Events

Recall of Device Recall Vacuette, Safety Blood Collection Set with Luer Adapter

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
    25738
  • Event Risk Class
    Class 2
  • Event Number
    Z-0797-03
  • Event Initiated Date
    2003-03-10
  • Event Date Posted
    2003-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26414
  • 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 needle portion of the safety blood collection sets, may become separated from the body of the luer adapter.
  • Action
    Consignees were notified via certified letter on/about 3/6/2003 and were advised to stop distributing the product immediately and to discard any remaining product in stock.

Device

Device Recall Vacuette, Safety Blood Collection Set with Luer Adapter

Manufacturer

Greiner VACUETTE North America
  • Manufacturer Address
    Greiner VACUETTE North America, 4238 Capital Drive, Monroe NC 28112
  • Source
    USFDA