Events

Recall of ANIMAS 2020 INSULIN INFUSION PUMP (WARRANTY REPLACEMENT 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
    32641
  • Event Risk Class
    II
  • Event Initiated Date
    2012-12-11
  • 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
    A small number of animas 2020 insulin infusion pumps are potentially affected by a misalignment of a component on the printed circuit board assembly. this component misalignment results in the insulin pump potentially measuring force conditions incorrectly resulting in false warnings and/or alarms. should the patient complete a load sequence or prime the insulin infusion pump and does not disconnect from the infusion set from the body the insulin infusion pump may dispense all of the insulin in the cartridge into the patient. there is no safety risk as long as the patient follows the instructions for use and always disconnects the infusion set prior to priming the pump changing the cartridge and rewinding the motor.

Device

ANIMAS 2020 INSULIN INFUSION PUMP (WARRANTY REPLACEMENT VARIOUS COLOURS)
  • Model / Serial
    Model Catalog: 100-384-51 (Lot serial: > 100 numbers contact mfg); Model Catalog: 100-385-51 (Lot serial: > 100 numbers contact mfg); Model Catalog: 100-380-51 (Lot serial: > 100 numbers contact mfg); Model Catalog: 100-381-51 (Lot serial: > 100 numbers contact mfg); Model Catalog: 100-382-51 (Lot serial: > 100 numbers contact mfg)
  • Product Description
    Animas 2020 Insulin Infusion Pump
  • Manufacturer
    ANIMAS CORPORATION

Manufacturer

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