Events

Recall of ANIMAS 2020 INSULIN INFUSION PUMP (VARIOUS COLOURS)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON INC..

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
    28018
  • Event Risk Class
    I
  • Event Initiated Date
    2010-03-23
  • 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 2020 and onetouch ping insulin pumps that have sustained 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

ANIMAS 2020 INSULIN INFUSION PUMP (VARIOUS COLOURS)
  • Model / Serial
    Model Catalog: 200-260-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 100-385-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-262-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-263-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-264-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-265-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-371-00 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-370-00 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-372-00 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-374-00 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-375-00 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 100-380-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 100-381-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 100-382-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 100-384-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Mod
  • Product Classification
    General Hospital and Personal Use Devices
  • Product Description
    Animas 2020 Insulin Pump
  • Manufacturer
    LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON INC.

Manufacturer

LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON INC.