Events

Recall of Device Recall Praxair Grab 'n Go Vantage unit, model PRX9495.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Praxair Distribution 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
    34252
  • Event Risk Class
    Class 2
  • Event Number
    Z-0579-06
  • Event Initiated Date
    2005-12-21
  • Event Date Posted
    2006-03-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43341
  • 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
    Regulator, Pressure, Gas Cylinder - Product Code CAN
  • Reason
    The units may experience a delay in oxygen flow upon initial actuation.
  • Action
    The recalling firm sent a recall letter, dated 12/21/05, to all consignees.

Device

Device Recall Praxair Grab 'n Go Vantage unit, model PRX9495.
  • Model / Serial
    All codes (product manufactured from March, 2005 to the present)
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was distributed to 27 institutions and 2 distributors located in OH, MA, IL, CA, UT, PA, MD, and IN and to 2 institutions in Canada: Moncton, NB and Ottawa, ON.
  • Product Description
    Praxair Grab ''n Go Vantage unit, model PRX-9495.
  • Manufacturer
    Praxair Distribution Inc.

Manufacturer

Praxair Distribution Inc.
  • Manufacturer Address
    Praxair Distribution Inc., 7261 Engle Road, Suite 306, Middleburg Heights OH 44130
  • Source
    USFDA