Events

Recall of BROSELOW/HINKLE PEDIATRIC EMERGENCY SYSTEM KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TRUDELL MEDICAL MARKETING LIMITED.

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
    141691
  • Event Risk Class
    II
  • Event Initiated Date
    2009-07-16
  • 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
    The broselow/hinkle intraosseus module which is part of the broselow/hinkle pediatric emergency system contains a 15g intraosseus needle that is not compatible with the iv extension set that is provided in the module. this may result in a leak at the connection and delay treatment.

Device

BROSELOW/HINKLE PEDIATRIC EMERGENCY SYSTEM KIT
  • Model / Serial
    Model Catalog: 7730PUR5 (Lot serial: 001K to 149K inclusive); Model Catalog: 7730RED5 (Lot serial: 001K to 149K inclusive); Model Catalog: 7730ORG5 (Lot serial: 001K to 149K inclusive); Model Catalog: 7730MOD (Lot serial: 001K to 149K inclusive); Model Catalog: 7730IALS (Lot serial: 001K to 149K inclusive); Model Catalog: 7730GRN5 (Lot serial: 001K to 149K inclusive); Model Catalog: 7730BLU5 (Lot serial: 001K to 149K inclusive); Model Catalog: 7730ALS (Lot serial: 001K to 149K inclusive); Model Catalog: 7730YEL5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730WHI5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730RED5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730PUR5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730ORG5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730MOD (Lot serial: 245F to 366F inclusive); Model Catalog: 7730IALS (Lot serial: 245F to 366F inclusive); Model Catalog: 7730GRN5 (Lot serial: 245F to 366F inclusive); Model Catalog: 7730BLU5 (Lot seria
  • Product Description
    BROSELOW/HINKLE PEDIATRIC SYSTEM KIT
  • Manufacturer
    TRUDELL MEDICAL MARKETING LIMITED

Manufacturer

TRUDELL MEDICAL MARKETING LIMITED