Events

Recall of Greiner bio-one, VACUETTE¿ TUBE, 9NC Coagulation Citrate 3.2%, 3.5ml blue cap-black ring, 24 racks of 50, 1200 pcs in total, non ridged, sandwich tube, Ref: 454332, Lot B040404, Expiry 2005-04, Sterile.

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
    29652
  • Event Risk Class
    Class 2
  • Event Number
    Z-1331-04
  • Event Initiated Date
    2004-07-27
  • Event Date Posted
    2004-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34289
  • 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
    Tubes, Vacuum Sample, With Anticoagulant - Product Code GIM
  • Reason
    Coagulation tubes may not have received the proper fill of citrate solution.
  • Action
    Consignees were notified by letter on 7/28/2004.

Device

Greiner bio-one, VACUETTE¿ TUBE, 9NC Coagulation Citrate 3.2%, 3.5ml blue cap-black ring, 24 rack...
  • Model / Serial
    Item no. 454332, Lot number B040404
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Greiner bio-one, VACUETTE¿ TUBE, 9NC Coagulation Citrate 3.2%, 3.5ml blue cap-black ring, 24 racks of 50, 1200 pcs in total, non ridged, sandwich tube, Ref: 454332, Lot B040404, Expiry 2005-04, Sterile.
  • 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