Events

Recall of Device Recall Baxter Interlink System NonDEHP I.V. Catheter Extension Set

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
    59263
  • Event Risk Class
    Class 2
  • Event Number
    Z-2837-2011
  • Event Initiated Date
    2011-07-06
  • Event Date Posted
    2011-07-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102086
  • 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
    Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.
  • Action
    The firm, Baxter, sent an "Urgent Product Recall" letter dated July 6, 2011 via first class mail to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to locate and remove all affected product from their facility; call Baxter Healthcare's Center for Service at 1-888-229-0001 between 7:00 am and 6:00 pm Central Time, Monday through Friday to return affected product and receive credit; complete and return the attached CUSTOMER REPLY FORM to Baxter via fax at 1-847-270-5457 or scan and email to fca@baxter.com and if you are a dealer, wholesaler or distributor/reseller, notify your customers of this recall. If you have questions regarding the communication, call The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.

Device

Device Recall Baxter Interlink System NonDEHP I.V. Catheter Extension Set
  • Model / Serial
    product code 2N3375, lot number UR09H05029, expiration date 8/25/2014.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including: AL, LA, MO, SD, TX and WV; and country of: Canada.
  • Product Description
    Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, 6.6(17 cm), Volume 0.8 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, single use nonpyrogenic fluid pathway; 200 sets per case; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 2N3375 || Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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