Events

Recall of Device Recall Container, IV

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
    58304
  • Event Risk Class
    Class 2
  • Event Number
    Z-1964-2011
  • Event Initiated Date
    2011-03-08
  • Event Date Posted
    2011-04-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99077
  • 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
    Tpn bags may leak during filling operation, due to bag manufacturing error.
  • Action
    The firm, BAXA, sent a "ExactaMix Bag Product Notice" dated March 8, 2011 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: If they do not intend to use the manual addition port, verify that the cap is firmly seated onto the port by gently tugging on the cap. If they do intend to use the manual addition port, they should snap off the additive port cap prior to compounding the bag. If they encounter a faulty additive port, contact Baxa Technical Support to receive credit and/or replacement on defective product only. To return affected bags, follow the instructions provided in the notice if the bags were purchased directly from Baxa or purchased from wholesaler, distributor or other 3rd party vendor. Additional copies of the return form can be retrieved by going to www.baxa.com/ebug OR by calling Baxa Technical Support at 800-678-2292. If you have any questions or concerns, contact the Sr. Vice President, Quality and Regulatory at (303) 400-2838 or Baxa Technical Support at 800-678-2292.

Device

Device Recall Container, IV
  • Model / Serial
    All codes sold since 7/23/2009.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Argentina, Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, Hong Kong, Ireland, Japan, Malaysia, Mexico, New Zealand, Panama, Puerto Rico, Singapore, South Korea, Taiwan, UK, Uruguay, Venezuela.
  • Product Description
    ExactaMix EVA Container, 3000mL, REF: 741, Sterile R, Baxa Corporation, Englewood, CO 80112. || A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set
  • Manufacturer
    Baxa Corporation

Manufacturer

Baxa Corporation
  • Manufacturer Address
    Baxa Corporation, 14445 Grasslands Dr, Englewood CO 80112
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA