Events

Recall of BATHMASTER 2000

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HOMECRAFT ROLYAN LTD.

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
    136704
  • Event Risk Class
    II
  • Event Initiated Date
    2007-10-05
  • 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
    Hand controls manufactured before 06/2002 did not have vents. if the battery is damaged gases can build and split the case. some redesigned controls (assembled 06/2002-10/2003) had labels placed over the vents.

Device

BATHMASTER 2000
  • Model / Serial
    Model Catalog: AA1353 (Lot serial: ALL MANUFACTURED PRE-2003/10); Model Catalog: AA1353T (Lot serial: ALL MANUFACTURED PRE-2003/10); Model Catalog: AA1231U (Lot serial: ALL MANUFACTURED PRE-2003/10); Model Catalog: AA1336 (Lot serial: ALL MANUFACTURED PRE-2003/10); Model Catalog: AA1336L (Lot serial: ALL MANUFACTURED PRE-2003/10); Model Catalog: AA1320 (Lot serial: ALL MANUFACTURED PRE-2003/10); Model Catalog: AA1390U (Lot serial: ALL MANUFACTURED PRE-2003/10); Model Catalog: AA1380 (Lot serial: ALL MANUFACTURED PRE-2003/10)
  • Product Description
    BATHMASTER 2000
  • Manufacturer
    HOMECRAFT ROLYAN LTD

Manufacturer

HOMECRAFT ROLYAN LTD
  • Manufacturer Address
    SUTTON
  • Source
    HC