Events

Recall of Baxter Clearlink System Luer Activated Universal VIal Adapter

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
    29014
  • Event Risk Class
    Class 2
  • Event Number
    Z-0194-05
  • Event Initiated Date
    2004-04-28
  • Event Date Posted
    2004-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32978
  • 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
    Inadequate directions for use may have contributed to an increase in infection rates at a small number of customers beginning use of the clearlink needleless device.
  • Action
    An Urgent Device Correction letter and reply form dated 4/28/04 were sent to all U.S. Clearlink customers, informing them of the reports of increased infection rates abd describing the revision of the product labeling with additional statements that relate to product usage and reinforcement of standard clinical practices and proper aseptic technique. The revised labeling statements are as follows: * Ensure clamp is open. Swab Luer activated surface with preferred antiseptic prior to first use and before every subsequent connection. * Don not swab Luer activated surface when clamp is closed or valve is recessed. Ineffective swabbibg may result. Replace if valve remains recessed. * Flush Luer activated valve after blood infusion/sampling. If valve cannot be cleared of blood, replace immediately. * Luer lock vacutainer holders, syringes and accessories are recommended for blood sampling. If blood remains on valve surface after sampling, swab surface. * If intermittently disconnecting set from Luer activated valve, immediately cover male Luer with a sterile replacement protector.

Device

Baxter Clearlink System Luer Activated Universal VIal Adapter
  • Model / Serial
    product code 2N8395, all lots
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, and internationally through Baxter subsidiaries to Macedonia, Nigeria, Saudi Arabia, South Africa, Ireland, Italy, Denmark, Germany, the Netherlands, Hong Kong, Indonesia, Singapore, Spain, Belgium, Norway, United Kingdom, France and Luxembourg.
  • Product Description
    Baxter Clearlink System Luer Activated Universal VIal Adapter, product code 2N8395; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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