Events

Recall of Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles, Product Code: 7103-44. The product was distributed in cases containing 50 bottles per case.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Trek Diagnostic Systems.

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
    31375
  • Event Risk Class
    Class 3
  • Event Number
    Z-0708-05
  • Event Initiated Date
    2005-03-04
  • Event Date Posted
    2005-04-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-12-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37750
  • 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
    System, Blood Culturing - Product Code MDB
  • Reason
    Blood culture bottles with an error in the bar code on the labels, were shipped.
  • Action
    The firm contacted its customers and notified them of the recall via telephone and fax on 3/4/2005 and a recall letter dated 3/4/2005 was sent to each customer via U.S. Mail on 3/7/2005. The letter states that a ''Return Goods Authorization'' for the amount of product shipped to each facility has been issued and asks that the customers return any unused portion of this lot to the firm for replacement.

Device

Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles, Product Code: 7103-44. The product wa...
  • Model / Serial
    Lot #144444SA, Expiration Date: 01/2006.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The blood culture bottles were distributed to the following states within the U.S.: MA, NY, TX, OH, MD, KY, OR, MO, NJ, PA, MI, FL, IN, NC, KS, GA, WI, & IL.
  • Product Description
    Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles, Product Code: 7103-44. The product was distributed in cases containing 50 bottles per case.
  • Manufacturer
    Trek Diagnostic Systems

Manufacturer

Trek Diagnostic Systems
  • Manufacturer Address
    Trek Diagnostic Systems, 982 Keynote Cir Ste 6, Cleveland OH 44131-1873
  • Source
    USFDA