Events

Recall of ADVANCED PERFUSION SYSTEM 1 - ROLLER PUMP

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
    53802
  • Event Risk Class
    II
  • Event Initiated Date
    2012-09-25
  • 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 single digital encoder cable assembly during inspection had a loose wire further investigation revealed a deviation in the height of a wire crimp could lead to a loose wire.

Device

ADVANCED PERFUSION SYSTEM 1 - ROLLER PUMP
  • Model / Serial
    Model Catalog: 816570 (Lot serial: #5950 TO #5953); Model Catalog: 816571 (Lot serial: #5950 TO #5953); Model Catalog: 816570 (Lot serial: #6621 TO #6640); Model Catalog: 816571 (Lot serial: #6621 TO #6640)
  • Product Description
    ADVANCED PERFUSION SYSTEM 1 4"SMALL ROLLER PUMP AND 6"LARGE ROLLER PUMP ENCODER CABLE
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.