Events

Recall of BAXTER 1550 HEMODIALYSIS MACHINE AND ACCESSORIES

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
    25485
  • Event Risk Class
    III
  • Event Initiated Date
    2010-05-11
  • 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
    Baxter has identified that subsequent to a prior device field correction in 2003-2004 some model 1550 hemodialysis instruments may have replacement circuit boards with incorrect versions of software. the correct versions of software are 4.1b (for system 4 instruments) and 3.0a (for system 3 instruments). a small number of replacement boards may also be affected.

Device

BAXTER 1550 HEMODIALYSIS MACHINE AND ACCESSORIES
  • Model / Serial
    Model Catalog: 6001238218 (Lot serial: 101260-01); Model Catalog: 6001238149 (Lot serial: 101260-01); Model Catalog: 5M5538 (Lot serial: 61338); Model Catalog: 6001238147 (Lot serial: 61338); Model Catalog: 6001238148 (Lot serial: 101260-01); Model Catalog: 6001238147 (Lot serial: 101260-01); Model Catalog: 5M5538 (Lot serial: 101260-01); Model Catalog: 6001238218 (Lot serial: 101256-10); Model Catalog: 6001238149 (Lot serial: 101256-10); Model Catalog: 6001238148 (Lot serial: 101256-10); Model Catalog: 6001238147 (Lot serial: 101256-10); Model Catalog: 5M5538 (Lot serial: 101256-10); Model Catalog: 6001238218 (Lot serial: 64840); Model Catalog: 6001238149 (Lot serial: 64840); Model Catalog: 6001238148 (Lot serial: 64840); Model Catalog: 6001238147 (Lot serial: 64840); Model Catalog: 5M5538 (Lot serial: 64840); Model Catalog: 6001238218 (Lot serial: 63560); Model Catalog: 6001238149 (Lot serial: 63560); Model Catalog: 6001238148 (Lot serial: 63560); Model Catalog: 6001238147 (Lot serial: 63560); Model Catalo
  • Product Description
    BAXTER 1550 HEMODIALYSIS INSTRUMENTS
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION