Events

Recall of Device Recall Winged Blood Collection Holdex Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Greiner VACUETTE North America.

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
    28126
  • Event Risk Class
    Class 2
  • Event Number
    Z-0388-04
  • Event Initiated Date
    2003-12-16
  • Event Date Posted
    2004-01-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31250
  • 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
    Product may have a defective connection.
  • Action
    Distributors and end users were notified by certified mail or fax on 12/16/2003.

Device

Device Recall Winged Blood Collection Holdex Set
  • Model / Serial
    Item #450271, Lot #12-8461
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to medical facilities in IN, NY and TX.
  • Product Description
    Holdex¿ + Butterfly, Blood Collection Set, Single use only. Sterile, Manufactured by : CA Greiner & Sohne Gmbh, Bad Haller Str. 32, A-4550 Kremsmunster, Austria.
  • Manufacturer
    Greiner VACUETTE North America

Manufacturer

Greiner VACUETTE North America
  • Manufacturer Address
    Greiner VACUETTE North America, 4238 Capital Dr, Monroe NC 28110-7681
  • Source
    USFDA