Events

Recall of INFUSION PUMP O.R. SYRINGE

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
    120232
  • Event Risk Class
    III
  • Event Initiated Date
    2011-03-08
  • 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
    On january 11 2011 baxter corporation notified customers that energizer c-size alkaline batteries should not be used with the infus.O.R. pump (recall number 60650). the purpose of this new communication is to inform customers that: a second device the mini-infuser system uses the same size battery and incorporates the same battery contact interface and that other brands of c-size alkaline batteries may incorporate the same feature that inhibits electrical contact.

Device

INFUSION PUMP O.R. SYRINGE
  • Model / Serial
    Model Catalog: 6461500 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2L3100 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 6465300R (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8171 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 6465300 (Lot serial: >1000 NUMBERS CONTACT MFR)
  • Product Description
    INFUSO.R. PUMP
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION