Events

Recall of BROSELOW/HINKLE PEDIATRIC EMERGENCY SYSTEM OXYGEN DELIVERY MODULE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARDINAL HEALTH 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
    128489
  • Event Risk Class
    II
  • Event Initiated Date
    2011-08-24
  • 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 potential sticky substance inside and/or outside of the mask. the sticky masks could result in inconvenience and in some cases there is a remote possibility of potential harm to the patient.

Device

BROSELOW/HINKLE PEDIATRIC EMERGENCY SYSTEM OXYGEN DELIVERY MODULE
  • Model / Serial
    Model Catalog: 7700GAW2 (Lot serial: LOT 2389 - 3659); Model Catalog: 7700OAW2 (Lot serial: LOT 2389 - 3659); Model Catalog: 7700PAW2 (Lot serial: LOT 2389 - 3659); Model Catalog: 7700RAW2 (Lot serial: LOT 2389 - 3659); Model Catalog: 7700WAW2 (Lot serial: LOT 2389 - 3659); Model Catalog: 7700YAW2 (Lot serial: LOT 2389 - 3659); Model Catalog: 7700BAW2 (Lot serial: LOT 0010 - 2530); Model Catalog: 7700BAW2 (Lot serial: LOT 2389 - 3659); Model Catalog: 7700YAW2 (Lot serial: LOT 0010 - 2530); Model Catalog: 7700WAW2 (Lot serial: LOT 0010 - 2530); Model Catalog: 7700RAW2 (Lot serial: LOT 0010 - 2530); Model Catalog: 7700PAW2 (Lot serial: LOT 0010 - 2530); Model Catalog: 7700OAW2 (Lot serial: LOT 0010 - 2530); Model Catalog: 7700GAW2 (Lot serial: LOT 0010 - 2530); Model Catalog: BP4530BR (Lot serial: LOT 0010 - 2530); Model Catalog: 7730FLY (Lot serial: LOT 2389 - 3659); Model Catalog: BP4530BR (Lot serial: LOT 2389 - 3659); Model Catalog: BP4030BR (Lot serial: LOT 2389 - 3659); Model Catalog: 7730POCH (Lot seria
  • Product Description
    Broselow Pediatric Emergency System Kit
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    HC