Events

Recall of TPN compounder disposable valve set

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
    29037
  • Event Risk Class
    Class 2
  • Event Number
    Z-0984-04
  • Event Initiated Date
    2004-04-30
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33019
  • 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
    Set, I.V. Fluid Transfer - Product Code LHI
  • Reason
    A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.
  • Action
    Consignees were notified by phone, fax and letter beginning 4/30/2004.

Device

TPN compounder disposable valve set
  • Model / Serial
    Order No. REF: 713
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including 6 military hospitals and two VA facilities. Foreign distribution to Argentina, Brazil, Canada, Columbia, Hong Kong, Korea, Malaysia, Mexico, Panama, Singapore, Taiwan, UK, and Venezuela.
  • Product Description
    Exacta-Mix Valve Set, Primary Valve Assembly
  • Manufacturer
    Baxa Corporation

Manufacturer

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