Events

Recall of Device Recall Baxter Interlink System

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
    25247
  • Event Risk Class
    Class 2
  • Event Number
    Z-0453-03
  • Event Initiated Date
    2002-12-18
  • Event Date Posted
    2003-01-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25456
  • 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, Transfer (Blood/Plasma) - Product Code KSB
  • Reason
    Leakage may occur at the inlet port.
  • Action
    The affected product codes and lot numbers were recalled by letter dated 12/18/02. The customers were informed of the potential leakage at the inlet port, and were requested to inspect their inventory for the affected products and destroy those found. The accounts were requested to complete the enclosed reply form and certificate of destruction and return them to Baxter for credit issuance.

Device

Device Recall Baxter Interlink System
  • Model / Serial
    Lots GR182865, GR184309, GR186569
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Interlink Y-Type Blood/Solution Set with Standard Bore 4-way Stopcock Extension Set, catalog #3C0116; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, Injection Site, Male Luer Lock Adapter, 97'' long, 10 drops per mL plus Standard Bore 4-way Stopcock Extension Set, 35'' long, 5.2 mL volume, Male Luer Lock Adapter; Baxter Healthcare Corporation, Deerfield, IL 60015
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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