Events

Recall of ACCU-CHEK ULTRAFLEX II

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ROCHE INSULIN DELVERY SYSTEMS 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
    26270
  • Event Risk Class
    I
  • Event Initiated Date
    2006-04-07
  • 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
    Increase in number of confirmed complaints assigned with luer lock-tube full or partial separations since early 2005. failure starts with partial separation of outer tube at connection to female luer-lock.

Device

ACCU-CHEK ULTRAFLEX II
  • Model / Serial
    Model Catalog: INF 04540972001 (Lot serial: >10 contact manufacturer); Model Catalog: INF 04540964001 (Lot serial: >10 contact manufacturer); Model Catalog: INF 04540921001 (Lot serial: >10 contact manufacturer); Model Catalog: INF 04540948001 (Lot serial: >10 contact manufacturer); Model Catalog: INF 04540930001 (Lot serial: >10 contact manufacturer); Model Catalog: INF 04540956001 (Lot serial: >10 contact manufacturer); Model Catalog: 04540808001 (Lot serial: >10 contact manufacturer); Model Catalog: INF 04540905001 (Lot serial: >10 contact manufacturer); Model Catalog: INF 04540883001 (Lot serial: >10 contact manufacturer); Model Catalog: INF 04540867001 (Lot serial: >10 contact manufacturer); Model Catalog: INF 04540824001 (Lot serial: >10 contact manufacturer); Model Catalog: INF04540786001 (Lot serial: >10 contact manufacturer)
  • Product Classification
    General Hospital and Personal Use Devices
  • Product Description
    ACCU-CHEK ULTRAFLEX II
  • Manufacturer
    ROCHE INSULIN DELVERY SYSTEMS INC.

Manufacturer

ROCHE INSULIN DELVERY SYSTEMS INC.
  • Manufacturer Address
    FISHERS
  • Source
    HC