Events

Recall of PC Holdex

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
    49367
  • Event Risk Class
    Class 2
  • Event Number
    Z-2198-2008
  • Event Initiated Date
    2008-08-05
  • Event Date Posted
    2008-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73213
  • 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 - Product Code FMI
  • Reason
    At removal of the tube from the holder the needle may dislodge and become stuck in the tube stopper with the blunt end of the needle facing out.
  • Action
    Consignees were notified by letter on 08/06/2008. Letters to Distributors instructed them to stop distribution of the affected product immediately and to hold any product of the lots they may have pending returned to Greiner bio-one. The were instructed to provide Greiner bio-one with a list of their customers who may have received the affected lot so that they can contact them. A Product Disposition form was included to be completed and returned to Greiner bio-one. Contact Greiner Bio-One North America, Inc. at 1-888-286-3883 for assistance.

Device

PC Holdex
  • Model / Serial
    Lot#: A030804
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, FL, IN, KS, KY, MO, MN, NC, OH, PA, TN, TX, UT, VA, WI and WV.
  • Product Description
    Plastic Cannula Holdex¿ Tube Holder, Item number: 450216. It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.
  • 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 28110-7681
  • Manufacturer Parent Company (2017)
    Greiner Holding Ag
  • Source
    USFDA