Events

Recall of ROOMER S

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HUMAN 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
    45051
  • Event Risk Class
    III
  • Event Initiated Date
    2015-11-05
  • 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
    Two identified problems that human care has decided to address. the first problem is related to a fixation screw on the telescopic hanger bar used on recalled device. this screw is located inside the unit hence not visible from the outside. a minor number of units have been detected where the level of loctite applied to the screw during manufacturing has been insufficient. this can cause the telescopic hanger bar to lose from its position and in a worst case fall out of its position. the second problem is related to the swivel hooks on the telescopic hanger bar. it has come to human cares attention that if the telescopic hanger bar is incorrectly used namely the swivel hooks on the hanger bar is faulty positioned before a patient transfer this can cause the sling out of its position which can result in a hazard to the user. it is important that the user manual is followed and that the hanger bar and its hooks are adjusted and positioned correctly prior to any patient transfer.

Device

ROOMER S
  • Model / Serial
    Model Catalog: 55300-XX (Lot serial: 32578510009); Model Catalog: 55300-XX (Lot serial: 32578510006); Model Catalog: 55220-XX (Lot serial: >10 lot numbers contact mfg); Model Catalog: 55210-XX (Lot serial: >10 lot numbers contact mfg); Model Catalog: 55200-XX (Lot serial: >10 lot numbers contact mfg)
  • Product Description
    ROOMER S
  • Manufacturer
    HUMAN CARE CANADA INC.

Manufacturer

HUMAN CARE CANADA INC.