Events

Recall of Easy Mate Portable Liquid Oxygen PM2200 Series

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Precision Medical, 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
    36547
  • Event Risk Class
    Class 2
  • Event Number
    Z-0153-2007
  • Event Initiated Date
    2006-10-04
  • Event Date Posted
    2006-11-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48887
  • 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
    Liquid Oxygen Container - Product Code BYJ
  • Reason
    Component assembly; the fill chuck is not assembled properly which may allow the device to come apart over time releasing its contents.
  • Action
    The recalling firm telephoned the company to inform them of the problem and to make them aware that replacements would be made available starting on 10/16/06.

Device

Easy Mate Portable Liquid Oxygen PM2200 Series
  • Model / Serial
    PM2200 Series. Model number 2201. Serial numbers P002892 through P005116
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to home care providers nationwide
  • Product Description
    Precision Medical- Easy Mate Portable Liquid Oxygen System (container), PM22010 Series, Model number 2201, Precision Medical, Inc., Northampton, PA 18067
  • Manufacturer
    Precision Medical, Inc.

Manufacturer

Precision Medical, Inc.
  • Manufacturer Address
    Precision Medical, Inc., 300 Held Dr, Northampton PA 18067-1150
  • Source
    USFDA