Events

Recall of Device Recall VACUETTE Safety Blood Collection Set Luer Adapter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Greiner Bio-One North America, 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
    64321
  • Event Risk Class
    Class 2
  • Event Number
    Z-0835-2013
  • Event Initiated Date
    2013-02-01
  • Event Date Posted
    2013-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115829
  • 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
    Needle, hypodermic, single lumen - Product Code FMI
  • Reason
    The vacuette safety blood collection set + luer adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.
  • Action
    Greiner Bio-One sent a notification letter dated January 31, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to stop distributing the affected product, complete the attached Product Disposition form and fax to GBO at 800-726-0052 or email to patech@gbo.com. GBO will contact customers for the return of the affected product after receiving the attached Product Disposition form. Customers were requested to provide the names of customers who may have received the product. For questions call 800-515-8112.

Device

Device Recall VACUETTE Safety Blood Collection Set Luer Adapter
  • Model / Serial
    Lot No. 12H27
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of FL, IL, KY, NY, NC, PA, OH, TX, VA
  • Product Description
    VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.
  • Manufacturer
    Greiner Bio-One North America, Inc.

Manufacturer

Greiner Bio-One North America, Inc.
  • Manufacturer Address
    Greiner Bio-One North America, Inc., 4238 Capital Dr, Monroe NC 28110
  • Manufacturer Parent Company (2017)
    Greiner Holding Ag
  • Source
    USFDA