Events

Recall of Baxter Colied Tube INFUSOR System cs

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Baxter Healthcare 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
    16553
  • Event Initiated Date
    2014-04-17
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Baxter Healthcare Ltd, 33 Vestey Drive, Mt Wellington, AUCKLAND
  • Reason
    Manufacturer has received complaints for infusion flow rates greater than intended for the listed portable elastomeric infusion systems. manufacturer is requesting that healtrhcare providers consider the instructions for use which explain facts that may impact resulting flow rate., point #5 of the instructions for use is incorrect and manufactrer will be making a change to this to reflect this information.
  • Action
    Instructions for use to be updated

Device

Baxter Colied Tube INFUSOR System cs
  • Model / Serial
    Model: 2C1071KJP 1C1071KJ 1C1073KJP 2C1075KJP 2C1080KJP 2C1082KJP and 2C1082KJ, Affected:
  • Manufacturer
    Baxter Healthcare Corporation

Manufacturer

Baxter Healthcare Corporation