Events

Recall of ORBIT 90 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
    105538
  • Event Risk Class
    I
  • Event Initiated Date
    2011-02-16
  • 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
    All lots of triad alcohol prep pads co-packaged and distributed with icu medical orbit 90 infusion sets and orbit micro infusion sets are being recalled because of concerns about potential contamination of the triad group's product with the bacteria bacillus cereus. the infusion sets are not contaminated and may continue to be used safely.

Device

ORBIT 90 SUBCUTANEOUS INFUSION SET
  • Model / Serial
    10 contact mfg"); Model Catalog: M4261 M4291 P1861 P1891 (Lot serial: ">10 contact mfg"); Model Catalog: P2461 P2491 P3061 P3091 (Lot serial: ">10 contact mfg"); Model Catalog: P4261 P4291 (Lot serial: ">10 contact mfg"); Model Catalog: P3051 P3081 P4251 P4281 (Lot serial: ">10 contact mfg"); Model Catalog: P1851 P1881 P2451 P2481 (Lot serial: ">10 contact mfg")" v-b-tooltip> Model Catalog: M1861 M2461 M2491 M3091 (Lot serial: ">10 contact mfg"); Model Catalog: M4261 M4291 P1861 P1891 (Lot serial: ">10 contact mfg"); Model Catalog: P2461 P2491 P3061 P3091 (Lot serial: ">10 contact mfg"); Model Catalog: P4261 P4291 (Lot serial: ">10 contact mfg"); Model Catalog: P3051 P3081 P4251 P4281 (Lot serial: ">10 contact mfg"); Model Catalog: P1851 P1881 P2451 P2481 (Lot serial: ">10 contact mfg")
  • Product Description
    ORBIT 90 SUBCUTANEOUS INFUSION SET
  • Manufacturer
    INSULINPUMPS.CA INC.

Manufacturer

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