Events

Recall of Device Recall LH Lithium Heparin tubes

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
    60748
  • Event Risk Class
    Class 2
  • Event Number
    Z-1081-2012
  • Event Initiated Date
    2011-12-14
  • Event Date Posted
    2012-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106390
  • 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, vials, systems, serum separators, blood collection - Product Code JKA
  • Reason
    The lithium heparin tubes may have a contamination with edta potassium.
  • Action
    Greiner Bio-One sent a "RECALL OF LITHIUM HEPARIN TUBES WITH EDTA CONTAMINATION" letter dated December 13, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete an attached Product Disposition Site Confirmation Form and to fax the form to 800-726-0052. This form will confirm that customers have discarded/destroyed all affected product. The firm will replace the product after receipt of the form. Contact the firm at 800-515-8112 for questions regarding this recall.

Device

Device Recall LH Lithium Heparin tubes
  • Model / Serial
    Item #456087, Lot #B07115 and B08116, Item #454244, #B091112, Item #456087CA, Lot #B091106, Item #456287, Lot #B101114, Item #454237, Lot #B091108 and Item #456287, Lot #B091110.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC 28110. || Venous blood collection tubes.
  • 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