Events

Recall of COMBI SET - HEMODIALYSIS BLOOD TUBING SET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by FRESENIUS MEDICAL CARE 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
    44394
  • Event Risk Class
    I
  • Event Initiated Date
    2010-11-20
  • 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
    An increase in the number of complaints of kinking for combiset blood volume monitor bloodlines (product codes: 03-2695-9 and 03-2795-7) had been noted beginning in the last weeks of october. further investigation into the root cause and completion of a health hazard assessment has led to the decision to issue a recall for the lots.

Device

COMBI SET - HEMODIALYSIS BLOOD TUBING SET
  • Model / Serial
    Model Catalog: 03-2795-7 (Lot serial: MORE THAN 10 LOT NUMBERS); Model Catalog: 03-2695-9 (Lot serial: MORE THAN 10 LOT NUMBERS)
  • Product Description
    Combiset Blood Volume Monitor Bloodline
  • Manufacturer
    FRESENIUS MEDICAL CARE CANADA INC.

Manufacturer

FRESENIUS MEDICAL CARE CANADA INC.