Events

Recall of Device Recall Clearlink

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
    26772
  • Event Risk Class
    Class 2
  • Event Number
    Z-1157-03
  • Event Initiated Date
    2003-07-16
  • Event Date Posted
    2003-08-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28404
  • 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
    There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
  • Action
    Recalled by letter dated 7/16/03. The accounts were informed of the potential for leaks in the set tubing, and asked to inspect their inventory for the affected product codes and lots, segregate any affected products found and discard them according to local procedures. The customers will receive credit for the discarded affected product.

Device

Device Recall Clearlink
  • Model / Serial
    catalog 2C8851, lot numbers UR141788 through UR167684. Please note: Baxter lot numbers are represented by an internal reference code ''UR'' followed by a six digit sequential number, or by the letter ''U'' followed by a six digit sequential number with and ''R'' suffix. Any lot number appearing within the identified six digit sequential number range is subject to the recall.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Mexico, Canada, Columbia, Australia, New Zealand and Taiwan
  • Product Description
    Clearlink System Nitroglycerin Set with DUO-VENT Spike, 60 drops/mL, 105'', PVC Tubing Segment, Luer Activated Valve, Male Luer Lock Adapter, catalog 2C8851; 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