Events

Recall of Device Recall Pharmacy Compounding System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxa Corporation.

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
    27695
  • Event Risk Class
    Class 2
  • Event Number
    Z-0210-04
  • Event Initiated Date
    2003-11-07
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30369
  • 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
    System/Device, Pharmacy Compounding - Product Code NEP
  • Reason
    If device stops due to an alarm or operater pause, inlet valves will remain open, allowing some unwanted mixing of ingredients in the valve chamber.
  • Action
    All users were contacted by phone and fax on 11/7/03 with instructions to safely use the device.

Device

Device Recall Pharmacy Compounding System
  • Model / Serial
    Catalog Number EM2400, all serial numbers.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Foreign distribution to UK. No government or military consignees.
  • Product Description
    Exacta-Mix 2400 pharmacy compounding system.
  • Manufacturer
    Baxa Corporation

Manufacturer

Baxa Corporation
  • Manufacturer Address
    Baxa Corporation, 14445 Grasslands Dr, Englewood CO 80112-7062
  • Source
    USFDA