Events

Recall of IR 1200 INSULIN INFUSION PUMP (VARIOUS COLOURS)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ANIMAS 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
    22779
  • Event Risk Class
    I
  • Event Initiated Date
    2010-04-01
  • 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
    Animas ir 1200 insulin pumps that have sustained an external impact may have damaged the force sensor which can cause the whole cartridge of insulin to be dispensed during the "load cartridge" step of the priming sequence. failure to follow safety instructions and disconnect the infusion set from the body during the "rewind load and prime" steps can lead to unintended delivery of insulin.

Device

IR 1200 INSULIN INFUSION PUMP (VARIOUS COLOURS)
  • Model / Serial
    Model Catalog: 200-150-51 (Lot serial: >10 numbers contact mfg); Model Catalog: IR 1200 (Lot serial: >10 numbers contact mfg); Model Catalog: 200-152-51 (Lot serial: >10 numbers contact mfg); Model Catalog: 200-151-51 (Lot serial: >10 numbers contact mfg); Model Catalog: 100-200-51 (Lot serial: >10 numbers contact mfg); Model Catalog: 100-292-51 (Lot serial: >10 numbers contact mfg); Model Catalog: 100-291-51 (Lot serial: >10 numbers contact mfg); Model Catalog: 100-290-51 (Lot serial: >10 numbers contact mfg); Model Catalog: 100-202-51 (Lot serial: >10 numbers contact mfg)
  • Product Classification
    General Hospital and Personal Use Devices
  • Product Description
    Animas IR 1200 Insulin Pump
  • Manufacturer
    ANIMAS CORPORATION

Manufacturer

ANIMAS CORPORATION
  • Manufacturer Address
    WEST CHESTER
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    HC