Events

Recall of PULSE DOSE OXYGEN CONSERVING CYLINDER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SUNRISE MEDICAL 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
    83512
  • Event Risk Class
    II
  • Event Initiated Date
    2007-02-06
  • 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
    There is the possibility that the retaining ring that holds check valve components inside of the nipple assembly may not be fully locked in place. internal check valve may collapse.

Device

PULSE DOSE OXYGEN CONSERVING CYLINDER
  • Model / Serial
    Model Catalog: PD1000A-CAN-ML6 (Lot serial: 06cm6000100 to 06cm6111020); Model Catalog: PD1000A-CAN-M6 (Lot serial: 06cml111004 to 06cml111017); Model Catalog: PD1000A-CAN-ML6 (Lot serial: 06cml111004 to 06cml111017); Model Catalog: PD1000A-CAN-M6 (Lot serial: 06cm6000100 to 06cm6111020)
  • Product Description
    devilbiss pd1000a and 535d oxyg. cyl.
  • Manufacturer
    SUNRISE MEDICAL CANADA INC.

Manufacturer

SUNRISE MEDICAL CANADA INC.