Events

Recall of Device Recall Baxter Solution Set for Epidural Use

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
    58913
  • Event Risk Class
    Class 2
  • Event Number
    Z-2708-2011
  • Event Initiated Date
    2011-05-31
  • Event Date Posted
    2011-06-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100585
  • 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, administration, intravascular - Product Code FPA
  • Reason
    The lot of baxter solution set for epidural use is being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. the reversed orientation of the slide clamp and roller clamp will cause the set to be incorrectly loaded into an infusion pump, resulting in fluid flow from the patient to the pump, rather than from the pump to the patient.
  • Action
    Baxter Healthcare sent Urgent Product Recall letters dated May 31, 2011, via UPS overnight delivery to all affected customers. The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate and remove all affected inventory from their facility and return it to Baxter after calling Baxter Healthcare Center for Service at 1-888-229-0001 to obtain the returned goods authorization The accounts were also requested to complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they can comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST. The Baxter Field Corrective Action Gatekeepers were also notified of this action via e-mail on 5/31/11, and instructed to notify their customers and ministries of health of the recall. *** The recall was expanded to include two additional lots of product code 2C7554s on July 11, 2011 via letter of the same date. The recall strategy remains the same as that of May 31, 2011. ***

Device

Device Recall Baxter Solution Set for Epidural Use
  • Model / Serial
    product code 2C7554s, lot GR293209 *** The recall was expanded to include lots GR291559 and GR294928 ***
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including Alabama, Arizona, California, Illinois, Kentucky, Louisiana, New Mexico, North Carolina, Ohio, Oregon, Tennessee and Washington, and internationally to Canada and South Africa.
  • Product Description
    Baxter Solution Set for Epidural Use, 110" (2.8 m), Male Luer Lock Adapter; a sterile, single use, nonpyrogenic fluid pathway for use with 6200 and 6300 series Flo-Gard Volumetric Infusion Pumps; Baxter Healthcare corporation, Deerfield, IL; product code 2C7554s || The tubing set is intended for use with Flo-Gard Infusion Pumps to provide epidural delivery of anesthetic or analgesic drugs for periods up to 96 hours.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA