Events

Recall of ACCU-CHEK SPIRIT INSULIN PUMP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ROCHE DIABETES CARE AG.

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
    97024
  • Event Risk Class
    II
  • Event Initiated Date
    2009-04-17
  • 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
    The insulin pump (numbers sn02053575 - sn10006093) may fail. this failure may present an intermittent or complete loss of function of the up and/or down buttons and in turn affect the desired pump operation.

Device

ACCU-CHEK SPIRIT INSULIN PUMP
  • Model / Serial
    Model Catalog: 04759729001 (Lot serial: SN02053575 TO SN10006093); Model Catalog: 04540492001 (Lot serial: SN02053575 TO SN10006093); Model Catalog: 04759702001 (Lot serial: SN02053575 TO SN10006093)
  • Product Description
    ACCU-CHEK SPIRIT INSULIN PUMP
  • Manufacturer
    ROCHE DIABETES CARE AG

Manufacturer

ROCHE DIABETES CARE AG
  • Manufacturer Address
    BURGDORF
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    HC