Events

Recall of CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GAMBRO RENAL PRODUCTS - MANUFACTURING OPERATIONS 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
    81471
  • Event Risk Class
    II
  • Event Initiated Date
    1999-08-24
  • 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
    The dialyser alarm does not sound when the maximum arterial pressure alarm limit is challenged.

Device

CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT
  • Model / Serial
    Model Catalog: (Lot serial: Lot numbers with prefix 11C); Model Catalog: (Lot serial: 05D 06D.); Model Catalog: (Lot serial: 12C 01D 02D 03D 04D)
  • Product Description
    Centrysystem 3 Dialysis Control Unit
  • Manufacturer
    GAMBRO RENAL PRODUCTS - MANUFACTURING OPERATIONS DIVISION

Manufacturer

GAMBRO RENAL PRODUCTS - MANUFACTURING OPERATIONS DIVISION
  • Manufacturer Address
    LAKEWOOD
  • Source
    HC