Events

Recall of REMSTAR PLUS CPAP SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDIGAS DIVISION OF PRAXAIR 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
    16865
  • Event Risk Class
    II
  • Event Initiated Date
    2008-05-08
  • 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
    There is a possibility that some packaged accessories (cushions and filters) may contain glass pieces originating from one plastic bag supplier.

Device

REMSTAR PLUS CPAP SYSTEM
  • Model / Serial
    Model Catalog: (Lot serial: >10 numbers contact mfg); Model Catalog: CA501S (Lot serial: >10 numbers contact mfg); Model Catalog: IN501S (Lot serial: Serial number M001564379); Model Catalog: CA501S (Lot serial: Serial number M001564379); Model Catalog: IN501S (Lot serial: >10 numbers contact mfg); Model Catalog: 652002 (Lot serial: >10 numbers contact mfg); Model Catalog: 1005792 (Lot serial: >10 numbers contact mfg); Model Catalog: 1009586 (Lot serial: >10 numbers contact mfg); Model Catalog: 4003 (Lot serial: >10 numbers contact mfg); Model Catalog: FC06566 (Lot serial: >10 numbers contact mfg); Model Catalog: CA1017454 (Lot serial: >10 numbers contact mfg); Model Catalog: 1002816 (Lot serial: >10 numbers contact mfg); Model Catalog: CA511HS (Lot serial: >10 numbers contact mfg); Model Catalog: 1017226 (Lot serial: >10 numbers contact mfg); Model Catalog: 1010771 (Lot serial: >10 numbers contact mfg); Model Catalog: 1012823 (Lot serial: >10 numbers contact mfg); Model Catalog: CA701HS (Lot serial: >10 nu
  • Product Description
    REMSTAR PLUS CPAP SYSTEM
  • Manufacturer
    MEDIGAS DIVISION OF PRAXAIR CANADA INC.

Manufacturer

MEDIGAS DIVISION OF PRAXAIR CANADA INC.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Praxair, Inc.
  • Source
    HC