Events

Recall of DIALYZER PSN

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAXTER HEALTHCARE CORPORATION RENAL DIVISION.

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
    32628
  • Event Risk Class
    II
  • Event Initiated Date
    2001-04-25
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Received and confirmed an increasing number of reports of fiber blood leaks from a small number of customers.

Device

DIALYZER PSN
  • Model / Serial
    Model Catalog: 5M1818 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 5M1817 (Lot serial: ALL SERIAL NUMBERS)
  • Product Description
    PSN 170 DIALYZER AND PSN 210 DIALYZER
  • Manufacturer
    BAXTER HEALTHCARE CORPORATION RENAL DIVISION

Manufacturer

BAXTER HEALTHCARE CORPORATION RENAL DIVISION
  • Manufacturer Address
    MCGAW PARK
  • Source
    HC