Events

Recall of COOK ASPIRATION UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by COOK (CANADA) 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
    61636
  • Event Risk Class
    II
  • Event Initiated Date
    2018-03-02
  • 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 internal mains wiring does not fully comply with the requirements of the medical electrical equipment standard iec60601-1 edition 3.0. iec60601-1 states that conductors and connectors of medical electrical equipment shall be secured or insulated so that accidental detachment shall not result in a hazardous situation. the k-mar-5200 mains wiring is secured but the mechanism is not considered suitable under the current version of iec60601-1.

Device

COOK ASPIRATION UNIT
  • Model / Serial
    Model Catalog: K-MAR-5200-US (Lot serial: >10 SEE MFR); Model Catalog: K-MAR-5200 (Lot serial: >10 SEE MFR)
  • Product Description
    COOK ASPIRATION UNIT;VACUUM PUMP
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.