Events

Recall of Baxter System 1000 Tina Hemodialysis Instrument

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Healthcare Renal Div.

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
    60183
  • Event Risk Class
    Class 2
  • Event Number
    Z-0173-2012
  • Event Initiated Date
    2011-09-19
  • Event Date Posted
    2011-11-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104698
  • 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
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • Reason
    The tina system was released to the customer with oos values for the pressure displays accuracy and leakage rate test.
  • Action
    Baxter Healthcare Corporation sent a service technician to the lone customer site on September 19, 2011 to correct the affected product. The technician executed all tests as established in the Service Manual, with acceptable results.

Device

Baxter System 1000 Tina Hemodialysis Instrument
  • Model / Serial
    product code S1000L3P, Serial Number 28130
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in Puerto Rico only.
  • Product Description
    Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085; product code S1000L3P. || Hemodialysis and Continuous Renal Replacement Therapy devices for acute and chronic hemodialysis
  • Manufacturer
    Baxter Healthcare Renal Div

Manufacturer

Baxter Healthcare Renal Div
  • Manufacturer Address
    Baxter Healthcare Renal Div, 1620 Waukegan Rd, Mc Gaw Park IL 60085-6730
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA