Events

Recall of SYSTEM 1000 DIALYSATE DELIVERY SYSTEM (TINA)

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

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
    97308
  • Event Risk Class
    III
  • Event Initiated Date
    2009-04-09
  • 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
    An arena instrument set to deliver 50 ml/min. may deliver betw'n 40 & 60 ml/min. contrary to operator and service manuals. sys1000 manuals do not specify blood flow accuracy as required by iec standard.

Device

SYSTEM 1000 DIALYSATE DELIVERY SYSTEM (TINA)
  • Model / Serial
    Model Catalog: SYS1000-L3PA (Lot serial: ALL LOTS); Model Catalog: SYS1000-L3DPHA (Lot serial: ALL LOTS); Model Catalog: SYS1000-L3PHA (Lot serial: ALL LOTS); Model Catalog: SYS1000-L3P (Lot serial: ALL LOTS); Model Catalog: SYS1000-L3PH (Lot serial: ALL LOTS); Model Catalog: SYS1000-L3PHDP (Lot serial: ALL LOTS); Model Catalog: ARENASPX-HR (Lot serial: ALL LOTS); Model Catalog: ARENASPX-BDH (Lot serial: ALL LOTS); Model Catalog: ARENASPP-H (Lot serial: ALL LOTS); Model Catalog: ARENASPP-DH (Lot serial: ALL LOTS)
  • Product Description
    SYSTEM 1000 DIALYSATE DELIVERY SYSTEM
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION