Events

Recall of SLEEP SAFE PAED

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
    20426
  • Event Risk Class
    II
  • Event Initiated Date
    2016-12-06
  • 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
    An increased number of leakages were reported due to over welded coils on the patient and drainage lines. this led to difficulties in unrolling the tubing set causing damage to the lines and possibility of leakage.

Device

SLEEP SAFE PAED
  • Model / Serial
    Model Catalog: 5017391 (Lot serial: >10 contact mfr); Model Catalog: 5016921 (Lot serial: >10 contact mfr); Model Catalog: 5016931 (Lot serial: >10 contact mfr)
  • Product Description
    SLEEP SAFE PAED;sleep safe set;SLEEP SAFE SET PLUS
  • Manufacturer
    FRESENIUS MEDICAL CARE CANADA INC.

Manufacturer

FRESENIUS MEDICAL CARE CANADA INC.