Events

Recall of VacuFlow Safe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Global Healthcare 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
    74952
  • Event Risk Class
    Class 2
  • Event Number
    Z-2870-2016
  • Event Initiated Date
    2016-08-09
  • Event Date Posted
    2016-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148888
  • 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
    The multi-sample needle retractable sheath may not fully retract over the needle during the changes of the blood collection tubes.
  • Action
    The distributors were first notified on August 9, 2016 via phone to place product on hold. They were notified of the recall on August 10, 20l6 by email.

Device

VacuFlow Safe
  • Model / Serial
    Model Number: MED 5223, Lot Number: 201505 l0
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    FL
  • Product Description
    MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientific, Sarasota, FGL 34243  Made in China.
  • Manufacturer
    Global Healthcare Inc

Manufacturer

Global Healthcare Inc
  • Manufacturer Address
    Global Healthcare Inc, 11350 Old Roswell Rd, Suite 700, Alpharetta GA 30009-2291
  • Source
    USFDA