Events

Recall of Device Recall Baxter Interlink System Huber Needle 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
    32191
  • Event Risk Class
    Class 3
  • Event Number
    Z-1048-05
  • Event Initiated Date
    2005-05-31
  • Event Date Posted
    2005-07-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39346
  • 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 product code 2n3709 extension sets with y-injections sites were placed in packages labeled as product code 2n3703 extension sets which do not have y-injection sites.
  • Action
    Baxter sent Urgent Product Recall dated 5/31/05 to their customers on the same date, to the attention of the Director of Materials Management. The accounts were informed of the potential mislabeling, and were requested to check their inventory of any product code labeled 2N3703 or 2N3709 with lot number FC04058. If any of the affected lot is found the accounts were instructed to call Baxter Healthcare Center for Service at 1-888-229-0001 to arrrange for product return and replacement. Any questions were referred to the Center for One Baxter at 1-800-422-9837.

Device

Device Recall Baxter Interlink System Huber Needle Extension Set
  • Model / Serial
    Lot FC04058
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Arkansas, Florida, Texas, North Carolina, Wisconsin and Japan.
  • Product Description
    Baxter Interlink System Huber Needle Extension Set; a sterile 10'' fluid pathway with an Interlink Y-Injection Site and 3/4'' x 22 gauge needle; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.; product code 2N3709
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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