Events

Recall of SARN'S CARDIOPLEGIA SET

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
    107700
  • Event Risk Class
    II
  • Event Initiated Date
    2011-03-30
  • 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
    Slow leak at the luer connection to the cardioplegia table line in various myocardial protection sets. air entrainment has been observed in the table line in each case of air entrainment the leaking connector had been exposed to negative pressure such as would occur when using an aortic vent in conjunction with the myocardial protection set.

Device

SARN'S CARDIOPLEGIA SET
  • Model / Serial
    Model Catalog: 16130 (Lot serial: ME12); Model Catalog: 16130 (Lot serial: MK02)
  • Product Description
    Cardioplegia set
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.