Events

Recall of Quick Shield with Snappy Safety Holder

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
    59918
  • Event Risk Class
    Class 2
  • Event Number
    Z-0179-2012
  • Event Initiated Date
    2011-08-11
  • Event Date Posted
    2011-11-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103997
  • 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
    Needle, hypodermic, single lumen - Product Code FMI
  • Reason
    Reports of the vacuette quickshield safety holders breaking during use due to a crack at the holder hub.
  • Action
    Greiner Bio-One sent a "QUICKSHIELD WITH SAFETY HOLDER" notification letter dated August 11, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to stop distributing and using the affected products. A Product Disposition Form was attached for customers to complete and return for replacements. Contact the firm at 888-266-3883 for questions concerning this recall.

Device

Quick Shield with Snappy Safety Holder
  • Model / Serial
    Item #450254, Lot numbers: B041104, B051105 and B071106.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-USA (nationwide) including the states of CO, IL, KY, NY, PA and VA.
  • Product Description
    Quick Shield with Snappy Safety Holder, Greiner bio-one. || The VACUETTE QUICKSHIELD with SNAPPY Tube Holder is intended to be used only with the VACUETTE Blood Collection Needles and VACUETTE Blood Collection Tubes as a system in routine venipuncture procedures. These devices are to be used by properly trained healthcare professionals only in accordance with these instructions.
  • 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