Events

Recall of MONITOR WITH ONE BLOOD PARAMETER MODULE AND ONE HCT/SAT PROBE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RYAN MEDICAL DISTRIBUTORS 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
    17028
  • Event Risk Class
    III
  • Event Initiated Date
    2013-06-06
  • 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
    In a recent review of in-house service procedures for the cdit 500 blood parameter monitoring system terumo cardiovascular systems (terumo cvs) determined that replacement of the sbc batteries (system batteries*) should be considered "routine maintenance:".

Device

MONITOR WITH ONE BLOOD PARAMETER MODULE AND ONE HCT/SAT PROBE
  • Model / Serial
    Model Catalog: 500A HCT (Lot serial: 3622); Model Catalog: 500A HCT (Lot serial: 3620); Model Catalog: 500A HCT (Lot serial: 3587); Model Catalog: 500A HCT (Lot serial: 3537); Model Catalog: 500A HCT (Lot serial: 3536); Model Catalog: 500A HCT (Lot serial: 3524); Model Catalog: 500A HCT (Lot serial: 3283); Model Catalog: 500A HCT (Lot serial: 3282); Model Catalog: 500A HCT (Lot serial: 3281); Model Catalog: 500A HCT (Lot serial: 3280); Model Catalog: 500A HCT (Lot serial: 3279); Model Catalog: 500A HCT (Lot serial: 3278); Model Catalog: 500A HCT (Lot serial: 3277); Model Catalog: 500A HCT (Lot serial: 3276); Model Catalog: 500A HCT (Lot serial: 3275); Model Catalog: 500A HCT (Lot serial: 3274); Model Catalog: 500A HCT (Lot serial: 3121); Model Catalog: 500A HCT (Lot serial: 3120); Model Catalog: 500A HCT (Lot serial: 3119); Model Catalog: 500A HCT (Lot serial: 3118); Model Catalog: 500A HCT (Lot serial: 3117); Model Catalog: 500A HCT (Lot serial: 3044); Model Catalog: 500A HCT (Lot serial: 3043); Model Catal
  • Product Description
    MONITOR 500 AHCT
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.