Events

Recall of Device Recall Baxter Vented Paclitaxel 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
    37362
  • Event Risk Class
    Class 2
  • Event Number
    Z-0620-2007
  • Event Initiated Date
    2007-02-16
  • Event Date Posted
    2007-03-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50530
  • 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
    IV - Product Code FPA
  • Reason
    Baxter has received reports of disconnections/leaks during use of vented paclitaxel administration sets.
  • Action
    Baxter sent the 2/16/07 Urgent Product Recall letter to affected customers, to the attention of the Director of Nursing with copies to the Materials Manager, via first class mail to advise them of the potential disconnections/leaks during use of the Vented Paclitaxel Administration Sets. The accounts were instructed to immediately discontinue use and segregate the listed affected lot numbers, and contact Baxter Center for Service at 1-888-229-0001 to arrange for the return and credit for the affected product. Any questions were directed to the Center for One Baxter at 1-800-422-9837.

Device

Device Recall Baxter Vented Paclitaxel Set
  • Model / Serial
    product code 2C7553, lots R06E13105, R06E17114, R06E25042, R06F15058, R06G11030, R06I13107, R06K03071
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including Switzerland, Australia, Canada, Hong Kong, India, Korea, Mexico, Malaysia, New Zealand, Panama, Phillipines, Singapore, Thailand and Taiwan.
  • Product Description
    Baxter Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP pump segment, 0.22 micron downstream high pressure filter, injection site, male Luer lock adapter; for use with rigid nonvented solution containers on Colleague and Flo-Gard 6201 and 6301 series pumps; Baxter Healthcare, Deerfield, IL 60015; product code 2C7553
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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