Events

Recall of ORBIT MICRO SUBCUTANEOUS INFUSION SET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INSULINPUMPS.CA 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
    39245
  • Event Risk Class
    II
  • Event Initiated Date
    2011-04-18
  • 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
    Icu reported that certain lots of orbit 90 and orbit micro infusion sets may incur damage due to movement during shipping resulting in bent needles. the damage is easily detectible within the unopened sterile tray. if the needle cover is not attached to the needle and/or the needle is bent the device is damaged and should not be used.

Device

ORBIT MICRO SUBCUTANEOUS INFUSION SET
  • Model / Serial
    Model Catalog: P2451 (Lot serial: >10 Lot Numbers.); Model Catalog: P4251 (Lot serial: >10 Lot Numbers.); Model Catalog: P3051 (Lot serial: >10 Lot Numbers.); Model Catalog: P4291 (Lot serial: Contact manufacturer.); Model Catalog: P4261 (Lot serial: Contact manufacturer.); Model Catalog: P3091 (Lot serial: Contact manufacturer.); Model Catalog: P3061 (Lot serial: Contact manufacturer.); Model Catalog: P2491 (Lot serial: Contact manufacturer.); Model Catalog: P2461 (Lot serial: Contact manufacturer.); Model Catalog: P1891 (Lot serial: Contact manufacturer.); Model Catalog: P1861 (Lot serial: Contact manufacturer.); Model Catalog: M4291 (Lot serial: Contact manufacturer.); Model Catalog: M4261 (Lot serial: Contact manufacturer.); Model Catalog: M3091 (Lot serial: Contact manufacturer.); Model Catalog: M2491 (Lot serial: Contact manufacturer.); Model Catalog: M2461 (Lot serial: Contact manufacturer.); Model Catalog: M1861 (Lot serial: Contact manufacturer.); Model Catalog: P4291 (Lot serial: >10 lot numbers.);
  • Product Description
    ORBIT MICRO SUBCUTANEOUS INFUSION SET
  • Manufacturer
    INSULINPUMPS.CA INC.

Manufacturer

INSULINPUMPS.CA INC.
  • Manufacturer Address
    OAKVILLE
  • Source
    HC