Events

Recall of Device Recall VersaSafe Plastic Cannula

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
    77696
  • Event Risk Class
    Class 2
  • Event Number
    Z-3030-2017
  • Event Initiated Date
    2017-06-30
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157542
  • 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
    Set, administration, intravascular - Product Code FPA
  • Reason
    Punctures in blister packaging that was detected during the packaging process.
  • Action
    BD sent an Urgent Medical Device Recall letter dated June 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use and return the affected lot to CareFusion for replacement. For recall related questions contact BD Support Center 1-888-562-6018.

Device

Device Recall VersaSafe Plastic Cannula
  • Model / Serial
    Lot No. 1470303001, 1570314802, 1470303002, 1570317701, 1470304601, 1570317702, 1470306602, 1570317703, 1470306301, 1570317704, 1470306602, 1570322001, 1470311301, 1660771501, 1470306301, 1470311302, 1470314801
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution in the states of : CO, IL, IN, MD, MI, NY, OH, & TX. and foreign countries of: Australia, New Zealand, & Japan.
  • Product Description
    VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 || Product Usage: || Used with secondary IV sets or syringes with a female luer lock adapter to administer fluid and medications through a needle or catheter inserted into a patients artery or vein.
  • Manufacturer
    CareFusion 303, Inc.

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