Events

Recall of Device Recall Baxter Interlink System Buretrol Solution Set with Large Bore 4Way Stopcock with Rotating Male Luer

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
    34290
  • Event Risk Class
    Class 2
  • Event Number
    Z-0656-06
  • Event Initiated Date
    2005-12-15
  • Event Date Posted
    2006-03-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-08-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43484
  • 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
    The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
  • Action
    Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include additional lots and product codes via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.

Device

Device Recall Baxter Interlink System Buretrol Solution Set with Large Bore 4Way Stopcock with R...
  • Model / Serial
    product code 3C0172, lot GR230631
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including Puerto Rico and American Samoa, and internationally to Canada, Australia, Japan, South Korea, Saudi Arabia, India, Mexico, Venezuela, Malaysia, East Timor and New Zealand.
  • Product Description
    Baxter Interlink System Buretrol Solution Set with Large Bore 4-Way Stopcock with Rotating Male Luer Lock Extension Set and Extension Set, product code 3C0172; An Rx sterile, nonpyrogenic fluid pathway; solution set: 84'', 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 3 injection sites and male Luer Lock adapter, stopcock extension set: 21'', 3.2 mL Vol with 2 injection sites and male luer adapter, and minivolume extension set: 6'', 0.5 mL Vol with microvolume tubing and retractable T-connector; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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