Events

Recall of AERIAL CUSHION

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by OTTO BOCK HEALTHCARE CANADA 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
    88311
  • Event Risk Class
    III
  • Event Initiated Date
    2014-02-13
  • 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
    Recent routine internal fire testing to test flammability after multiple washings of the device (n=5) of the whole cushion (cover and foam) in water after 40 degrees celsius revealed a potential risk of flammability from the product (the "testing failure"). this testing failure contradicts the information contained in the company's instructions for use wherein it states: "hand wash all foam breathair components in warm water at 40 degrees celsius using a standard mild detergent. dno not use fabric softner. rinswe well.".

Device

AERIAL CUSHION
  • Model / Serial
    Model Catalog: 476C00=SK705 (Lot serial: >100 numbers contact mfg); Model Catalog: 476C00=SK702 (Lot serial: >100 numbers contact mfg); Model Catalog: 476C00=SK707 (Lot serial: >100 numbers contact mfg); Model Catalog: 476C00=SK706 (Lot serial: >100 numbers contact mfg); Model Catalog: 476C00=SK701 (Lot serial: >100 numbers contact mfg); Model Catalog: 476C00=SK704 (Lot serial: >100 numbers contact mfg); Model Catalog: 476C00=SK703 (Lot serial: >100 numbers contact mfg)
  • Product Description
    Aerial Cushion
  • Manufacturer
    OTTO BOCK HEALTHCARE CANADA LTD.

Manufacturer

OTTO BOCK HEALTHCARE CANADA LTD.