address
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA