Events

Recall of Device Recall Baxter Interlink System ContinuFlo Solution Set 3Port Manifold 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
    60608
  • Event Risk Class
    Class 2
  • Event Number
    Z-0478-2012
  • Event Initiated Date
    2011-12-06
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105970
  • 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
    Stopcock, i.V. Set - Product Code FMG
  • Reason
    During production of the iv sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection.
  • Action
    The firm, Baxter, sent an "Urgent Product Recall" letter dated December 6, 2011, via first class mail to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to inspect all locations where their facility's inventory is located for products with the affected lot numbers; return the affected product; request a credit or replacement by calling Baxter Healthcare Center for Service at 1-888-229-0001 between 7:00am to 6:00pm Central time, Monday through Friday; complete and return the attached Customer Reply Form via fax to: 1-847-270-5457, or scan and email to fca@baxter.com; and if they are a dealer, wholesaler, or distributor/reseller that distributed any affected product to other facilities, please notify their customers of this recall. If you have any questions regarding the communication, please 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 ContinuFlo Solution Set 3Port Manifold Extension Set
  • Model / Serial
    product code 2C6951, lot number GR296053
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: Alaska, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Washington, Wisconsin and West Virginia; and country of: New Zealand.
  • Product Description
    Baxter Interlink System Continu-Flo Solution Set, length 89" (2.3 m), 2 Injection Sites, Male Luer Lock Adapter, 3-Port Manifold with Check Valves, Vol. 1.0 mL, Extension Set, Vol. 5.6 mL, Length 39" (99 cm), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 2C6951 || Intended use: for the administration of sterile I.V. fluids to the patient
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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