Events

Recall of INFINITY ORANGE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MAQUET-DYNAMED 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
    28224
  • Event Risk Class
    II
  • Event Initiated Date
    2012-12-13
  • 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
    A certain diode on the pcb assembly that may result in insufficient voltage to a portion of the pump. if this condition occurs the pump will display "er13" and immediately sound an alarm or the pump will shut down entirely. if the er13 error occurs after initiation of the pump operation there is a small potential for a delay in therapy. although unlikely a delay in therapy could result in a patient not receiving prescribed nutrition and may pose a potential for dehydration or hypoglycemic episode. no illnesses or injuries have been reported as of the date of this notification.

Device

INFINITY ORANGE
  • Model / Serial
    Model Catalog: INFORNG (Lot serial: > 10 numbers contact mfg); Model Catalog: INFKIT2 (Lot serial: >100 numbers contact mfg)
  • Product Description
    INFINITY ORANGE SMALL VOLUME ENTERAL FEEDING PUMP
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC