Events

Recall of Baxter 2B8011 Empty INTRA VIA Container with PVC Ports

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

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
    69181
  • Event Risk Class
    Class 1
  • Event Number
    Z-0084-2015
  • Event Initiated Date
    2014-09-16
  • Event Date Posted
    2014-10-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129814
  • 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
    Container, i.V. - Product Code KPE
  • Reason
    Particulate matter found inside the fluid path.
  • Action
    Baxter issued a letter to their consignees stating the following: Baxter is requesting that you take the following actions: Action to be taken if product was purchased directly from Baxter. 1. Locate and remove all affected product from all locations in your facility (the product code and lot numbers can be found on the individual product package or shipping carton). 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your Baxter eight-digit ship-to account number ready when calling. 3. Complete the enclosed customer reply form , and return it to Baxter by either tax or scanned e-mail. 4. If you distributed any of the affected products to other facilities, please conduct a recall with your end-user customers in accordance with your customary procedures. Baxter distributed product 2B8011 lot U R 13D 15112 to customers between 4/26/2013 and 6/20/2013. Baxter distributed product 2B8013 lot UR13K1 4095 to customers between 11 /27/2013 and 3/ 10/2014. Action to be taken if product was received from an alternate source. 1. Locate and remove all of the affected products from all locations in your facility (the product code and lot numbers can be found on the individual product package or shipping carton). 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229- 0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your ship-to account number ready when calling. 3. Follow your supplier's reply and recall process. Please do not return the customer reply form to Baxter.

Device

Baxter 2B8011 Empty INTRA VIA Container with PVC Ports
  • Model / Serial
    Product code: 2B8011 Lot Number: UR13D15112
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including Puerto Rico, and the country of Canada.
  • Product Description
    Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. || The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
  • Manufacturer
    Baxter Healthcare Corp

Manufacturer

Baxter Healthcare Corp
  • Manufacturer Address
    Baxter Healthcare Corp, 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA